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Research governance and the dynamics of science: A framework for the study of governance effects on research fields

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Maria Nedeva, Mayra M Tirado, Duncan A Thomas, Research governance and the dynamics of science: A framework for the study of governance effects on research fields, Research Evaluation , Volume 32, Issue 1, January 2023, Pages 116–127, https://doi.org/10.1093/reseval/rvac028

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This article offers a framework for the study of research governance effects on scientific fields framed by notions of research quality and the epistemic, organizational, and career choices they entail. The framework interprets the contested idea of ‘quality’ as an interplay involving notion origins, quality attributes, and contextual sites. We mobilize the origin and site components, to frame organizational-level events where quality notions inform selections, or selection events . Through the dynamic interplay between notions selected at specific sites , we contend, local actors enact research quality cumulatively , by making choices that privilege certain notions over others. In this article, we contribute in four ways. First, we propose an approach to study research governance effects on scientific fields. Second, we introduce first- and second-level effects of research governance paving the way to identify mechanisms through which these different levels of effects occur. Third, we assert that interactions between research spaces and fields leading to effects occur in the context of research organizations, and at nine key selection events. Fourth, and lastly, we discuss an empirical test on an illustration case to demonstrate how this approach can be applied.

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• Published: 18 February 2020

Governance of health research funding institutions: an integrated conceptual framework and actionable functions of governance

• Pernelle Smits 1 &
• François Champagne 2  

Health Research Policy and Systems volume  18 , Article number:  22 ( 2020 ) Cite this article

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Health research has scientific, social and political impacts. To achieve such impacts, several institutions need to participate; however, health research funding institutions are seldom nominated in the literature as essential players. The attention they have received has so far focused mainly on their role in knowledge translation, informing policy-making and the need to organise health research systems. In this article, we will focus solely on the governance of national health research funding institutions. Our objectives are to identify the main functions of governance for such institutions and actionable governance functions. This research should be useful in several ways, including in highlighting, tracking and measuring the governance trends in a given funding institution, and to forestall low-level governance.

First, we reviewed existing frameworks in the grey literature, selecting seven relevant documents. Second, we developed an integrated framework for health research funding institution governance and management.

Third, we extracted actionable information for governance by selecting a mix of North American, European and Asian institutions that had documentation available in English (e.g. annual report, legal status, strategy).

The framework contains 13 functions – 5 dedicated to governance (intelligence acquisition, resourcing and instrumentation, relationships management, accountability and performance, and strategy formulation), 3 dedicated to management (priority-setting, financing and knowledge transfer), and 5 dedicated to transversal logics that apply to both governance and management (ethics, transparency, capacity reinforcement, monitoring and evaluation, and public engagement).

Conclusions

Herein, we provide a conceptual contribution for scholars in the field of governance and health research as well as a practical contribution, with actionable functions for high-level managers in charge of the governance of health research funding institutions.

Peer Review reports

Research governance needs careful consideration, not only for the sake of good governance but also for the added benefits gained from an efficient health research sector in terms of the health of the population. To reinforce research governance, some actors advocate and push for the strong and explicit handling of fragmented science policy – policy-makers push for a pragmatic research agenda where there are benefits to the economy or to population groups, researchers advocate for the steering of research on health systems governance, and research organisations, such as universities and research funding institutions, decide on topics of focus and ways to attribute funds.

Health research, and research in general [ 1 ], has scientific, social and political impacts [ 2 ]. Health research performance can be measured in terms of productivity (i.e. number of papers per researcher), quality (i.e. number of highly cited papers), impact on healthcare quality, health status or the economic value of patented products (i.e. new devices) [ 3 ], and public engagement [ 4 , 5 , 6 ]. While there is no international consensus on the best indicators for health research [ 7 ], and there are limitations inherent to its metrics (time, attribution, etc. [ 8 ]), there is now consensus that the benefits of health research require counting, and that “ how health research systems should best be organized is moving up the agenda of bodies such as the World Health Organization ” [ 9 ].

Health research systems vary noticeably across countries, for instance, within the Western Pacific region [ 10 ], eastern Mediterranean countries [ 11 ], Latin American countries [ 12 ] or African countries [ 13 , 14 ]. A comprehensive framework would provide tools to compare systems, facilitate the identification of the range of options and guide the measurement of their characteristics in order to point out ideas for complementary arrangements.

About governance of health research by funding institutions

Health research funding institutions with a national scope encompass politics and government, advisory bodies, organisations funding research, intermediary organisations and institutions performing research, either agencies, ministries or institutes (henceforth named institutions); we refer to funding institutions of science or of health science systems that are publicly run and that cover basic and applied health research. Tetroe refers to major public research funders responsible for funding health research at the national level [ 15 ].

Few frameworks on health research systems are available. Two characteristics can be distinguished, namely governance and/or management functions. Though the ‘governance’ and ‘management’ of research might be understood and used as synonyms [ 16 ], we distinguish governance functions from those of management based on notions of internal and external environments. Following Mitchell and Shortell’s [ 17 ] typology of governance and management functions, we consider governance as being primarily concerned with positioning health research relative to the external environment in which it operates, while management is primarily concerned with daily tasks and implementation.

Broadly speaking, governance of health research “ is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they sponsor or permit ” [ 16 ].

Some frameworks might consider the health research delivery level or they may be more generic. In general, they mainly emphasise what governance or management features need to be enacted inside the organisations that deliver research, such as universities and research centres, highlighting the roles of researchers and public administrators [ 16 , 18 ] or even the potential role of policy-makers [ 15 , 19 , 20 ]. Research funding institutions are seldom nominated in the literature as essential players in health research governance (HRG). Indeed, research on funding institutions has not received broad attention [ 21 , 22 , 23 , 24 ] but is slowly growing with WHO’s Health Research Policy and Systems initiative [ 9 ] and reflections on knowledge translation [ 25 ]. We will focus solely on HRG and the management of national funding institutions.

The intent of this paper is to provide an overall framework of HRG and management for funding institutions. The content is designed to support health research reformers, funding institution managers and government officials in charge of health research development. It applies to all research under the responsibilities of funding institutions, be it health services, public health, biomedical or clinical research.

We will first provide a framework of research governance and management applied to the health domain for funding institutions. We will then present international cases of funding institutions and how they enact functions and build upon case descriptions to draw some practical applications of the HRG functions for funding institutions. We finally discuss the applications for funding institutions.

Review of existing frameworks

Existing frameworks (Table 1 ) were identified via a grey literature search for all hits on Google using the following keywords: frame* OR model, combined with “Health research governance” OR “governance of health research” OR (“research for health” + “governance”) anywhere in the page. We also ran Google scholar [ 26 , 27 ], searching anywhere in the article, for the first 600 hits using the following keywords in the title: “Health research governance” OR “governance of health research” OR (“research for health” + “governance”).

We excluded references that were specific to one theme, for example, genomic or epidemic, as well as those dedicated to one institutional level (e.g. university), private institutions, advocacy-oriented institutions (e.g. think tanks), or a single aspect of governance (e.g. law, ethics) or a population (e.g. librarians). We included references that were specific to public organisations (e.g. agency, ministry, institute) and the national level.

Theoretical development of conceptual integrated framework

The methodology to develop the framework of HRG is based on the integration of the existing frameworks related to (health) research governance and to the governance of health [ 28 ].

One author of the present paper read the identified frameworks and classified the dimensions lists as per their governance, management or principles content. Whenever the authors provided a classification, we copied and pasted what they considered governance, management or principles into our documentation. When authors did not provide any specific classification, we used the definitions of governance and management used to develop the integrated framework. Governance refers to broad functions or ‘know-why’, the vision and relationships to the external environment, management refers to ‘know-what’ and operational daily tasks carried out within the environment of the institution, and transversal functions refer to ‘know-how’. Those transversal functions are, in essence, the principles that apply to governance and management functions.

Practical application of newly developed framework to a sample of institutions

The methodology used to analyse cases was a two-step process involving the selection of countries (Table  2 ) and institutions (Table  3 ). We sought research funding institutions from a diversity of countries. The selection of countries rests upon the acknowledged leadership in English-speaking health research production and a mix of North American, European and Asian countries.

The criteria for being a major provider of research funds were being funding institutions from the public sector, national in scope, funding health-related research and being a major provider of research funds. A team composed of professors, researchers, consultants and managers from funding institutions and research centres (total of 6 individuals; 2 from the field of governance, 1 finance, 1 academic training, 2 international management, equally coming from academic and practical background; 4 of these directly worked with funding institutions) selected the cases.

The information included in this study was extracted from documentary sources, including reports of the selected funding institutions available as of November 2018 (annual report, strategic plan), related strategic information whenever available from the website of the selected funding institutions as consulted in November 2018 (e.g. organisational chart, procedures, mission), and the legal status of the selected funding institutions (i.e. the constitutive act in force) (See Appendix – data sources for further details). Some institutions documented their strategy and actions at much more detailed levels than others; we considered what was mentioned independently of the level of detail.

One member of the study team read through all documentation, and then extracted and classified information relevant to the stated dimensions of the framework (Tables 6 , 7 , 8 , 9 and 10 ). A round of verification and collection of complementary data took place by sending a request to each institution for comments from the direction of communication, cc’d to the contact of the head manager of each funding institution. Out of seven institutions contacted, we received three answers. The institutions were asked for the following information: (1) to complete information about their institution, and (2) to comment on the validity of the five governance-related dimensions (e.g. Do they make sense to you? Are they clear? Anything missing?).

Brief review of the existing frameworks

A national framework on HRG outlines the understanding of a government about its vision of health research, internal and external roles, and the philosophy behind running high-standard health research. It is a formal statement on how to improve research and safeguard the public [ 29 ]. It gives clear directions on what to work on and how to practice efficiently in order for the population to benefit from health research results and new knowledge. Such frameworks eventually include people, institutions and activities, and enable the health research system to generate and use knowledge for the benefits of health. A framework provides a systematic tool to portray the health research system in a systematic manner [ 30 ].

At least eight recent frameworks on health research are available – the Department of Health in the United Kingdom published a framework that gives details on standards and responsibilities for health research [ 31 ]; the Council on Health Research for Development (COHRED) developed a framework with technical components of particular aspects of health research systems [ 32 ]; Pang et al. synthesised a consultation on the foundation for health research systems [ 33 ]; Rani et al. presented the governance and management functions extracted from a consultation in low- and middle-income countries [ 10 ]; the Canadian Institutes of Health Research (CIHR) offers principles and stewardship details for the collection and use of data overall [ 34 ]; the European Observatory mainly provides a set of principles that can be divided into managerial and governing mechanisms [ 35 ]; and, finally, the Australian Research Council sets a step-wise framework to manage research projects [ 36 ].

Some frameworks focus more on research governance for research institutions (universities, etc.), others encompass research governance for funding institutions. Indeed, the National Institute for Health and Care Excellence (NICE) and the National Health and Medical Research Agency (NHMRC) frameworks focus extensively on the aspects that need to be considered by an institution receiving NICE or NHMRC funds. In these frameworks, dimensions are closer to a set of steps to be filled from the inception to the closing of a research project. All other frameworks refer to governance (sometimes called “ stewardship ” by Pang et al. [ 33 ]), management and a set of more or less detailed principles. Explicit concerns for ethics and public participation are prevalent among these principles (see Table  4 , columns C1 to C8).

Some frameworks provide an overarching set of dimensions, whereas others delve into the specifics of either management or governance. Indeed, the COHRED and European Observatory frameworks are both designed as overarching frames, covering multiple dimensions. In the case of COHRED, 15 dimensions provide many details on principles for managerial- or governance-related aspects. The European Observatory framework similarly gives a broad view of what dimensions to consider, although it condenses the number of dimensions down to five.

The European Observatory framework appears as the most overarching framework. Each of the principles proposed is accompanied by a set of specific mechanisms that help those in charge of governance or managerial functions to act accordingly. For instance, the principle ‘accountability’ includes mechanisms for managerial functions, such as competitive bidding, and some mechanisms for governance purposes such as conflict of interest policies and codes of conduct.

The COHRED framework is based on ‘key aspects’ of health research and has ‘action guidelines’ attached to each of them, covering governance and management functions. Key aspects include a conducive environment for ethics and leadership, a solid base of policies, priorities and management, and the ability to perform and produce in the areas of resources, optimisation and international integration. It is formatted in the spirit of a step-by-step guide to improving research governance at the national and institutional levels. It lists good practices and advice such as formalising partnership arrangements and ensuring transparency through the ranking process.

Pang et al.’s [ 33 ] framework builds four functions. One essential pillar is ‘stewardship’, whereby vision, priorities and monitoring provide direction for health research. ‘Financing’ makes it possible to get funds in and to allocate funds with accountability; the ‘creation and sustainability of human and physical resources’ and ‘the production and use of research’ complete the framework. Note that production and use of research belongs to both the governance functions and the management functions categories if organisations are performing research and knowledge transfer. Accountability is related to financing.

Rani et al. [ 10 ] propose essential governance and management functions based on consultation with low- and middle-income countries, advocating for the improvement of ethics committees and of registries to record funding and research data.

The CIHR framework is organised into five main functions of governance. As the framework relates both to health research and health-related data, the dimensions reported have a digital flavour, focusing on data quality, open access, data visibility and so forth. The transfer of these five broad guiding principles and five components (vision, culture, resources, skills, access) can easily apply to organisations and systems running research projects, right up to health research governing bodies such as funding institutions. This framework is particularly concerned with reaching out to all involved stakeholders and with compulsory actions, specifying who is responsible and what activities have to be checked and approved.

The NICE framework is particularly concerned with each and every person working at or for NICE itself, clarifying the roles, responsibilities and institutions to contact in different scenarios.

NHMRC’s Australian framework provides a roadmap for those organisations and systems running research projects who need to comply with high-standard research governance.

All the above frameworks seem relevant for a funding institution. In the following section, we propose an integrated framework. Dimensions that were cited by others are integrated into the encompassing governance and management HRG framework that we propose below. We distinguish which functions are more closely related to management functions and which are more closely related to principles or governance.

Conceptual integrated framework on governance and management of health research by funding institutions

We propose to build the Framework on Governance of Health Research (FGHR) upon these existing frameworks (Table  4 , column C9). FGHR also grows out of our understanding of governance in health research and health systems, our observation of governance practices in health research and health systems, and the inputs from the above frameworks. We acknowledge that, at times, delimitations might be blurry between governance and management functions. Therefore, we decided to organise the FGHR around three groups of functions (governance, management, transversal functions), as presented in Fig.  1 . Here, governance is shown on the outside of the figure, representing broad functions (or know-why), management functions (or know-what) are shown inside the circle and are run within the standards set by governance and some transversal encompassing functions are present in both governance and management levels (or know-how).

Framework on governance of health research

The composition of FGHR reflects governance functions, management functions and transversal functions. Governance functions reveal the steering activities that actors and institutions must undertake to ensure a fit between the health research system and the external environment. Management functions correspond to activities to be carried out internally on a daily basis to ensure the pursuit of health research for funding institutions, universities, research centres and principal investigators. Transversal functions qualify management functions and the effects required from the actualisation of governance functions. The term refers to good practices and excellence in the exercise of management and governance in health research, namely transparency, capacity-building, monitoring and evaluation, and ethics.

FGHR is composed of five governance functions, three management functions, and four essential types of know-how. The framework’s five governance functions are ‘intelligence acquisition’, ‘resourcing and instrumentation’, ‘relationship management’, ‘accountability and performance’, and ‘strategy formulation’. Intelligence acquisition is the production and acquisition of the knowledge necessary for providing a vision for the health research that the organisation supports and for the consultation and recruitment of adequate expertise. Resourcing and instrumentation refers to the acquisition and generation of the means to achieve strategic goals through board meetings, reports and reviews, inward flow of monetary resources, and the means to support the development of governance structures and activities such as explicit responsibility and task descriptions. Relationship management is concerned with ensuring good and efficient connections, both with the external environment and internally with insiders such as the direction committee. Accountability and performance relate to the ability of the organisation to exercise good governance through instituting the means to track its own development and activities as a governance structure. This function relates to a reflexive capacity of governance. Formulating mission and vision is the process of setting up the strategic content, mission, vision and priorities with adequate policies and ethical codes to exercise governance functions.

The framework’s three management functions are ‘priority-setting’, ‘financing’ and ‘knowledge transfer’. Priority-setting refers to the process of setting up midterm actions that match the vision of the organisation. Financing refers to the outward flow of monetary resources as funds are allocated. Knowledge transfer covers the organisation’s support for knowledge-transfer activities. It can be organisation-led, such as the funding institution facilitating meetings between the scientific community and politicians, or related to research funding, whereby researchers can apply for specific knowledge-transfer grants.

The five transversal functions of the framework are based on essential types of know-how underlying HRG and management; they are ‘ethics’, ‘transparency’, ‘capacity reinforcement’, ‘monitoring and evaluation’, and ‘public engagement’. Ethics refers to the quality of a process, either governance functions or management functions in the selection of board members or in the attribution of grants through peer-review processes. Transparency refers to the disclosure of procedure and results, for example, having clear and publicly available criteria for election to boards and committees, posting the names of successful research grant applicants online, or providing free access to publications. Capacity reinforcement relates to a continuous organisational effort to support the development of human resources, in terms of either board members or staff employed by the organisation in a management function as well as the support for capacity development when funding students. Monitoring and evaluation cover processes of data collection and analysis to follow-up on, estimate the performance of, and benchmark organisational processes and results. Public engagement refers to efforts to reach out and/or integrate the population or groups of the population in an authentic and continuous decision-making process.

This FGHR intends to establish principles for carrying out health research at the national level. The scope of the FGHR covers the responsibility of the public system for the governance of health research – from the top-level decision-making organisations that fund research to the recipient organisations that implement research projects in health domains. The framework is directly relevant to those who target, fund, manage, host, conduct, participate and accredit health research. It can theoretically apply to all health research related to studies sponsored by the ministry level, to research carried out within a geographical area, and to research funded totally or partially with national-level public funds.

The framework seeks to establish the essential functions and values of health research conduct. Existing requirements binding research communities or existing laws and requirements designed to protect research participants, to ensure confidentiality, and so forth, are not integrated at this point. The responsibilities of institutions and actors can be defined in future steps.

These governance functions do corroborate some of the governance tasks for research policy and practice in health mentioned by Mitchell and Shortell’s [ 17 ], namely obtaining financial resources and providing measures for accountability.

Practical application of the newly developed framework in terms of governance

We further refer to actionable functions as useful actions [ 37 ] that bring clear directions [ 38 ] to enact governance. We decided to focus solely on governance functions because much is already written on management and ethics in research.

Description of the research environment by case

Each year, funding institutions individually invest between US $90 million and US $31 billion in health research to fund researchers, trainees and projects. Some countries, such as Canada and the United States, organise their budget around thematic research organisations and some countries flag available funding on thematic studies rather than organisations (Table  5 ).

A direct comparison between funding institutions is difficult to establish, with some reporting the prevalence of researchers and trainees currently supported on a yearly basis, others the incidence of researchers and trainees newly funded during the year. A wide diversity prevails in terms of funding models. CIHR in Canada favours investigator-initiated grants, whereby researchers nominate a topic of research in which they are proficient and for which they would like to receive funding. In Singapore, the opposite dynamic seems to prevail, with the majority of funds dedicated to targeted grants on specific topics of interest to the government. Our main intent in presenting several cases is to provide a practical look at various governance frameworks and to extract empirical applications.

Analysis of governance functions in health research funding institutions by case

Intelligence acquisition

‘Intelligence acquisition’ refers to the means put in place by funding institutions to acquire their strategic knowledge and expertise. The design of funding institutions’ strategic actions might be influenced by the policy domain, for example, by government authorities or ministries. In such a situation, these inputs come from a logic of top-down representative democracy. A mixture of bottom-up inputs also seems to be widespread in funding institutions, with the participation of direct and indirect beneficiaries of funded health research; indeed, patients, the public and researchers do contribute their share of knowledge to formulate, comment on or format policies.

While funding institutions do receive some inputs, they might also look for information directly relevant to their mission as it emerges. To do so and remain open to environmental opportunities, a proactive structure might be put in place to investigate early policy developments of interest to the institution, as is done in the Netherlands (Table  6 ).

The mobilisation of external knowledge may be complemented by knowledge acquisition on the internal processes of a funding institution. In so doing, the institution presents a strong signal that it is a learning organisation willing to adjust as needed. Internal reviews provide evidence on which to build a continuous improvement dynamic, both within the funding institution and for its external partners. The National Institutes of Health (NIH) explicitly places a high priority on learning processes – its strategic plan proposes that it will excel as a federal institution, it reviews its peer-review processes, uses bibliometrics to indicate the value of a programme, conducts PhD workforce analysis so as to better predict the optimal number of fellows the NIH can support, and reduces the administrative burden by distinguishing between unavoidable burdens and those that are merely due to custom or habit.

As a conclusion to the dimension of intelligence acquisition, one operational and empirical application would be to consider the following aspects:

Top-down versus bottom-up influence of outsiders

Proactive versus reactive knowledge hunting

Presence versus scarcity of organisational learning procedures

Strategy formulation

‘Strategy formulation’ refers to the exchange processes that guide the actions of founding institutions. It can take the form of developing founding documents and principles. The evidence to feed such long-term and structural decisions comes from insiders from the health research system, researchers, academics, health ministry representatives, and so forth. It might also derive from the ultimate beneficiaries of health research (citizens) and those outside the system (congress members, etc.). Another difference between the funding institutions that are developing their long-term vision, mission and policies is their openness and integration of non-health-related actors and whether it is solely focused on the health sector or not. Some institutions call for medical providers and health institutes to collaborate on the design and elaboration of a strategy. However, because the health sector opened up decades ago to the wide range of determinants of health, it is now well established that the health of the population is largely dependent on interventions made in sectors that do not fall under the jurisdictions of health ministries. Therefore, the involvement of non-health-labelled institutes and representatives is or has to be considered by funding institutions; for example, Australia’s funding institution opens its strategy to online commentary from any sector (Table  7 ).

As a conclusion to the dimension of strategy formulation, one operational and empirical application would be to consider the following aspects:

Research insider versus research outsider

Single health sector versus multiple sector inputs

Resourcing and instrumentation

‘Resourcing and instrumentation’ refers to the tools that are put in place to finance, fund and support the development and implementation of an institution’s strategy. Financing is the act of collecting and receiving money to run the institution; the sources of money can be public and/or private. The NIH, for example, is much closer to the private sector than other institutions portray themselves to be. Instrumentation, such as guidelines and policies, is developed for the internal functioning of an institution; for example, the description of selection criteria for committees. Online tools might also be available to support research external to the institutions, for example, the guidelines for university ethics committees as provided in Australia. Support given to researchers might be facilitated through open resources where researchers compete on broad-spectrum grants or be targeted to the needs of some government agenda or ministry priority, as happened in Australia when the then Minister of Health and Ageing requested additional committees (see Table 8 ). The organisational processes involved in providing money to universities, grantees, scholars and research centres – both public and private – so as to implement institution programmes through projects funded can be closely informed to reframe funding schemes. To encourage high standards of research, and highly competitive researchers, institutions look at ways to move forward in a globalised research environment and to support researchers accordingly. Sweden, for example, is reflecting upon researchers’ mobility. To align with institutions’ missions to bring value to the population and improve health, institutions such as those in the United Kingdom, propose a model of reporting in which care is explicitly taken to use plain English in order to favour clear communication of funding applications (Table  8 ). In this way, institutions encourage both international engagement and the translation of research results into health practices.

As a conclusion to the dimension of resourcing and instrumentation, one operational and empirical application would be to consider the following aspects:

Providing support material for the entire research community versus restricting it to grantees

Providing open grants versus targeted grants

Pushing or not for linkages to healthcare benefits

Questioning or not competitiveness in a globalised research environment

Management of relationships

‘Management of relationships’ refers to the preoccupation with interacting in meaningful and constructive ways with the institutions’ partners – be they insiders of the institution, such as the heads of the constituting institutes of an institution at CIHR Canada, or outsiders such as politicians or institutions unrelated to the health sector.

Some institutions run activities and set seats on boards for their internal partners (CIHR scientific agency, see Table  9 ). They might also connect with outside funding institutions to set up multi-institution funding for innovations or grants covering boundary work and transversal research. Such efforts to build up complementary programmes and to invite collaborators might be customary or recurrent. Over time, such recurrent relationships and exchanges with outsiders become institutionalised in the institution processes. They might also be at the pilot-testing phase or in an early development stage, when institutions establish bridges with partners on a more intermittent basis. In 2005, CIHR in Canada organised a pilot project with parliamentarians named ‘Health Researcher’s Day on the Hill’, and planned to send newsletters to members of Parliament three times a year since 2012 [ 41 ]; in Sweden, researchers and politicians are convened to a shared event on a yearly basis.

As a conclusion to the dimension of management of relationships, one operational and empirical application would be to consider the following aspects:

Internal versus external partners

Intermittent versus recurrent partnerships

Accountability and performance

‘Accountability and performance’ is the process by which a funding institution follows its own development and activities and is reflexive about its governance capacity. Because funding institutions might or do oversee the quality and integrity of the research they are funding, some have developed procedures to ensure high standards for research quality. Follow-up on research quality can take the form of inquiry into fraud in attributions of funding and the manipulation of results. Sweden, stricken by the Macchiarini case on gross scientific misconduct [ 42 ], installed a Research Misconduct Board to address such issues. Publishing information online regarding, for example, who sits on committees, who receives funds, and what type and amount of funding is received is another transparency mechanism employed by funding institutions such as CIHR in Canada and the NHS in the United Kingdom (Table  10 ).

Additionally, what happens behind the closed doors of granting committees might take different forms. It might address the internal processes of committees, their selection criteria or their mandates, or it might address the committee’s final decision regarding the list of grantees. An institution might therefore focus more or less on disclosing its internal procedures or on its committees’ final decisions.

As a conclusion to the dimension of accountability and performance, one operational and empirical application would be to consider the following aspects:

Disclosure from process to results

Follow-up on diverging behaviour or not

Whether to put committee-related information online or not

In conclusion, we extracted a few specific operational dimensions salient to the governance of health research by funding institutions (Table  11 ).

We would like to discuss the validity of the framework for governance of health research funding institutions.

One could argue that the framework is not valid because it is based on a limited set of existing frames. Here, it is assumed that a sample is sufficient for the identification of elements of governance. A framework can be developed from a deductive approach, mobilising a catalogue of theories and knowledge from scholars. It can also be developed from an inductive approach, this time mobilising hands-on knowledge from the institutions themselves. We mainly borrowed from both approaches to develop the integrated framework, being rooted in practice, and also keeping an open door to the approaches of scholars who might have previously developed deductive frameworks. The literature refers to publications by Rani et al. [ 10 ] and Pang et al. [ 33 ], both of which use practitioners’ consultations to draw their framework.

The strength of the integrated framework will also rely upon developing it on high variability cases, including internal variability among institutions and external variability among the institutions’ national environments. The selected institutions of this study cover all health research topics rather than simply topics that fall under unique categories of medical research (e.g. stem cell), social sciences and humanities (e.g. management of primary care), or engineering (e.g. radiation therapy); they are quite homogeneous in that regard. However, at this stage, we applied the integrated framework to seven cases, and observed a wide variability of capacities within each research funding institution. In the United States, the NIH was created in 1930 and cumulates almost 90 years of experience, whereas the United Kingdom’s National Institute for Health Research was the last to be established in 2006, from the evolution of a previous agency. Canada’s CIHR operated on around US$ 800 million in 2017–2018 (equivalent to over CAN$1 billion), whereas Singapore’s National Medical Research Agency mobilises about half that budget, at US$ 492 million in 2016, leading to a population equivalent of approximately one-seventh that of the Canadian one. Having highly variable internal capacity and yet still portraying a similar set of governance dimensions reinforces the strength of the framework, especially its governance functions. Following a similar line of reasoning, all seven cases operate in diverse national environments and still present consistency through the presence of the five governance functions. Altogether, we argue that the variability of cases reinforces the validity of the governance functions.

Another issue that might arise is that selected institutions might not make it possible to portray the extent of the dimensions of governance at stake. The dimensions first come from the review of frameworks in use, which were then put to the test on seven cases. Notice that we do not intend here to claim that one funding institution is doing a better job than another, or to compare across cases; the highlight is on dimensions, not cases. Any initial dimension that was irrelevant can be expected to be absent from cases, though this was not observed herein. All five governance functions were indeed mentioned by all seven cases. Additionally, one could argue that, initially, we might have missed a dimension important to governance, which is conceptually correct. Furthermore, the analysis of cases would not have made it possible to identify extra dimensions in an easy way as we did not look for a specific additional dimension, nor might such an extra dimension be easily identifiable through documentary analysis. Thus, the test of the governance functions on seven cases could invalidate a dimension if it were to be absent in one or more cases (especially for institutions outside Canada, Australia and the United Kingdom that were also feeding the review of the frames), and it could temporarily validate the importance of an initial dimension that was present in all cases, yet it cannot validate the extent of the governance functions.

Note that this study by no means provides an exhaustive list of HRG settings and mechanisms in selected countries, nor does it compare which funding institutions perform best. Additionally, the intent of this analysis of actionable functions is to identify pragmatic actions under the dimensions (only in terms of governance) of the framework rather than to assess the same institutions on these dimensions.

Although research is ultimately undertaken by researchers in public or private organisations, universities, institutes and centres, we do not intend to provide a framework for institutions hosting research projects, for example, organisations such as the Saskatchewan Health Research Foundation, which recently published a governance framework and policies, mainly for its board.

Two main contributions come out of this work. First, we bring a conceptual contribution for scholars in the field of governance and health research. We developed an encompassing framework for the governance of health research by national funding institutions. The framework contains 13 functions, wherein 5 are dedicated to governance, 3 dedicated to management, and 5 dedicated to transversal principles that apply to both governance and management. The framework grew out of the combination of existing governance frameworks for health research funding institutions. Second, we bring a practical contribution for high-level managers in charge of governance of health research funding institutions. The framework was broken down into operational dimensions of governance to render the governance function of the framework more actionable. The operational dimensions are extracted from a multiple-case study of seven selected health research funding institutions from North America, Europe and Asia, and the specific actions they put in place to exercise their governance, especially regarding intelligence acquisition, strategy formulation, resourcing and instrumentation, management of relationships, and accountability and performance.

The framework is useful in several ways, namely to point out low-level governance and to track, measure and forestall it. In a sense, pointing out low-level governance can help funding institutions by illuminating whenever one or more functions are given little to no attention. An institution that does not manage partnerships in a diverse and efficient way, seeking out inputs from one or two key players in the private sector, for instance, will be poor at answering the health challenges of its population. It will not perform as well as an institution with open processes that feed the debate as to which challenges must be addressed in the health sector and other sectors that determine the health of the population. Though one institution might, at its inception, choose to focus on one privileged relationship with a specific national partner, governance maturity towards more encompassing actions for improving health through research will, in the long run, rely on a more diverse set of partnerships.

The framework can help in tracking the maturity curve of governance for an institution. Take, for instance, an institution willing to shift gears towards stronger influence in health research – surely tightening ties with partners or focusing funding and exploring wider funding contributors would be an option. The framework could be starting material for performance measurement on the institution’s governance. It could help to develop indicators on each function so that a board can follow-up changes in governance style – putting more or less emphasis on intelligence acquisition or on accountability, or else putting more or less emphasis on some more operational aspects of governance, for instance, acquiring intelligence from institutions’ top influencers, such as politicians, or else making sure citizens get a stronger voice in the governance discussion of institutions. Finally, the framework can be of use to forestall unwanted shifts in governance. Being aware of the current type of governance of the institution, leaning more or less towards one function or another, being more or less prone to the top-down or bottom-up influence of outsiders, for instance, merely implies the institution could take measures against travelling down a road it did not intend to take.

What is left to be done regarding governance of health research funding institutions? We suggest four avenues. Governance does not stand alone as a single action that high-level managers run. Governance is underpinned by principles, or in other words, by what it means for those institutions to operate ‘good’ governance. We suggest those principles are ethics, transparency, capacity reinforcement, monitoring and evaluation, and public engagement. These compose the underlying know-how that applies to either governing or daily management. Further investigation is needed into what it means, in operational terms, to engage the public in accountability or in resourcing, and the like. Additionally, governance runs hand in hand with daily management. Further thought must be given to the complementarity of governance and managerial functions – what does it mean in operational terms? Additionally, and perhaps more intriguingly or more promisingly for better health research, what are the operational governance actions that are in contradiction with some of these operational management actions in place in funding institutions? Finally, in some countries, provincial research funding institutions are key players in funding research and might or not align with national governance standards. Investigating governance functions and actionable functions for provincial funding agencies is an avenue. The same governance and management functions would likely apply to any organisation across health research. The ways in which each function translates into operations in practice is more likely specific by level.

Availability of data and materials

The data that support the findings of this study are listed in the Appendix.

Abbreviations

Canadian Institutes of Health Research

Council on Health Research for Development

Framework on Governance of Health Research

Health research governance

National Health and Medical Research Agency

National Institute for Health and Care Excellence

National Institutes of Health

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Acknowledgements

We want to thank Beverley Mitchell for her work reviewing the draft and respondents from the institutions.

This paper was developed after a work commissioned in 2012 as part of a contract between the co-authors and the Centre Hospitalier Universitaire de Montréal. The institution did not intervene in any way, nor did it read, comment on or approve the manuscript at any stage.

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PS developed the article and analysed data. FC commented the manuscript. Both authors read and approved the final manuscript.

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Data sources

Sources for the United States of America:

National Institutes of Health (NIH)-Wide Strategic Plan Fiscal Years 2016–2020.

Website of NIH on strategic plan and mission (consulted June 4th, 2019, at https://www.nih.gov/about-nih/what-we-do/mission-goals ).

Sources for Canada:

Canadian Institutes of Health Research (CIHR) Act, S.C. 2000, C.6.

CIHR. 2015. Health Research Roadmap II: Capturing Innovation to Produce Better Health and Health Care for Canadians. Strategic Plan 2014/15–2018/19.

CIHR Annual Report 2017–18.

Website of CIHR on strategic plan and mission (Consulted June 4th, 2019, at http://www.cihr-irsc.gc.ca/e/22754.html ).

Sources for Australia:

National Health and Medical Research Agency (NHMRC) Strategic Direction 2015–16 to 2018–19.

National Health and Medical Research Council Act 1992. No. 225, 1992 as amended.

NHMRC Annual Report 2016–2017.

Website NHMRC on strategic plan and mission (Consulted June 4th, 2019 at https://www.nhmrc.gov.au/about-us/publications/nhmrc-corporate-plan-2018-2019#toc__32 ).

Sources for Singapore:

National Medical Research Agency (NMRC) Translating Research into Better Health Annual Report FY2016.

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Website of NMRC Who we are (Consulted June 4th, 2019 at https://www.nmrc.gov.sg/who-we-are ).

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Smits, P., Champagne, F. Governance of health research funding institutions: an integrated conceptual framework and actionable functions of governance. Health Res Policy Sys 18 , 22 (2020). https://doi.org/10.1186/s12961-020-0525-z

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What is research governance?

This section provides guidance on the responsibilities of the College in relation to research governance and principles of good practice for health and social care research

Research governance can be defined as a broad range of regulations, principles and standards of good practice that exist to achieve and continuously improve research quality across all aspects of healthcare in the UK and worldwide. It can also be defined as regulations, principles and standards for projects outside of healthcare research, including good study conduct.

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Research Governance applies to everyone connected to research including Chief Investigators, Researchers, their employer(s) or support staff. For those in healthcare research it can also apply to those in a healthcare role, such as care professionals.

By healthcare research, we mean  any health-related research which involves humans, their tissue and/or data.

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For non-healthcare research, this could include:

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Book contents

• Frontmatter
• Editorial board
• Acknowledgements
• List of contributors
• Introduction
• 25 Ethical principles for medical research involving human subjects
• 26 The Belmont Report: ethical principles and guidelines for the protection of human subjects of research
• 27 ICH Good Clinical Practice Guideline
• 28 Governance arrangements for NHS research ethics committees
• 29 The research governance framework for health and social care
• 30 EU Clinical Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
• 31 European Convention on human rights and biomedicine (ETS 164) and additional protocol on the prohibition of cloning human beings
• 32 Good research practice
• 33 Research: the role and responsibilities of doctors
• 34 Guidelines for company-sponsored safety assessment of marketed medicines (SAMM)
• 35 Guidelines for medical experiments in non-patient human volunteers
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• 37 Multi-centre research in the NHS – the process of ethical review when there is no local researcher
• 38 Medical devices regulations and research ethics committees
• 39 NHS indemnity – arrangements for clinical negligence claims in the NHS
• 40 Clinical trial compensation guidelines
• 41 Research ethics: guidance for nurses involved in research or any investigative project involving human subjects
• 42 Ethical principles for conducting research with human participants
• 43 Statement of ethical practice
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• 45 Transitional guidelines to facilitate changes in procedures for handling ‘surplus’ and archival material from human biological samples
• 46 Code of practice on the use of fetuses and fetal material in research and treatment (extracts from the Polkinghorne Report)
• 47 Guidance on the supply of fetal tissue for research, diagnosis and therapy
• 48 Guidance on making proposals to conduct gene therapy research on human subjects (seventh annual report – section 1)
• 49 Report on the potential use of gene therapy in utero
• 50 Human fertilisation and embryology authority – code of practice (extracts)
• 51 Guidelines for researchers – patient information sheet and consent form
• 52 ABPI Guidance note – patient information and consents for clinical trials
• 53 The protection and use of patient information (HSG(96)18/LASSL(96)5)
• 54 The Caldicott Report on the review of patient-identifiable information – executive summary December 1997
• 55 Personal information in medical research
• 56 Use and disclosure of medical data – guidance on the Application of the Data Protection Act, 1998, May 2002
• 57 Guidelines for the ethical conduct of medical research involving children
• 58 Clinical investigation of medicinal products in the paediatric population
• 59 Guidelines for researchers and for ethics committees on psychiatric research involving human participants – executive summary
• 60 The ethical conduct of research on the mentally incapacitated
• 61 Volunteering for research into dementia Alzheimer's Society
• 62 Knowledge to care: research and development in hospice and specialist palliative care – executive summary
• 63 NUS guidelines for student participation in medical experiments and guidance for students considering participation in medical drug trials
• 64 Ethical considerations in HIV preventive vaccine research
• 65 2002 international ethical guidelines for biomedical research involving human subjects
• 66 1991 international guidelines for ethical review of epidemiological studies
• 67 Operational guidelines for ethics committees that review biomedical research
• 68 Registration of an institutional review board (IRB) or independent ethics committee (IEC)
• 69 International guidelines on bioethics (informal listing of selected international codes, declarations, guidelines etc. on medical ethics/bioethics/health care ethics/human rights aspects of health)

29 - The research governance framework for health and social care

Published online by Cambridge University Press:  08 January 2010

Research governance framework

Research is essential to the successful promotion of health and well-being. Many of the key advances in the last century have depended on research, and health and social care professionals and the public they serve are increasingly looking to research for further improvements.

This country is fortunate to be able to draw upon a wide range of research within the health and social care systems. Most of this is conducted to high scientific and ethical standards. However, recent events have made us all painfully aware that research can cause real distress when things go wrong. The proper governance of research is essential to ensure that the public can have confidence in, and benefit from, health and social care research.

This Research Governance Framework reflects a wide range of discussions with the NHS and all the Department of Health's partners in health and social care research. We have considered carefully the responses to our earlier consultation and the issues raised in meetings with stakeholders.

I am grateful to all who have helped us with this important task. We now need to continue to work together to ensure that this Research Governance Framework for Health and Social Care is implemented successfully. In this way, we can provide the public with the reassurance it has the right to expect, and ensure that we can continue to reap the benefits of research.

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• The research governance framework for health and social care
• Edited by Sue Eckstein , King's College London
• Book: Manual for Research Ethics Committees
• Online publication: 08 January 2010
• Chapter DOI: https://doi.org/10.1017/CBO9780511550089.031

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What is research governance?

The standards and principles of the Research Governance Framework currently apply to all research that relates to the responsibilities of the Secretary of State for Health. This includes any research undertaken by academic or independent bodies/ individuals, in or with social care agencies, as well as research undertaken by those agencies themselves.

The purpose of Research Governance is to ensure the highest standards of quality in research. This covers scientific quality and standards of ethics, and all related management aspects in the setting up, conduct, reporting and progression to healthcare improvements.

The Research Governance Framework sets out responsibilities for all involved in research: researchers (including students and their supervisors), care professionals, funding bodies, hosts, employers, and sponsors of research.

Acting as a Sponsor

The Sponsor is an individual, organisation or group taking responsibility for securing the arrangements to initiate, manage, monitor and finance a study. For any research that takes place in the context of the NHS or Social Care services, it is necessary that a Sponsor is identified. The Sponsor is normally expected to be the lead employer of the research team, the lead health or social care organisation, or the main funder.

Main responsibilities

The Sponsor has the responsibility for ensuring that all the necessary arrangements are in place before the study can proceed, including:

• Assure that research study has obtained scientific quality approval from the necessary bodies;
• Ensure that the study has obtained ethical approval;
• Ensure arrangements are in place for the monitoring and reporting of research;
• Ensure the research team have access to resources and support to deliver the research as proposed.

If you wish the University to act as the Research Sponsor of a project, under the terms of the  Department of Health's Research Governance Framework , please download a  copy of this form , complete and get agreement from your Faculty’s Dean. A copy of the form must then be sent to Sarah Taylor in RBDO.

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UK Policy Framework for Health and Social Care Research

This policy framework sets out principles of good practice in the management and conduct of health and social care research in the UK. 

These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.

It is for organisations and individuals that have responsibilities for health and social care research. This includes funders, sponsors, researchers and their employers, research sites and care providers.

The policy framework applies to health and social care research involving patients, service users or their relatives or carers. This includes research involving them indirectly, for example using information that the NHS or social care services have collected about them.

The Health Research Authority and the health departments in Northern Ireland, Scotland and Wales have developed the policy framework following  public consultation . It replaces the separate Research Governance Frameworks in each UK country with a single, modern set of principles for the whole UK.

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You can read the UK Framework for Health and Social Care Research in full on our website or download the UK Framework for Health and Social Care Research (PDF) .

We welcome your comments on the framework, which will help us improve future versions; and any examples of where you have used the framework as part of your work.

"I welcome publication of the UK Policy Framework for Health and Social Care Research which sets out the principles of good practice in the management and conduct of health and social care research across the UK. The Framework will ensure that the public will  continue to feel safe when they take part in research and it will enable researchers to develop innovations which will help to improve the quality of health and care in the UK."

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Research governance: implications for health library and information professionals

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• 1 School of Business Information, Faculty of Business and Law, Liverpool John Moores University, UK. [email protected]
• PMID: 12641525
• DOI: 10.1046/j.1471-1842.2003.00413.x

The Research Governance Framework for Health and Social Care published by the Department of Health in 2001 provides a model of best practice and a framework for research in the health and social care sector. This article reviews the Department of Health Research Governance Framework, discusses the implications of research governance for library and information professionals undertaking research in the health- and social-care sector and recommends strategies for best practice within the information profession relating to research governance. The scope of the Framework document that covers both clinical and non-clinical research is outlined. Any research involving, amongst other issues, patients, NHS staff and use or access to NHS premises may require ethics committee approval. Particular reference is made to the roles, responsibilities and professional conduct and the systems needed to support effective research practice. Issues such as these combine to encourage the development of a quality research culture which supports best practice. Questions arise regarding the training and experience of researchers, and access to the necessary information and support. The use of the Framework to guide research practice complements the quality issues within the evidence-based practice movement and supports the ongoing development of a quality research culture. Recommendations are given in relation to the document's five domains of ethics, science, information, health and safety and finance and intellectual property. Practical recommendations are offered for incorporating research governance into research practice in ways which conform to the Framework's standards and which are particularly relevant for research practitioners in information science. Concluding comments support the use of the Research Governance Framework as a model for best practice.

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Next-Generation Management & Governance Framework Unveiled at LIVE 2024 Conference Will Empower IT Leaders in an Era of Exponential IT

Launched during a keynote at Info-Tech Research Group's LIVE 2024 IT conference, hosted at the Bellagio in Las Vegas , the firm's updated Management & Governance (M&G) framework now encompasses 50 comprehensive capabilities designed to help CIOs systematically improve core performance and elevate the role of IT in an Exponential era.

TORONTO , Sept. 19, 2024 /CNW/ - Info-Tech Research Group has introduced its next-generation Management & Governance (M&G) Framework at its LIVE 2024 IT conference. Presented by Jack Hakimian , Senior Vice President of Research and Advisory, the new M&G Framework delivers a comprehensive, structured view of IT capabilities across ten critical domains. It is articulated around a forward-looking view of the world, where exponential technologies transform businesses and organizations. This framework gives CIOs and IT executives the tools to deliver on growing organizational expectations by aligning their initiatives with business objectives, driving innovation, and systematically improving IT performance.

Unveiled during Hakimian's featured keynote at LIVE 2024, IT Management & Governance: The Next Evolution , the updated M&G Framework is built to help IT leaders navigate the complexities of Exponential IT, where rapid technological advancements demand greater agility, maturity, and foresight. This next-generation framework enables IT executives to not only partner effectively with the rest of the organization but also to lead the technological transformation and become drivers of business growth.

"As disruptive technologies like generative AI radically transform how businesses operate through the autonomization of business capabilities, the role of IT needs to expand beyond its traditional boundaries,"  says Jack Hakimian , Senior Vice President of Research Development. "This M&G Framework and our derived diagnostic tools and blueprints give IT executives the means to assess and enhance their core processes, helping them transition from operational management to strategic leadership in their organizations."

The latest version of the firm's M&G Framework reflects the evolving challenges that IT organizations currently face, including the need for rapid innovation, effective risk management, and the elimination of silos within IT departments. With 50 interconnected processes spanning key domains such as Governance, Risk & Compliance, People & Leadership, Data & AI, as well as Security & Privacy, the framework equips CIOs with a comprehensive view of the capabilities needed to elevate their IT teams from tactical executors to strategic enablers.

Info-Tech's newly unveiled M&G Framework update focuses on helping IT leaders execute the following for their organizations:

Break down silos  and foster a more integrated approach to IT operations.

Assess process maturity and assign ownership to ensure accountability.

Align IT strategy with business goals , positioning IT as a key driver of organizational success.

Elevate leadership capabilities across the IT function, ensuring that all domain leaders operate under a standardized management and governance framework.

" The M&G Framework enables CIOs to transform their IT organizations into cohesive, efficient units capable of driving value across the business ," explains Hakimian. "Using the structured, data-driven approach that we've proposed, IT leaders can address capability gaps and manage critical processes that ensure their teams are well-prepared to deliver on Exponential IT principles. "

Each of the following ten domains in the M&G Framework is designed to help IT leaders address specific challenges, providing a roadmap for long-term, sustainable growth:

Governance, Risk & Compliance – Includes areas such as business continuity management, internal controls, risk management, and business value maximization.

Strategy & Innovation – Encompasses IT innovation, stakeholder alignment, IT strategy, and quality management.

Project & Portfolio Management – Covers IT portfolio management, project management, and organizational change management.

Enterprise Architecture – Includes service management and IT product management.

People & Leadership – Features talent management, leadership culture and values, knowledge management, and IT organizational structure.

Data & Artificial Intelligence – Includes data governance, AI strategy, data development and integration, as well as data insights and analytics.

IT Financial & Vendor Management – Covers resource management, vendor portfolio management, and vendor performance management.

Security & Privacy – Focuses on security operations, identity and access management, as well as privacy program management.

Infrastructure & Operations – Includes cloud management, change and release management, and service desk operations.

Applications –  Focuses on application strategy, requirements gathering, application portfolio management, and app maintenance.

Hakimian's keynote at LIVE 2024, which was presented on the second day of the three-day conference, emphasized that IT leaders are at the helm of their organization's journey into Exponential IT – a future where technology evolves rapidly and exponentially, demanding that IT departments adapt, innovate, and lead. The new M&G Framework is a direct response to these demands, providing CIOs with the foundation to not only meet today's challenges but thrive in tomorrow's exponentially digital landscape.

Built specifically for CIOs and senior IT leaders, the M&G Framework provides a roadmap to not only improve IT performance but also raise the profile of IT within the broader business context. By standardizing processes, improving leadership capabilities, and driving accountability, CIOs can ensure their IT organizations are aligned with overall business strategy and capable of delivering exceptional results.

For more detailed information on the ten domains and each of the elements within them, visit Info-Tech's Management & Governance page .

For media inquiries, including requests for interviews with featured speakers and experts at LIVE 2024, or for access to session recordings and additional content, please contact [email protected] . For conference-related press releases and images, please visit the online Info-Tech LIVE 2024 Media Kit . 

About Info-Tech Research Group Info-Tech Research Group  is one of the world's leading research and advisory firms, proudly serving over 30,000 IT and HR professionals. The company produces unbiased, highly relevant research and provides advisory services to help leaders make strategic, timely, and well-informed decisions. For nearly 30 years, Info-Tech has partnered closely with teams to provide them with everything they need, from actionable tools to analyst guidance, ensuring they deliver measurable results for their organizations.

To learn more about Info-Tech's divisions, visit McLean & Company  for HR research and advisory services and  SoftwareReviews  for software-buying insights.

Media professionals can register for unrestricted access to research across IT, HR, and software and hundreds of industry analysts through the firm's Media Insiders program. To gain access, contact [email protected] .

For information about Info-Tech Research Group or to access the latest research, visit infotech.com  and connect via LinkedIn  and X .

View original content to download multimedia: https://www.prnewswire.com/news-releases/next-generation-management--governance-framework-unveiled-at-live-2024-conference-will-empower-it-leaders-in-an-era-of-exponential-it-302252891.html

SOURCE Info-Tech Research Group

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2024/19/c5790.html

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• Technology Research

Next-Generation Management & Governance Framework Unveiled at LIVE 2024 Conference Will Empower IT Leaders in an Era of Exponential IT

Author(s): Sufyan Al-Hassan

September 19, 2024 – Info-Tech Research Group has introduced its next-generation Management & Governance (M&G) Framework at its LIVE 2024 IT conference. Presented by Jack Hakimian, Senior Vice President of Research and Advisory, the new M&G Framework delivers a comprehensive, structured view of IT capabilities across ten critical domains. It is articulated around a forward-looking view of the world, where exponential technologies transform businesses and organizations. This framework gives CIOs and IT executives the tools to deliver on growing organizational expectations by aligning their initiatives with business objectives, driving innovation, and systematically improving IT performance.

Unveiled during Hakimian’s featured keynote at LIVE 2024, IT Management & Governance: The Next Evolution , the updated M&G Framework is built to help IT leaders navigate the complexities of Exponential IT, where rapid technological advancements demand greater agility, maturity, and foresight. This next-generation framework enables IT executives to not only partner effectively with the rest of the organization but also to lead the technological transformation and become drivers of business growth.

“As disruptive technologies like generative AI radically transform how businesses operate through the autonomization of business capabilities, the role of IT needs to expand beyond its traditional boundaries,” says Jack Hakimian , Senior Vice President of Research Development. “This M&G Framework and our derived diagnostic tools and blueprints give IT executives the means to assess and enhance their core processes, helping them transition from operational management to strategic leadership in their organizations.”

The latest version of the firm’s M&G Framework reflects the evolving challenges that IT organizations currently face, including the need for rapid innovation, effective risk management, and the elimination of silos within IT departments. With 50 interconnected processes spanning key domains such as Governance, Risk & Compliance, People & Leadership, Data & AI, as well as Security & Privacy, the framework equips CIOs with a comprehensive view of the capabilities needed to elevate their IT teams from tactical executors to strategic enablers.

Info-Tech’s newly unveiled M&G Framework update focuses on helping IT leaders execute the following for their organizations:

• Break down silos and foster a more integrated approach to IT operations.
• Assess process maturity and assign ownership to ensure accountability.
• Align IT strategy with business goals , positioning IT as a key driver of organizational success.
• Elevate leadership capabilities across the IT function, ensuring that all domain leaders operate under a standardized management and governance framework.

“ The M&G Framework enables CIOs to transform their IT organizations into cohesive, efficient units capable of driving value across the business ,” explains Hakimian. “Using the structured, data-driven approach that we’ve proposed, IT leaders can address capability gaps and manage critical processes that ensure their teams are well-prepared to deliver on Exponential IT principles. ”

Each of the following ten domains in the M&G Framework is designed to help IT leaders address specific challenges, providing a roadmap for long-term, sustainable growth:

• Governance, Risk & Compliance – Includes areas such as business continuity management, internal controls, risk management, and business value maximization.
• Strategy & Innovation – Encompasses IT innovation, stakeholder alignment, IT strategy, and quality management.
• Project & Portfolio Management – Covers IT portfolio management, project management, and organizational change management.
• Enterprise Architecture – Includes service management and IT product management.
• People & Leadership – Features talent management, leadership culture and values, knowledge management, and IT organizational structure.
• Data & Artificial Intelligence – Includes data governance, AI strategy, data development and integration, as well as data insights and analytics.
• IT Financial & Vendor Management – Covers resource management, vendor portfolio management, and vendor performance management.
• Security & Privacy – Focuses on security operations, identity and access management, as well as privacy program management.
• Infrastructure & Operations – Includes cloud management, change and release management, and service desk operations.
• Applications – Focuses on application strategy, requirements gathering, application portfolio management, and app maintenance.

Hakimian’s keynote at LIVE 2024, which was presented on the second day of the three-day conference, emphasized that IT leaders are at the helm of their organization’s journey into Exponential IT – a future where technology evolves rapidly and exponentially, demanding that IT departments adapt, innovate, and lead. The new M&G Framework is a direct response to these demands, providing CIOs with the foundation to not only meet today’s challenges but thrive in tomorrow’s exponentially digital landscape.

Built specifically for CIOs and senior IT leaders, the M&G Framework provides a roadmap to not only improve IT performance but also raise the profile of IT within the broader business context. By standardizing processes, improving leadership capabilities, and driving accountability, CIOs can ensure their IT organizations are aligned with overall business strategy and capable of delivering exceptional results.

For more detailed information on the ten domains and each of the elements within them, visit Info-Tech’s Management & Governance page .

For media inquiries, including requests for interviews with featured speakers and experts at LIVE 2024, or for access to session recordings and additional content, please contact [email protected] . For conference-related press releases and images, please visit the online Info-Tech LIVE 2024 Media Kit .

About Info-Tech Research Group

Info-Tech Research Group is one of the world’s leading research and advisory firms, proudly serving over 30,000 IT and HR professionals. The company produces unbiased, highly relevant research and provides advisory services to help leaders make strategic, timely, and well-informed decisions. For nearly 30 years, Info-Tech has partnered closely with teams to provide them with everything they need, from actionable tools to analyst guidance, ensuring they deliver measurable results for their organizations.

To learn more about Info-Tech’s divisions, visit McLean & Company for HR research and advisory services and SoftwareReviews for software-buying insights.

Media professionals can register for unrestricted access to research across IT, HR, and software and hundreds of industry analysts through the firm’s Media Insiders program. To gain access, contact [email protected] .

For information about Info-Tech Research Group or to access the latest research, visit infotech.com and connect via LinkedIn and X .

Media Contact

Sufyan Al-Hassan, Senior PR Manager

Info-Tech Research Group

[email protected] | +1 (888) 670-8889 x2418

To speak to one of our Analysts, Contact Info-Tech Public Relations [email protected] OR CALL US: 1-888-670-8889 Canada: 1-844-618-3192 International: +1-519-432-3550

Please confirm the appointment time and click Schedule.

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Catalysing Environmental Action: a Governance Framework for Enhancing Individual Participation in Sub-Saharan Africa’s Plastic Circular Economy

• Open access
• Published: 17 September 2024

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• Ambisisi Ambituuni   ORCID: orcid.org/0000-0002-2803-2528 1 ,
• Olubunmi Ajala 2 ,
• Patrick Schroeder 3 &
• Muyiwa Oyinlola 4  

Plastic waste poses a significant challenge to achieving sustainable production and consumption of resources, particularly in sub-Saharan Africa where effective governance and waste management systems are lacking. In this paper, we develop an empirical understanding of the influence of public governance system on promoting circular economy (CE) for plastic actions among individuals. Through a survey of 1475 participants across five sub-Saharan African countries, we tested five hypotheses drawing on New Governance Theory and CE Action Recipe to explore the relationship between governance and individual’s actions supporting CE for plastic. We found that a governance system that supports CE practices and exhibits governance efficiency is positively associated with individuals’ actions supporting CE for plastic. The awareness of government policies, laws and regulations, institutions, processes, and programmes have a significant impact on individuals’ engagement in plastic circularity practices. The paper’s theoretical and governance implications highlight the relevance of public governance in shaping action towards a CE for plastic at the individual level.

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Introduction

The challenges of plastic waste remain an obstacle to the attainment of several UN intersecting sustainable development goals (SDGs) (Schroeder et al. 2019 ; Ayeleru et al. 2020 ; Kan and Miller 2022 ). The issue of plastic waste management has international and local implications (Sebille et al. 2015 ; Tulashie et al. 2022 ). Geyer et al. ( 2017 ), for example, estimates that globally, over 8300 million metric tons (Mt) of virgin plastics have been produced to date. As of 2015, approximately 6,300 Mt of plastic waste had been generated, of which only about 9% was recycled, 12% was incinerated, and 79% was accumulated in landfills or the natural environment. The volume and longevity of plastic waste coupled with a lack of effective public governance and waste management systems make the problem even more complex in developing countries, particularly in sub-Saharan Africa (SSA) (Adebiyi-Abiola et al. 2019 ; Ncube et al. 2021 ; Debrah et al. 2022 ; Chiaroni et al. 2022 ). While current per capita plastic consumption levels are comparatively low in SSA, the anticipated growth in plastic consumption necessitates forward-looking planning to address the challenges of plastic waste (UNEP 2018 ).

In recognition of the negative impact of the linear economy of “take, make, dispose” there has been an increase in research on the transition to circular economy (CE) as a solution to the problem of plastic waste (Geissdoerfer et al. 2017 ; de Jesus and Mendonça 2018 ; Mayer et al. 2019 ; Lee et al. 2021 ; Cramer 2022 ). We define CE as the concept of a cyclical, closed-loop, regenerative system where resource input and waste, emissions and energy leakage are reduced, and redesign and reuse of products are prioritised (Murray et al. 2017 ; Kirchherr et al. 2017 ; Liu et al. 2018 ; Beheshti et al. 2023 ). For plastic waste, a circular system ensures that the value of products, materials and resources is maintained in the economy for as long as possible (Merli et al. 2018 ).

The analysis of how to govern the transformational change from the present, mainly linear economy to a CE is being pursued by two main approaches. The first and widely researched is the network governance approach which involves collaboration among stakeholders who are keen to contribute to transformational change (Chembessi et al. 2021 ; Cramer 2022 ; Foraste 2023 ). This approach to CE leverages the collective knowledge, resources, and capabilities of the network to drive change, promote innovation, and create shared value (Ddiba et al. 2020 ). But the network governance approach can be constrained by power dynamics within collaborative networks, lack of accountability and public participation, poor information sharing framework, and the inability to scale and replicate of networks (Joshi et al. 2019 ; Ayeleru et al. 2020 ; Rótolo et al. 2022 ). The second governance approach is the public governance approach to CE (Fitch - Roy et al. 2020 ; Wu et al. 2021 ; Mihai et al. 2022 ; Cramer 2022 ). The pubic governance approach represents the conventional role of government as the guardian of the common good (Cramer 2022 ; Hu et al. 2024 ). This approach applied to the CE for plastic aims to manage and regulate the production, use, and disposal of plastic materials through policies, regulations, and public institutions to promote sustainable consumption and production and reduce waste to a minimum The limitations of the public governance approach have been reported in the literature and include poor regulatory regimes, insufficient CE infrastructure, poor public awareness and participation, and limited market and financial barriers (Geng and Doberstein 2008 ). These limitations are more pronounced in weak public governance contexts such as those found in many SSA countries (Godfrey et al. 2021 ; Essien and Spocter 2023 ).

However, across the literature on both the network and public governance approaches, the emphasis is on how CE is applied in business and policy-making (Spekkink et al. 2022 ), and surprisingly, we noticed the absence of empirical research that addresses the interaction between CE governance and citizen’s individual actions particularly as it relates to issues of plastic waste. Even where indicative research exists, these only provide collective action perspectives in the context of organised citizen initiatives (Smith and Seyfang 2013 ; Smith et al. 2014 ; Hossain 2016 , 2018 ), social innovation (Pel et al. 2016 ; van der Have and Rubalcaba 2016 ; Loorbach et al. 2020 ) and digital ecosystem in controlling plastic waste (Khatami et al. 2023 ). These studies do not explore in-depth how an individual’s CE actions can be shaped by public governance or what public governance aspects motivate CE behavioural changes within individuals in their daily lives (Isenhour and Reno 2019 ; Temesgen et al. 2021 ). By overlooking this critical building block of social considerations, CE research has been criticised for being overly optimistic regarding the capacity of society to integrate government policies (Calisto Friant et al. 2020 ).

Addressing the gap in literature on the intersection between public governance approaches and individual’s actions as consumers is particularly important for the CE for plastic for two reasons. First, large volumes of plastic waste emanate from individuals as consumers (Hage 2007 ; Geyer et al. 2017 ; Mallick et al. 2023 ). The transition from a linear model to a CE, particularly in weak public governance contexts such as those found in many SSA countries (Grant and Oteng-Ababio 2021 ), strongly depends on the conduct of individuals (Ncube et al. 2021 ), some of whom are indigenous and institutionalised within informal settings (Oduro et al. 2021 ; Essien and Spocter 2023 ). Broadly speaking, the effectiveness of CE strategies for waste management in general hinges on a symbiotic relationship between public governance and individual responsibility (van Weelden et al. 2016 ; Parajuly et al. 2020 ). Public governance approaches, including policy-making, regulation, and infrastructure development, provide the necessary framework for implementing CE practices (Kharola et al. 2022 ). However, these approaches must be complemented by active participation from individuals (e.g., exploring reuse options, selling second hand, returning instead of stockpiling, and recycling instead of wrongly discarding), who are the primary agents of consumption, waste generation and CE (van Weelden et al. 2016 ; Oteng-Ababio). Second, circularity of the plastic value chain is about ensuring circular flows of plastics resources by closing the loop between post-use and production (Chiaroni et al. 2022 ). To close this loop and prevent plastic waste and leakage into the environment, an individual’s actions need to be aligned with the concept of circularity, and this alignment happens in the context of public governance and regulatory initiatives (or lack thereof). Hence, we set out to address this knowledge gap and respond to the call in literature of the need to understand the enabling factors for the diffusion of CE (Kirchherr et al. 2017 ; Schr ö der et al. 2019 ; Chiaroni et al. 2022 ; Cader et al. 2023 ), particular the factors that motivate an individual’s action supporting a CE for plastic as they intersect with governance frameworks (Zink and Geyer 2017 ; Corvellec et al. 2022 ; Spekkink et al. 2022 ). We argue that even though our research is focused on plastic CE, understanding the dynamics of the relationship between individual’s CE actions and governance and regulatory initiatives (or lack thereof) has broader CE implications for waste management in general. This is because both a CE and waste management systems must integrate individual actions with governance structures to create a cohesive approach to resource utilisation and waste reduction (Salvia et al. 2021 ).

The aim of this paper is to explore the enabling factors for the diffusion of the governance of plastic CE, specifically, the focus is on understanding the motivations behind individuals’ engagement in plastic CE actions and examining how these motivations intersect with the context of public governance. Hence, we ask: what public governance aspects motivate plastic CE practices and actions in individuals within weak public governance contexts such as those found in many SSA countries ? To address this question, we developed and tested 5 hypotheses using survey data from 1475 participants across 5 SSA countries. The focus of the SSA context is deliberate as many. Many SSA countries exhibit weak waste management and public governance structures (Sibanda et al. 2017 ; Salvia et al. 2021 ) despite the opportunities of propagating CE practices with economic benefits (Zapata Campos and Zapata 2013 ). Hence, this context presents unique challenges and opportunities for understanding how governance frameworks can influence individual actions towards plastic CE, and to uncover how individuals’ motivations and actions can contribute significantly to CE practices despite the lack of strong regulatory support. The high levels of plastic waste generation, and the environmental challenges from inadequate waste management infrastructure also makes the region an urgent area of study for CE transition strategies (Adebiyi-Abiola et al. 2019 ; Debrah et al. 2022 ; Chiaroni et al. 2022 ). The findings from SSA contexts can, therefore inform policy development within the region and in regions with similar governance challenges across the global south.

Our results show how CE governance systems including codified policies, laws, and regulations, shape individual behaviours and influence their adoption of plastic circularity practices. The ability of governance system to achieve its objectives in the most effective and resource-efficient manner also plays a critical role in promoting the overall plastic CE in SSA. Our results also suggest that as the Individual Factor (which includes concern about plastic waste, willingness to take action, and a sense of environmental responsibility) increases, so does the likelihood of an individual taking action towards CE for plastic. Hence, we develop an empirical understanding of the role of governance in promoting plastic CE actions at the micro individual level, with theoretical and governance implications.

The rest of the paper is structured as follows. Section 2 presents the theoretical framework and hypotheses of the paper. Section 3 presents the method whilst section 4 presents the results. Section 5 discusses the theoretical and governance implications and finally, section 6 discusses the conclusion and limitations of the paper.

Theoretical Framework and Hypotheses Development

Two analytical approaches to the implementation of CE exist in literature. The first approach focuses on macro-level strategies (Yuan et al. 2006 ; Geng and Doberstein 2008 ). Here, CE is adopted at an administrative and policy level such as country, region, or city and follows a top-bottom approach to CE. The micro-level of analysis, on the other hand, shifts its focus toward governance of firms and consumers and the intersections with circular behaviours, and focuses on a bottom-up approach, with the aim of spreading sustainability practices and culture among all society stakeholders (Ghisellini et al. 2016 ; Pomponi and Moncaster 2017 ). The micro-level analysis also emphasises the need to acknowledge and create sustainable patterns of consumption and production through the propagation of transformational governance in society from institutions to businesses and consumers (Sauv é et al. 2016 ; Ghisellini et al. 2016 ).

According to Lynn et al., ( 2000 p.236), governance encompasses the “regimes of laws, administrative rules, judicial rulings, and practices that constrain, prescribe, and enable government activity, where such activity is broadly defined as the production and delivery of publicly supported goods and services.” The government’s role in public governance is not a constant but a variable, given the existence of governance models ranging from state-centric to more society-centred approaches (De la Mora-De la Mora 2023 ). The ‘old’ governance embodies the traditional notion of top-down steering by national governments, and emphasises the extent of control the government can exert over social and economic activities (Kjaer 2004 ). In contrast, the ‘new’ governance is characterised by increased interactions between the centre and society as underpinned by the new governance theory (Rhodes 1996 )- often involving more self-steering within networks and individual actions. New governance inculcates the concept of responsibility- which is predominantly understood as a post-subjectivist view -on responsibility that understands individualisation (Shamir 2008 ; Soneryd and Uggla 2015 ). Here, institutional boundaries are blurred, and political processes socially and spatially diffuse (Lund 2006 ). In practical terms, this means that individuals, rather than solely institutions, have an important role in advancing CE practices. This role can manifest in various ways. Individuals as consumers can be encouraged to make conscious choices regarding product usage, recycling habits, and overall sustainable consumption (Van Dam 1996 ; Essien and Spocter 2023 ). They can contribute innovative solutions to enhance resource efficiency and reduce waste, and participate in community engagement, encouraging collaboration, and advocating for supportive policies that incentivise and promote circular practices.

From a post-subjective perspective, governance transcends conventional institutional structures in recognition of the agency of individuals (Ulibarri et al. 2023 ) as active contributors to the meaning-making process. It posits that the efficacy of CE governance hinges on the meaning work by individuals as actors (Benford and Snow 2000 ). Meaning work- also termed as signifying work or meaning construction- encompasses the process of shaping, sustaining, and challenging an individual’s comprehension of the world (Benford and Snow 2000 ). This involves attributing subjective meaning to objects, expressions, and actions, facilitating the intelligibility of one’s surroundings (Goffman 1974 ; Blomsma et al. 2023 ). In the context of CE, the notion of meaning work becomes relevant as it illustrates how an individual as an actor within a CE governance system is shaped by their understanding of sustainability and determines appropriate actions. Various factors contribute to the meaning-work establishing process, such as CE governance contexts, enactment, present cues, and the ability to permit reinterpretation (Weick 1995 ; Weick et al. 2005 ). Meaning work aims to organise these factors and the overall experience of the world into a coherent framework, and to determine which understandings guide actions. Ultimately, meaning work is not about revealing the objective reality but focuses on creating ‘action recipes’ by aligning past experiences, internalised concepts, and new stimuli to form a foundation for action (Blomsma et al. 2023 ).

In Fig. 1 below we build on the work of Blomsma ( 2018 ) and Blomsma et al. ( 2023 ) which is also an extension of the work of Benford and Snow ( 2000 ) by adding a CE ‘action’ element to the framework to make sense of how individuals’ behaviour intersects with plastic CE governance system and how such intersection may result in individual CE actions. At the defining a purpose stage of the action recipe framework, the focus is on the importance of effective waste and resource management, driven by the identification of problems (such as plastic pollution) or the absence of specific benefits (e.g., circularity and resource optimisation). Circular strategies are then formulated to address these issues. Subsequently, root causes are identified, linked to circular strategies, and relevant high-level actions are developed to mitigate the issue. This represents the elaboration step and can involve the establishment of a governance system that includes both codified, regulatory, and formal responsibilities, and those based instead on individual actions (Savini and Giezen 2020 ). Proaction involves the identification of actors necessary for implementing the proposed solution, along with motivations for their beneficial involvement (Blomsma et al. 2023 ). How these stages of CE action recipes are achieved is well documented in literature (see for example Blomsma 2018 ; Blomsma et al. 2023 ; Islam et al. 2023 ). But a micro level analysis is required to identify what aspects of public governance motivates action and means of ensuring individual participation in CE practices.

Theoretical conception of CE action recipe and individual action

In the context of the public governance of CE for plastic, we argue that action happens when individuals participate in CE based on their understanding of the benefits of CE. This is triggered by cues and interpretation of self-motivation, including an individual’s sense of responsibility or concern for the environment, and the interpretation formal CE public governance system (or lack thereof) (Isenhour and Reno 2019 ). For example, the plastic and solid waste management governance system in Kenya, as outlined by the National Environmental Management Authority (NEMA), aims to promote the adoption of CE practices across the municipal authorities with the support of technology technologies (Salvia et al. 2021 ). But despite the plastic bag bans legislated in Kenya in 2017, plastic bags are ever-present in markets across the country. NEMA recognises the, challenge to achieving this in Kenya, including issues related to funding, governance, infrastructure, and factors related to individual’s ability to act. It advocates for governance system that establishes a common platform for action between stakeholders to overcome these challenges with a view of waste (particularly plastic waste) as a means of job creation and economic development (Moore 2012 ; Millington and Lawhon 2019 ). The solid waste management governance system in Zambia acknowledges CE issues related to indiscriminate dumping, overflowing landfills, and the limited circularity of waste streams, including plastic waste (Clube and Hazemba 2024 ). However, despite the integration of several CE practices in the public governance framework, the predominant approach in practice remains predominantly linear (Chileshe and Moonga 2019 ; Edomah 2020 ). Delays in progress can be attributed to policy obstacles, particularly evident in issues related to ownership and coordination, poor implementation and enforcement of current laws, lack of encouragement for innovations, and a failure to integrate the informal sector (Edomah 2020 ; Fitch - Roy et al. 2021 ; Clube and Hazemba 2024 ).

In Nigeria, a public governance system specific to plastic waste management is almost non-existent, despite the over 2.5 million tonnes of plastic waste generated annually and despite Nigeria’s ranking as the ninth globally among countries with the highest contributions to plastic pollution (Duru et al. 2019 ; Dumbili and Henderson 2020 ). The broader solid waste management approach in Nigeria is hinged on the monopoly of agencies of state governments (sub-national governments) who are constrained by their lack of capacity to tackle the problems of solid waste management. This is compounded by challenges associated with insufficient financial resources; non-compliance to laws and lack of individuals’ awareness and actions to mitigate plastic pollution (Ike et al. 2018 ). The governance challenges identified in Kenya, Zambia and Nigeria emerges as cues that constraint individual action and responsiveness to the CE benefits (Romeela and Thokozani 2015 ; Ezeudu et al. 2021 ; Olabomi 2024 ). In the case of Rwanda, governance of plastic CE been found to be more focussed and includes a formal governance system based on enacted laws, useful in mobilising the individual action and participation (Essien and Spocter 2023 ). In particular the Law N° 57/2008 of 10/09/2008 relating to the prohibition of manufacturing, importation, use and sale of polythene bags. This is matched with leadership and political commitments for the reduction of unnecessary plastic packaging and products. This commitment also motivates practices for individuals to participate in the work of government via individual action that helps in the propagation of public discourse and voluntary actions towards a CE for plastic (Ogutu et al. 2023 ). But even such governance approach found in Rwanda is not immune to the CE challenges encountered in the public sector such as financial constraints, limited human resources, poor infrastructure, poor supervision etc (Awortwi 2004 ; Spoann et al. 2019 ). Consequently, many scholars have increasingly called for research to mobilise individual action toward CE (Zink and Geyer 2017 ; Corvellec et al. 2022 ; Spekkink et al. 2022 ). Hence, our theoretical framework considers the motivation that emerges when citizens as individuals intersect with public governance system (Bingham et al. 2005 ). Indicative research shows that governance system influence participation and actions towards CE (Farla et al. 2012 ; Cramer 2022 ). We, therefore, hypothesise that a CE governance system will shape an individual’s ethos of modern society, which influences their actions towards CE. Thus, the following hypothesis (H1) was postulated:

H1: There is a positive relationship between Governance System and individual’s action towards plastic CE

Beyond the availability of a public governance system is the need for governance efficiency. Governance efficiency refers to the aspects of governance that affect the effectiveness of the aforementioned governance system (Christensen 2021 ; Cramer 2022 ). Governance efficiency affects the ability of government institutions to leverage their knowledge and power to effectively formulate, implement, and monitor regulations, engage stakeholders, and allocate resources towards plastic CE practices. (Georg 2015 ; Fratini and Jensen 2017 ; Fratini et al. 2019 ). Governance efficiency builds confidence in the public regarding the implementation of efficient plastic waste management programs upon which the transition to plastic CE can be achieved. It is also important for actively engaging with stakeholders, including businesses and consumers, to promote sustainable practices (Bellezoni et al. 2022 ).

Governance efficiency is important in the creation of an enabling environment for plastic CE by providing the necessary commitment, resources, funding, and support (Araujo Galvão et al. 2018 ; Ormazabal et al. 2018 ). It ensures that institutions shape the knowledge and ideas that circulate within society, influencing how individuals and organisations understand and approach waste management and the transition to CE (Fischer and Newig 2016 ; Kanda et al. 2019 ). Because governance efficiency is essential for the effective implementation of CE governance systems, we anticipate that it affects the overall efficiency of plastic CE. When CE governance is efficient, it can effectively lead to better enforcement of regulations, effective engagement with stakeholders, and efficient allocation of resources towards sustainable CE practices, which can lead to a more efficient overall plastic CE practices. We define the overall plastic CE efficiency as the effectiveness of plastics CE framework from the combined effects of governance system that ensures efficient collection, sorting, and recycling of plastic waste (Corona et al. 2019 ; Maione et al. 2022 ), and the individual’s concern about plastic waste in their environment, willingness to act, and whether an individual feels that they are responsible for the environment (Niskanen et al. 2020 ; Calisto Friant et al. 2020 ). Hence, we state the following two hypotheses (H2 and H3):

H2: There is a positive relationship between Governance Efficiency and Governance System affecting plastic CE action .

H3: Governance efficiency positively influences the overall efficiency of CE for plastics .

Circularity emerges as a theoretically, practically, and ideologically notion (Corvellec et al. 2022 ). Norms and discourses shape the dominant ideological beliefs, values, and attitudes towards CE and influence the diffusion of CE practices (Siyambalapitiya et al. 2018 ). In SSA, for instance, the norms of circularity are entrenched in the practicality and ideology of livelihoods of indigenous communities in the form of creating regenerative systems that sustain, restore, and are respectful of the Earth (Calisto Friant et al. 2020 ). An individual’s plastic CE action can, therefore, include one or several actions such as avoiding the use of single-use plastic items, reusing plastic items, and proper disposal (Valenzuela and Böhm 2017 ; Vonk 2018 ). Given the scale of the problem of plastic waste (Geyer et al. 2017 ), individuals are concerned about plastic waste in their environment and its impact on their health. In fact, a number of variables can be associated with an individual’s circularity action. As discussed earlier, this can include an individual’s concern about plastic waste in their environment, willingness to take action and engage in plastic CE, and whether an individual feels that they are responsible for the environment (Niskanen et al. 2020 ; Calisto Friant et al. 2020 ). We called these variables Individual Factor and propose the following hypothesis (H4):

H4: There is a positive relationship between Individual Factor and an individual’s action supporting CE for plastics .

Individual Factor can affect how governance efficiency impact individual’s plastic CE action (Niskanen et al. 2020 ; Calisto Friant et al. 2020 ). The way individuals think about, value, and prioritise circularity can influence their willingness and ability to adopt CE practices (Al-Awlaqi and Aamer 2022 ). For example, indicative research shows that individuals who have a strong environmental consciousness or a deep sense of responsibility towards the environment may be more likely to engage in circular practices (Calisto Friant et al. 2020 ), regardless of governance efficiency. Conversely, even when policies and regulations are in place, individuals who do not have a strong sustainability mindset may not be motivated to engage in circular practices. Therefore, we postulate hypothesis (H 5) as follows.

H5: Individual Factor can mediate Governance Efficiency and Individual’s plastic CE action.

Research Method

Framework construct.

Our paper aims to provide empirical evidence of the enabling CE factors (Kirchherr et al. 2017 ; Chiaroni et al. 2022 ) that intersect public governance of CE and individual’s plastic CE actions (Zink and Geyer 2017 ; Isenhour and Reno 2019 ; Temesgen et al. 2021 ; Corvellec et al. 2022 ; Spekkink et al. 2022 ). Hence, we posit that two broad factors will directly determine an individual’s plastic CE action, i.e., the Individual Factor and the Governance System (Calisto Friant et al. 2020 ; Cramer 2022 ; Morseletto 2023 ; Van Opstal and Borms 2023 ). Both the Individual Factor and the Governance System are latent variables determined by a number of measurement variables. We illustrate the latent variables and our 5 hypotheses in the conceptual framework in Fig. 2 below.

Conceptual framework and hypotheses

Our construct measures an individual’s plastic CE action by their responses, i.e., if they have taken action towards plastic CE before. This forms our dependent variable with a binary outcome of “No” or “Yes”. The Individual Factor in our model is a latent variable with 4 indicators (INDF1 – INDF4). This factor assesses how concerned an individual is about plastic waste and how responsible an individual feel for the environment, both measured on a 5 Likert scale. The remaining 2 indicators under the individual factor control for individuals’ awareness of plastic waste laws in their respective countries and their willingness to take action. These are measured using binary outcome of “No” or “Yes”.

The Governance System is a latent variable with 3 indicators (GOVS1 – GOVS3). They are measured by the overall effect of plastic waste management (binary), the response to the question ascertaining if the barrier to action is related to the knowledge of CE laws, regulation and policy mandates, and the response to the question regarding the convenience of government collection infrastructure. Both questions are measured on a 5-point Likert scale. Finally, Governance Efficiency is made up of 5 indicators (GEFF1 – GEFF5). This mediator controls for the efficiency of CE in the country using responses to the question of CE efficiency, confidence in the country’s law enforcement, and political factors that incentivise plastic CE, all measured also on a scale of 1–5. The mediator also uses the indicator, asking if the government is doing enough with a binary outcome of “No” or “Yes”. Table 1 presents the snapshot of our factors, respective indicators and their corresponding survey question area. The table also presents the summary statistics of all variables in our model. Variables that are binary have a minimum value of 0 and a maximum value of 1 while other variables (Likert scale) have a minimum of 1 and a maximum of 5.

Data Collection

To test the hypotheses in our conceptual framework, we utilise Structural Equation Modelling (SEM) because it is a robust and powerful statistical tools used in CE research (Khan et al. 2020 ; Centobelli et al. 2021 ). We opted for a SEM as a quantitative approach because SEM allows us to analyse complex relationships between observed and latent variables, thereby providing a comprehensive understanding of the interactions within our conceptual framework (Hair et al. 2011 ). To achieve this, we surveyed 1475 individuals in Nigeria, Kenya, Zambia, Namibia, and Rwanda for this study because they cover a wide representation of SSA. Our choice of SSA as a geographical region is motivated by scale of the problem of plastic waste in the region and the varying levels of effectiveness of governance and waste management systems (Adebiyi-Abiola et al. 2019 ; Ncube et al. 2021 ; Debrah et al. 2022 ; Chiaroni et al. 2022 ). For instance, Nigeria, as the 9 th largest global plastic polluter, faces a considerable challenge with plastic waste, inadequate waste management infrastructure and governance systems (Ike et al. 2018 ; Ezeudu et al. 2021 ; Olabomi 2024 ). Kenya, is known for its progressive policies, but witnessed a failed comprehensive ban on plastic bags (Salvia et al. 2021 ). It, therefore, offers insights into the ineffectiveness of stringent regulations in governance context. Zambia provides a perspective from a landlocked country with unique logistical challenges in waste management amidst a rapid demographic shifts (Clube and Hazemba 2024 ). Namibia, with its low population density, presents a contrast in terms of waste generation and management practices (Kadhila et al. 2023 ; Erasmus et al. 2024 ). Lastly, Rwanda is recognised for its pioneering plastic band and effective enforcement, making it a model for policy implementation (Ogutu et al. 2023 ). Hence, by covering these five countries, we aim to capture a broad spectrum of experiences and practices in plastic waste management across SSA to ensure the generalisability and applicability of our emerging findings to other contexts similar to those within and beyond SSA.

Geographic diversity was ensured by a wide continental coverage (East, West and South); significant differences in economy size (Nigeria with a GDP of $375.8 billion versus Rwanda with a GDP of $9.137 billion) and population (190 million in Nigeria to 2.5 million in Namibia). A stratified random sampling technique (Kadilar and Cingi 2005 ) was used to select individuals across rural, peri-urban, and urban communities across the 5 sampled SSA countries to ensure representation and confidence in the collected data set. The strata were based on the living conditions (rural, peri-urban, and urban) and socioeconomic status. A door-to-door electronic structured questionnaire was designed and administered (between March - April 2021) based on the research hypotheses and literature review. The questionnaire was pretested and validated before the actual data collection. The data collection was conducted by trained field researchers who followed ethical and privacy protocols. We opted for a quantitative approach because it enables us to objectively measure and analyse the data collected from a large sample size, thereby ensuring the reliability and generalisability of our findings (Bowerman et al. 2011 ; Etikan et al. 2015 ). Quantitative methods facilitate the testing of hypotheses through statistical analysis (Field 2009 ). As opposed to qualitative methods, this allowed us to quantify the strength and direction of relationships between variables. Additionally, this approach provides the rigor needed to validate our conceptual framework and ensure that our conclusions are supported by empirical evidence (Khan et al. 2020 ; Centobelli et al. 2021 ).

Table 2 presents the summary statistics of observations in our data. The table shows the distribution by gender in which our sample is almost equally split between male and female. The distribution by age also shows that all age groups are represented, and the distribution implicitly reflects SSA demography where over 50% are below age of 35 (May and Turbat 2017 ). The distribution by education also shows that every group is represented with a fair distribution to reflect the demography in most SSA countries. The distribution by location shows that 4 countries (Kenya, Nigeria, Rwanda and Zambia) are well represented. However, Namibia still has about 6% of respondents in our data.

Data Analysis

To analyse our dataset, we utilise SEM and opted for the covariance-based SEM (CB-SEM) (Hair et al. 2011 ) instead of the partial least squares SEM (PLS-SEM) because we are interested in understanding the relationship between the governance of plastic CE and actions of individuals towards plastic CE rather than attempting to predict the phenomena (Weston and Gore 2006 ). Hence, we test our hypotheses by assessing the significance of the regression coefficient for each of the factors in relation to the plastic CE action for H1, H2 and H4. For H3 and H5, we test the hypotheses by assessing the significance of their overall coefficients (post estimation tests). We reject the implicit null hypothesis whenever the P-value of the coefficient is less than 0.05, otherwise, we fail to reject the implicit null hypothesis when the P-value is greater than 0.05.

Assessment of the measurement model

We allowed many of our variances to covary (which is one of the strengths of SEM) to satisfy the reliability of our indicator measurement. Table 3 presents other validity checks such as checking the Comparative Fit Index (CFI) of our model. A good model is expected to have a Comparative Fit Index (CFI) that is close to 1 (Kolade et al. 2022 ). Our measurement model gave 0.99 CFI. Furthermore, the CMIN/DF is expected to be less than 3 (Weston and Gore 2006 ; Kolade et al. 2022 ), our model returned 1.67.

To assess the reliability of our indicators, we compared our model to the saturated model in Table 4 . According to Anderson and Gerbing ( 1984 ) a good model should have a chi2 likelihood ratio greater than 0.05. In our case, the ratio was 0.085. Additionally, we compared the baseline model to the saturated model, where a good fit model should have a chi2 likelihood ratio of less than 0.05 (StataCorp, 2021 ). Our model reported a ratio of 0.000. Finally, our baseline comparison uses the Tucker-Lewis Index (TLI) which is a fit index commonly used in SEM to evaluate the goodness of fit of our model. TLI is also known as the Non-Normed Fit Index (NNFI). It is a relative fit index that compares the fit of the specified model to a null model (a model where all variables are uncorrelated. TLI close to 1 suggests a good fit (Hu and Bentler 1998 , 1999 ). Our model produced a TLI value of 0.98. We therefore conclude that our model’s goodness of fit is good.

Structural model and hypothesis testing

After evaluating the goodness-of-fit indexes, we tested the research hypotheses describing the causal relationships among the constructs of the structural equation model. We accept the hypotheses with positive coefficient (β) and a p-value of less than 5% or lower. A p-value of 5% or lower is often considered to be statistically significant (Greenland et al. 2016 ). The result of the hypotheses testing is shown in Tables 5 and 6 show the summary of the hypotheses and their corresponding decision. H1 is positive and significant (β = 0.5470, p  < 0.05). This means that Governance System is positively associated with plastic CE action of individuals. The implication of the result suggests that where there exists visible plastic CE government policies, laws and regulations, institutions, processes and programs, there is a significant impact on an individual’s adoption of circularity practices.

In H2 and H3, we differentiate the availability of plastic CE Governance System from Governance Efficiency and how the Governance Efficiency affect the overall plastic CE efficiency. Given that resource availability has been identified as one of the prominent barriers of propagating CE Governance System in SSA, the focus on efficiency is needed to ensure that scarce resource are effectively used in the implementation of governance system. Our analysis shows that Governance Efficiency is positively associated with the Governance System and it is statistically significant ( β  = 0.0769, p  < 0.05), therefore, H2 is upheld. H3 is also upheld (β = 0.0691, p  < 0.05) and shows that efficient governance practices play a critical role in promoting the overall plastic CE in SSA.

H4 was upheld and confirms that there is a positive relationship between Individual Factor and individual’s plastic CE action (β = 1.0316, p  < 0.05). This finding brings to focus the role of individuals as consumers and users and shows that individuals are willing to take self-motivated CE action.

H5 posed that individual factor, as a mediator, could influence the relationship between governance efficiency and an individual’s plastic CE action. Our findings show that while the correlation between governance efficiency and an individual’s plastic CE action is positive (β = 0.0246), the p-value of 0.4 makes the result statistically insignificant.

Theoretical Implications

We explore the diffusion of the CE for plastic, specifically, focusing on understanding the enablers of individual action and participation in plastic CE within the context of public governance in SSA. We draw on action recipe (Benford and Snow 2000 ; Blomsma 2018 ) and theorised new governance framework from a post-subjectivist view (Shamir 2008 ; Soneryd and Uggla 2015 ) to make sense of the important role individuals have in advancing CE practices. Our findings provide a refine understanding of extant plastic CE governance theory as it provides a micro level analysis of individuals as plastic CE actors within public governance context, closing the gap in CE literature which overlooks this dimension. This is important as plastic pollution, particularly in SSA, mostly emanate from individuals as consumers (Hage 2007 ; Geyer et al. 2017 ; Mallick et al. 2023 ), and limited availability of resource in SSA context constraints the operation of formal waste management systems (Godfrey et al. 2021 ). Hence CE public governance that motivates actions from citizens as individual consumers becomes very relevant in this context (Geng and Doberstein 2008 ; Ghisellini et al. 2016 ; Pomponi and Moncaster 2017 ).

From the results of H1, H2 and H3, our work highlights how CE governance systems including codified policies, laws, and regulations, can shape individual action and influence their adoption of plastic CE practices. The ability of governance system to achieve its objectives in the most effective and resource-efficient manner possible also plays a critical role in promoting the overall plastic CE efficiency in SSA. Efficient governance system would aim to reduce plastic waste and promote the reuse, recycling, and recovery of plastic materials through effective waste management processes, the enactment of policies that are effective and build confidence in individuals, and support the economic benefits of waste (Geng and Doberstein 2008 ; Millington and Lawhon 2019 ; Godfrey et al. 2021 ; Maione et al. 2022 ). Hence, beyond the existence of governance system, our findings show that an efficient governance system also motivates individual action towards plastic CE. This findings align with the literature focusing on CE in businesses which suggest that a governance system that support the transition to CE, motivate innovations that addresses changes and develop enabling political agendas (Farla et al. 2012 ; Debrah et al. 2022 ). For instance, as noted in the case of Rwanda, efficient governance system ensures citizen participate in community service clean-up activities known as Umuganda. This reinforce the importance of individual responsibility for waste management (Ogutu et al. 2023 ; Essien and Spocter 2023 ). In this sense, our study shows the nuanced perspective of how efficient governance system can be consider as a form of cues that facilitates (re)interpretation and establishes meaning work. The cue can emerge from the an individuals’ visibility of how government institutions utilise knowledge and power to effectively formulate, implement, and monitor regulations and engage stakeholders in the propagation of plastic CE practices. (Georg 2015 ; Fratini and Jensen 2017 ; Fratini et al. 2019 ). This influences individual action and shapes subjectivity towards plastic CE actions. Our research indicates a crucial link between individuals’ perceptions of the governance system’s efficiency and the effectiveness of their actions within the context of plastic CE. This connection highlights a fundamental aspect of the action element of the CE action recipe we introduced in theorising our research (Benford and Snow 2000 ; Blomsma 2018 ; Blomsma et al. 2023 ). It suggests that individuals are not passive bystanders subject to governance; rather, they actively engage in shaping and reinforcing governance systems (Liu et al. 2009 ; Cramer 2022 ). Once CE purpose is identified, and governance system established at the elaborative stage of the action recipe, our findings shows that the degree to which actors perceive the governance system’s effectiveness significantly influences the outcomes of their actions to participate in plastic CE (Lund 2006 ). This is useful in mobilising the action of individuals in informal setting in recognition of their supplementary CE practices and the impact they can make to waste management given the challenges faced by both private and public sector within the SSA context (Essien and Spocter 2023 ).

In H4 we test the relationship between Individual Factor and an individual’s plastic CE action. The result suggests that as the Individual Factor (which includes concern about plastic waste, willingness to take action, and a sense of environmental responsibility) increases, so does the likelihood of an individual taking action towards plastic CE. This action could include avoiding single-use plastic items, reusing plastic items, and proper disposal (Corona et al. 2019 ; Maione et al. 2022 ; Shah and Yang 2023 ). The Individual Factor essentially forms the ingredients of ‘action’ in the action recipe for plastic CE (Blomsma 2018 ; Blomsma et al. 2023 ). The concern about plastic waste in the environment can be seen as the motivation or the ‘why’ of the action. The willingness to take action and engage in plastic CE can be seen as the commitment or the ‘will’ of the action (Benford and Snow 2000 ; Blomsma 2018 ). The feeling of responsibility for the environment can be seen as the ‘moral or ethical’ grounding of the action. The actions themselves - avoiding single-use plastic items, reusing plastic items, and proper disposal - are the steps of the action recipe (Maione et al. 2022 ; Shah and Yang 2023 ). They are the practical manifestations of the Individual Factor. The positive significance of this hypothesis suggests that our theoretical conception of the action recipe can be effective when individuals are concerned, willing, and feel responsible. This finding expands the literature of environmental value and shows the importance of an individual’s concern, will, and morals on pro-environmental actions (see for example Nilsson et al. 2004 ; Shah and Yang 2023 ; Steg et al. 2011 ).

H5 add an important dimension to the action recipe argument. While the action recipe focuses on concern, will, and morals of individuals (the Individual Factor), H5 highlights the role of broader social and institutional contexts (Governance Efficiency) in influencing these factors (Ranta et al. 2018 ). Although the correlation between governance efficiency and an individual’s plastic CE action is positive, the statistical insignificance (p-value of 0.4) suggests that governance efficiency alone may not be a strong determinant of an individual’s plastic CE action. This result shows the complexity of the issue - individual actions towards plastic CE are influenced not only by personal attitudes and behaviours but also by the efficiency of governance systems and other external factors. This could mean that the effectiveness of the action recipe is contingent on the broader context within which it is applied. For instance, an individual might be willing and motivated to take action (e.g., avoiding single-use plastic items, reusing plastic items, and proper disposal), but if the governance system does not provide the necessary infrastructure or incentives, the individual might find it difficult to carry out these actions. Therefore, efforts to drive plastic CE practices must consider both the Individual Factor (concern, will, and morals) and the facilitating environment (governance efficiency and broader social and institutional contexts) (Schr ö der et al. 2023 ). By improving governance efficiency and addressing other external factors that influence action, it may be possible to create a more conducive environment for individuals to follow the action recipe. This could lead to more significant and sustained positive changes in plastic CE actions (Wang et al. 2018 ; Christensen 2021 ).

Policy Implications

In practice, our work provides important findings that can be used by policymakers for governance reforms in SSA to develop policies, laws, and regulations that support the transition to a CE for plastics. Our findings emphasise the need for an efficient CE governance system that aims to reduce plastic waste and promote reuse, recycling, and recovery of plastic materials. This can be achieved through effective waste management processes, enactment of policies that are effective and build confidence in individuals, with visible impact, and support for innovative plastic recovery processes (Georg 2015 ; Fratini and Jensen 2017 ; Fratini et al. 2019 ; Christensen 2021 ; Cramer 2022 ). But the challenge to establish an efficient governance system must be noted, particularly in the SSA context. Resource constraints and limitations in institutional capacity can all impose restrictions on the efficiency of governance systems (Awortwi 2004 ; Spoann et al. 2019 ). Therefore, it becomes crucial to tailor solutions that consider the particular ways in which CE action recipe are employed to validate the governance system(s) enacted for plastic CE. Additionally, our study show that the efficiency of governance systems alone is insufficient in addressing SSA’s plastic waste challenges, hence the need to pay attention to individual factors that motivate plastic CE. To achieve this, policymakers should leverage the concerns of individuals about plastic waste in their environment, their willingness to take circularity actions, and their sense of responsibility towards the environment, to shape policy discourse in favour of plastic CE (Valenzuela and Böhm 2017 ; Vonk 2018 ).

Conclusion and Future Research Directions

This empirical study finds that a governance system that supports CE practices and exhibits efficiency is positively associated with individuals’ adoption of actions supporting CE of plastic. Awareness of plastic CE government policies, laws, regulations, institutions, processes, and programs has a significant impact on individuals’ engagement in circularity practices. The research also shows that the Individual Factor - which includes concern about plastic waste, willingness to take action, and a sense of environmental responsibility- is positive associated with an individual’s plastic CE actions. The research highlights the relevance of public governance in shaping action towards plastic CE at the individual level. The study’s theoretical and governance implications can inform policymakers and practitioners in developing effective governance strategies and policies to drive circularity practices and address plastic waste challenges. This is particularly useful in the SSA context where resource availability has been identified as one of the prominent barriers to propagating CE.

Finally, the limitations of the study should be noted. While we mitigated some of the limitations of the door-to-door survey by providing rigorous training for data collectors and implementing a robust electronic data collection platform with geolocation, it is still possible that respondents may have provided answers they believe the interviewer wanted to hear. Nonetheless, we believe that this data collection method is best suited for collecting survey data from participants with varied levels of education involved in a technical research topic. Also, while the study provides valuable insights on the impact of public governance in shaping action towards plastic CE, this is mainly through the examination of the relationships between governance system, governance efficiency, and individual factors. It does not account for other potential factors that could also play a role, such as economic factors, technological capabilities, or social norms. Future research could consider a more comprehensive analysis that includes these additional factors. Future research should also be conducted to draw on aspects related to the plastic CE behavioural disposition including tendencies or inclinations of individuals to engage in behaviours that support the principles of plastic CE within SSA. Such research might benefit from qualitative methods that can explore in-depth aspects of an individuals planned behaviour to compliment the action recipe perspective of this paper.

Data availability

Survey data will be made available on request.

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This work was supported by the UKRI GCRF under Grant EP/T029846/1.

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Nine recommendations for the next EU Framework Programme for Research and Innovation

The SNSF makes suggestions for the new EU Framework Programme for Research and Innovation (FP10). The SNSF calls for a strong framework programme that addresses global challenges and contributes to Europe's prosperity.

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Society is currently facing major challenges, with the climate crisis, pandemics, wars and growing populism on the rise worldwide against a backdrop of increasing geopolitical tensions. It is therefore important to set the course for the future with the next EU Framework Programme – the world's largest research and innovation funding programme. The current Horizon Europe Framework Programme runs until 2027.

With its position paper, the Swiss National Science Foundation (SNSF) is contributing to the shaping of the next EU Framework Programme for Research and Innovation (2028-34). It sets out the vision and expectations for FP 10 from the perspective of Swiss research funding.

Five key principles

The position paper defines five principles for the development of the next EU Framework Programme for Research and Innovation. Excellence should be the main criterion for research funding, in line with the Excellence Model of the Swiss National Science Foundation and the principles of the Coalition for Advancing Research Assessment (CoARA). The Framework Programme should promote diversity in the European research landscape and continue the path of Open Science already taken in the previous Framework Programme. As openness is crucial to the success of science, the Framework Programme should foster the global exchange of knowledge and ideas. Restrictions to this principle should be limited to highly sensitive topics and to cases in which cooperation is contrary to European values and principles. The Framework Programme should promote dialogue and cooperation with the public and with politicians in order to develop solutions to future challenges and seize opportunities. Last but not least, the Framework Programme should be based on values such as academic freedom, institutional autonomy and the principles of research ethics and integrity in all areas of the scientific process.

Nine recommendations

For the next EU Framework Programme to be ambitious and effective, the SNSF recommends:

• Strengthening global perspectives on research and innovation FP10 should adopt an ambitious strategy for global cooperation based on common principles and values.
• Reinforcing a multidimensional approach to sustainability A holistic approach to sustainability should be developed with investments at all levels and in all areas of research. This includes strengthening the dialogue between society and science, promoting inclusion and supporting the financial sustainability of projects and project partners.
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Next-Generation Management & Governance Framework Unveiled at LIVE 2024 Conference Will Empower IT Leaders in an Era of Exponential IT

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Sep 19, 2024, 11:36 ET

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Launched during a keynote at Info-Tech Research Group's LIVE 2024 IT conference, hosted at the Bellagio in Las Vegas , the firm's updated Management & Governance (M&G) framework now encompasses 50 comprehensive capabilities designed to help CIOs systematically improve core performance and elevate the role of IT in an Exponential era.

TORONTO , Sept. 19, 2024 /PRNewswire/ - Info-Tech Research Group has introduced its next-generation Management & Governance (M&G) Framework at its LIVE 2024 IT conference. Presented by Jack Hakimian , Senior Vice President of Research and Advisory, the new M&G Framework delivers a comprehensive, structured view of IT capabilities across ten critical domains. It is articulated around a forward-looking view of the world, where exponential technologies transform businesses and organizations. This framework gives CIOs and IT executives the tools to deliver on growing organizational expectations by aligning their initiatives with business objectives, driving innovation, and systematically improving IT performance.

Unveiled during Hakimian's featured keynote at LIVE 2024, IT Management & Governance: The Next Evolution , the updated M&G Framework is built to help IT leaders navigate the complexities of Exponential IT, where rapid technological advancements demand greater agility, maturity, and foresight. This next-generation framework enables IT executives to not only partner effectively with the rest of the organization but also to lead the technological transformation and become drivers of business growth.

"As disruptive technologies like generative AI radically transform how businesses operate through the autonomization of business capabilities, the role of IT needs to expand beyond its traditional boundaries,"  says Jack Hakimian , Senior Vice President of Research Development. "This M&G Framework and our derived diagnostic tools and blueprints give IT executives the means to assess and enhance their core processes, helping them transition from operational management to strategic leadership in their organizations."

The latest version of the firm's M&G Framework reflects the evolving challenges that IT organizations currently face, including the need for rapid innovation, effective risk management, and the elimination of silos within IT departments. With 50 interconnected processes spanning key domains such as Governance, Risk & Compliance, People & Leadership, Data & AI, as well as Security & Privacy, the framework equips CIOs with a comprehensive view of the capabilities needed to elevate their IT teams from tactical executors to strategic enablers.

Info-Tech's newly unveiled M&G Framework update focuses on helping IT leaders execute the following for their organizations:

• Break down silos  and foster a more integrated approach to IT operations.
• Assess process maturity and assign ownership to ensure accountability.
• Align IT strategy with business goals , positioning IT as a key driver of organizational success.
• Elevate leadership capabilities across the IT function, ensuring that all domain leaders operate under a standardized management and governance framework.

" The M&G Framework enables CIOs to transform their IT organizations into cohesive, efficient units capable of driving value across the business ," explains Hakimian. "Using the structured, data-driven approach that we've proposed, IT leaders can address capability gaps and manage critical processes that ensure their teams are well-prepared to deliver on Exponential IT principles. "

Each of the following ten domains in the M&G Framework is designed to help IT leaders address specific challenges, providing a roadmap for long-term, sustainable growth:

• Governance, Risk & Compliance – Includes areas such as business continuity management, internal controls, risk management, and business value maximization.
• Strategy & Innovation – Encompasses IT innovation, stakeholder alignment, IT strategy, and quality management.
• Project & Portfolio Management – Covers IT portfolio management, project management, and organizational change management.
• Enterprise Architecture – Includes service management and IT product management. 
• People & Leadership – Features talent management, leadership culture and values, knowledge management, and IT organizational structure.
• Data & Artificial Intelligence – Includes data governance, AI strategy, data development and integration, as well as data insights and analytics.
• IT Financial & Vendor Management – Covers resource management, vendor portfolio management, and vendor performance management.
• Security & Privacy – Focuses on security operations, identity and access management, as well as privacy program management.
• Infrastructure & Operations – Includes cloud management, change and release management, and service desk operations.
• Applications –  Focuses on application strategy, requirements gathering, application portfolio management, and app maintenance.

Hakimian's keynote at LIVE 2024, which was presented on the second day of the three-day conference, emphasized that IT leaders are at the helm of their organization's journey into Exponential IT – a future where technology evolves rapidly and exponentially, demanding that IT departments adapt, innovate, and lead. The new M&G Framework is a direct response to these demands, providing CIOs with the foundation to not only meet today's challenges but thrive in tomorrow's exponentially digital landscape.

Built specifically for CIOs and senior IT leaders, the M&G Framework provides a roadmap to not only improve IT performance but also raise the profile of IT within the broader business context. By standardizing processes, improving leadership capabilities, and driving accountability, CIOs can ensure their IT organizations are aligned with overall business strategy and capable of delivering exceptional results.

For more detailed information on the ten domains and each of the elements within them, visit Info-Tech's Management & Governance page .

For media inquiries, including requests for interviews with featured speakers and experts at LIVE 2024, or for access to session recordings and additional content, please contact [email protected] . For conference-related press releases and images, please visit the online Info-Tech LIVE 2024 Media Kit . 

About Info-Tech Research Group Info-Tech Research Group  is one of the world's leading research and advisory firms, proudly serving over 30,000 IT and HR professionals. The company produces unbiased, highly relevant research and provides advisory services to help leaders make strategic, timely, and well-informed decisions. For nearly 30 years, Info-Tech has partnered closely with teams to provide them with everything they need, from actionable tools to analyst guidance, ensuring they deliver measurable results for their organizations.

To learn more about Info-Tech's divisions, visit McLean & Company  for HR research and advisory services and  SoftwareReviews  for software-buying insights. 

Media professionals can register for unrestricted access to research across IT, HR, and software and hundreds of industry analysts through the firm's Media Insiders program. To gain access, contact [email protected] .

For information about Info-Tech Research Group or to access the latest research, visit infotech.com  and connect via LinkedIn  and X .

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UN E-Government Survey 2024

This thirteenth edition of the United Nations E-Government Survey, released in 2024, provides a comprehensive assessment of the digital government landscape across all 193 Member States. The 2024 Survey highlights a significant upward trend in the development of digital government worldwide, with increased investment in resilient infrastructure and cutting-edge technologies. The global average value of the E-Government Development Index (EGDI) shows substantial improvement, with the proportion of the population lagging in digital government development decreasing from 45.0 per cent in 2022 to 22.4 per cent in 2024. Despite significant progress in digital government development, the EGDI averages for the African region, least developed countries, and small island developing States remain below the global average, underscoring the need for targeted efforts to bridge existing gaps.

At the local level, the Survey continues to assess city portals using the Local Online Services Index (LOSI). The LOSI findings reflect steady progress but also highlight persistent disparities between national and local e-government performance, pointing to the need for focused initiatives to strengthen digital government at the municipal level. This edition introduces the new Digital Government Model Framework, providing countries with a comprehensive road map for the effective planning, implementation and assessment of digital government initiatives. A short addendum explores the integration of AI in digital government development, emphasizing the importance of maximizing benefits and minimizing risks to achieve balanced governance.

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• Chapter 1 : A Digital Government Model Framework for Sustainable Development
• Chapter 2 : Global Trends in E-Government
• Chapter 3 : Regional E-Government Development and the Performance of Country Groupings
• Chapter 4 : Local E-Government Development
• Addendum on Artificial Intelligence and Digital Government
• Full report and Annex (print version)
• Technical Appendix (print version)

This publication is currently available only in English. Translations into other official UN languages (Arabic, Chinese, French, Russian, and Spanish) are in progress and will be posted as soon as they become available.

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Global Launch Materials – 17 September 2024

• Click here to view the E-Government Survey 2024 Press Release
• Statement by Mr. Navid Hanif, Assisstant Secretary General (ASG), UN DESA
• Presentation by Mr. Vincenzo Aquaro, Chief, Digital Government Branch, DPIDG/UN DESA
• View the 2024 United Nations E-Government Survey Global Launch Event on UN Web TV on-demand

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National e-government toolkit.

This toolkit equips you with the knowledge and resources to improve online public service delivery in your jurisdiction. Through clear guides, insightful examples, and practical tools, you'll gain the skills to deliver efficient, inclusive online services for all. You'll become an OSI Expert, learning about each component from institutional framework to technology, participation, service and content provision, as well as the e-government literacy subcomponent of HCI. Discover how to leverage technology and best practices for effective service delivery, while understanding how improved e-government drives progress towards SDGs and national development objectives.

Local E-Government Toolkit

The learning outcomes of this training toolkit address common challenges in implementing and improving government capacities for inclusive and effective local e-government. Designed to overcome these barriers, the toolkit fosters a more effective realization of LOSI (Local Online Services Index) components. It focuses on developing skills to deliver efficient, inclusive online services, becoming proficient in OSI and HCI components, and understanding the link between e-government and sustainable development. By mastering these areas, participants contribute to the attainment of SDG11 for Sustainable Cities and Communities.

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Possibility of the optimum monitoring and evaluation (M&E) production frontier for risk-informed health governance in disaster-prone districts of West Bengal, India

• Moumita Mukherjee 1 , 2 &
• Anuj Batta 3 , 4  

Journal of Health, Population and Nutrition volume  43 , Article number:  148 ( 2024 ) Cite this article

Metrics details

An efficient M&E system in public healthcare is crucial for achieving universal health coverage in low- and middle-income countries, especially when the need for service remains unmet due to the exposure of the population to disaster risks and uncertainties. Current research has conducted exploratory and predictive analyses to estimate the determinants of sustainable M&E solutions for ensuring uninterrupted access during and after disasters. The aim was to estimate the efficiency of reaching a higher M&E production frontier via the Cobb‒Douglas model and stochastic frontier model as the basic theoretical and empirical frameworks. The research followed a deductive approach and used a stratified purposive sampling method to collect data from different layers of health and disaster governance in a flood-prone rural setting in the Malda, South 24 Parganas and Purulia districts in West Bengal, India. The present mixed-method study revealed multiple challenges in healthcare seeking during disasters and how a well-structured M&E system can increase system readiness to combat these challenges. The stochastic frontier model estimated the highest M&E frontier producing the most attainable M&E effectiveness through horizontal convergence between departments, enhanced coordination, the availability of frontline health workers at health centers, the adoption of learned innovation and the outsourcing of the evaluation component to external evaluators to improve M&E process quality. Although the study has several limitations, it shows the potential to increase technical and allocative efficiency through building skills in innovative techniques and applying them in process implementation. In the future, research on strategy improvement followed by real-world evidence-based policy advocacy is needed to increase the impact of M&E on access to healthcare services.

Introduction

The normative approach for designing health policy directives evolved gradually in the history of healthcare economics, shifting the focus from free market solutions to altruistic solutions to correct market failures [ 1 ]. Despite the availability of effective equitable health schemes, covariate shocks such as natural disasters interrupt equitable access to healthcare, impacting population health outcomes, with greater impacts on the child population [ 2 , 3 , 4 , 5 ]. Additionally, the impact is manifold in a less-equipped, less resilient supply-side environment, aggravating poor health outcomes [ 6 , 7 , 8 ]. One major component of the strengthening health system is focusing on enhancing different elements of any select implementation, such as SMART goal setting and adopting an efficient innovative M&E toolkit [ 9 ]. Given this context, this study aims to investigate the determinants of an efficient and effective M&E system to increase the health system’s resilience and render uninterrupted services during disasters. It attempts to explore the role of resource availability, local governance and moderating catalysts to strengthen it to push the existing M&E frontier to a markedly higher but attainable level.

The impact of natural disasters on population and health is evident from UNISDR [ 7 ] and World Bank [ 10 ] reports. Over a period of two decades, natural disasters affected 4.4 billion people and killed 1.3 billion people, and the world economy incurred a $2 trillion loss. Between 1970 and 2020, natural hazards affected 6.9 billion people and killed more than 2 million people in the Asia–Pacific region, indicating that the impact intensified over time [ 11 ]. Among the different influencing factors, systemic gaps in the M&E component of social programmes eventually contribute to increasing the gaps in social achievements, leading to increased economic costs [ 12 ]. The direct economic cost of disasters is increasing to $170 billion, indicating significant concerns for policymakers [ 8 ].

Among the different types of natural disasters, floods, cyclones or heatwaves affect the health status of children living in coastal areas, riverbank regions or arid regions [ 4 ]. These events influence the population directly by increasing morbidity and mortality due to a lack of access to safe water and sanitation and indirectly by prohibiting access to health centers due to inundation or extreme heat [ 13 , 14 , 15 ]. An increase in the incidence of common ailments creates pressure on the health system with less readiness even for routine health services, contributing to disaster-led social inequity, which is a greater global health concern [ 16 , 17 , 18 , 19 , 20 ]. Under the changing climate scenario, in 2050, South Asia is expected to have 59.1 million undernourished children under the age of five, which is greater than that in any other developing region [ 15 ]. The current study explored ways to improve system readiness through sustainable M&E solutions to reduce the impact of climatic shock-induced health shocks on poor children in the exposed pockets of the three districts in West Bengal, India, and identified the determinants of an effective M&E model for strengthening governance.

Interrupted service availability during disasters increases child-specific health deprivations—mortality and morbidity—and increases vulnerability further [ 21 , 22 , 23 , 24 , 25 ]. Gaps in M&E system effectiveness through improvements in operational efficiency are considered impactful interventions, which are missing in many health system responses to disasters [ 13 , 26 ]. As reported in the literature, M&E enhances the volume and veracity of program outcomes by identifying the best resource allocation and process improvement methods, which, if replicated in other similar contexts, can contribute to greater social benefits [ 27 , 28 ]. Monitoring is an M&E component that assesses the process and outputs throughout the implementation period, whereas evaluation measures the degree of outcome achievement at different time points [ 29 ]. A lack of understanding about ex ante, ex post and intermittent analyses is responsible for the limited awareness of the importance of the effectiveness of the M&E system as a success accelerator in healthcare programmes. With respect to the efficiency gaps in the M&E component of governance, the World Bank [ 10 ] study has shown that ontological gaps in the logical framework, unskilled resource use in program implementation, and irregular periodic evaluation of performance and process are contributors to the failure of the M&E component to ensure effectiveness. Zedtwitz and Gassmann [ 30 ] inferred from their research that internationalization of the M&E component can increase the operational efficiency of the M&E system through adoption of innovation, which ultimately increases comparative advantage [ 31 ]. One study assessing the process effectiveness of a nutrition programme in Gujarat, India, revealed that 89% of frontline workers lacked orientation training, whereas another study showed that capacity building for Anganwadi workers improved performance quality significantly and contributed to programme coverage [ 32 , 33 ]. Moreover, M&E performance depends on several internal governance attributes, such as the culture of decision-making, efficiency in resource allocation, availability of skilled health human resources, and social leadership capabilities [ 34 , 35 ]. One recent study demonstrated the application of novel analytics to predict the progress and trends of certain diseases to control their spread [ 36 ]. They proposed a hybrid model combining logistic and susceptible-exposed-infectious-recovered (SEIR) models so that forecasting based on existing trends can be made with the highest accuracy [ 36 ]. If such novel and innovative concepts are adopted and analytic-driven M&E is designed, it might exponentially increase M&E effectiveness. Second, in terms of innovative monitoring systems, another study on air quality monitoring revealed that monitoring air quality during lockdowns during pandemics helped to assess how to maintain good air quality even when situations became normal. Furthermore, a study evaluating public health disaster response in North America revealed that learning from previous M&E implementation challenges is a major barrier to improving M&E effectiveness [ 37 ]. According to a set of studies, the lack of initiatives in learning from the past lessons of health response programmes during and after a disaster retards the exploration of factors that may improve process efficiency and enhance M&E effectiveness [ 26 , 37 , 38 , 39 , 40 , 41 , 42 ]. Therefore, a smart monitoring system built on lessons learned from past implementations during a disaster can help create effective policy decisions and maintain efficient service delivery learning from structured innovative monitoring systems adopted during a disaster [ 26 , 37 , 42 , 43 , 44 ].

The stochastic frontier model has been applied in the literature to determine the degree and magnitude of influence of the technical efficiency and quality dimensions of M&E systems with higher reliability and robustness [ 45 ]. Additionally, other contributors visible in different studies are the lack of initiatives and related resource allocation aimed at capacity-strengthening initiatives for community health workers [ 46 , 47 , 48 ]. Furthermore, studies adopting stochastic frontier analysis or data envelopment analysis have identified significant catalysts responsible for successfully amplifying the impact of enabling factors [ 49 ]. Among them, system strategies, along with convergent service delivery linking different line departments, are found to be significant, on the basis of which the M&E theoretical framework under exposure to covariate shocks is sometimes constructed [ 50 ]. Given the context of the present research, the stochastic frontier model is applied, and different layers of models are tested to obtain the best model with a higher level of technical efficiency where system factors are considered independent variables.

Notably, different initiatives have started to test how far an integrated M&E system can increase the efficiency of programs to enhance child health outcomes. In this process, different components include capacity building by mid-level practitioners and implementers responsible for delivering child-centric services; designing a risk and impact M&E framework for health governance; and covering preparedness, response and mitigation components in health disaster management plans. This comprehensive plan aims to ensure child-specific healthcare services during disasters and reduce the defaulter rate. In this process, an integrated M&E system must be tested with periodic spatial and temporal analyses of child-specific indicators to inform the system of risk to fill the service delivery gaps. Therefore, a comprehensive situation analysis becomes a prerequisite before developing a context-specific M&E model for designing specific indicators and testing its feasibility, and the current study makes little effort in this direction.

According to the Intergovernmental Panel on Climate Change [ 51 ], to reduce the severity, interconnectedness, and irreversibility of the impacts of climate change, risk-informed institutions are necessary to help in the adaptation process, reducing exposure to risk and vulnerability to climate events. Enhanced M&E output adds to the adaptation process, further increasing coping ability and system resilience to combat shocks. Climatic and nonclimatic drivers influence the severity of child-centric health service delivery, affecting supply-side performance and the community's responsiveness to policies and programs [ 52 ]. The evidence suggests that community inclusiveness increases in an efficient supply-side environment, ensuring return on investment in child-centric services [ 52 ]. Effective management through the production of an ideal quantity of M&E output with quality has become a threshold standard for ensuring the improvement of development indicators in vulnerable geographical pockets [ 16 , 35 , 53 ].

Given this context, the current research objective is to conduct a situation analysis to estimate the risk-informed M&E production frontier with the least inefficiency after identifying the supply-side vulnerabilities and risks in accessing child health services. This objective is to satisfy the goal of increasing the elasticity of service effectiveness by reaching a higher M&E frontier in three of the disaster-prone districts in West Bengal, India.

Therefore, reducing the social and economic costs of targeting implementation gaps during disasters is crucial [ 8 ]. In such circumstances, the potential of strengthening M&E is less realized with suboptimal capabilities, as is the case for other developing counterparts worldwide [ 9 , 60 , 61 , 62 ]. Exploring the determinants of M&E effectiveness is the step in formulating the pathway of periodic risk and impact analysis to strengthen the M&E system. The three districts in West Bengal State of India considered in this study—Malda, South 24 Parganas and Purulia—are in such a vulnerable pocket; thus, periodic climate risk and impact analyses are needed to ensure service delivery during and after the occurrence of natural hazards. Therefore, exploring the factors affecting M&E effectiveness when designing a framework for periodic climate risk and impact analysis is needed to increase health system readiness.

The Smart Art of Literature Summary.

Methodology

Smart art methodology chart

Study area and population

West Bengal is situated on the east and stretches from the mountains to the sea. West Bengal is divided into five administrative divisions, Burdwan, Jalpaiguri, Presidency, Medinipur and Malda, which are further divided into 23 districts. The region is very distinct from hills to the riverine delta.

The state has a total area of 88,752 square kilometers, is the 14th largest in terms of area, is home to nearly 92 million people and is the 4th most populous state in India. It is the second most densely populated area, with a population density of 1028 people per square kilometer. The population of West Bengal increased from 80.2 million in 2001 to 91.3 million in 2011, accounting for 7.5% of India’s total population. The child population (0–17 years) constitutes 33 percent of the total population (29.9 million), and adolescents (10–19 years) constitute 20 percent (18.2 million). It is predominantly rural in nature, with almost 32% of the urban population being in the 4th highest urbanized state in India. The Schedule Caste (23.5%) and Schedule Tribe (5.8%) are the major socially marginalized groups in the state. The sex ratio in West Bengal between 2001 and 2011 increased from 934 females per 1000 males to 950 females per 1000 males. Although the literacy rate improved from 69.0% in 2001 to 76.3% in 2011, the female literacy rate was lower than the male literacy rate by 11% points [ 63 ] (Table  1 ).

The demographic profiles of the population in the study districts are presented along with the state- and country-level figures. The percentage of the female population is almost identical and less than 50% of that of the male population across the districts. A little heterogeneity is evident with respect to the child population; however, the sex ratio depicts a similar pattern of male‒female distribution as that reflected in the adult population. The percentage of the socially marginalized population is much greater in South 24 Parganas and Purulia and is greater than the state average. The female literacy rate is higher for South 24 Parganas. The unemployment rate is very high across districts.

Data collection

The study involved a desk review of the literature on the current health status of children and their access to healthcare during normal times vis-à-vis disaster time in the district of concern to design the instruments under a mixed-method approach following positivism and critical realism philosophy. A review of the literature was conducted as background research for the main primary study. The research databases searched included ProQuest and Google Scholar with filters for the last five years; public healthcare; journal articles; and the English language. The search terms used were as follows: monitoring and evaluation in healthcare, sustainable healthcare, healthcare for disaster management, healthcare efficiency, healthcare effectiveness, disaster management healthcare, monitoring and evaluation, flood areas, stochastic frontier model, social and economic cost for disaster management, Cobb‒Douglas model, child health, and public healthcare for disaster management. The results indicated that there were slightly more than 400 conference and journal articles in the first stage. However, to maintain the quality of the articles, the search was limited to journal articles, which resulted in 296 journal articles. Among those 296 journal articles, 46 were included because of their relevance to the current research.

The study followed a stratified purposive sampling procedure to create a sample of respondents. The community development blocks are stratified by the degree of vulnerability according to the exposure to disaster, namely, more vulnerable, moderately vulnerable and less vulnerable, by collecting information about the impact on sector-specific indicators. Service providers are purposively selected from the block-level governance of select blocks. The quantitative data are collected via a structured questionnaire, and at the block level, officials who are interviewed face-to-face individually are selected:

Block Medical Officers, Health (BMOH) from the Department of Health and Family Welfare (DH&FW);

Child development project officers (CDPOs) and block welfare officers (BWOs) from the Department for Women and Child Development (DWD&CD);

Block Disaster Management Officers (BDMO) from the Department of Disaster Management and Civil Defense (DM&CD);

School inspectors (SIs) from the School Education Department (SED) and assistant engineers (AEs) from the Public Health Engineering Department (PHED).

The participants were interviewed to identify programme implementation-related challenges due to the occurrence of hazards to assess the barriers to service delivery at all levels of governance due to floods. In each of the districts, 60 to 75 officials from the selected departments are engaged through departmental convergence to ensure uninterrupted delivery of healthcare services to the children during the disaster. Among them, 10 CDPOs, 10 BDMOs and 10 BMOHs, 10 SIs, and 5 other officials, such as AE, BWO and SBCC workers, were interviewed from each of the 3 districts to assess the research issue, and a total of 112 interviews were successful.

Smart art: conceptual and analytical framework

The collected data are preprocessed via Stata 14.0. The data wrangling steps include normalization and missing value handling. The internal consistency between the items used to create the variables is tested via Cronbach’s alpha test on the items constituting the governance variables. The Cronbach’s alpha values revealed that almost all the variables, except Diversity in Connectivity, exhibited greater consistency among the items composing the variable (Table  2 ). The estimated stochastic frontier models have undergone different postestimation techniques, namely, the likelihood ratio (LR) test, efficiency test (AIC) and consistency test (BIC). STATA 14.0 was used for the econometric analysis of the quantitative data. Bivariate and multivariate analyses were performed to explore the research objectives.

The study contributes to the strategic management of implementation programmes at the block level of governance in 3 select disaster-prone districts in West Bengal, India. The findings will help to build and maintain an integrated M&E system to ensure child-centric health and nutrition services during disasters. It helps block-level governance identify how far vertical and horizontal departmental integration, learning and adaptation of innovation and, to some extent, timely outsourcing of select M&E components are the determinants of a successful and effective M&E system to run uninterrupted services. The goal is to reduce child mortality, malnutrition and morbidities in vulnerable populations.

Context of child health outcomes—associated risks due to gaps in healthcare access in West Bengal and in the study districts

According to the findings of the National Family Health Survey 5 (IIPS, [ 2 ]), the percentage of respondents who had four or more ANC visits was 75.8%, which is higher than the state average in Malda and South 24 Parganas and profoundly low in Purulia. Moreover, most of them visit from the first trimester (72.6%), indicating improvement in coverage of full antenatal care services in the state, where similar patterns, such as full ANC check-ups, are visible across the study districts (higher than the state average in Malda and South 24 Parganas and lower in Purulia). In contrast, PNC check-ups are lower in Malda, such as in the Purulia district, than in the state average. The percentage of women who had a live birth in the five years preceding the survey and who received a postnatal check within two days of birth for their most recent birth was 68.0%. A total of 91.7 percent of deliveries in a health facility cover both private and public facilities, and approximately 3 out of 4 institutional deliveries have taken place in public facilities. Although the rate of institutional delivery was greater at the state level than at the district level, the opposite scenario is evident with respect to delivery in public facilities, which was surprisingly greater in Purulia. The percentage delivered with assistance from health personnel was 94.1%, which was lower in Malda than in the state and other district averages under study, revealing similar patterns, such as PNC uptake—reflecting a shortage of skilled health workers leading to less access to their service in terms of availability, which demands further research. Among women who had a live birth in the 5 years preceding the survey for the most recent birth that was delivered in a public health facility, the average out-of-pocket expenditure per delivery in a public health facility was Rs. 2683 and is comparatively lower in Malda district. The percentage of children (12–23 months) who were fully vaccinated before the survey (according to a vaccination card or the mother's recall) was 87.8%. The percentage who received the most vaccinations in a public health facility was 96.3% in the state. Immunization uptake was greater in South 24 Parganas than in the state average (Table  3 ).

Findings from the primary study

The distribution of respondents in the three study districts revealed the highest degree of participation in Purulia, a comparatively moderate degree of participation in Malda and the lowest degree of participation in South 24 Parganas.

This study gathered information on the existing M&E structure at the governance level, the frequency of data collection and analysis for monitoring, and the nature of the evaluation conducted. Evidently, M&E activities are mostly the responsibility of block-level officials appointed as M&E personnel. According to the interviewed block representatives of governance, monthly monitoring is practiced by most of them in Purulia (83.7%), 65.7% of them in South 24 Parganas, whereas only 33.3% of the block representatives interviewed in Malda reported the practice of monthly monitoring activity. Among the representatives of Malda, more than 50% reported that they practice annual monitoring of routine services. In contrast, evaluation reflects the joint participation of gram panchayat and block-level officials, with district-specific variation in the degree of responsibility, as reflected in the study (Figs.  1 and 2 ).

Distribution of the respondents in the three study districts

District-level monitoring and evaluation system prevailing at the time of the study

Results from the stochastic frontier models (Table  4 )

The LR test results assume that Model 1 is nested in Model 2, Model 2 is nested in Model 3 and Model 3 is nested in Model 4. The P values revealed that Model 2 was better than Model 1, Model 3 was better than Model 2, and Model 4 was the best model among the four estimated models (Table  5 ). AIC tests the efficiency and has shown that Model 4 is the best finite-dimensional model with the assumption that the true (unknown) model has infinite dimensions. On the other hand, according to the results of the BIC tests of consistency, where the true model is finite, the best correct model is Model 4, which satisfies the condition that the probability of achieving technical efficiency toward the value ‘1’ increases with increasing population size.

Therefore, all the tests show that Model 4 is the best model and produces the highest level of technical efficiency. Next, the firm's degree of returns to scale in the production process is tested. Therefore, deviation from the use of constant returns to scale is not significantly different from zero (Table  6 ).

Figure  1 A shows the distributional pattern of the predicted technical efficiency of Model 1 and Model 2, and Fig.  1 B shows that for Model 3 and Model 4. It is evident that the distributions of predicted technical efficiency are right skewed in Model 1 and Model 2, which are corrected after the implementation of learning and innovation (Model 3) and partial outsourcing in the M&E process (Model 4).

In Model 1, four inputs are incorporated—health human resources, availability of medical stock and equipment, and degree of horizontal and vertical integration within the healthcare department and other line departments—to determine whether they have any significant influence on M&E performance effectiveness during or after a disaster. Model 1 shows that the availability of ANM and ASHA in health centers, the condition of the health centers due to flood exposure, and the degree of convergence between departments affect the effectiveness of the M&E system in generating smooth health care access during a disaster. As reflected in the model, the availability of ASHA and ANM in the center during a disaster and constrained working conditions in the center increase the need for integrated M&E coordination to ensure proper preparedness analysis and planning, depicting significantly greater M&E effectiveness at the 95% and 99% levels of significance, respectively. The model also reflects that ‘excellent to satisfactory’ levels of horizontal convergence in M&E activities with a team of health workers and integrated coordination between health and disaster management to prepare a joint health action plan for disaster-prone GPs (to implement in pre, during- and postdisaster situations adopting scientific risk and impact analysis techniques) significantly increase the effectiveness of the M&E system—at the 99% level of significance, with a moderate magnitude of influence on the average effectiveness. However, the influence of diversity and connectivity was not significant. The combined technical and allocative efficiency estimated from this model is 0.136 .

In Model 2 , variables representing the moderating factor set ‘efficiency of M&E strategies’ comprising ‘Learning and Innovation Development’, ‘Quality of Implementation Process', and 'Learning and Adaptation’ are included to test the second hypothesis. The capacity development of frontline workers with innovative approaches in data collection, maintenance, analysis and planning helps to sustain the contribution of the labor component significantly at the 95% level of significance. Moreover, learning and adopting the innovative M&E approach significantly increases M&E effectiveness at the 99% level. Model 2 shows that both governance factors positively but not significantly affect M&E effectiveness; the direct influence of horizontal convergence and vertical integration becomes weaker. Therefore, departmental convergence and integrated coordination affect M&E performance effectiveness through efficient M&E strategies. This is reflected through integrated learning and adaptation and shows that the combined efficiency increases from 0.136 to 0.160 .

The results improve further in Model 3, where the interaction between the adoption of learned innovation and process quality improvement is included. In other words, technical improvement in the process of risk and impact analysis, e.g., with the learning and application of analytics, is likely to strengthen the usability of the M&E system. This model shows that the significance levels of all the other model factors are confounded by the inclusion of innovative risk and impact assessment processes—more specifically, they are based on real-time evidence. It can be inferred that the impact of disasters on operational efficiency gradually weakens. This model reflects a sharp increase in efficiency from 0.160 to 0.944 .

To increase efficiency further ( Model 4), this model is tested by incorporating a new variable, outsourcing of some of the M&E components, for example, ex ante and ex post evaluations, to remove M&E operational bias and improve effectiveness. Therefore, if the implementation of periodic health risk and impact assessment is conducted with quality improvement in the M&E process and outsourcing the evaluation component to external evaluators significantly influences M&E effectiveness at the 95% level of significance, the predicted efficiency level increases from 0.944 to 0.946 ( marginally ) (Fig.  3 ).

Technical efficiency charts

In summary, the present research explored how to improve the M&E system of health service delivery in disaster-prone vulnerable pockets by adopting a convergence mode with disaster management and different line departments to ensure child-centric services. This study revealed that governance-related factors influence the achievement of the highest M&E production possibility frontier. The adoption of innovation is key to success, along with the outsourcing of certain components. It also tested ways to improve the technical and allocative efficiency of the comprehensive M&E system to push it to the highest effectiveness frontier, identifying the best possible combination of inputs. This study contributes to the theory of the M&E effectiveness strategy by applying the foundational theory of the neoclassical production function to combat system inefficiencies during any disaster. The conceptualization of a present-day implementation research problem from a neoclassical theoretical lens strengthened its root. This helps to compute robust results when a stochastic model is applied for empirical analysis. This could be termed a novel contribution of the present study, although it is small and indicative given the limited geographical focus. Future research should test this strategic model in different geographic settings as well as in different disaster contexts, such as M&E, for surveillance and pandemic management.

The current study tested how far systemic factors affect the comprehensive M&E production possibility frontier and how the levels of combined technical and allocative efficiency of an integrated M&E system can be enhanced so that the health system can reach maximum effectiveness in terms of the frontier. The stochastic frontier model thus estimated the best possible input combinations to achieve the maximum possible effectiveness (output) in controlling the impact of the disaster on health service delivery. The geographical setting selected for the primary study was three disaster-prone areas in West Bengal on the basis of the relatively high degree of exposure to risk and vulnerabilities.

To ensure health service delivery during a disaster, the Disaster Management and Civil Defense departments, which are equipped with technical assistance from an international organization, have initiated the process of developing an integrated M&E system where the selected districts are chosen as the implementation settings [ 65 , 66 , 67 ]. It comprises components to assess the risks and vulnerabilities in access, the status of service delivery gaps under exposure to risk, and how it impacts child health outcomes. The initiative aims to reduce child-specific health vulnerabilities, adjusting system risk through increasing system resilience. The current study examined how system resilience can be ensured through increasing technical efficiency in the allocation and utilization of system resources with efficient M&E strategies (integrated departmental coordination, action, capacity building and implementation). The study tested how much the initiatives help increase M&E effectiveness, measured in terms of reaching the highest M&E production possibility frontier (when technical efficiency → 1, i.e., the maximum), assuming that higher M&E performance (production) increases the resilience of the system and adjusts it to disaster risk to ensure child-specific services. The present study is a valuable addition to this initiative from the academic side, as it focuses only on the health sector.

The results of the stochastic frontier model have led to different policy dimensions. First, Model 1 shows that the implementation of integrated M&E in convergence mode has greater efficiency in terms of performing effectively. This study is in line with studies that investigated how far a nutrition programme can be successful at achieving horizontal integration with health and education [ 5 , 68 , 69 , 70 ]. Hawkes et al. [ 71 ] mentioned that these opportunities are not yet optimally utilized; therefore, the current contribution adds further. Another study exploring the impact of horizontal and vertical system coordination on the efficiency of the health system in Kenya has shown that challenges in integrated coordination increase transaction cost-reducing efficiency, which decreases the effectiveness of the health system [ 72 ]. Another study has shown that inefficient management strategies during the COVID-19 pandemic resulted in delayed health system responses, affecting health services in terms of delayed care, e.g., orthopedic and neurological surgeries in government hospitals in the West Bank of the Palestinian territories [ 73 ]. Therefore, if health system resilience is not built by correcting the weaker components of the system, service delivery can be jeopardized during any disaster.

Second, Model 2 shows that components of M&E strategic efficiency significantly facilitate sustaining the impact of the enabling input of the M&E effectiveness production function through reducing diversity elements and enhancing the connectivity elements in vertical and horizontal integration. The significance of horizontal convergence, connectivity and vertical coordination influencing M&E performance via innovation in M&E capacity building for frontline workers may be due to integrated preparedness planning at the GP level in disaster-prone areas. If it can be added to the district-level platform involving other concerned-line departments connected to child-centric healthcare services, the effectiveness of the intervention will increase, as found in other programmes [ 23 , 65 , 66 , 67 , 74 ].

The empirical model also reflects that vertical integration in governance is highly important for increasing M&E effectiveness, which is in line with the findings of a study in which the monitoring of frontline workers in Gujarat, India, was not successful at achieving results due to a lack of vertical integration in governance, as it created a less efficient frontline system [ 32 , 75 ]. However, the current study has found a solution to create effectiveness through the adoption of innovations, such as the application of analytics, to improve database management by integrating all the vertical levels, which is visible in two other studies. One study conducted in Uganda showed that improving the health system's capacity innovatively by altering and strengthening resources at integrated and connected local service delivery points increased health system performance in a sustainable manner, which is evident from the findings of the current research [ 62 ]. Another study in Nigeria exploring the impact of capacity building of health workers on program effectiveness has shown that contextually customized training materials, guided supervision, innovation in data collection and validation methods using comparable monitoring indicators improved the performance of state malaria programs under vertical integration [ 76 ].

Another study in Uganda showed that one of the most underutilized components in health systems management is the proper use of health records and that a mismatch between frontline workers’ and policy-level willingness to build technical capacities is a significant determinant of less utilization; however, such mismatch was not significantly evident in our study [ 61 ]. This indicates that the presence of system- and policy-level willingness is the primary criterion for increasing data utilization. In the absence of such information, the initiative for adopting innovation in building efficient M&E strategies will be difficult to initiate. A study in the KSA on health system transformation showed that knowledge building at the implementation level should be combined with research plans and efforts to build strong research governance, which was not tested in the current study and should be focused on the next level of research after the initiation of implementation [ 77 ].

However, studies exploring the usability of a strong M&E system as an innovative governance tool show that an integrated M&E system comprising the collection and analysis of bottom-up data and good coordination among policymakers, stakeholders and service providers foster need-driven decisions and policies that ultimately reduce the likelihood of market failure—as evident from a study that explored the capability of a monitoring system to monitor the health workforce in the German Federal State of Rhineland-Palatinate and matches the inference of the current study [ 78 ]. Therefore, it can be inferred that the success of an M&E system depends not only on the willingness of the service provider or policy maker but also on the need to integrate crucial stakeholders in the whole process, starting from the planning phase to the implementation phase, to increase its effectiveness. The current study has shown similar findings—M&E effectiveness increases with inter- and intradepartmental integration—and when innovation is adopted, health governance factors use innovation as an instrument to increase M&E effectiveness.

It is apparent that in Model 3, the incorporation of one interaction term has improved the predictability and explanatory power of the stochastic frontier model between learning and adaptation and process quality innovation. We examined whether the integrated health work force was trained with innovative technology to improve the quality of the data collection, analysis and use of data integrating the coordination between the health department and disaster management department. The results showed that the quality of the periodic child risk and impact assessment could be improved. In line with the current research, a systematic literature review exploring the barriers to and facilitators of implementing trauma-informed healthcare has shown that the perceived significance of the initiative for policymakers and implementers, flexible policy and training merged with the process of aligning changes, and user feedback analysis are the main enablers [ 34 ]. Several studies have identified the importance of the lessons learned to create efficient M&E systems and achieve effective public health responses during disasters [ 26 , 37 , 41 ]. In line with these studies, the current research has shown that improving the effectiveness is possible when learning is deployed in the process. Although the current study included implementers at the ground level, state-level policymakers are involved in the next stage of exploration.

Furthermore, according to Model 3, if the health workforce is trained on innovative concepts during capacity-building activities, the quality of implementation improves through learning, adaptation and application. Concerning the use of innovation, one mixed methods study in England assessing the fidelity of a digital health service programme to the structure specification has shown that variation in the delivery of the digital diabetes prevention programme by four different providers may influence the effectiveness of the process, which was continuously improved on the basis of user experience feedback [ 79 ]. Two recent studies have shown the relevance of adopting innovative monitoring systems and applying big data analytics [ 36 , 43 , 44 ]. They have shown how such innovation contributes to more effective informed policy decisions with higher accuracy and minimum error [ 36 , 43 , 44 ]. Therefore, further research is needed to assess how training on innovation will be procured and how fidelity to the requirements of health governance will be created to ensure an appropriate threshold of effectiveness. Thus, periodic risk and impact analysis becomes highly effective at ensuring access to services during disasters embedded in horizontal and vertical integration between and within departments.

Model 4 incorporates one variable representing the views of different stakeholders on M&E outsourcing to increase M&E effectiveness. According to the respondents, outsourcing M&E activities to external evaluators or agencies significantly increases the effectiveness of the intervention. The literature reflects differing views of outsourcing when a sector faces any disruption—whether technological, social, or natural [ 10 ]. In such circumstances, that sector designs short-term plans to resume and long-term plans for recovery to maintain service continuity sustainably [ 10 , 62 , 80 , 81 , 82 ]. Studies by Aragão and Fontana [ 80 ] explored the policy inclination to disfavour outsourcing during disruptions such as natural disasters and inferred through their study that the efficient use of outsourcing increases the likelihood of service continuity during such disruptions. However, legal and procedural factors should be investigated further to understand the comprehensive set of enablers and barriers to outsourcing affecting service continuity.

M&E skill building significantly increases operational efficiency and process quality, influencing M&E effectiveness under departmental convergence. The integrated M&E with the disaster management department jumps to a significantly higher frontier with the training and adoption of innovations. Finally, outsourcing the evaluation component can further enhance the efficiency level to reach a higher level of M&E frontiers given contextual adversities.

Study limitations

This study has several limitations. The study was limited by its very small sample size due to time, cost and mobility constraints. Second, the study followed purposive sampling to select the interviewees. However, when the study was conducted, the concept of integrated M&E was piloted in select blocks, which is one of the reasons for purposive selection. In the future, a large-scale longitudinal study should be designed to conduct a large survey covering multiple districts following a stratified random sampling procedure. Second, the analysis uses only classical approaches. No analysis has been conducted to propose a comprehensive decision support system using machine learning/deep learning algorithms. Therefore, it might lack higher predictive accuracy and precision. Future research is required to consider this dimension.

The present work adds value to the literature in many ways. These findings provide a direction for strengthening the decision support system (DSS) of integrated local governance and identifying the contextual determinants. This study fills such a knowledge gap for any social programme as visible in the literature [ 32 , 45 , 75 ]. Furthermore, to make the system more effective and accessible, each program can design an M&E DSS automating the whole process, starting from data acquisition to analytics and evaluation while considering the determinants related to the data and performing real-time analysis. This topic is under consideration for future research.

The proposed integrated process can be utilized to form a workforce team at the gram panchayat, block and district levels, and the comprehensive fully proofing M&E system can eventually be realized as a pilot. Furthermore, the collection of real-time data for developing preparedness plans can assure health service delivery during a disaster. Two connected real-time databases need to be trained via machine learning and deep learning techniques to modify the action plan regularly and guide the health workforce in disaster-prone areas. Lessons from the implementation in the form of impact evaluation are then documented and applied for further modifications and changes if needed. In the next phase, the tested model can be replicated in other similar vulnerable locations with continuous process improvements based on the user experience, ultimately reducing the impact of disasters on the health outcomes of vulnerable children.

Moreover, the development and maintenance of electronic risk and impact analysis of healthcare services in disaster-prone districts are planned after the development of technical skills among ground-level workers while setting an M&E technical hierarchy at each level of governance on the basis of learning. Continuous research at the implementation level is required to establish, test, implement and run the process cyclically so that the predicted level of M&E output can be achieved after ensuring the predicted level of technical efficiency. Further exploration is recommended to test how to minimize technical inefficiencies via the use of digital health tools to increase social benefits by reducing the cost of intervention.

Availability of data and materials

This information has been added as supplementary material.

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Acknowledgements

The authors are grateful for the support received from international intergovernmental organizations and nongovernmental organization officials to strengthen the methodology of the study given the contextual realities. Considerable support has been received from the Department for Disaster Management and Civil Defense in the districts of Malda, South 24 Parganas and Purulia of West Bengal from assistance to arrange meetings and face-to-face interviews with general logistics and effective coordination, without which data collection would not have been possible. The authors are extremely grateful to Einfach Business Analytics Pvt. Ltd., Kolkata, India, to take the initiative to conduct the research.

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Dr. Moumita Mukherjee has conceptualised the research problem, conducted review of existing literature, collected, analysed and interpreted the analysis. Mr. Batta has contributed in the methodology—conceptualising, identifying the modelling technique and helping in the interpretation. Dr. Mukherjee wrote the paper. Mr. Batta contributed in writing a part of the methodology, and in formatting the paper.

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The ethical approval is attached. The survey tool and method are designed while keeping in mind the gender and sociocultural sensitivities and rights of the respondents, not in violation of any of them. Informed consent was obtained from all the departments and the respondents before the interviews began. If any of the respondents denied replying, the interviewer stopped there and moved to the next respondent. The interviewers explained the purpose of the interviews and ensured that all the information remained confidential and was used only for the study. The personal details of the respondents are not revealed anywhere.

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Additional file1, variable description.

The variables used for testing the hypotheses via the stochastic frontier model are the availability of ASHA and ANM in the center during a disaster; the running conditions of the center during a disaster, which are based on the impact on the availability and condition of the medicine stock; the equipment, water supply, and sanitation in the center during and after a disaster; the degree of departmental convergence in decentralized governance to create a risk-informed M&E plan; the vertical integration adopted in building M&E strategies within a department for the poor and vulnerable population; and the strategic efficiency (moderating factor), which includes the technical efficiency of the strategy used—Learning and Innovation Development, Learning and Adaptation and Quality of Implementation process. The dependent variable was M&E production in the healthcare system.

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Mukherjee, M., Batta, A. Possibility of the optimum monitoring and evaluation (M&E) production frontier for risk-informed health governance in disaster-prone districts of West Bengal, India. J Health Popul Nutr 43 , 148 (2024). https://doi.org/10.1186/s41043-024-00632-1

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Research governance: ethical issues

Anne slowther.

1 Clinical Research Fellow, Ethox Centre Department of Public Health and Primary Care, University of Oxford, Oxford OX3 7LF

Petra Boynton

2 Lecturer, Department of Primary Care and Population Sciences, University College London, London N19 5LW, UK

3 Senior Research Fellow, Department of Primary Care and Population Sciences, University College London, London N19 5LW, UK

Healthcare research is haunted by a history of unethical studies in which profound harm was caused to vulnerable individuals. Official systems for gaining ethical approval for research, designed to prevent a repetition of these shameful examples, can prove bureaucratic and inflexible in practice. The core ethical principles of respect for autonomy, prevention of harm, promotion of benefit, and justice (which form the basis of professional codes of research conduct) must be applied flexibly to take account of contextual, methodological, personal and practical considerations. Ensuring that the design and conduct of all research is ethically sound is the responsibility of all involved—including researchers, research institutions, ethics review committees and regulatory bodies.

INTRODUCTION

Recognizing and responding to the ethical dimension of research is a fundamental part of the research governance process. Ethical codes of practice and regulatory frameworks reflect concern about actual or potential examples of unethical research. Translating these broad ethical principles into the specific context of individual research projects in different social and cultural settings poses challenges for researchers, ethics review committees, and regulatory bodies. 1 Concepts such as informed consent are open to interpretation and influence within specific social and political contexts. In France, for example, legal and ethical guidelines are less restrictive in relation to research on patients who lack competence than in other European countries, reflecting a cultural tradition that places more emphasis on therapeutic benefit than self determination. 2 In this paper, we explore the relationship between fundamental ethical principles, the ethics review process, and the conduct of medical research, with particular attention to the principle of informed consent.

CORE ETHICAL PRINCIPLES FOR HEALTHCARE RESEARCH

The Nuremberg Code 3 was developed in response to the medical experiments conducted under the Nazi regime. Its main focus was on protecting research participants from harm and ensuring that they had given valid consent. Other examples of potentially harmful research on participants who were not fully informed or who had no choice whether to participate 4 - 6 have reinforced the need to protect research participants from harm and obtain informed consent. These are the two core principles of the Declaration of Helsinki 7 which was developed by the World Medical Association and first adopted in 1964. Its most recent version was ratified in 2000. The Helsinki declaration, and other international codes of research, has tended to be interpreted as referring to clinical or biomedical research. In recent years there has been increasing recognition of the need for ethical regulation of other forms of research (for example in the social sciences) and of activities that have not traditionally been classified as research (such as medical audit). This reflects earlier discussion in the series regarding `what is research?', the delineation between different research-type activities and the sometimes varied application of ethical principles to these according to the label used (e.g. audit, quality improvement or research). 8 From an ethical perspective, it is the nature of the study undertaken, and the involvement of participants in the study, that generates the requirement to comply with the principles of ethical conduct, and not the label given to it. Some national and international codes of research ethics are listed in Box 1 .

National and international ethical codes of conduct in healthcare research

A third principle articulated in many ethical codes is to promote benefit. Research should benefit either research participants directly, or the wider population, and the benefit of the research should significantly outweigh the potential harm to participants. Additional ethical principles may come to light when particular examples of research practice cause concern. The principle of justice, for example, was a key concern in the debate over studies of HIV treatments in developing countries. 9 , 10 The principles of honesty and integrity (of researcher, research institution and research sponsor) were highlighted by the Olivieri case, in which a researcher was impeded in publishing her concerns over toxicity of a study drug in a trial funded by a pharmaceutical company. 11

These core principles inform the duty of care that a researcher owes to research participants, and the duty that a research institution or sponsor owes to both participants and researchers. The purpose of the ethical review process is to ensure that the researcher and research sponsor are discharging their duty of care to research participants, informed by the core ethical principles set out in the national and international codes of conduct ( Table 1 ). While the main focus of the review process is on the effect of research on the participants, there is also an ethical requirement to identify and minimize potential harm to researchers. Reports have previously documented researchers encountering physical and psychological harm during the research process. 12 , 13 This includes risk of exposure to disease, 14 distress, or physical and emotional abuse from participants, carers or colleagues. 15 Whilst some types of fieldwork have rightly been identified as `dangerous', 12 , 13 risk and harm to researchers may also arise in areas considered `safe' 13 and through coding or analysing data that concerns sensitive issues. 16 Researchers from ethnic or sexual minorities or who are untrained or inexperienced may be particularly vulnerable, 11 , 14 and in many cases researchers are offered little in the way of protection. 15

Mapping ethical principles onto a research ethics application form using the standard UK form as an example

BALANCING BENEFITS AND RISKS

A key requirement of ethical codes is that the importance of the research objective is in proportion to the inherent risk to the participant. In a clinical trial, there is a potential direct benefit to some research participants (for example, the opportunity to take a new, highly effective medicine that is not yet licensed for general use). But a clinical trial would be unethical in the absence of clinical equipoise (i.e. if the researchers knew beyond doubt that the drug was more effective than other interventions, they would not be justified in withholding it from half the participants). What the participant is being asked to do is share in the uncertainty (they might gain some benefit—but they might be randomized to the control arm, or the new medication might prove less effective than existing treatments, or have harmful side effects). In other words, there is rarely a guarantee of direct benefit for the individual clinical trial participant. An important rule of thumb is that a `control' intervention should equate to best available treatment—or at the very least, to best usual care. For this reason, it is rarely acceptable to have a placebo or `no intervention' arm when testing drugs, educational interventions, or healthcare policies except in situations where no intervention has ever been shown effective.

The main benefit of much observational research is to future patients or to society in general—for example, phase two vaccine trials on healthy volunteers or epidemiological studies to identify risk factors for specific diseases. But being in a research study may bring indirect (secondary) benefits to the participant. Assessing these benefits, like assessing risk, is not straightforward. Secondary benefits may include closer monitoring of a patient's condition in the therapeutic research or increased feelings of self worth through knowledge that they are helping others. 17 In reviewing a proposal a research ethics committee needs to form a view on the relative risks and benefits of the research, but researchers must also carefully consider this balance at the earlier stage of developing the research protocol, as part of their duty of care to participants.

In weighing up the risk-benefit balance in research, the following should be taken into account:

• The importance, originality and topicality of the research question
• The scientific validity of the study
• The likelihood of achieving meaningful results—for example, the capacity of the study to recruit adequate numbers
• The potential impact (on the participants, the local community, the disease group, the global community)
• The potential risks to participants and researchers (discussed in paper two of this series). 17

In the UK, it is no longer part of the remit of the research ethics committee to evaluate the science of a proposal, but they are required to obtain independent information on the risks and benefits of the proposed research. A study that involves significant risk of harm to research participants will need to show a significant potential benefit. For example, many studies of new malaria vaccines involve infecting participants with malaria via mosquito bites. The potential harm to the participants from contracting malaria if the vaccine is ineffective may be considered justifiable (provided they have given informed consent) because of the huge potential benefit to the world wide community in developing such a vaccine.

RESPECT FOR AUTONOMY AND INFORMED CONSENT

Respect for the integrity and autonomy of the individual underpins the requirement for informed consent of research participants. One of the key functions of ethical review is ensuring that consent for participation in research is properly obtained and documented. The process of obtaining consent must be sensitive to the cultural values of the potential participants if their autonomy is to be truly respected. This is particularly relevant when research is conducted in communities that may not share the cultural values of the researchers, for example research in developing countries, or with refugee populations. Valid consent for any medical procedure, be it research or clinical care, requires that: ( a ) the person is informed of the nature of the procedure, including its likely risks and benefits; ( b ) the person is competent to make the decision; and ( c ) the decision is made freely and without coercion. All three elements of the consent procedure need to be considered in the specific context of the proposed research, and all three are informed by the principle of respect for autonomy.

Information

Research participants cannot make an autonomous choice about whether to participate in a study if they do not have information that is relevant to their making that choice. In research, as in clinical practice, there are two key factors in ensuring that consent is truly informed. One is the content of the information provided, its accuracy, comprehensiveness and clarity. The other is the process of information sharing, how it is presented, the context in which it occurs, time allowed for reflection and discussion, and the balance of power between researcher and participant. The process of information sharing will vary depending on the type of research. A questionnaire survey may require only a clear information sheet whereas a clinical trial of a new drug treatment will involve a more complex process more akin to a clinical consultation. In this situation the model of concordance may be useful. 18 Provision of information requires particular care when the research involves vulnerable groups, for example children, or when there are language and cultural differences between researcher and participant. Researchers working with Navajo interpreters using a translation of the standard consent form in a diabetes clinical trial found that the consent process caused `embarrassment, confusion and misperceptions that promoted mistrust'. 19

Voluntariness

Valid consent must be freely given. Researchers and research ethics committees need to consider whether the process of obtaining informed consent includes implicit or explicit coercion of participants. For example, presentation of information can emphasize benefits of participation and obfuscate risks, or payment to participants may potentially be coercive, depending on the context and amount offered. The context in which patients are approached, or asked for their consent may be coercive, for example if not enough time is allowed for participants to consider the information. A more subtle area of potential coercion is the relationship between researcher and research participant. In many instances of healthcare research the researcher is also the participant's medical carer and patients may fear that refusal to participate in a study will jeopardize their care. Health research within universities has raised concerns about the overuse of student participants and the pressure they experience due to a fear of losing course credits or upsetting their tutors. 20

A valid consent requires that the person giving consent is competent to do so. Competence is assessed in relation to the decision being made, for example a 14 year old may be competent to consent to take part in a survey on smoking behaviour in adolescents but not competent to consent to take part in a phase two study of an HIV vaccine. The legal definition of capacity (in English law) to consent to medical treatment (which would probably also apply to research) is that the person understands the relevant information, believes the information and is able to evaluate the information and make a choice. 20 It is possible to conduct research with patients who are not competent to give consent, including children, but national and international guidelines, and in some countries specific legislation, 21 place limits on the type of research that can be carried out (see Table 2 ). In most cases consent or assent of a family member or someone with legal responsibility for the participant will be required. In general, research cannot be carried out on individuals who lack capacity to give consent unless it is not possible to conduct the research in any other way—for example, research on neonates or in intensive care. In these cases the research should be therapeutic (i.e. have the potential to benefit the research participants), or if non therapeutic must involve minimal harm.

Guidelines for research on persons who lack capacity to consent

RESEARCH WHERE CONSENT IS DIFFICULT OR IMPOSSIBLE TO OBTAIN

There are some situations where consent for research studies is difficult or impossible to obtain, even from people who are capable of giving it. The development of national and international regulatory frameworks for the conduct of research, the expansion of the focus of such frameworks to include different methodological paradigms—for example, social science research—and the increasing emphasis on individual informed consent within these regulatory frameworks, has raised challenges for both researchers and the research ethics community. An example of this is an increasing emphasis in UK law on consent to use stored data and tissue for research purposes which has generated heated debate within some research communities with claims that whole categories of research will become virtually no-go areas. UK guidelines for researchers have been developed in some of these areas. 22 - 24 More recently, there has been some movement away from a blanket ban approach to research where there is no individual consent to one where researchers are encouraged to present an argument for conducting the research with reference to: the benefits of the research; the need for this type of study; the risk of harm to participants; and the reason why individual consent cannot be obtained. There has also been an increasing interest in exploring concepts of informed consent in contexts where individual consent is difficult or impossible to obtain, and in developing alternative models of consent that may be both practically achievable and ethically justifiable in these situations. Table 3 gives some examples of these models. Thus the focus on individual informed consent has led to an evolving and richer interpretation of the concept of consent. This may facilitate ethical research by permitting some research to be conducted without individual informed consent while not disregarding the key ethical principle of respect for autonomy.

Examples of research where consent is difficult to obtain

RCT, Randomized clinical trial; NHS, National Health Service; CEO, Chief Executive Officer; CVA, cerebrovascular accident

CONCLUSIONS

In conducting healthcare research, both researchers and participants are to some extent a means to an end—the improvement of healthcare for patients and/or the general population. It is thus essential that healthcare research in all its forms is underpinned by core ethical principles that protect participants and researchers from harm and respect their integrity as individuals. Ethical review and governance processes play an important role in ensuring that these core principles are translated into the practice of research. There is some concern that the potential benefits of medical research are not given enough weight in the ethical review process, and that the inflexibility of informed consent requirements has led to potentially valuable research being lost. 25 , 26 Reducing unnecessary bureaucracy may facilitate the passage of research protocols through the ethical review process. The UK Department of Health has recently published a report on the operation of NHS research ethics committees that makes recommendations in this area. 5 As healthcare research becomes more diverse—both in the type of research and the populations studied—ethics committees, researchers and research sponsors face a continuing challenge in interpreting and balancing these principles in specific situations without severely limiting the progress of important research, which may in itself be harmful.

This is the third and final paper in a series on research governance [Series editors: Trisha Greenhalgh and Sara Shaw]