social care research ethics committee

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Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011.

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants.

Ii standards and guidance for entities that establish research ethics committees, standard 2. composition of research ethics committees.

The research ethics committee (REC) is constituted according to a charter or other document that establishes the manner in which members and the Chair will be appointed. The appointing entity ensures that the REC has a multidisciplinary and multisectoral membership, that its composition is gender balanced, that it reflects the social and cultural diversity of the communities from which research participants are most likely to be drawn, and that it includes individuals with backgrounds relevant to the areas of research the committee is most likely to review.

The entity establishing the REC takes the following factors into consideration when appointing members.

• Members include individuals with scientific expertise, including expertise in behavioural or social sciences; health care providers; members who have expertise in legal matters and/or ethics; and lay people whose primary role is to share their insights about the communities from which participants are likely to be drawn.
• Lay people and other members, whose primary background is not in health research with human participants, are appointed in sufficient numbers to ensure that they feel comfortable voicing their views.
• In order to enhance independence, committee membership includes members who are not affiliated with organizations that sponsor , fund, or conduct research reviewed by the REC (see also Standard 4 ).
• Committees are large enough to ensure that multiple perspectives are brought into the discussion. To this end, quorum requirements provide that at least five people, including at least one lay member and one non-affiliated member, are present to make decisions about the proposed research.

Standard 3. Research ethics committee resources

The entity establishing the REC supports it with adequate resources, including staffing, facilities, and financial resources to allow the REC to effectively carry out its responsibilities.

As an integral part of a health research institution or health system, an REC receives:

• support staff, adequate in number and training to enable the REC to carry out its technical and administrative responsibilities;
• adequate resources for the staff to fulfil its assigned functions, including office space and equipment and supplies (e.g. computers, stationery, telephones, photocopying machines, shredding machine) to conduct administrative business, to store committee files, and to keep documents secure and confidential;
• access to appropriate space for the committee to meet and adequate means for members to communicate as needed between meetings;
• adequate financial resources to permit the committee to produce high-quality work;
• if considered necessary by the entity establishing the REC , resources necessary to compensate REC members, unless they are already being compensated for their time and effort on the REC through other means.

Standard 4. Independence of research ethics committees

Policies governing the REC include mechanisms to ensure independence of the REC's operations, in order to protect decision-making from influence by any individual or entity that sponsors, conducts, or hosts the research it reviews. Such policies provide at a minimum that REC members (including the Chair) remove themselves from the review of any research in which they or close family members have a conflicting interest.

To ensure that the REC cannot be pressured to approve or disapprove particular protocols, the charter, by-laws, policies and/or procedural rules of the REC provide that:

• the REC 's membership includes at least one person with no connection to the organization that sponsors or conducts the research under review;
• researchers, sponsors, and funders may attend an REC meeting to answer questions about their research protocols and associated documents, but they are not present when the REC reaches decisions about their proposed research;
• senior decision-makers of the entity creating the REC , or of any organization that sponsors or conducts the research reviewed by the REC (such as the director of an institution, or his or her agent), do not serve as members of the REC or its Chair;
• the entity that establishes the REC ensures that REC members are protected from retaliation based on positions taken with respect to REC-related matters or review of research projects.

Standard 5. Training the research ethics committee

Training on the ethical aspects of health-related research with human participants, how ethical considerations apply to different types of research, and how the REC conducts its review of research, is provided to REC members when they join the committee and periodically during their committee service.

The training provided to REC members, either directly by the appointing entity or through cooperative arrangements with other RECs and/or organizations that provide education on research ethics, focuses on:

• the role and responsibilities of the REC , and its role vis-à-vis other relevant entities, according to relevant international guidelines (e.g. the Council for International Organizations of Medical Societies [CIOMS] International Ethical Guidelines for Biomedical Research, CIOMS International Ethical Guidelines for Epidemiological Research, International Council on Harmonization [ICH] Good Clinical Practice [GCP] guidelines in the case of clinical trials), national laws, and institutional policies;
• the full range of ethical considerations relevant to research with human participants;
• the application of such ethical considerations to different types of research;
• basic aspects of research methodology and design (for members who lack such background);
• the impact of different scientific designs and objectives on the ethics of a research study;
• the various approaches for recognizing and resolving the tensions that can arise among different ethical considerations and modes of ethical reasoning.

When training is supported by research sponsors, mechanisms are in place to ensure that the sponsor has no control, direct or indirect, over the content of the training.

Standard 6. Transparency, accountability, and quality of the research ethics committee

Mechanisms exist to make REC operations transparent, accountable, consistent, and of high quality.

The entity establishing the REC employs reliable means to evaluate whether the staff and members of the REC routinely follow the REC's policies, rules, and written procedures (see Standard 9 ), with special attention to whether the ethical considerations articulated in international guidelines and national standards are being considered and applied consistently and coherently.

• Such evaluations are conducted by knowledgeable and unbiased people at regular, pre-defined intervals using a pre-defined format; internal assessments are supplemented periodically by independent external evaluations.
• The entity establishing the REC is committed to consider and, when appropriate, follow up on the findings and recommendations of the internal and external evaluations.
• The results of the evaluation are of a type that can aid the REC in reviewing its practice and appraising performance (rather than apportioning blame), while also assuring the public that research is being reviewed according to established standards.
• Researchers, research participants, and other interested parties have a means of lodging complaints about the REC ; such complaints should be reviewed by an entity other than the REC itself, and appropriate follow-up actions should be taken.
• Researchers have a means of discussing concerns with REC members, both on general matters and in response to REC decisions on particular research studies.
• REC decisions, excluding confidential information, are made publicly available, through mechanisms such as clinical trial registries, web sites, newsletters, and bulletin boards.

All rights reserved. Publications of the World Health Organization are available on the WHO web site ( www.who.int ) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: tni.ohw@sredrokoob ).

Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press through the WHO web site ( http://www.who.int/about/licensing/copyright_form/en/index.html ).

• Cite this Page Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants. Geneva: World Health Organization; 2011. II, Standards and guidance for entities that establish research ethics committees.
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• Composition of research ethics committees
• Research ethics committee resources
• Independence of research ethics committees
• Training the research ethics committee
• Transparency, accountability, and quality of the research ethics committee

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Please note you do not have access to teaching notes, problem or safeguard research ethics review in social care research and the mental capacity act 2005.

Social Care and Neurodisability

ISSN : 2042-0919

Article publication date: 2 August 2010

The Mental Capacity Act 2005 (HM Government, 2005) introduced safeguards to protect people who lack capacity from intrusive research. While these safeguards stemmed from predominantly medical ethical review concerns and developments aimed to protect people from physical and psychological damage and harm, the Act relates to all forms of research. The implications of the requirements of the Act for the conduct of social care research and the identification of helpful approaches or development of new knowledge concerning people who may lack capacity are, as yet, unknown. There are some concerns that the Act does not fully account for social research, does not recognise its importance to and differences from health‐related research, and may even hamper such research from taking place. This paper describes the findings and implications from a research project funded by the Social Care Institute for Excellence (SCIE) and the Department of Health that considered the impact of the Mental Capacity Act 2005 on the ethical scrutiny and development of social care research. The particular focus of the study was processes relating to university research ethics committees (URECs). The study was undertaken in two stages, beginning with an online survey of UREC policies and procedures and was followed by interviews with social care researchers working in areas in which people may lack capacity according to the terms of the Act. Recommendations for research ethics review are made that will be of importance to practitioners, policy‐makers and researchers.

• Mental Capacity Act 2005
• Social care

Parker, J. , Penhale, B. and Stanley, D. (2010), "Problem or safeguard? Research ethics review in social care research and the Mental Capacity Act 2005 ", Social Care and Neurodisability , Vol. 1 No. 2, pp. 22-32. https://doi.org/10.5042/scn.2010.0430

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Copyright © 2010, Emerald Group Publishing Limited

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NHS research ethics committees

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• Louise Robinson , senior lecturer in primary care 1 ,
• Deborah Murdoch-Eaton , professor of medical education 2 ,
• Yvonne Carter , dean 3
• 1 Institute of Health and Society, Newcastle University, Newcastle NE2 4AA
• 2 Medical Education Unit, School of Medicine, University of Leeds, Leeds LS2 9NL
• 3 Warwick Medical School, University of Warwick, Coventry CV4 7AL
• a.l.robinson{at}ncl.ac.uk

Still need more common sense and less bureaucracy

National Health Service research ethics committees exist to ensure that research performed within the NHS complies with recognised ethical standards and to protect the rights, safety, and dignity of all actual or potential participants. In the past decade the operation of research ethics committees has come under, and continues to come under, close scrutiny. Researchers now consider the process of acquiring ethical approval to be so onerous that it is compromising clinical research. 1 2 3 Medical educators also think that the process is too unwieldy to allow undergraduate students to acquire research experience, 4 an essential learning outcome required by the General Medical Council. 5

To understand why such dissatisfaction has arisen we need to go back to the early 2000s, when the Central Office for Research Ethics Committees (COREC) was established and the Department of Health issued the Research Governance Framework for Health and Social Care . 6 The implementation in 2001 of the European Union Directive 2001/20/EC (the clinical trials directive) forced changes in the system, leading …

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Research Ethics Service and Research Ethics Committees

The Health Research Authority and the Devolved Administrations provide a Research Ethics Service so that research proposals relating to their areas of responsibility can be reviewed by a Research Ethics Committee (REC). Research Ethics Committees protect the rights, safety, dignity and wellbeing of research participants. Managing the Research Ethics Committees in England is one of the Health Research Authority’s core functions.

We have a duty to provide an efficient and robust ethics review service that maximises UK competitiveness for health research and maximises the return from investment in the UK, while protecting participants and researchers.

We have a dual mission to protect the  rights, safety, dignity and well-being of research participants  and to facilitate and promote ethical research that is of potential benefit to participants, science and society. 

The Research Ethics Service consists of: 

• Research Ethics Committees (RECs) across the UK reviewing health and social care research
• volunteer members and chairs that sit on NHS/HSC RECs

The Governance Arrangements for Research Ethics Committees (GAfREC) describe what is expected from RECs when reviewing research proposals.

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After ethical review

Mental Capacity Act

Social Care Research Ethics Committee - Mental Capacity Act 2005

The Mental Capacity Act (MCA) 2005 provides a statutory framework for people who may not be able to make their own decisions, for example because of learning difficulties, brain injury or mental health problems. It sets out who can take decisions, in which situations, and how they should go about this. The Act applies to England and Wales only.

To undertake research with those that lack capacity, the MCA requires a researcher to obtain approval from an ‘appropriate body’. The Social Care REC is recognised by the Secretary of State as an appropriate body.

The Department of Health have produced a Fact Sheet (50kb PDF file) for Social Scientists about the Mental Capacity Act. The Fact Sheet looks at the MCA, the kinds of research it covers, obtaining consent and frequently asked questions.

NRES have also produced a number of guidance documents and an on-line toolkit about research and the MCA. The documents and on-line toolkit are available from the NRES website .

There is a MCA resource section on the SCIE website which aims to provide accessible resources that people will come to as their first port of call in relation to the MCA – when people want to know what already works and what might work in future.

Website developed and maintained by the Social Care Institute for Excellence (SCIE) .

Social Care Research Ethics Committee

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ENRICH has been developed by the National Institute for Health and Care Research (NIHR), and is a resource supported by the NIHR. The website is maintained by the NIHR School for Social Care Research, and the ENRICH Network is managed by the NIHR Clinical Research Network.

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