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Human Origins Studies: A Historical Perspective

• Tom Gundling 1  

Evolution: Education and Outreach volume  3 ,  pages 314–321 ( 2010 ) Cite this article

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Research into the deep history of the human species is a relatively young science which can be divided into two broad periods. The first spans the century between the publication of Darwin’s Origin and the end of World War II. This period is characterized by the recovery of the first non-modern human fossils and subsequent attempts at reconstructing family trees as visual representations of the transition from ape to human. The second period, from 1945 to the present, is marked by a dramatic upsurge in the quantity of research, with a concomitant increase in specialization. During this time, emphasis shifted from classification of fossil humans to paleoecology in which hominids were seen as parts of complex evolving ecosystems. This shift is in no small part due to the incorporation of neo-Darwinian synthetic theory. Finally, technological innovation and changes in social context are considered as influences on human origins studies.

Introduction

Considering the grand sweep of history, the realization that human beings gradually evolved from some non-human ancestor represents a very recent insight. Even so, the goal of this one brief essay cannot be to provide an in-depth description and analysis of every significant development within the field of paleoanthropology, but rather to identify broad patterns and highlight a collection of “events” that are most germane in shaping current understanding of our evolutionary origin. These events naturally include the accretion of fossil material, the raw data which is the direct, if mute, testimony of the past. These fossil discoveries are situated among technological breakthroughs, theoretical shifts, and changes in the sociocultural context in which human origins studies were conducted. It is only through such a contextualized historical approach that we can truly grasp our current understanding of human origins. Foibles of the past remind us to be critical in assessing newly produced knowledge, yet simultaneously we can genuinely appreciate the enormous strides that have been made.

In addition to selective coverage, a second caveat is that this review will focus on research by scientists writing in English. Non-modern hominids Footnote 1 are a cosmopolitan bunch, having been discovered throughout Africa, Asia, and Europe, and there is a significant literature in other languages. In an effort to ameliorate both of these shortcomings, numerous secondary references are included in the bibliography, providing more in-depth information on specific topics. For example, some texts approach the history of paleoanthropology by detailing a single time period (Bowler 1986 ), early human species (Walker and Shipman 1996 ), or researcher (Morell 1995 ), and there are quite a few that consider the subject more comprehensively (Leakey and Goodall 1969 ; Reader 1988 ; Lewin 1997 ; Tattersall 2008 ). In addition, there are a handful of encyclopedia format tomes (Jones et al. 1994 ; Spencer 1997 ; Delson et al. 2000 ), textbooks (Conroy 2005 ; Cela-Conde and Ayala 2007 ; Klein 2009 ), and “coffee table” popular volumes (Stringer and Andrews 2005 ; Johanson and Edgar 2006 ) that in part address the history of human origins studies. Moreover, these texts contain abundant references to the primary literature if that level of scrutiny is desired.

In seeking to provide a useful heuristic framework for the purposes of this particular essay, human origins studies can be broken down into two very broad periods. The first is roughly the century between 1850 and 1950 when research, often conducted by individuals with training outside of anthropology, focused on taxonomy and phylogeny. In other words, although scientists were cognizant that climate change (e.g., northern hemisphere glaciations) would have directly impacted the evolution of early humans, they were mainly interested in collecting “missing links,” naming them, and creating family trees. The second period, from 1950 to the present, is characterized by the relatively rapid development of paleoanthropology as it is currently practiced. Here the emphasis is only partly on the hominids themselves, with ecological context being of equal importance.

The Emergence of Human Origins Studies

This review begins with two mid-nineteenth century developments which are often conflated, but were initially distinct. The first is the acceptance of a temporal association of human material culture (stone tools), with extinct Ice Age mammals (Van Riper 1993 ; Sommer 2007 ). This was significant in that it opened up a considerable prehistory for the human species, well beyond estimates derived from literal scriptural interpretation. However, while acknowledging a lengthy antiquity for the human species, there was, at the time, no reason to suspect that the makers of the stone tools were not fully modern humans in a biological sense. The second major development was the publication of Darwin’s On the Origin of Species in 1859 (Darwin 1859 ). Darwin is rightfully credited with being the most influential, although by no means the first individual to broach the subject of descent with modification, or transmutation theory, as he put it (for an overview of pre-evolutionary ideas related to human origins, see Greene 1959 , Bowler 2003 ). Darwin’s central thesis was that all living species shared a common ancestry, with “endless forms most beautiful” having diverged via natural selection, and although he only briefly mentioned his own species the inference was clear. These two events dovetailed into the now quotidian, but then controversial, notion that humans had evolved over a vast expanse of time (Grayson 1983 ).

While Darwin was initially reticent to discuss human evolution in any detail, his colleague Thomas H. Huxley harbored no such reluctance when he published Man’s Place in Nature: Essays in 1863 (Huxley 1900 ). Darwin freely admitted that the veracity of his audacious proposal would have to withstand paleontological scrutiny and that his theory would collapse in the absence of transitional fossil forms. Huxley’s advantage, beyond his more outspoken personality, was that he actually had a fossil human to describe. The first Neandertal recognized by science was discovered in 1856; however, its description only appeared in English three years later, just as Darwin was going to press (Trinkaus and Shipman 1993 ). Huxley provided a detailed description of the eponymous cranium coupled with carefully composed line drawings (Huxley 1900 ). However, while the importance of the Neandertals in providing empirical evidence documenting an ancient and morphologically distinct human form cannot be discounted, these people hardly bridged the gap separating humans and the great apes. Although a few dissenting voices denied the close evolutionary relationship among humans and the “man-like” apes, and consequently an ape phase of human ancestry, most scientists accepted the overwhelming morphological and embryological evidence in support of just such a relationship. This acceptance was in no small part due to Huxley’s meticulous comparison of gorilla and human anatomy in which he concluded that the gorilla and its close relation, the chimpanzee, represented the nearest approach to humanity in nature.

If Neandertals were more or less human, then more distant, primitive “missing links” remained to be discovered. Just such fossils were recovered on the island of Java in the 1890s by Dutch physician Eugene Dubois, who had traveled to Indonesia as part of the army but with the express purpose of finding the remains of primitive humans (Shipman 2001 ). Java Man consisted of a skull cap, a femur, and a few isolated teeth which taken in combination suggested an early human with a much smaller cranial capacity relative to Neandertals or Homo sapiens (roughly 1,000 vs. 1,500 cubic centimeters), although the femur appeared modern. Dubois did not receive the universal accolades and acceptance he coveted, but his fossils bolstered the conventional wisdom at the time that humans first evolved somewhere in Asia.

During the early twentieth century, the early hominid fossil record grew significantly, if not exponentially, and evolution was widely accepted in scientific circles even while large segments of the lay public remained skeptical. Certainly, there were disagreements over whether natural selection was a sufficient evolutionary mechanism in itself (Bowler 1983 ), but the basic premise of biological change through time was affirmed. The recovery of additional Neandertal remains in Europe refuted lingering claims of pathology regarding the original Neander Valley specimen and solidified the interpretation that the latter was representative of a population of archaic humans occupying Ice Age Europe. Some Neandertal remains were interpreted as not only indicating intentional internment but also associated funerary ritual. The European fossil record was extended significantly with the recovery of a robust lower jaw from Mauer, Germany discovered in 1907.

In 1912 in England, heretofore devoid of non-modern hominid remains despite the prominence of several British scholars in human origins studies, the announcement of hominid fossils from Piltdown was warmly received locally, if with some incredulity abroad. Piltdown was significant since it reified the “brain first” hypothesis, in which primitive humans evolved a large brain before other key human traits evolved. Although a favorite of intelligent design creationism advocates, Piltdown is actually a beautiful example of the scientific method at work, whereby new evidence eventually calls into question prior interpretation, and in this case recognition of intentional fraud (Spencer 1990 ). It was, after all, a new relative dating method measuring the fluorine content of fossils that in 1953 exposed the non-contemporaneity of the jaw and skull. In any case, in the first decades of the twentieth century, a fairly simple human family tree was beginning to emerge (see McCown and Kennedy 1972 and especially Delisle 2007 for exceptions). Relatively small-brained Pithecanthropus led to the more capacious Neandertals and Piltdown, who in turn evolved into modern H. sapiens . Yet the truly ape-like human ancestors remained elusive.

Africa as the Cradle of Humanity

In 1921 a skull bearing superficial resemblance to European Neandertals was recovered as part of mining operations at a place called Broken Hill in Northern Rhodesia (now Zambia). Rhodesian Man marks the recovery of the first in a very long line of non-modern hominids from the African continent. A mere four years later, University of Witwatersrand anatomist Raymond Dart, Australian by birth and having been trained in England, published a brief paper describing the fossil skull of a juvenile “ape” discovered in a limestone quarry near Taung, South Africa. Dart identified certain features of the face, the teeth, the cranium, and the brain of Australopithecus africanus that foreshadowed those of H. sapiens and made the startling claim that what was essentially a bipedal ape signaled the beginning of the human lineage separate from the African great apes.

Initially, with only the one individual, and a juvenile at that, Dart found little support. His most ardent advocate, Scottish physician and paleontologist Robert Broom discovered additional fragmentary remains of the australopithecines, as they were then called, in other South African caves in the 1930s, but these were initially insufficient to sway opinion (Dart 1959 ). This was perhaps due to the near-simultaneous discovery of significant hominid remains from Zhoukoutien (Dragon Bone Hill) in China which quickly eclipsed whatever controversy the diminutive skull from Taung elicited, and despite Broom’s ongoing efforts. As was the case with Java Man, the more complete Chinese fossils fulfilled the expectations of many scientists who anticipated that earliest human ancestors evolved to the East. Comparative analysis of the Javanese and Chinese fossils revealed a great deal of similarity, and all of the fossils were ultimately subsumed in the species Homo erectus .

The Neo-Darwinian Synthesis and the New Physical Anthropology

For several disparate reasons, the decades following the end of World War II (WWII) rather quickly led to a science of paleoanthropology that is recognizably modern. One significant factor relevant in the U.S. if not everywhere, was the dramatic upsurge in enrollment at colleges and universities. The G.I. Bill and subsequent effects of Civil Rights legislation that greatly increased access to higher education meant that millions more students went to college and hence the expansion of existing campuses and programs and in some cases the appearance of entirely new colleges and universities Footnote 2 . As a result, greater numbers of faculty were required who could teach courses and supervise research in diverse academic programs, which in turn led to an attendant rise in the numbers of graduate students themselves who went on to secure positions at institutions of higher learning. Consequently, many disciplines experienced significant increases in research activity, including physical anthropology, and it is worth noting that this was the first generation of researchers whose formal training was in physical anthropology, not in some allied field such as anatomy or medicine. The dramatic rise in practitioners not only increased the knowledge base in terms of simple quantity, but specialization within the field also began to emerge.

A second crucial development that transformed human evolutionary studies was theoretical in nature. Changing ideas regarding the process of evolution had been fermenting and roiling in biology circles for several decades before they infiltrated the study of human origins. In essence, a consensus was reached among biologists ( sensu lato ) that Darwinian natural selection acting on variation arising from random mutation was a sufficient mechanism to explain evolutionary change. For anthropologists, although questions of taxonomy and phylogeny remained important, the intellectual fallout of the so-called neo-Darwinian synthesis led to the “New Physical Anthropology” in which early hominid fossils, rather than representative of some platonic archetype, were interpreted as unique members of variable populations. Focusing on evolution as a process effecting change in populations over time, in contrast to the comparatively myopic sorting of the resulting pattern , arguably represents the most significant theoretical shift in thinking about evolution since Darwin.

Given the comparative de-emphasis on iconic types, the bloated alpha taxonomy of the past was reduced to a mere handful of hominid species displaying previously under-appreciated within species variability. This great reduction in hominid names and consequent simplification of hominid family trees has led some modern scholars to lament what they see as a return to the bad old days of teleology and orthogenesis. Yet there can be little doubt that the “splitting” taxonomic philosophy of the past where almost every new specimen received a new species or quite frequently a new genus name was in dire need of revision.

Just as species types came under scrutiny, so did the concept of evolutionary grades which had up to this point made clear distinctions between the categories of ape and human. While this may have provided some welcome taxonomic clarity, it was artificial in that it ignored the evolutionary reality that at some point members of the human lineage were very ape-like. This realization, obvious in retrospect, led to the widespread acceptance of the South African australopithecines as human ancestors, and the important corollary that bipedalism preceded other distinctive human attributes (Gundling 2005 ).

In addition to increased research activity and theoretical shifts, by the early 1960s technological innovations for the first time permitted the creation of a reliable absolute timescale of human evolution. Comparative protein analysis demonstrated that the African apes were most similar genetically to H. sapiens , inferring their recent common ancestry to the exclusion of other apes and monkeys. Molecular clocks based upon mutation rates and calibrated by the fossil record suggested that this common ancestor lived as little as a few million years ago, although recent estimates put this ancestor at seven to five million years ago. Consequently, known early and middle Miocene ape species became suspect as purported human ancestors, since they preceded the split between the hominid and great ape lineages. Most notably this eventually led to the downfall of Ramapithecus , a Miocene ape genus once widely hailed as a very ancient and very primitive hominid Lewin ( 1997 ).

While molecular studies of living species effectively imposed a theoretical maximum on the age of the hominid lineage, the temporal framework of human origins was further clarified with the introduction of the new potassium argon (K-Ar) method of absolute dating. Louis and Mary Leakey had been scouring the fossil-bearing sediments in and around eastern Africa’s Great Rift Valley for decades when Mary discovered the skull of a robust australopithecine at Olduvai Gorge in 1959. Significantly, Zinjanthropus , the genus coined for the new skull, was discovered within sediments near the base of the Pleistocene Epoch. Volcanic minerals from associated strata were dated to approximately 1.75 million years ago using the K–Ar method, nearly double the age estimated from using other more crude means. This greatly expanded time range certainly bolstered claims for the australopithecines as human ancestors rather than extinct collateral cousins to the “true” human lineage, yet to be discovered.

As an aside, Louis Leakey’s interest in understanding the human past was not limited to the collection of fossils. Sherwood Washburn, a main architect of the new physical anthropology, along with Irven DeVore, conducted pioneering studies of savanna baboons, large-bodied, terrestrial, and highly social primates that served as living proxies for modeling early hominid behavioral ecology (Washburn and DeVore 1961 ). Leakey, on the other hand, took a more phylogenetically based approach and hired scholars to conduct research into the behavior of the great apes as a potential new data source informing hypotheses of early hominid behavior. Jane Goodall was the first, studying chimpanzee behavior at Gombe in Tanzania, then came Dianne Fossey who undertook a longitudinal study of mountain gorillas in Rwanda, and finally Birute Galdikas traveled to Indonesia to conduct field studies of the orangutan (see Kinzey 1987 and De Waal 2001 for more recent primate studies that explicitly address questions of human behavioral evolution).

The emergence of paleoanthropology as a truly multidisciplinary endeavor, concerned with a more holistic picture of our evolutionary past, was a logical extension of the post-WWII new physical anthropology which eschewed simple classification and promoted variable populations as the unit of study. Naturally, these hominid populations did not exist in a vacuum but were components of complex, evolving ecosystems. Hence, field work began to emphasize the collection of greater contextual data in an effort to reconstruct biological and physical environments in which these human ancestors existed and evolved. One of the first field projects to adopt this new approach was an international expedition centered around the Omo River Valley in southern Ethiopia, beginning in 1967. Remarkably, of the 50 papers collected in the resulting volume, only five primarily focus on the hominid remains themselves (Coppens et al. 1976 ).

Early Human Diet and Subsistence

One major aspect of early hominid ecology that occupied researchers engaged in such multidisciplinary efforts was subsistence, which has understandably been of great interest to paleoanthropologists, particularly after 1950 as scientists endeavored to contextualize the fossil remains of distant ancestors. What early humans ate, how food was acquired and processed, even how it was distributed among members of a social group, became viable questions. Throughout the 1950s and 1960s it was widely assumed that the social, cognitive, and technological skills associated with big-game hunting drove the evolution of the human species; in fact the allure of “Man the Hunter” is longstanding in Western thought (Cartmill 1993 ). Raymond Dart, as part of his second foray into human origins studies, proposed that Australopithecus had already developed a hunting strategy facilitated by a technology comprised of durable animal parts that he referred to as the osteodontokeratic (bone, tooth, horn) culture. This concept was enthusiastically embraced by writer Robert Ardrey, who published a series of four popular novels documenting the success of these “killer apes” in the context of a changing environment (e.g., Ardrey 1976 ). Research scientists were only slightly less enthusiastic in championing such ideas (Lee and DeVore 1968 ) which remain popular, if more nuanced today (Wrangham and Peterson 1996 ).

Mirroring changes in the broader society, by the early 1970s some anthropologists challenged the “Man the Hunter” hypothesis and developed an alternative that focused on the central role of women in child rearing and gathering of food resources (Dahlberg 1981 ). These studies used ethnographic data from extant food-foraging societies, the rarity of which injected a sense of urgency on the part of anthropologists. Not long after the “Women the Gatherer” model appeared as a second wave feminist rejoinder to the previously unquestioned authority of “Man the Hunter,” another group of researchers also began to question the big-game hunting scenario. Archeologists, geologists, and paleontologists began working on “site formation processes” to get a better understanding of how assemblages of fragmented animal bones and stone tools came to be commingled. Over the next few decades, often with recourse to modern ecosystems as analogs, one of the main conclusions drawn from the new science called taphonomy (=laws of burial) was the potential importance of scavenging. The association of “bones and stones” was no longer assumed to be the signature of hominid big-game hunting but instead interpreted as meals containing essential fat and protein scavenged by early humans. Perhaps even more disconcerting, some sites were reinterpreted as the remains of carnivore kills occasionally including early humans themselves (Brain 1981 ; Hart and Sussman 2008 ).

Here’s Lucy

If Mary and Louis Leakey’s discoveries at Olduvai put the Great Rift Valley on the map, during the 1970s eastern Africa was validated as the center of early hominid studies. The Leakey’s son Richard established himself on the east side of Lake Turkana in northern Kenya, where his expeditions uncovered a prolific cache of early hominid fossils, some of which corroborated the occasionally controversial claims made by his parents a decade earlier. Sediments around the lake yielded hominid fossils of robust australopithecines, early members of genus Homo , and an early African variant of Asian H. erectus , these days referred to as Homo ergaster (Leakey and Lewin 1978 ). The latter includes a mostly complete skeleton, KNM-WT15000, which has become iconic for the species (Walker and Shipman 1996 ).

Arguably the most significant fossil discovery of the 1970s was another partial skeleton, AL-288, from Hadar, Ethiopia, better known as Lucy (Johanson and Edey 1981 ). Here was a single individual represented by numerous skeletal elements, and although her morphology was generally similar to the “gracile” australopithecines of South Africa, she was even more primitive in some respects. Consequently her discoverers coined a new species name, Australopithecus afarensis that included not only the Hadar specimens but fossils collected by Mary Leakey’s expedition at Laetoli in Tanzania. The latter is renowned for its famous footprint trail preserved in solidified volcanic ash, imparting convincing evidence for bipedalism at 3.6 million years ago. Hadar is also replete with datable volcanic sediments, and Lucy’s status as the most primitive hominid was reinforced by firm radiometric dates which placed the fossils at greater than 3.0 million years ago, at the time astonishingly ancient.

One other significant event from the 1970s bears mentioning. Although the American Journal of Physical Anthropology was first published in 1918, it is perhaps surprising that a journal explicitly dedicated to the study of human evolution did not appear in the U.S. until 1972. Since then the Journal of Human Evolution has been the premier academic forum for publications related to human evolution, and in 1992, the Paleoanthropology Society was established, which organizes its own conference and publishes an online journal.

Modern Human Origins

The question of modern human origins has been debated for centuries, long predating paleoanthropology as a scientific discipline. One of the central issues, which became particularly evident as Renaissance and Enlightenment Europeans began to travel the globe on a regular basis, was how to explain the physical diversity of human populations. Two broad perspectives emerged, one which viewed all people as having a single origin and another which believed that supposedly distinct races had separate origins. The pre-Darwinian debates between so-called monogenists and polygenists were recast with the advent of an evolutionary paradigm in the mid-nineteenth century. Within this new theoretical context, monogenists believed that all living humans evolved from a common ancestor that was already H. sapiens , while the polygenists believed that the races had deeper roots and had descended from different non-modern ancestors (e.g., H. erectus or in a few instances different ape species). A major step towards resolving this debate came in 1987 with an analysis of living human mitochondrial DNA diversity which concluded that H. sapiens had a recent African origin. The discovery of essentially modern human fossils at the 160,000-year-old site of Herto, Ehtiopia, provides paleontological support for a recent African origin, and many subsequent genetic studies have supported this basic conclusion. However, the possibility of some gene flow between migrating early modern humans and local archaic populations remains plausible (compare Stringer and McKie 1996 and Wolpoff and Caspari 1998 , also see Relethford 2003 for a geneticist’s perspective).

Conclusion: Twenty-First Century Paleoanthropology

New fossil discoveries, technological innovations, theoretical advances, and social transformations will continue to inform knowledge of our deep past. Recovery of hominid fossils, some from previously unknown time periods and geographic locations, continues at a brisk rate. Many of the most significant recent discoveries are beginning to fill in the crucial African late Miocene time period during which our lineage ramified from that leading to the chimpanzee (Gibbons 2006 ). Of particular note, one of these fossils was discovered in Chad, quite a distance from established sites in the Great Rift Valley, challenging the long standing hypothesis that hominids evolved in the savanna grasslands of eastern Africa while the African ape ancestors remained sequestered in their tropical rainforest refugium. Moreover, botanical, faunal, and geological evidence associated with very early fossil hominids in Ethiopia and Kenya intimate a forested environment, a discovery that clearly constrains hypotheses explaining the success of the bipedal adaptation.

Other significant fossil discoveries from the early Pleistocene site of Dmanisi in the Republic of Georgia have energized discussion of the initial expansion of early humans beyond the tropics of Africa (Wong 2006 ). Not only are these fossils considerably older than prior known Eurasian specimens, but they are morphologically primitive, especially in terms of stature and cranial capacity, and are associated with very simple (“mode 1”) lithic technology. These early migrants hardly manifest the tall striding bipeds equipped with comparatively advanced Acheulian bifacial tools so often depicted in earlier “out of Africa” scenarios Footnote 3 , which are at least in part based on the iconic WT15000 skeleton mentioned earlier.

Perhaps the most surprising discovery of the last decade is the diminutive 18,000-year-old skeleton from the Indonesian island of Flores, which has sparked a spirited, occasionally acrimonious debate between those advocates of a replacement model of modern human origins and those inclined towards regional continuity (Morwood and van Oosterzee 2007 ). The former, comprised of the team who made the discovery and their allies, interpret the remains as those of a surprisingly primitive hominid akin to early Homo , and perhaps the first documented example of the effects of island dwarfing on an early human population. Other scholars believe the remains to be those of a pathological modern human, whose illness resulted in a cascade of skeletal and dental anomalies. Ongoing research on Flores and other nearby locations will undoubtedly resolve this debate.

New discoveries are not limited to the paleontological record but also include behavioral information gleaned from archaeology. Symbolic expression in the form of language, art (including music), and religion is undoubtedly one of the most distinctive human traits. Evidence for such behavior has proved elusive beyond the seeming cultural explosion perceived in the Upper Paleolithic of Europe beginning around 35,000 years before present. However, archeological evidence for at least some of these behaviors has recently been coaxed out of several sites in sub-Saharan Africa. Advanced utilitarian objects such as blades and harpoons have been recovered well back into the Middle Stone Age and use of ochre and shells for body adornment has been found at sites approaching 100 kiloannum (Balter 2009 ).

Recent advances also include a plethora of technological innovations that have allowed anthropologists to hone traditional inquiries in the areas of dating (e.g., single crystal, laser fusion, argon–argon dating), systematic analysis (e.g., geometric morphometrics), and paleoenvironmental reconstruction (e.g., stable isotope analysis). The badly distorted remains of the spectacular 4.4 megaanum skeleton of Ardipithecus ramidus from Aramis, Ethiopia was restored in part using digital imaging technology (Gibbons 2009 ). Additionally, new technology is facilitating, perhaps even driving, novel questions such as those related to the emergence of the unique human life history pattern.

While fossils provide real-time evidence for human evolution, signals from our ancient past are also encoded into our modern DNA. The groundbreaking work of the 1960s effectively demonstrated our close affinity with the African great apes, and today’s genomic analyses comparing humans and chimpanzees are beginning to reveal differences in much finer detail than heretofore possible. Already several areas within the human genome have been identified as having undergone intense selection; these regions may be related to the evolution of the especially dexterous human thumb, reduction of muscles of mastication in the wake of the ability to cook food, the greatly enlarged neo-cortex, and our ability for spoken language.

In addition to modern DNA analyses, ancient DNA analysis has informed the “Neandertal problem” providing preliminary evidence in support of the replacement hypothesis, at least in Europe, whereby modern humans arriving there equipped with Upper Paleolithic technology drove the indigenous Neandertals to extinction. Even more recent genomic analyses, however, suggest that a small but detectable degree of interbreeding occurred when expanding modern human populations emerging from the African tropics encountered Neandertal populations in the Middle East around 120,000 years before present (Gibbons 2010 ).

In conclusion, our understanding of human origins, like all scientific knowledge, is the result of an ongoing, iterative process. Over the last few decades, the accelerating pace of fossil discoveries and the incorporation of innovative technologies have corroborated and enhanced much of what we already suspected to be true, although there have been a few surprises. No doubt this pattern will continue into the foreseeable future as we slowly, yet inexorably, piece together the circumstances by which our lineage became human.

Hominidae (=hominid) is the biological group (clade) to which humans and their extinct ancestors belong. For many current scholars, this group is distinguished at some lower taxonomic level, usually the tribe Hominini (=hominin). In this study, I maintain the traditional use of Hominidae simply to be consistent with the historical literature. For the same reason, I use the subfamily designation Australopithecinae (=australopithecine) for all of the African “bipedal apes.” This group is certainly paraphyletic, to use the modern jargon, and as a result an increasing number of scholars prefer to use the less formal term australopith to lump together the various African species.

According to the U.S. Census Bureau, there were about 2.2 million students enrolled in U.S. colleges in 1950. That number doubled by 1963 to just less than 4.4 million and doubled again to over 9 million by 1972.

I usually avoid this term despite its heavy usage within the scientific community. I believe that the “Out of Africa” trope perpetuates an anti-Africa bias which seems to suggest that early humans, on several occasions, left Africa wholesale as if there was something inherently undesirable about the place. I suppose that “hominid extra-tropical range expansion” doesn’t have the same ring, but it is more accurate.

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Best History Research Paper Topics

Dive into the world of historical scholarship with our comprehensive guide to the best history research paper topics . Primarily designed for students tasked with writing history research papers, this guide presents a curated list of 100 exceptional topics, divided into 10 distinct categories, each with a unique historical focus. The guide offers clear and practical advice on how to choose the most compelling history research paper topics, and provides 10 handy tips on crafting an outstanding research paper. In addition to academic guidance, the guide introduces the superior writing services of iResearchNet, a reliable option for students needing customized history research papers.

Comprehensive List of Best History Research Paper Topics

The following comprehensive list of the best history research paper topics is crafted to stimulate your curiosity and ignite your passion for historical study. These topics cover a range of historical periods and geographical locations to cater to the diverse interests of history students.

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Ancient History Topics

• The Causes and Effects of the Fall of the Roman Empire
• Daily Life in Ancient Egypt
• The Influence of Alexander the Great’s Conquests on the Hellenistic World
• The Role of Women in Spartan Society
• The Construction and Significance of the Great Wall of China
• The Impact of Confucianism on Ancient Chinese Society
• Trade Routes and their Role in the Expansion of Ancient Civilizations
• The Cultural and Political Influence of the Phoenician Civilization
• Comparing Democracy in Ancient Greece to Modern Democracy
• The Religious Practices and Beliefs of the Mayans

Medieval History Topics

• The Role of the Catholic Church in Medieval Europe
• The Impact of the Black Death on Medieval Society
• The Cultural Significance of the Knights Templar
• Gender Roles and Family Structure in Medieval Japan
• The Causes and Consequences of the Hundred Years War
• The Political Structure of the Byzantine Empire
• The Influence of the Carolingian Renaissance on Europe
• The Role of Vikings in European Trade and Exploration
• The Crusades: Causes, Events, and Consequences
• The Architecture and Symbolism of Gothic Cathedrals

Early Modern History Topics

• The Causes and Effects of the Protestant Reformation
• The Role of the Enlightenment in the French Revolution
• The Impact of the Scientific Revolution on European Society
• The Socioeconomic Consequences of the Industrial Revolution
• The Influence of the Ottoman Empire on Southeast Europe
• The Role of Slavery in the Colonial Economies
• The Politics and Culture of the Renaissance in Italy
• European Imperialism in Africa and Asia
• The Cultural and Political Impacts of the Mughal Empire
• The American Revolution: Causes, Events, and Legacy

Modern History Topics

• The Causes and Global Consequences of World War I
• The Great Depression: Causes and Effects
• The Role of Propaganda in World War II
• The Impact of the Cold War on International Relations
• The Civil Rights Movement in the United States
• The Fall of the Berlin Wall and the End of the Cold War
• The Effects of Decolonization in the 20th Century
• The Role of Women in the World Wars
• The Formation and Impact of the European Union
• The Causes and Consequences of the Arab Spring

Asian History Topics

• The Cultural Impact of the Silk Road in Asia
• The Effects of Colonial Rule in India
• The Legacy of the Mongol Empire in Asia
• The Cultural and Political Changes in China’s Cultural Revolution
• The Korean War: Causes, Events, and Consequences
• The Role of Samurai in Feudal Japan
• The Impact of the Opium Wars on China
• The Influence of Buddhism on Asian Cultures
• The Cambodian Genocide under the Khmer Rouge
• The Role of Gandhi in India’s Independence

American History Topics

• The Impact of the New Deal on the American Economy
• The Vietnam War: Causes, Events, and Legacy
• The Influence of the Beat Generation on American Culture
• The Role of Manifest Destiny in Westward Expansion
• The Cuban Missile Crisis and Its Effects on the Cold War
• The Women’s Suffrage Movement in the United States
• The Native American Civil Rights Movement
• The Role of the Transcontinental Railroad in American Expansion
• The Civil War: Causes, Events, and Aftermath
• The Immigration Wave at Ellis Island: Causes and Effects

European History Topics

• The Impacts of the Russian Revolution
• The Influence of Martin Luther’s Theses on Europe
• The British Empire: Rise, Dominance, and Fall
• The Role of Art in the French Revolution
• The Impact of the Spanish Inquisition on Spain and its Colonies
• The Rise and Influence of Fascism in Europe
• The Role of the Catholic Church in the Middle Ages
• The Consequences of the Treaty of Versailles
• The Formation and Impact of NATO
• The Role of the Media in the Fall of the Berlin Wall

African History Topics

• The Effects of Apartheid in South Africa
• The Influence of the Trans-Saharan Trade on West African Societies
• The Role of Nelson Mandela in Ending Apartheid
• The Scramble for Africa and its Effects on the Continent
• The Impact of the Atlantic Slave Trade on West Africa
• The Rwandan Genocide: Causes and Consequences
• The Role of the African Union in Continental Politics
• The Impact of Islam on North Africa
• The Decolonization of Africa in the 20th Century
• The Role of Women in Pre-Colonial African Societies

Military History Topics

• The Influence of Technological Innovations on Warfare
• The Role of the French Foreign Legion in Global Conflicts
• The Impact of the Manhattan Project on World War II and Beyond
• The Role of the Spartans in Ancient Greek Warfare
• The Impact of Drones on Modern Warfare
• The Influence of the English Longbow on Medieval Warfare
• The Role of the Maginot Line in World War II
• The Impact of Naval Power on the British Empire
• The Influence of Nuclear Weapons on International Politics
• The Role of Propaganda in World War I

This expansive list of best history research paper topics offers a comprehensive exploration of the past, crossing different eras, regions, and themes. They form a rich tapestry of human experience and a foundation for understanding our present and future. Choose a topic that piques your interest, ignites your curiosity, and promises a journey of intellectual discovery. Remember that the exploration of history is a journey into the roots of our shared humanity and an exploration of the forces that shape our world.

History and What Range of Best Research Paper Topics it Offers

As a subject of study, history is more than a chronological list of events, dates, and prominent figures. History is the exploration of human experiences, societal changes, political upheavals, cultural transformations, economic shifts, and technological advancements across different periods and regions. This exploration allows us to understand how the past has shaped our present and how it can potentially shape our future. It teaches us to appreciate the complexities and nuances of human nature and society, making history a rich field for research paper topics.

History is an interdisciplinary field, interweaving elements from various areas of study, including politics, sociology, economics, anthropology, geography, and literature. This interdisciplinary nature provides a wide array of best history research paper topics. Moreover, the global scope of history further broadens the pool of topics, as it encompasses every region of the world and every period from the dawn of human civilization to the present day.

Exploring Different Periods

Historical research often focuses on specific periods, each offering unique topics for exploration. For instance, Ancient History provides topics related to ancient civilizations like Rome, Greece, Egypt, China, and India, and key events such as Alexander the Great’s conquests or the fall of the Roman Empire.

The Medieval Period offers topics related to the socio-political structure of societies, the influence of religion, the impact of plagues, and the role of significant historical figures. Researching the Renaissance can focus on cultural, artistic, and scientific revolutions that have shaped the modern world.

The Modern History category contains topics related to significant events and transformations, such as world wars, the Great Depression, the Cold War, decolonization, and various national and international movements.

Geographical Perspectives

Geographical focus is another common approach in historical research. Asian history encompasses topics ranging from the influence of Confucianism in China to the impact of colonial rule in India. European history explores events such as the Enlightenment, the French and Russian revolutions, and the formation of the European Union. American history topics can cover everything from Manifest Destiny to the Civil Rights Movement. African history can delve into the effects of the Atlantic Slave Trade, the apartheid era, and decolonization.

Thematic Approaches

In addition to period- and region-based topics, history offers an extensive range of thematic topics. These themes often intersect with other disciplines, leading to exciting interdisciplinary research opportunities.

Social and cultural history, for instance, covers diverse topics such as the influence of the Harlem Renaissance on African American culture, the counterculture movement of the 1960s, the role of film and television in shaping societies, or the impacts of the Internet on global culture.

Military history provides a wide range of topics related to warfare, strategy, technological developments, and the influence of military conflicts on societies and politics. From the use of the English longbow in medieval warfare to the impact of drones on modern warfare, this field offers a variety of fascinating topics.

Making the Right Choice

The choice of a research paper topic in history should ideally be guided by your interest, the available resources, and the requirements of your assignment. With such a wide range of topics, it can be challenging to make a choice. But remember, a good history research paper topic is not just about the past; it should also engage with the present and potentially shed light on the future. The best research paper topics are those that not only delve deep into the annals of history but also resonate with current issues and debates.

The study of history is a gateway into the vast narrative of human civilization. With an extensive range of periods, regions, and themes to choose from, history offers a rich reservoir of research paper topics. As we delve into the past, we discover the forces that have shaped our world, gain insights into the human experience, and glean lessons for our future. This journey of exploration makes history an incredibly exciting field for research papers.

How to Choose Best History Research Paper Topics

Choosing the best history research paper topic can be the first step towards a rewarding intellectual journey. It’s not just about meeting academic requirements; it’s about uncovering facets of the past that intrigue you and may potentially contribute to the broader understanding of history. Here are twenty in-depth tips that will guide you through the process and help you select the best topic for your history research paper.

• Understand the Assignment: Understanding your assignment’s requirements is the primary and most critical step in selecting a topic. Take time to carefully read the guidelines given by your instructor. Are there any specific historical periods, geographical regions, or themes you are required to focus on? Do the instructions indicate the scope or complexity level of the topic? Comprehending the parameters set by your instructor will significantly narrow down your options.
• Choose a Time Period: One way to approach the topic selection is by focusing on a particular time period that sparks your interest. It could be anything from the Bronze Age, to the Renaissance, to World War II. The more interested you are in the chosen time period, the more engaged you will be in the research process.
• Pick a Region: Similar to choosing a time period, selecting a particular region or country can also help narrow down potential topics. Are you fascinated by the history of East Asia, intrigued by ancient Egypt, or drawn to the socio-political history of Europe? Starting with a geographic focus can provide a strong foundation for your research.
• Identify a Theme: In addition to or instead of a time period or region, you might want to choose a theme that you wish to explore. Themes can range from political history, cultural history, history of science and technology, to gender history, among others. A thematic approach can offer a unique perspective and can even allow you to cross over different time periods or regions.
• Conduct Preliminary Research: Even before you have a firm topic in hand, engage in some preliminary research. This could involve reviewing textbooks, scholarly articles, or reputable online resources related to your chosen period, region, or theme. Preliminary research can give you a general sense of the historical context and inspire potential topics.
• Seek Inspiration from Existing Works: As part of your preliminary research, look at other research papers, theses, or dissertations in your area of interest. This can give you a good idea of what has been done, what gaps exist in the research, and where your research could potentially fit in.
• Scope Your Topic: The scope of your topic should be proportionate to the length and depth of your paper. If your paper is relatively short, a narrow, focused topic would be more suitable. For a longer and more complex paper, a broader topic that explores multiple facets or perspectives would be more appropriate.
• Consider the Relevance: Another aspect to consider when selecting a topic is its relevance. Does the topic have any relation to the course you are undertaking? Does it reflect on current historical or social debates? A topic that connects your historical research to broader academic or social issues can make your paper more impactful and engaging.
• Look for Unique Angles: While not every research paper can revolutionize the field, striving for some degree of originality in your work is always a good practice. Look for unique angles, underexplored areas, or new perspectives on a well-trodden topic. Presenting a fresh approach can make your paper more interesting for both you and your readers.
• Assess the Availability of Sources: Your research paper is only as good as your sources. Before finalizing your topic, make sure there are enough primary and secondary sources available to you. This could be in the form of books, academic articles, documentary films, archives, databases, or digital resources.
• Evaluate the Feasibility: Beyond the availability of sources, consider other practical aspects of your chosen topic. Is it feasible to conduct the research within the given time frame? Is the topic too complex or too simplistic for your current academic level? A realistic evaluation of these factors at an early stage can save you a lot of time and effort down the line.
• Reflect on Your Interests: Above all, select a topic that genuinely piques your curiosity. A research paper is a significant undertaking, and your interest in the topic will sustain you through potential challenges. If you are passionate about the topic, it will reflect in your writing and make your paper more compelling.
• Solicit Feedback: Seek advice from your instructor, classmates, or any other knowledgeable individuals. They may be able to provide valuable feedback, point out potential pitfalls, or suggest different perspectives that can enrich your research.
• Be Flexible: Be prepared to tweak, adjust, or even overhaul your topic as you delve deeper into the research process. New information or insights may emerge that shift your focus or challenge your initial assumptions.
• Bridge the Past and Present: Try to find topics that allow you to connect historical events or phenomena with contemporary issues. This can provide additional depth to your paper and may also appeal to a broader audience.
• Consult Specialized Encyclopedias and Guides: These can provide overviews of various topics and can often suggest areas for research. They also offer bibliographies which can serve as a starting point for your research.
• Draft a Preliminary Thesis Statement: Once you have a potential topic, try drafting a preliminary thesis statement. This can help you focus your ideas and give you a clear direction for your research.
• Ensure Your Topic Meets the Assignment Goals: Check back with your assignment guidelines to make sure your chosen topic meets all the requirements. It’s a good idea to do this before you start your in-depth research.
• Be Ready to Invest Time and Effort: Choose a topic that you are ready to spend time on. Remember, you will be working on this topic for an extended period, so choose something that you find interesting and engaging.
• Enjoy the Process: Finally, remember that the process of researching and writing a history paper can be a source of enjoyment and intellectual satisfaction. Choose a topic that not only meets academic requirements but also gives you a sense of accomplishment and discovery.

Choosing the best history research paper topic is not merely about fulfilling an academic requirement. It’s about setting the stage for a journey into the past, an exploration of humanity’s collective memory. The right topic will not only make this journey enjoyable but also deeply enlightening. By considering these tips, you can select a topic that resonates with you and holds the potential for a meaningful scholarly contribution.

How to Write a Best History Research Paper

Writing a history research paper can be a rewarding experience, providing an opportunity to delve into the past and explore the events, ideas, and personalities that have shaped our world. However, crafting a high-quality paper requires more than just an interest in the subject matter. It involves thorough research, analytical thinking, and clear, persuasive writing. Here are twenty comprehensive tips on how to write a best history research paper.

• Understand the Assignment: Begin by thoroughly understanding the assignment. Ensure you grasp the requirements, the scope of the paper, the format, and the deadline. Clear any doubts with your professor or peers before you start.
• Select a Suitable Topic: As discussed earlier, choosing an appropriate topic is crucial. It should be engaging, manageable, and meet the assignment’s requirements. Consider your interests, the available resources, and the paper’s scope when choosing the topic.
• Conduct In-Depth Research: Once the topic is decided, embark on thorough research. Use a variety of sources, such as books, academic journals, credible online sources, primary sources, and documentaries. Remember to take notes and record the sources for citation purposes.
• Formulate a Thesis Statement: The thesis statement is the central argument or point of your paper. It should be clear, concise, and debatable, providing a roadmap for your entire paper. The thesis statement should guide your research and each main point you make in your paper should support this central idea.
• Create an Outline: An outline helps organize your thoughts and arguments. Typically, it should include an introduction (with the thesis statement), body paragraphs (with topic sentences), and a conclusion. Each point in your outline should be a reflection of your thesis statement.
• Start with a Strong Introduction: The introduction should be engaging, provide some background on the topic, and include the thesis statement. It sets the tone for the rest of your paper, so make it compelling and informative.
• Develop Body Paragraphs: Each body paragraph should focus on one main idea that supports your thesis. Begin with a topic sentence, provide evidence or arguments, and then conclude the paragraph by linking it back to your thesis. Be clear and concise in your arguments.
• Use Evidence Effectively: Support your arguments with evidence from your research. This could include quotations, statistics, or primary source materials. Remember to interpret the evidence and explain its relevance to your argument.
• Maintain a Logical Flow: The ideas in your paper should flow logically from one point to the next. Use transitional words and phrases to maintain continuity and help guide your reader through your paper.
• Write a Compelling Conclusion: Your conclusion should sum up your main points, restate the thesis in light of the evidence provided, and possibly offer areas for further research or a concluding insight. It should leave the reader with something to think about.
• Cite Your Sources: Always cite your sources properly. This not only gives credit where it’s due but also strengthens your argument by indicating the breadth of your research. Ensure you follow the required citation style (APA, MLA, Chicago, etc.).
• Revise for Clarity and Coherence: After finishing your initial draft, revise your work. Check for clarity, coherence, and consistency of argument. Ensure each paragraph has a clear focus, and that the paragraphs flow smoothly from one idea to the next.
• Proofread: Proofread your paper for grammar, punctuation, and spelling errors. Such errors can distract from the content and undermine your credibility as a writer. Reading your paper aloud or having someone else read it can help catch errors you might have missed.
• Seek Feedback: Before finalizing your paper, consider seeking feedback from your professor, peers, or a writing center tutor. They can provide valuable perspectives and suggestions for improvement that you might not have considered.
• Write in a Formal Academic Style: Your paper should be written in a formal academic style. Avoid slang, colloquialisms, and overly complex language. Be clear, concise, and precise in your expression.
• Avoid Plagiarism: Plagiarism is a serious academic offense. Ensure that all ideas and words that are not your own are properly cited. When in doubt, it’s better to over-cite than to under-cite.
• Stay Objective: A good history paper is objective and does not include personal opinions or biases. It relies on facts and evidence, and presents balanced arguments. Stick to the evidence and avoid emotional language.
• Be Original: Strive for originality in your argument and interpretation. While your topic might not be entirely new, your perspective on it can be. Don’t be afraid to challenge established interpretations if you have evidence to support your argument.
• Use Primary Sources Wisely: Primary sources are invaluable in historical research. However, remember that they should be used to support your argument, not to construct it. Your analysis and interpretation of the sources are what matters.
• Enjoy the Process: Finally, remember to enjoy the process. Writing a research paper is not just an academic exercise, but a journey into the past. It’s a chance to learn, explore, and contribute to our understanding of history.

In conclusion, writing a best history research paper requires careful planning, thorough research, clear writing, and detailed revision. However, the process can be highly rewarding, leading to new insights and a deeper understanding of history. These tips provide a comprehensive guide to help you craft a top-notch history research paper. Remember, history is a continually evolving dialogue, and your paper is your chance to join the conversation.

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Science | February 2, 2021

An Evolutionary Timeline of Homo Sapiens

Scientists share the findings that helped them pinpoint key moments in the rise of our species

Brian Handwerk

Science Correspondent

The long evolutionary journey that created modern humans began with a single step—or more accurately—with the ability to walk on two legs. One of our earliest-known ancestors, Sahelanthropus , began the slow transition from ape-like movement some six million years ago, but Homo sapiens wouldn’t show up for more than five million years. During that long interim, a menagerie of different human species lived, evolved and died out, intermingling and sometimes interbreeding along the way. As time went on, their bodies changed, as did their brains and their ability to think, as seen in their tools and technologies.

To understand how Homo sapiens eventually evolved from these older lineages of hominins, the group including modern humans and our closest extinct relatives and ancestors, scientists are unearthing ancient bones and stone tools, digging into our genes and recreating the changing environments that helped shape our ancestors’ world and guide their evolution.

These lines of evidence increasingly indicate that H. sapiens originated in Africa, although not necessarily in a single time and place. Instead it seems diverse groups of human ancestors lived in habitable regions around Africa, evolving physically and culturally in relative isolation, until climate driven changes to African landscapes spurred them to intermittently mix and swap everything from genes to tool techniques. Eventually, this process gave rise to the unique genetic makeup of modern humans.

“East Africa was a setting in foment—one conducive to migrations across Africa during the period when Homo sapiens arose,” says Rick Potts , director of the Smithsonian’s Human Origins Program. “It seems to have been an ideal setting for the mixing of genes from migrating populations widely spread across the continent. The implication is that the human genome arose in Africa. Everyone is African, and yet not from any one part of Africa.”

New discoveries are always adding key waypoints to the chart of our human journey. This timeline of Homo sapiens features some of the best evidence documenting how we evolved.

550,000 to 750,000 Years Ago: The Beginning of the Homo sapiens Lineage

Genes, rather than fossils, can help us chart the migrations, movements and evolution of our own species—and those we descended from or interbred with over the ages.

The oldest-recovered DNA of an early human relative comes from Sima de los Huesos , the “Pit of Bones.” At the bottom of a cave in Spain’s Atapuerca Mountains scientists found thousands of teeth and bones from 28 different individuals who somehow ended up collected en masse. In 2016, scientists painstakingly teased out the partial genome from these 430,000-year-old remains to reveal that the humans in the pit are the oldest known Neanderthals , our very successful and most familiar close relatives. Scientists used the molecular clock to estimate how long it took to accumulate the differences between this oldest Neanderthal genome and that of modern humans, and the researchers suggest that a common ancestor lived sometime between 550,000 and 750,000 years ago.

Pinpoint dating isn't the strength of genetic analyses, as the 200,000-year margin of error shows. “In general, estimating ages with genetics is imprecise,” says Joshua Akey, who studies evolution of the human genome at Princeton University. “Genetics is really good at telling us qualitative things about the order of events, and relative time frames.” Before genetics, these divergence dates were estimated by the oldest fossils of various lineages scientists found. In the case of H. sapiens, known remains only date back some 300,000 years, so gene studies have located the divergence far more accurately on our evolutionary timeline than bones alone ever could.

Though our genes clearly show that modern humans, Neanderthals and Denisovans —a mysterious hominin species that left behind substantial traces in our DNA but, so far, only a handful of tooth and bone remains—do share a common ancestor, it’s not apparent who it was. Homo heidelbergensis , a species that existed from 200,000 to 700,000 years ago, is a popular candidate. It appears that the African family tree of this species leads to Homo sapiens while a European branch leads to Homo neanderthalensis and the Denisovans.

More ancient DNA could help provide a clearer picture, but finding it is no sure bet. Unfortunately, the cold, dry and stable conditions best for long-term preservation aren’t common in Africa, and few ancient African human genomes have been sequenced that are older than 10,000 years.

“We currently have no ancient DNA from Africa that even comes near the timeframes of our evolution—a process that is likely to have largely taken place between 800,000 and 300,000 years ago,” says Eleanor Scerri, an archaeological scientist at the Max Planck Institute for the Science of Human History in Germany.

300,000 Years Ago: Fossils Found of Oldest Homo sapiens

As the physical remains of actual ancient people, fossils tell us most about what they were like in life. But bones or teeth are still subject to a significant amount of interpretation. While human remains can survive after hundreds of thousands of years, scientists can’t always make sense of the wide range of morphological features they see to definitively classify the remains as Homo sapiens , or as different species of human relatives.

Fossils often boast a mixture of modern and primitive features, and those don’t evolve uniformly toward our modern anatomy. Instead, certain features seem to change in different places and times, suggesting separate clusters of anatomical evolution would have produced quite different looking people.

No scientists suggest that Homo sapiens first lived in what’s now Morocco, because so much early evidence for our species has been found in both South Africa and East Africa. But fragments of 300,000-year-old skulls, jaws, teeth and other fossils found at Jebel Irhoud , a rich site also home to advanced stone tools, are the oldest Homo sapiens remains yet found.

The remains of five individuals at Jebel Irhoud exhibit traits of a face that looks compellingly modern, mixed with other traits like an elongated brain case reminiscent of more archaic humans. The remains’ presence in the northwestern corner of Africa isn’t evidence of our origin point, but rather of how widely spread humans were across Africa even at this early date.

Other very old fossils often classified as early Homo sapiens come from Florisbad, South Africa (around 260,000 years old), and the Kibish Formation along Ethiopia’s Omo River (around 195,000 years old).

The 160,000-year-old skulls of two adults and a child at Herto, Ethiopia, were classified as the subspecies Homo sapiens idaltu because of slight morphological differences including larger size. But they are otherwise so similar to modern humans that some argue they aren’t a subspecies at all. A skull discovered at Ngaloba, Tanzania, also considered Homo sapiens , represents a 120,000-year-old individual with a mix of archaic traits and more modern aspects like smaller facial features and a further reduced brow.

Debate over the definition of which fossil remains represent modern humans, given these disparities, is common among experts. So much so that some seek to simplify the characterization by considering them part of a single, diverse group.

“The fact of the matter is that all fossils before about 40,000 to 100,000 years ago contain different combinations of so called archaic and modern features. It’s therefore impossible to pick and choose which of the older fossils are members of our lineage or evolutionary dead ends,” Scerri suggests. “The best model is currently one in which they are all early Homo sapiens , as their material culture also indicates.”

As Scerri references, African material culture shows a widespread shift some 300,000 years ago from clunky, handheld stone tools to the more refined blades and projectile points known as Middle Stone Age toolkits.

So when did fossils finally first show fully modern humans with all representative features? It’s not an easy answer. One skull (but only one of several) from Omo Kibish looks much like a modern human at 195,000 years old, while another found in Nigeria’s Iwo Eleru cave, appears very archaic, but is only 13,000 years old . These discrepancies illustrate that the process wasn’t linear, reaching some single point after which all people were modern humans.

300,000 Years Ago: Artifacts Show a Revolution in Tools

Our ancestors used stone tools as long as 3.3 million years ago and by 1.75 million years ago they’d adopted the Acheulean culture , a suite of chunky handaxes and other cutting implements that remained in vogue for nearly 1.5 million years. As recently as 400,000 years ago, thrusting spears used during the hunt of large prey in what is now Germany were state of the art. But they could only be used up close, an obvious and sometimes dangerous limitation.

Even as they acquired the more modern anatomy seen in living humans, the ways our ancestors lived, and the tools they created, changed as well.

Humans took a leap in tool tech with the Middle Stone Age some 300,000 years ago by making those finely crafted tools with flaked points and attaching them to handles and spear shafts to greatly improve hunting prowess. Projectile points like those Potts and colleagues dated to 298,000 to 320,000 years old in southern Kenya were an innovation that suddenly made it possible to kill all manner of elusive or dangerous prey. “It ultimately changed how these earliest sapiens interacted with their ecosystems, and with other people,” says Potts.

Scrapers and awls, which could be used to work animal hides for clothing and to shave wood and other materials, appeared around this time. By at least 90,000 years ago barbed points made of bone— like those discovered at Katanda, Democratic Republic of the Congo —were used to spearfish

As with fossils, tool advancements appear in different places and times, suggesting that distinct groups of people evolved, and possibly later shared, these tool technologies. Those groups may include other humans who are not part of our own lineage.

Last year a collection including sophisticated stone blades was discovered near Chennai, India , and dated to at least 250,000 years ago. The presence of this toolkit in India so soon after modern humans appeared in Africa suggests that other species may have also invented them independently—or that some modern humans spread the technology by leaving Africa earlier than most current thinking suggests.

100,000 to 210,000 Years Ago: Fossils Show Homo sapiens Lived Outside of Africa

Many genetic analyses tracing our roots back to Africa make it clear that Homo sapiens originated on that continent. But it appears that we had a tendency to wander from a much earlier era than scientists had previously suspected.

A jawbone found inside a collapsed cave on the slopes of Mount Carmel, Israel, reveals that modern humans dwelt there, alongside the Mediterranean, some 177,000 to 194,000 years ago. Not only are the jaw and teeth from Misliya Cave unambiguously similar to those seen in modern humans, they were found with sophisticated handaxes and flint tools.

Other finds in the region, including multiple individuals at Qafzeh, Israel, are dated later. They range from 100,000 to 130,000 years ago, suggesting a long presence for humans in the region. At Qafzeh, human remains were found with pieces of red ocher and ocher-stained tools in a site that has been interpreted as the oldest intentional human burial .

Among the limestone cave systems of southern China, more evidence has turned up from between 80,000 and 120,000 years ago. A 100,000-year-old jawbone, complete with a pair of teeth, from Zhirendong retains some archaic traits like a less prominent chin, but otherwise appears so modern that it may represent Homo sapiens . A cave at Daoxian yielded a surprising array of ancient teeth , barely distinguishable from our own, which suggest that Homo sapiens groups were already living very far from Africa from 80,000 to 120,000 years ago.

Even earlier migrations are possible; some believe evidence exists of humans reaching Europe as long as 210,000 years ago. While most early human finds spark some scholarly debate, few reach the level of the Apidima skull fragment, in southern Greece, which may be more than 200,000 years old and might possibly represent the earliest modern human fossil discovered outside of Africa. The site is steeped in controversy , however, with some scholars believing that the badly preserved remains look less those of our own species and more like Neanderthals, whose remains are found just a few feet away in the same cave. Others question the accuracy of the dating analysis undertaken at the site, which is tricky because the fossils have long since fallen out of the geological layers in which they were deposited.

While various groups of humans lived outside of Africa during this era, ultimately, they aren’t part of our own evolutionary story. Genetics can reveal which groups of people were our distant ancestors and which had descendants who eventually died out.

“Of course, there could be multiple out of Africa dispersals,” says Akey. “The question is whether they contributed ancestry to present day individuals and we can say pretty definitely now that they did not.”

50,000 to 60,000 Years Ago: Genes and Climate Reconstructions Show a Migration Out of Africa

All living non-Africans, from Europeans to Australia’s aboriginal people, can trace most of their ancestry to humans who were part of a landmark migration out of Africa beginning some 50,000 to 60,000 years ago , according to numerous genetic studies published in recent years. Reconstructions of climate suggest that lower sea levels created several advantageous periods for humans to leave Africa for the Arabian Peninsula and the Middle East, including one about 55,000 years ago.

“Just by looking at DNA from present day individuals we’ve been able to infer a pretty good outline of human history,” Akey says. “A group dispersed out of Africa maybe 50 to 60 thousand years ago, and then that group traveled around the world and eventually made it to all habitable places of the world.”

While earlier African emigres to the Middle East or China may have interbred with some of the more archaic hominids still living at that time, their lineage appears to have faded out or been overwhelmed by the later migration.

15,000 to 40,000 Years Ago: Genetics and Fossils Show Homo sapiens Became the Only Surviving Human Species

For most of our history on this planet, Homo sapiens have not been the only humans. We coexisted, and as our genes make clear frequently interbred with various hominin species, including some we haven’t yet identified. But they dropped off, one by one, leaving our own species to represent all humanity. On an evolutionary timescale, some of these species vanished only recently.

On the Indonesian island of Flores, fossils evidence a curious and diminutive early human species nicknamed “hobbit.” Homo floresiensis appear to have been living until perhaps 50,000 years ago, but what happened to them is a mystery. They don’t appear to have any close relation to modern humans including the Rampasasa pygmy group, which lives in the same region today.

Neanderthals once stretched across Eurasia from Portugal and the British Isles to Siberia. As Homo sapiens became more prevalent across these areas the Neanderthals faded in their turn, being generally consigned to history by some 40,000 years ago. Some evidence suggests that a few die-hards might have held on in enclaves, like Gibraltar, until perhaps 29,000 years ago. Even today traces of them remain because modern humans carry Neanderthal DNA in their genome .

Our more mysterious cousins, the Denisovans, left behind so few identifiable fossils that scientists aren’t exactly sure what they looked like, or if they might have been more than one species. A recent study of human genomes in Papua New Guinea suggests that humans may have lived with and interbred with Denisovans there as recently as 15,000 years ago, though the claims are controversial. Their genetic legacy is more certain. Many living Asian people inherited perhaps 3 to 5 percent of their DNA from the Denisovans.

Despite the bits of genetic ancestry they contributed to living people, all of our close relatives eventually died out, leaving Homo sapiens as the only human species. Their extinctions add one more intriguing, perhaps unanswerable question to the story of our evolution—why were we the only humans to survive?

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Brian Handwerk is a science correspondent based in Amherst, New Hampshire.

Articles on Human history

Displaying 1 - 20 of 31 articles.

Lucy, discovered 50 years ago in Ethiopia, stood just 3.5 feet tall − but she still towers over our understanding of human origins

Denise Su , Arizona State University

Don’t feel bad about bingeing TV. Humans have binged stories for thousands of years

Darius von Guttner Sporzynski , Australian Catholic University

The secrets of Maya child sacrifice at Chichén Itzá uncovered using ancient DNA

Adam "Ben" Rohrlach , University of Adelaide and Rodrigo Barquera , Max Planck Institute for Evolutionary Anthropology

Humans have been altering nature for thousands of years – to shape a sustainable future, it’s important to understand that deep history

Todd Braje , University of Oregon

First evidence of ancient human occupation found in giant lava tube cave in Saudi Arabia

Mathew Stewart , Griffith University ; Huw Groucutt , University of Malta , and Michael Petraglia , Griffith University

Ancient DNA reveals children with Down syndrome in past societies. What can their burials tell us about their lives?

Adam "Ben" Rohrlach , University of Adelaide and Kay Prüfer , Max Planck Institute for Evolutionary Anthropology

People once lived in a vast region in north-western Australia – and it had an inland sea

Kasih Norman , Griffith University ; Chris Clarkson , The University of Queensland ; Corey J. A. Bradshaw , Flinders University ; Frédérik Saltré , Flinders University , and Tristen Anne Norrie Jones , University of Sydney

New path for early human migrations through a once-lush Arabia contradicts a single ‘out of Africa’ origin

Michael Petraglia , Griffith University ; Mahmoud Abbas , Shantou University , and Zhongping Lai , Shantou University

In a Stone Age cemetery, DNA reveals a treasured ‘founding father’ and a legacy of prosperity for his sons

Adam "Ben" Rohrlach , University of Adelaide and Maïté Rivollat , Université de Bordeaux

Drugs and religion have been a potent combination for millennia, from cannabis at ancient funerary sites to psychedelic retreats today

Gary Laderman , Emory University

DNA study opens a window into African civilisations that left a lasting legacy

Nancy Bird , UCL

We thought the first hunter-gatherers in Europe went missing during the last ice age. Now, ancient DNA analysis says otherwise

Adam "Ben" Rohrlach , University of Adelaide

We found 2. 9-million - year-old stone tools used to butcher ancient hippos – but likely not by our ancestors

Julien Louys , Griffith University and Thomas Plummer , Queens College, CUNY

5,700 years of sea-level change in Micronesia hint at humans arriving much earlier than we thought

Juliet Sefton , Monash University ; Andrew Kemp , Tufts University , and Mark D. McCoy , Southern Methodist University

8 billion humans: How population growth and climate change are connected as the ‘Anthropocene engine’ transforms the planet

Manfred Laubichler , Arizona State University

First-ever genetic analysis of a Neanderthal family paints a fascinating picture of a close-knit community

Laurits Skov , Max Planck Institute for Evolutionary Anthropology and Richard 'Bert' Roberts , University of Wollongong

World’s earliest evidence of a successful surgical amputation found in 31, 000-year -old grave in Borneo

Tim Ryan Maloney , Griffith University ; Adam Brumm , Griffith University ; Adhi Oktaviana , Griffith University ; India Ella Dilkes-Hall , The University of Western Australia ; Maxime Aubert , Griffith University ; Melandri Vlok , University of Sydney , and Renaud Joannes-Boyau , Southern Cross University

Mysterious marks on boomerangs reveal a ‘forgotten’ use of this iconic Aboriginal multi-tool

Eva Francesca Martellotta , Griffith University ; Michelle Langley , Griffith University , and Paul Craft , Indigenous Knowledge

A forgotten settlement in the Cradle of Humankind adds a note to southern African history

Tim Forssman , University of Pretoria

Baby steps: this ancient skull is helping us trace the path that led to modern childhood

Tanya M. Smith , Griffith University ; Philipp Gunz , and Zeray Alemseged , University of Chicago

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The Universal Declaration of Human Rights and the Modern History of Human Rights

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Beginning with the phrase “all human beings are born free and equal in dignity and rights,” the Universal Declaration of Human Rights (UDHR) proclaims its purpose of establishing global human rights from the outset. As a common standard of achievement for all signatory nations, the UDHR constitutes an essential cornerstone in the modern history of human rights by drawing upon ancient to contemporary philosophies, responses to the heinous crimes of World War II, and various visions for future human rights standards. Despite diverging viewpoints from many of the drafting parties and states, the UDHR eventually transcended conflict to form the underpinnings of a moral compass for all of humankind. This essay first explores how the UDHR came into formation by reviewing the historical origins of human rights, global dynamics prior to the UDHR, the drafting process and key debates involved, and finally its achieved compromise and ultimate unanimous adoption. Then, the essay examines ways in which the UDHR has evolved, from both a legal and moral angle, since its adoption in the context of past achievements and current challenges. From a historical point of view, I argue that the UDHR is a living document that has and is expected to change as our societies continue to evolve.

Keywords: human rights, human rights project, international human rights, UDHR, Universal Declaration of Human Rights, human rights standards, Human Rights Commission, global human rights, future human rights, United Nations, United States Declaration of Independence, political rights, economic rights, social

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• 18 May 2023

Human-evolution story rewritten by fresh data and more computing power

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The widely held idea that modern-day humans originated from a single region of Africa is being challenged. Models using a vast amount of genomic data suggest that humans arose from multiple ancestral populations around the continent. These ancient populations — which lived more than one million years ago — would have all been the same hominin species but genetically slightly different.

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Why Human Subjects Research Protection Is Important

Background: Institutional review boards (IRBs), duly constituted under the Office of Human Research Protection, have the federally mandated responsibility of reviewing research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in any study. The road leading to the current regulations and ethical considerations has been long and checkered.

Methods: This paper reviews the history of human subjects participating in research, including examples of egregious events, and the ethical analyses that precipitated the evolution of the mandated protections afforded participants in research under current federal regulations.

Results: Key documents—from the Nuremberg Code in 1947 to the Belmont Report in 1978 to Moral Science: Protecting Participants in Human Subjects Research in 2011—that have informed the ethics debate regarding human subjects protection in research activities are presented in light of their historic significance, highlighting the complexity of the issues surrounding protection of human subjects in research.

Conclusion: The examples from history and the scarcity of contemporary examples demonstrate that the regulations for the protection of humans participating in research have evolved in a way that minimizes the probability that subjects will be harmed when they choose to participate in research. The examples also reinforce the importance of individual responsibility. Failure of IRBs to provide appropriate review and oversight can lead to severe consequences, as can abrogation by the investigator to place the well-being of the subjects as the primary responsibility in any research protocol. Understanding how we arrived at the current approach and some of the failures that directed this course can support efforts to continually reevaluate and improve the safety of subjects who are willing to participate in research activities.

INTRODUCTION

Participation of human subjects in research presents a challenging ethical dilemma. A research subject may be asked to participate in a study of no benefit and no substantial risk or in a study with the potential for significant benefit but also significant risk. In placebo-controlled studies, subjects may be exposed to significant risk for no benefit to the individual. These variants are confounded by treatment protocols—most commonly encountered in oncology trials—that compare the effect of an investigational arm to the standard of care, further blurring the distinction between research and medical treatment.

Institutional review boards (IRBs) have the federally mandated responsibility to review research involving human subjects to ensure that a proposed protocol meets the appropriate ethical guidelines before subjects may be enrolled in the study. The road leading to the current regulations and ethical considerations has been long and checkered. The system that has evolved minimizes the risks for unethical behavior and serious adverse events but is not infallible. Understanding how we have arrived at the current approach and analyzing some of the ethical lapses that directed this course support efforts to continually reevaluate the regulations in order to improve the safety of subjects who are willing to participate in research activities.

EVOLUTION OF HUMAN SUBJECTS PROTECTION

Our current approach to human subjects protection has evolved with efforts to understand questionable ethical behavior in research over the course of several hundred years. One might suggest that the jester conscripted to sample the king's food to ensure that it was safe to eat presaged the use of vulnerable populations as subjects for research, but the evolution of the management of smallpox is perhaps a more applicable early perspective on research in humans. Three centuries ago, reports of good outcomes following variolation—inhalation of the scabs from persons infected with smallpox—were circulating in Asia. In 1717, Lady Mary Wortley Montagu, the wife of the British ambassador to Turkey, became an advocate of variolation after learning about it in Constantinople. In 1721, after she returned to England, Lady Montagu and the Princess of Wales urged variolation of “several prisoners and abandoned children” by having smallpox scabs inserted under their skin. Several months later, the children and prisoners were deliberately exposed to smallpox. When none contracted the disease, the procedure was deemed safe, and members of the royal family were treated according to this new protocol. 1

Later that same century, Edward Jenner developed inoculation with a vaccine. Many of his contemporaries had noted that milkmaids who had contracted cowpox seemed immune to the much more lethal smallpox. In May 1796, Jenner isolated material from the cowpox lesions on the milkmaid Sarah Nelms and inoculated 8-year-old James Phipps who developed fever and malaise about 9 days after the inoculation. Some accounts report that Phipps was the son of Jenner's gardener. A few months later, Jenner deliberately inoculated Phipps with material from fresh smallpox lesions, and the child remained healthy. The adoption of this process was not immediate but slowly spread and is widely cited as the first scientific approach proving vaccination. 2

This early use of children and prisoners portends a long history of selecting what are now considered vulnerable populations to be the subjects of research. Participation was commonly without consent, with no knowledge of their participation, and with no explanation of the research. Information was withheld from those selected to participate in research activities perceived as dangerous to more acceptable members of society, and the therapies developed were generalized only if they were proven relatively safe and effective in what are now recognized as vulnerable populations.

Numerous instances of research experiments in subsequent years exposed vulnerable subjects to risk, including a pivotal research disaster in Germany just before World War II that led to regulations for human subjects participation in research projects.

The Reich Circular of 1931

As reported by Sir Graham Wilson in the book The Hazards of Immunization , “Between 10 December 1929 and 30 April 1930, 251 of 412 infants born in the old Hanseatic town of Lubeck received three doses of BCG [bacillus Calmette-Guerin] vaccine by the mouth during the first ten days of life. Of these 251, 72 died of tuberculosis, most of them in two to five months and all but one before the end of the first year. In addition, 135 suffered from clinical tuberculosis but eventually recovered; and 44 became tuberculin-positive but remained well.” 3

Bonah and Menut describe how Albert Calmette was able to establish the BCG vaccine as a nonexperimental “prophylactic treatment” against tuberculosis. 4 By definition, a medical experiment, as opposed to any other medical action, has definite ethical implications and consequences. Even though the BCG vaccine was in experimental stages, Calmette convinced a court that the vaccine was a “post-experimental, routine medical treatment.” By avoiding the definition of an experiment, Calmette did not have to inform the children's parents about the risks of the vaccine. As a result of this tragedy, Dr Julius Moses, a critic of unethical human experimentation who referred to “experimental mania,” drafted guidelines for human experimentation. After debate in parliament and the press, the guidelines were published and became official in 1931. The guidelines applied to everyone in Germany. 5 , 6

These rules for research in human subjects were issued as the Reich Circular of 1931 ( Figure 1 ). The document is quite informative for its contrast with later events in Germany and worth reviewing for correlation with ethical concepts now well accepted in ethical thinking. It is worth noting that these guidelines emphasize special responsibilities for utilization of “innovative therapy,” suggesting a similar level of responsibility for these procedures as for research.

The Reich Circular, 1931 6

World War II and the Nuremberg Code

Despite the ethical ideals espoused in the Reich Circular, the travesty of the Holocaust followed shortly afterward, leading to war criminal trials after the surrender of Germany ended World War II in Europe.

The Nuremberg trials that began in 1945 and concluded in 1947 were held in response to the atrocities Germany committed during the war. The so-called Doctors’ Trial represents a major turning point in human research protection. Twenty-three physicians were indicted, accused of crimes against humanity by conducting criminal scientific and medical experiments on concentration camp prisoners. Sixteen defendants were found guilty. 7

Several German doctors had argued that no international law or informal statement differentiated between legal and illegal human experimentation, despite the aforementioned Reich Circular. Two US doctors who worked with the prosecution during the trial, Andrew Ivy and Leo Alexander, objected to this argument. On April 17, 1947, Dr Alexander submitted a memorandum to the United States Counsel for War Crimes outlining 6 points defining legitimate medical research. The trial verdict reiterated almost all of these points in a section entitled Permissible Medical Experiments and expanded the original 6 points into 10. These 10 points became known as the Nuremberg Code ( Figure 2 ). 8

The Nuremberg Code, 1947 10

Similar atrocities were carried out on Chinese citizens in Japanese camps; of particular note are the biological warfare experiments at Unit 731 in the Pacific theater that were obscured by agreements made during the surrender of Japan and with the complicity of the United States. 9 The details of these atrocities remained classified until they were acknowledged by Congress in the Japanese Imperial Government Disclosure Act of 2000 (Pub L No. 106-567, Title VIII of the Intelligence Authorization Act of 2000) that called for declassification and release of records related to Japanese war crimes during World War II. 10

Declaration of Helsinki

The tenets of the Nuremberg Code, while guiding the future for human research protection, represent a military code of conduct with no standing in civil international or US law. By absolutely requiring the voluntary consent of the individual, the Nuremberg Code notably does not address the needs of children or other special populations unable to provide consent. The Nuremberg Code inspired the World Medical Association (WMA)—an international association currently comprised of 114 national medical associations, including the American Medical Association—to propose a similar code of conduct for participating members by publishing the Declaration of Helsinki in 1964. This document reiterates the provisions of the Nuremberg Code and expands the provisions to allow for the participation of children and other potentially compromised subjects in research. The Declaration of Helsinki serves as a guideline for ethical research and has been amended 7 times, most recently at the WMA General Assembly in October 2013, to reflect contemporary ethical issues as they have evolved since the initial statement in 1964. 11

Ethics Violations in the United States

Meanwhile, research continued in the United States with particular concerns attached to research involving vulnerable populations, exemplified by numerous studies involving institutionalized children and studies that breached ethically sound research practices. Henry Beecher, a well-recognized physician at Massachusetts General Hospital, surveyed the contemporary literature to identify ethical concerns and organized lectures around his observations. These lectures eventually culminated in a special article published in the New England Journal of Medicine in 1966. 12

In “Ethics and Clinical Research,” Beecher reported that he had reviewed 100 consecutive articles published in 1964 “in an excellent journal,” and after culling his list to address the editor's request, selected 12 articles that demonstrated serious ethical concerns. The purpose of Beecher's article was to demonstrate the widespread lapse in ethical issues in medical research and to encourage reform in the ethical approach to human subjects research that inspired Congress to reconsider legislative reforms for human subjects protection.

An article by Jean Heller that appeared in the Washington Star on July 25, 1972 placed an exclamation point in the history of human research ethics. 13 Heller reported on a long-term study sponsored by the US Public Health Service on the effect of syphilis if left untreated in poor rural African American subjects. Officially known as the “Tuskegee Study of Untreated Syphilis in the Negro Male,” the study enrolled 399 subjects with syphilis and 201 uninfected controls from the African American community surrounding Tuskegee, AL for “treatment of bad blood.” In exchange for taking part in the study, the men received free medical examinations, free meals, and burial insurance but were not given the benefit of providing informed consent. No treatment was provided; the research plan was to follow the subjects to establish a natural history for the disease if left untreated. Although originally projected to last 6 months, the study continued for 40 years. 14

Treatments available at the onset of the trial in 1932, even if provided, were not very effective and would have been heavy metals, involving at least 30 months of treatment, a 30% cure rate, and significant toxicity. By 1945, penicillin had been proven to be an effective therapy for syphilis with few side effects. Once penicillin was established as effective, the US Public Health Service set up centers for treatment but determined that the data from the Tuskegee experiments were too important to abandon and decided that the study should be continued with no treatment provided to the participants. Similar determinations were made in subsequent years, with the last review occurring as recently as 1969. 14

While medical research such as the Tuskegee study garnered most of the attention for ethical lapses, other areas of research involving human subjects also raised concerns. The Milgram experiments carried out in the early 1960s at Yale University are a lightning rod for discussion of ethical issues in human subjects research in social sciences. 15 Intrigued by the Nuremberg trials defendants’ argument that they were simply following orders, Stanley Milgram set out to determine if the German defendants were particularly obedient to authority figures compared to other members of society. Milgram recruited subjects for an experiment in learning via newspaper ads. The male research subjects were assigned to act as a teacher asking questions of a learner (a confederate of Milgram) who was attached to electrodes. The teachers were instructed to increase the severity of electrical shocks if the learner answered the questions incorrectly. Shocks were labeled from 15v to 450v, with 15v indicated as mild, 300v as severe, and 450v as XXX. Many of the teacher subjects eventually shocked the learner at 450v and exhibited increasing signs of distress as the shocks they delivered increased in perceived severity. 15 These experiments evoked significant concern among those in social sciences in regard to the questionable ethics of the deception used, as well as the potential for long-term psychological harm that might be incurred by unwitting participants.

Federal Policy for Protection of Human Subjects and the National Research Act

The public outcry over the Tuskegee study, other reports of ethical lapses in both medical and social research, and the alarm in the medical community raised by Dr Beecher's article in the New England Journal of Medicine led Congress to action. On May 30, 1974, the US Department of Health, Education, and Welfare (DHEW), responsible for oversight of the National Institutes of Health, replaced previous policies with comprehensive regulations governing the protection of human subjects (45 CFR §46). 16 One month later in July 1974, Congress passed the National Research Service Award Act of 1974 (Pub L No. 93-348). 17 Title II of the act, Protection of Human Subjects of Biomedical and Behavioral Research, created the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. Along with being assigned several other tasks, the National Commission was directed to make recommendations to the DHEW secretary about the ethical principles that should underlie human subjects research. 18

The Belmont Report

The National Commission issued several reports in response to the directives. The most notable among a collection of important documents is the Belmont Report, named after the Smithsonian conference center where the group convened, that was issued in 1978. 19 This document, widely regarded as the landmark analysis of ethics in human subjects research, serves as the foundation for discussion of ethical concerns in research ethics involving human subjects, as well as the source of federal regulations for research established by the Office for Human Research Protections (OHRP).

The Belmont Report is divided into three sections. The first section briefly states the National Commission's recognition that even as the report was being written, the distinction between medical practice and research was blurred. The report defines medical practice as “interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation for success. Research, on the other hand, is defined as “an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships).” This section further expounds on the conflation between the use of the terms experimental and research. When used in reference to a procedure or treatment that significantly deviates from typical (ie, a treatment that is “new, different or untested”), the report notes that an “experimental” treatment is not necessarily research. Although they excluded “experimental” treatment from research and the applicable anticipated regulations, the National Commission strongly recommended that such treatments should eventually be incorporated into formal research protocols “to determine if they are safe and effective.” The first section of the Belmont Report concludes with the recognition that practice and research may go hand in hand: “the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.” 19 This language is reminiscent of the Reich Circular recommendation regarding “innovative therapy.”

The second section is the heart of the report and defines three principles that should guide the discourse surrounding any ethical concerns related to research in human subjects: respect for persons, beneficence, and justice. The principle of nonmaleficence, now commonly accepted as one of the four principles of biomedical ethics, was notably absent.

• Respect for persons : The principle of respect for persons requires that “individuals should be treated as autonomous agents,” and those with “diminished autonomy are entitled to protection.” These concepts inform “two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.” The National Commission defines the elements that would be necessary to qualify as an autonomous individual and explores circumstances that would define those who should be considered to be of diminished autonomy and thus deserving of protection.
• Beneficence : The principle of beneficence as defined by the National Commission encompasses the concept of do no harm included in the Hippocratic Oath and notes that the term is commonly thought “to cover acts of kindness or charity that go beyond strict obligation.” The National Commission proposes two general rules that inform beneficence as an obligation: “(1) do not harm and (2) maximize possible benefits and minimize possible harms.” The implications of these duties within the context of both individual investigators and society at large are examined.
• Justice : The principle of justice is posed as the following question: “Who ought to receive the benefits of research and bear its burdens?” This principle is broad in potential implications and can be summarized as evaluating the appropriate distribution of the risks and burdens of research among individuals, groups, or even situations in which inherent inequalities may need to be considered to reach an ethically informed decision. The National Commission proposes the following framework for beginning these discussions: “(1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.” The discussion of justice continues with the historic context for including the principle of justice and how lapses in justice (ie, the Tuskegee study) were the primary impetus for the formation of the National Commission.

The final section of the Belmont Report addresses the application of these principles and the implications of their requirements when considering three important elements of research involving human subjects: informed consent, assessment of risks and benefits, and selection of subjects for research.

Informed consent. The consent process has three components: information, comprehension, and voluntariness. Reaching agreement on an appropriate standard for evaluating the quality of information that should be provided to potential participants about a proposed research project is difficult and eventually ends with the suggestion that the standard of “the reasonable volunteer” might best fulfill the requirements of respect for persons, beneficence, and justice. A caveat is provided, citing the problem posed by research where “informing subjects of some pertinent aspect of the research is likely to impair the validity of the research,” a key area of ethical concern (lack of disclosure) raised by the Milgram study discussed previously. The National Commission proposes that such studies may only be appropriate if “(1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them,” further noting that “Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.” 19

Regarding the component of comprehension, the Belmont Report states, “The manner and context in which information is conveyed is as important as the information itself.” The level of comprehension is also important within the context of the individual's ability to understand the information, with emphasis that the obligation for ensuring subject understanding increases in importance relative to the level of risk posed by participation in the study. The National Commission suggests that some level of questioning the subject to ensure comprehension is appropriate and even suggests that written responses to questions may be appropriate if risks are exceptionally high. 19 If participation of subjects with compromised abilities is anticipated, researchers must be particularly diligent in evaluating the level of comprehension by the subject's proxy and ensure that the proxy is indeed capable of representing the best interests of the subject. The report even suggests that the proxy might need to be present or available during the research interventions to withdraw the subject from the study if the proxy perceives that withdrawal may be in the subject's best interest.

Voluntariness is a concept consistently emphasized in the Reich Circular, the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Although voluntariness may appear to be self-evident, it may be the most difficult concept to address. The Belmont Report emphasizes that the subject must be “free of coercion and undue influence.” Coercion is specifically defined as “an overt threat of harm” and in most circumstances is relatively easy to evaluate. However, arguments can be made about what defines “undue influence.” Discussions about appropriate levels of compensation for participation are common, particularly when studies involve financial or other considerations made to possibly financially compromised subjects. The Belmont Report specifically notes, “inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.” Other concerns related to undue influence involve social standing, employment, or other circumstances that may be difficult to assess but are worthy of consideration for individual subjects.

Assessment of risks and benefits. The National Commission notes that a favorable risk/benefit assessment is associated with the principle of beneficence. This definition is particularly appropriate in that the National Commission's interpretation of beneficence includes the duty of nonmaleficence. The Belmont Report examines the meaning of risk and benefit in the setting of potential types of harm that may be experienced by individual subjects, the families of the individual subjects, society at large, or special groups of subjects in society. Benefits are also discussed in relation to the individual and society at large. In summarizing the risks and benefits of research, the Belmont Report states

…assessment of the justifiability of research should reflect at least the following considerations:

Brutal or inhumane treatment of human subjects is never morally justified.

Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures.

When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject—or, in some rare cases, to the manifest voluntariness of the participation).

When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits.

Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process. 19

Selection of subjects for research. The third element, selection of subjects for research, finds its primary guidance in the principle of justice where the moral requirements demand that the procedures and outcomes for the selection of subjects are fair to the individual and within the social context. Participation in potentially beneficial research should be fairly distributed to all who wish to participate, and risky research should not be offered only to less desirable subjects. In the context of society, risks should be distributed after careful consideration of the burdens and the ability of individuals in identifiable groups to bear those burdens. As a generalization, adults should be considered before children, and participation by institutionalized individuals should invoke very careful consideration. Even with these safeguards, the National Commission believed that the selection of subjects may continue to reflect injustice arising from social, racial, sexual, and cultural biases institutionalized in society. Harking back to the ethical concerns that prompted the National Commission, the Belmont Report concludes with the following: “One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.” 19

Although not included in the body of the report, a footnote specifically addresses the difficulty in extrapolating these tenets to human subjects research in the social sciences: “Because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the Commission specifically declines to make any policy determination regarding such research at this time. Rather, the Commission believes that the problem ought to be addressed by one of its successor bodies.” 19 An appropriate ethical approach for some areas of social and psychological studies remains elusive. Matthew Salganik, professor of sociology at Princeton University, discusses the issues surrounding the difficulty in applying the Belmont Report recommendations at his blog. 20

The Belmont Report was submitted to Congress on April 18, 1979.

Other Reports by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research

Although the Belmont Report is the centerpiece for the analysis of research in human subjects, the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research provided significant additional guidance for Congress to consider as the legislators moved forward to formulate regulations for the governance of human subjects in research. During the 4 years of the National Commission's appointment, other publications provided analysis of concerns related to specific questions (Table), and many of the recommendations were incorporated into the subsequent regulations for human subjects protection. 21

Table .

Human Subjects Protection in Research Reports From the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1974-1978 21

FOIA, Freedom of Information Act.

Principles of Biomedical Ethics

Another landmark publication from 1979 deserves attention for its sustained influence on the field of biomedical ethics and its deviation from the three ethical principles put forth by the Belmont Report. In Principles of Biomedical Ethics , Tom Beauchamp and James Childress argue for inclusion of nonmaleficence as an independent principle to formulate the now-familiar four principles that inform contemporary bioethical discourse. 22 As previously noted, nonmaleficence is considered a duty under the umbrella of the principle of beneficence in the Belmont Report. Beauchamp and Childress maintained that the tradition to do no harm central to the tenets of the Hippocratic Oath incorporates the concept of nonmaleficence at its core and is essential to any discussion of the ethics of medical practice. As such, they argued, this concept should be considered as separate from and not subsidiary to beneficence: “First, to confuse them is to obscure distinctions that we make in ordinary moral discourse. Second, ordinary moral discourse expresses the defensible conviction that we have certain duties not to injure others that are not only distinct from but also more stringent than our duties to benefit others.” 22 The authors make the distinction that the negative duty to cause no harm should be encompassed by nonmaleficence, and the positive but not so strongly established moral duty to benefit others should constitute the core of beneficence. The authors acknowledged that other eminent scholars disagreed with the separation of nonmaleficence and beneficence, but they constructed an argument that has been upheld by the historic inclusion of nonmaleficence in most bioethics discussions following their book's original publication (the book is now its seventh edition). The book has had a significant influence on the still-evolving field of bioethics contemporary to its publication and the Belmont Report. Both authors regularly served as staff members for the Kennedy Institute Intensive Bioethics Course, and Beauchamp served as staff philosopher for the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research that produced the Belmont Report. The authors acknowledged the influence of several other members of the commission and other colleagues who contributed significantly to their deliberations as their work progressed.

US Legislative Updates, 1981

DHEW officially became the Department of Health and Human Services (HHS) in 1980, and in response to the Belmont Report, the HHS and the US Food and Drug Administration (FDA) significantly revised their protection of human subjects regulations in 1981 (45 CFR §46 and 21 CFR §50). 16 , 18 , 23

These regulations specifically address concerns related to vulnerable populations in Subparts B, C, and D, incorporating the recommendations from the National Commission. The Research on the Fetus report 24 informed Subpart B (additional protections for pregnant women, human fetuses, and neonates), Subpart C (additional protections for prisoners) reflected the recommendations in Research Involving Prisoners , 25 and Subpart D (additional protections for children) was informed by the Research Involving Children report. 26

HUMAN SUBJECTS PROTECTION OVERSIGHT

Oversight in the united states.

To this point, this review has focused on some of the historic events and documents precipitating evaluation of the ethical requirements for human subjects research in the United States and a review of the regulations that evolved from that history. The question not yet addressed is how these regulations should be enforced. As with the discussion of research ethics, the approach to enforcement of regulations also lies within the National Research Service Award Act of 1974 (Pub L No. 93-348). 17 In addition to establishing the National Commission responsible for the Belmont Report, the National Research Act elected to perpetuate the regulatory mechanism for research extant within many departments of DHEW that evolved from the US Public Health Service requirements initiated by the Surgeon General in 1966. The background of this development is described in William Curran's article, “Government Regulation of the Use of Human Subjects in Medical Research: The Approach of Two Federal Agencies.” 27

This system for review of human subjects research within DHEW as described in The Institutional Guide to DHEW Policy on Protection of Human Subjects 28 became the model for institutional review boards (IRBs) that the National Research Act would require of grantees and contractees for review of research involving human subjects. The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research was specifically charged with reviewing the function of IRBs and making recommendations for integrating the role of the IRB into the regulatory process to provide oversight of the application of ethical principles and of the regulations. 18

On September 1, 1978, the National Commission completed the less spectacular but equally important report, Institutional Review Boards , 29 before submitting the Belmont Report on September 30 that same year. Institutional Review Boards outlines the National Commission's concept of the ideal environment for the application of the federal regulations.

In the introduction to the report, the National Commission provides this understated assessment of the role of the IRB: “This review of proposed research by IRBs is the primary mechanism for assuring that the rights of human subjects are protected.” 29 The document outlines the ideal responsibilities of the IRB in the oversight of research to ensure that human subjects receive appropriate protections and ethical treatment for their willingness to participate in research, sometimes at no benefit to themselves. The National Commission summarized their objective as follows:

In the recommendations that follow, the Commission expresses its judgment about the ways in which those elements [that must be considered in balancing society's interests in protecting the rights of the subjects and in developing knowledge that can benefit the subjects or society as a whole] ought to be brought to bear on research practices, so that a reasonable and ethical balance of society's interests may be attained.

The Commission's deliberations begin with the premise that investigators should not have sole responsibility for determining whether research involving human subjects fulfills ethical standards. Others, who are independent of the research, must share this responsibility, because investigators are always in positions of potential conflict by virtue of their concern with the pursuit of knowledge as well as the welfare of the human subjects of their research.

The Commission believes that the rights of subjects should be protected by local review committees operating pursuant to federal regulations and located in institutions where research involving human subjects is conducted. 29

The document continues this proposal and is seemingly all-inclusive in its conception of the IRB. Highlights include a list of the requirements that must be met to approve research and details for reviewing and approving the consent process, including the essential elements to be included and the safeguards that should be in place to ensure that the process is respected. Specific recommendations also address the constitution of the IRB; how it should be funded; and legal protections for the board, the process, and its members.

Most of the recommendations from the Institutional Review Boards report were incorporated into the HHS regulations—HHS being the responsible federal agency—as part of the rules revision in 1981 in response to the Belmont Report and several other publications of the National Commission. Acting independently from HHS, the FDA also adopted IRBs as a regulatory mechanism, with regulations first issued in 1981 as part of the agency's response to provisions of the National Research Act. 18 , 30

One particularly relevant recommendation of the National Commission from Institutional Review Boards remained outstanding after the changes in 1981: “Recommendation (1) (A) Federal law should be enacted or amended to authorize the Secretary of Health, Education, and Welfare to promulgate regulations governing ethical review of all research involving human subjects that is subject to federal regulation.” 29

The report notes significant “variations arising out of differences in wording, imposition of additional requirements, introduction of minor changes, etc.” among the different agencies apart from DHEW involved in research involving human subjects and expresses concern that this variability places an unnecessary burden on the individual IRBs for interpreting and properly enforcing the regulations. The National Commission's recommendation was to establish “DHEW as the sole authority” for regulations, expressing the belief that such a rule “would reduce the burden on IRBs to interpret and apply the regulations to which they are subject. Moreover, uniformity would assure a minimum level of protection to human subjects of research, no matter which federal agency is supporting the research or which entity is conducting it.” 29 Having inherited the mantle of responsibility from the now-extinct DHEW and recognizing the reality of this assessment, the newly designated HHS explored implementation of this recommendation, particularly as it related to the function of IRBs. As with most changes affecting multiple branches of government, the process became complex. In December 1981, the President's Commission for the Study of Ethical Problems in Medicine and in Biomedical and Behavioral Research, a new commission appointed by Congress in 1978, entered the fray and recommended that all federal departments and agencies adopt the HHS regulations (45 CFR §46). In addition, an ad hoc Committee for the Protection of Human Subjects—composed of representatives and ex officio members from departments and agencies that conducted, supported, or regulated research involving human subjects—was appointed in May 1982 by the president's science advisor to respond to the recommendations of this new commission. After much consideration and negotiation, these efforts were finally addressed by adoption of the Federal Policy for the Protection of Human Subjects, known as the Common Rule, in 1991 and codified in the individual regulations by 15 federal departments and agencies. Each of these agencies includes in its chapter of the Code of Federal Regulations (CFR) section numbers and language that are identical to those of the HHS codification at 45 CFR §46, Subpart A for the regulation of human subjects participation in research. The HHS regulations also include Subparts B, C, and D as additional regulations pertaining to vulnerable subjects. 16 , 31

In addition to harmonizing the regulations across agencies of the federal government, the Common Rule requires institutions that receive funds for research involving human subjects from federal agencies that are signatories to the Common Rule to certify that the research has been reviewed and approved by an IRB that meets the specific requirements for composition, for functioning, and for the criteria followed to approve research. By mandate of the Common Rule, IRBs are empowered to approve, require modifications of, or disapprove research activities and are required to conduct continuing review of ongoing research at least annually.

The FDA concurs with the Common Rule but claims special privilege in not signing on to it. In the Federal Register of November 10, 1988 (53 FR 45678), the agency proposed to amend its regulations in 21 CFR §50 and §56 so that they conformed to the Federal Policy for the Protection of Human Subjects to the extent permitted but noted that the FDA is a regulatory agency that rarely supports or conducts research under its regulations. 32

International Oversight

With the adoption of the Common Rule, regulations for human subjects research conducted within the United States became well established, but research has never been confined by the borders of the United States. Even though a project funded by federal monetary support may have some leverage to require adherence to US regulations, significant numbers of human research subjects participate in studies well beyond the influence of the US regulations. The international norms for participation of human subjects in research evolved along a course that frequently cross-pollinated with the concepts culminating in the Common Rule. The Declaration of Helsinki was an early statement of basic tenets that should apply to all research involving human subjects, and it has continued to evolve, with updates reflecting new issues as they become relevant. While addressing the ethical concepts, the Declaration of Helsinki does not provide an organizational or regulatory framework for human subjects protection. Providing this framework on an international basis presented a challenge well beyond the challenge of harmonizing regulations across different federal agencies as was accomplished by the Common Rule. The difficulties encountered in implementing the Common Rule represent only a microcosm of the enormous task of harmonizing regulatory and organizational concepts across the borders of different cultures and political systems. However, this task was particularly relevant because of the evolution of research into an international enterprise with multicenter drug trials and the expansion of vaccine trials in children. Many of these studies are conducted by multinational contract research organizations that have access to populations of subjects with exposure to diseases that may not be widely encountered in the United States.

An argument can be made that the process for oversight of human subjects in research at the international level started in 1948 before the Declaration of Helsinki when the United Nations Educational, Scientific and Cultural Organization (UNESCO) joined with the World Health Organization (WHO) to establish a permanent Council for Coordination of International Medical Congresses, formally constituted in Brussels in 1949 as a nongovernmental organization with the purpose of facilitating “the exchange of views and scientific information in the medical sciences by securing continuity and coordination between international organizations of medical sciences, by making their work known, and by providing them with material aid where necessary.” 33 The scope of activities gradually expanded to include collaborative efforts among international medical activities in addition to the coordination of participating congresses. In 1992, the name of the council was changed to the Council for International Organizations of Medical Sciences (CIOMS), and its statutes were revised to reflect the expanded role. 33

The original council ventured into medical research by organizing a 1959 meeting in Vienna under the auspices of UNESCO and the WHO “to discuss the principles, organization and scope of ‘controlled clinical trials,’ which must be carried out if new methods or preparations used for the treatment of disease are to be accurately assessed clinically.” The executive secretary summarized the meeting: “The conference was in itself an experiment.” 34

Following this meeting, the council became much more involved in considerations regarding research and particularly the participation of human subjects in research trials, eventually publishing Proposed International Guidelines for Biomedical Research Involving Human Subjects in 1982. The purpose of the guidelines was “to indicate how the ethical principles that should guide the conduct of biomedical research involving human subjects, as set forth in the Declaration of Helsinki, could be applied, particularly in developing countries, given their socioeconomic circumstances, laws and regulations, and executive and administrative arrangements.” 35 This quote is from the background notes for International Ethical Guidelines for Biomedical Research Involving Human Subjects published in 1993 after discussion and reconsideration of the comments received in response to the proposed guidelines. 35

The publication of the guidelines in 1993, soon after the name change to CIOMS, represented a landmark for international research ethics. The steering committee included an international staff of 24 members and an even larger list of advisors and consultants. The committee was co-chaired by Robert Levine from Yale University, who was listed as a “Special Consultant” on the Belmont Report and authored the first four articles for discussion in the appendix to the Belmont Report, and John H. Bryant, an American physician with a distinguished career in international medical practice. In addition to the Declaration of Helsinki, the International Ethical Guidelines for Biomedical Research Involving Human Subjects was strongly influenced by the Belmont Report as demonstrated by the inclusion of the following text under the heading General Ethical Principles:

All research involving human subjects should be conducted in accordance with three basic ethical principles, namely respect for persons, beneficence and justice. It is generally agreed that these principles, which in the abstract have equal moral force, guide the conscientious preparation of proposals for scientific studies. 35

The guidelines acknowledge the evolution of the principles following the publication of the Belmont Report with the statement, “Beneficence further proscribes the deliberate infliction of harm on persons; this aspect of beneficence is sometimes expressed as a separate principle, non-maleficence (do no harm).” 35

The table of contents of the 1993 International Ethical Guidelines for Biomedical Research Involving Human Subjects , provided in Figure 3 , outlines the subjects the steering committee felt to be the most pertinent issues for research conducted in an international setting. In addition to the obvious influence of the Declaration of Helsinki, this document reinterprets many of the issues presented in the Belmont Report, in reports from the presidential commissions, and in 45 CFR §46, Subparts A, B, C, and D to provide an adaptable set of guidelines suitable for application across a broad spectrum of cultural and political environments. The notable exception to the similarities with the US regulations is the inclusion of a guideline titled “Compensation of Research Subjects for Accidental Injury” that provides for the following: “Research subjects who suffer physical injury as a result of their participation are entitled to such financial or other assistance as would compensate them equitably for any temporary or permanent impairment or disability. In the case of death, their dependents are entitled to material compensation. The right to compensation may not be waived.” 35 To date, no uniform program for compensation of human subjects injured in research is addressed in the US regulations.

Table of Contents, International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993 35

The International Ethical Guidelines for Biomedical Research Involving Human Subjects was updated in 2002, and CIOMS continues its efforts to revise the guidelines as dictated by changes in research requiring human subjects.

THE GUATEMALA SEXUALLY TRANSMITTED DISEASES STUDY

All the efforts described to this point promoted regulations and procedures based on an ethically sound approach to protecting human subjects who, by consent or proxy, will be participating in research. The ethics of the research environment seems to have improved as a result of these efforts both in the United States and internationally. Notable instances of particularly egregious studies have come to light since the publication of the Belmont Report, but most of these studies originated before that document was issued. One study in particular raised eyebrows for its similarity to the transgressions committed in the Tuskegee study and, after investigation, was found to have ties to the Tuskegee study.

In October 2010, the United States disclosed that the US Public Health Service sponsored studies of sexually transmitted diseases in Guatemala beginning in 1946. This exposé began with the discovery of documents among papers donated by Dr John Cutler to the library at the University of Pittsburgh. Before retiring, Cutler was on the faculty at the university's School of Public Health following a long career in the US Public Health Service where he had been one of the staff members involved with the Tuskegee study. Hoping to gain insight into the Tuskegee study, Dr Susan Reverby from Wellesley was reviewing Cutler's papers when she came across previously unknown information about experiments investigating sexually transmitted diseases in Guatemala that Cutler and his associates conducted. 36 An account in the American Journal of Public Health reports that “… more than 5000 uninformed and unconsenting Guatemalan people were intentionally infected with bacteria that cause sexually transmitted diseases” and many were never treated. 37

When the details of these experiments came to light, they precipitated an apology from President Barack Obama and specific directives to the Presidential Commission for the Study of Bioethical Issues, a commission appointed by Obama, to “convene a panel to conduct, beginning in January 2011, a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government. I also request that the Commission oversee a thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study” ( Figure 4 ). 38

Directive from President Barack Obama to investigate the Guatemalan studies, 2010 38

The Presidential Commission's first report, “ Ethically Impossible” STD Research in Guatemala from 1946 to 1948 , provides a detailed account of the history surrounding the Guatemala studies and all of the supporting evidence. In the preface, the Presidential Commission reports, “With dual responsibilities to give a full and fair accounting of events largely hidden from history for nearly 65 years and also provide an assessment of the current system, the Commission decided to publish two reports. This is the first report, a historical account and ethical assessment of the Guatemala experiments.” 38

The specific political circumstances in which the experiments were conceived and carried out is critical to gaining some understanding of how ethically questionable research, however ill-conceived, was carried out by people who most probably had good intentions. The significance of the deleterious effects of sexually transmitted diseases among troops in World War II and how those effects precipitated the experiments are difficult to understand in today's world of effective antibiotics. In the 1940s wartime environment, however, understanding all aspects of sexually transmitted diseases was perceived as a crucial aspect of the military's ability to field an effective fighting force for the war in Europe. The experiments must be viewed in this historic context to understand the powerful motivation behind the studies.

The “ Ethically Impossible ” report includes an excerpt from a 1943 letter from Dr Joseph Earle Moore, Chair of the Subcommittee on Venereal Diseases under the National Research Council, to A. N. Richards, Chair of the Medical Research Committee of the Office of Scientific Research and Development, in which Moore wrote that he expected “approximately 350,000 fresh infections with gonorrhea [in the Armed Forces], [which] will account for 7,000,000 lost man days per year, the equivalent of putting out of action for a full year the entire strength of two full armored divisions or of ten aircraft carriers.” 38 Moore estimated that the cost of treating the anticipated infections would be $34 million, equivalent to approximately $440 million today, adjusted for inflation.

Within this context, serious planning to meet the challenge of understanding and treating sexually transmitted diseases appears to have coalesced at the national level in 1942. Planning for these studies continued through the following year, with one of the principals suggesting “the possibility of using federal prisoners, Army prisoners, or conscientious objectors as an alternative” for research subjects. 38 In 1943, experiments began at the US Penitentiary in Terre Haute, IN, that continued for 2 years. The focus of the experiments was on efforts to infect prisoners with Neisseria gonorrhoeae to test various methods for prophylaxis and treatment. Isolates of bacteria were applied directly to the penises of subjects in an effort to reliably infect the “volunteers.” However, the failure to reliably infect subjects in this fashion clearly indicated that studies of prophylactic techniques would not be possible with this approach, leading to consideration of other options.

The studies were performed under the direction of Dr John F. Mahoney, then head of the US Public Health Service/Venereal Disease Research Laboratory (VDRL) set up within the US Marine Hospital in Staten Island, NY. Mahoney directed the Terra Haute prison studies from his Staten Island laboratory, while 28-year-old Dr Cutler ran the studies at the prison. Following the end of World War II in 1945, the military support for the studies was less enthusiastic, but the Public Health Service remained committed to supporting the research with plans to move the research to Guatemala. A 1947 article Mahoney published in the Journal of Venereal Disease Information provides some insight into why the studies were moved: “It has been considered impractical to work out, under postwar conditions in the United States, the solution of certain phases concerned with the prevention and treatment of syphilis. These problems are largely concerned with the development of an effective prophylactic agent for both gonorrhea and syphilis and the prolonged observation of patients treated with penicillin for early syphilis. Because of the relatively fixed character of the population and because of the highly cooperative attitude of the officials, both civil and military, an experimental laboratory in Guatemala City has been established….” 39

As fate would have it, a Guatemalan physician named Funes, who had served a fellowship at the VDRL and returned to Guatemala, was essential to the transition of the studies to his country. In August 1946, Cutler transitioned from Terra Haute to Guatemala at Funes's urging. Cutler staffed a clinic that provided the regular health inspections required for registered sex workers and suggested that the facility provide an environment of “normal exposure” through which sexually transmitted diseases could be more predictably transmitted. The studies in Guatemala evaluated possible prophylactic intervention “in cooperation with the Guatemalan Venereal Disease Control Department” that Funes directed and the local penitentiary “where exposure of volunteers to infected prostitutes would provide the testing opportunities.” 38 Enrolling prisoners, a contained and restricted population, after they had had sexual intercourse with commercial sex workers known to be infected with sexually transmitted diseases, promised to establish, according to Cutler, a “rapid and unequivocal answer as to the value of various prophylactic techniques” through the preferred technique of “normal exposure.” 38

After beginning with studies of “normal exposure” in prisoners, Cutler expanded the population of research subjects to include patients in a psychiatric hospital and again tried artificial means of infection, including scarification—mechanically damaging the skin and mucous membranes of the penis—to enhance the likelihood of infecting the subject. An even more aggressive study included at least 7 women in a psychiatric institution who were infected by the injection of syphilis specimens directly into the subarachnoid space surrounding the brain. Only 5 of them later received medical therapy. 38 In addition, studies to follow the serology of children in a large orphanage were undertaken to better understand the specificity of tests for sexually transmitted diseases, an additional goal of the Guatemalan studies.

Studies in which subjects were intentionally infected were completed in the later months of 1948, and Cutler left Guatemala in December 1948 to join a WHO Disease Demonstration Team in India. From April 1949 to July 1950, this team worked to establish a venereal disease control demonstration in various parts of India and teach advanced methods of control for sexually transmitted diseases. Meanwhile, the US Public Health Service hired Funes and another Guatemalan physician, Dr Salvado, to continue “the observation of certain of the patient groups” after Cutler left Guatemala. Funes's staff collected data on residents of the orphanage, inmates of the penitentiary, individuals from the psychiatric hospital, schoolchildren, and the members of “various Indian tribes in the vicinity of Guatemala” who had participated in the experiments. Funes was hired to “advise concerning the clinical examinations of treated patients, their re-treatment as may be required, the collection of blood specimens for serologic examinations at periodic intervals, the preparation and shipment of all blood specimens collected for serologic examination” to the United States, and “the submission of such reports as may be necessary for the completion of the study of this patient group.” 38 Based on the one report available in the Cutler Documents, Funes and his staff followed approximately 248 people from the mental institution, completing 243 blood draws and 170 lumbar punctures. Several of those subjects tested positive for syphilis during the follow-up experiments. The subjects from the psychiatric hospital were followed until at least 1953. The published work resulting from the Guatemala experiments also indicates that Funes continued to do serological testing on the children at the orphanage until at least 1949.

The experiments in Terra Haute were conducted and supported by many of the same people involved in the Guatemala experiments with the same goal of finding suitable prophylaxes for sexually transmitted diseases. However, throughout their discussion of the background leading to the experiments in the United States and the subsequent Guatemalan experiments, the Presidential Commission provides details of concerns voiced among those planning the studies. These details construct a compelling argument that all along the way there was an undercurrent of concern that the studies proposed were at the least controversial, most probably unethical, and in some instances arguably illegal. The Presidential Commission reached the conclusion that “Conducting the experiments in Guatemala provided an opportunity to work with reduced concern for some of the key obstacles associated with the Terre Haute experiments: fear of adverse legal consequences and bad publicity.” In a footnote to the report, the authors point out that “These concerns followed the researchers to Guatemala, however, as evidenced by some of their efforts to limit and restrict access to information about the work.” 38

The Presidential Commission summarized their findings as follows: “In the Commission's view, the Guatemala experiments involved unconscionable violations of ethics, even as judged against the researchers’ own understanding of the practices and requirements of medical ethics of the day.” The report concludes

Although some individuals are more blameworthy than others, the blame for this episode cannot be said to fall solely on the shoulders of one or two individuals. The unconscionable events that unfolded in Guatemala in the years 1946 to 1948 also represented an institutional failure of the sort that modern requirements of transparency and accountability are designed to prevent. In the final analysis, institutions are comprised of individuals who, however flawed, are expected to exercise sound judgment in the pursuit of their institutional mission. This is all the more true and important when those individuals hold privileged and powerful roles as professionals and public officials. One lesson of the Guatemala experiments, never to take ethics for granted, let alone confuse ethical principles with burdensome obstacles to be overcome or evaded, is a sobering one for our own and all subsequent generations. We should be ever vigilant to ensure that such reprehensible exploitation of our fellow human beings is never repeated. 38

The second charge from President Obama to the Presidential Commission was to provide a “thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government.” The Presidential Commission addressed this directive in their report Moral Science: Protecting Participants in Human Subjects Research that was completed in December 2011. 40

Regarding whether the regulations would prevent abuses similar to the studies in Guatemala, the Commission noted, “Existing evidence suggests both that the rules governing federal research today adequately guard against abuses analogous to those perpetrated in Guatemala in the 1940s and that current regulations generally appear to protect people from avoidable harm or unethical treatment, insofar as is feasible given limited resources, no matter where U.S.-supported research occurs.” 40 The report summary continued as follows:

The current U.S. system provides substantial protections for the health, rights, and welfare of research subjects and, in general, serves to “protect people from harm or unethical treatment” when they volunteer to participate as subjects in scientific studies supported by the federal government. However, because of the currently limited ability of some governmental agencies to identify basic information about all of their human subjects research, the Commission cannot say that all federally funded research provides optimal protections against avoidable harms and unethical treatment. The Commission finds significant room for improvement in several areas where, for example, immediate changes can be made to increase accountability and thereby reduce the likelihood of harm or unethical treatment. 40

The report outlines the Presidential Commission's observations and recommendations based on a thorough review of federally funded research, including studies that may involve human subjects in other countries. One issue the Commission raised was the general lack of accessibility to data: “there is no ready source that comprehensively describes its [the federally funded human research enterprise] basic characteristics, such as level of funding, or number of studies, subjects, or geographic locations. Instead, what exists are isolated pockets of information and some descriptive summaries.” 40 This difficulty in acquiring information prompted the Presidential Commission's first recommendation to improve accountability through public access: “accountability can and should be refined through improving access to basic information about the scope and volume of human subjects research funded by the government.” The commission cites precedent for this recommendation from the Institute of Medicine–issued Responsible Research: A Systems Approach to Protecting Research Participants , with its recommendation to extend the oversight system to all research, regardless of funding source or research setting. 41

Treatment and compensation for research-related injuries were also identified as an issue of concern, a subject that has been scrutinized regularly in past discussions as human research protection has evolved. Obama's Commission noted that this issue still required attention at the time of their review, pointing out that most other developed countries require sponsors, investigators, or others engaged in research to provide treatment or reimbursement free of charge to the subject for research-related injury or illness. As discussed earlier, one of the deviations from the general agreement between CIOMS and US regulations is the recommendation for subject compensation in the CIOMS guidelines. The Presidential Commission “draws a bright line affirming the view of most bioethicists and others, including the majority of nations supporting human subjects research around the globe, that human subjects should not individually bear the costs of care required to treat harms resulting directly from that research.” 40 Recognizing that previous bioethics commissions and other advisory bodies had opined in favor of compensation or treatment for research-related injuries with relative silence by the government, the Commission advocated a response as to reasons for changing or maintaining the status quo. This issue remains open with no progress as this article is being written.

The Commission also asked that the OHRP examine, recognize, and define when protections delineated in foreign laws and regulations are accepted as equivalent to US regulations and exercise its longstanding authority to recognize these protections when available. Protections offered by international partners have been a source of confusion, as the federal regulations state that equivalent protections from international studies should be accommodated but do not provide guidance for how they should be defined. This directive has been reevaluated several times since its inception, including a specific request from the United Kingdom in 2007 to provide a determination of equivalence for human research protections afforded by UK regulations. As of the Commission's report in 2011, the OHRP had not formally recognized any country's protections as equivalent.

The Commission also noted that the FDA, while not signatory to the Common Rule, does adhere to the regulations at 45 CFR §46, Subpart A whenever possible and accepts data from foreign studies that comply with certain international standards for human subjects protection, such as studies that abide by good clinical practice, the Declaration of Helsinki, or certain host country regulations. This practice should provide a model to develop a system for recognizing equivalent protections as currently regulated by provisions in the Common Rule.

In its final recommendation, Promoting Current Federal Reform Efforts, the Presidential Commission called for broad reform of federal research rules and procedures beyond simply addressing equivalent protections.

The Commission supports the federal government's proposed reforms to:

a) Restructure research oversight to appropriately calibrate the level and intensity of the review activities with the level of risk to human subjects;

b) Eliminate continuing review for certain lower-risk studies and regularly update the list of research categories that may undergo expedited review;

c) Reduce unnecessary, duplicative, or redundant institutional review board review in multi-site studies. Regardless of the process used to review and approve studies, institutions should retain responsibility for ensuring that human subjects are protected at their location as protection of human subjects includes much more than institutional review board review. The use of a single institutional review board of record should be made the regulatory default unless institutions or investigators have sufficient justification to act otherwise;

d) Make available standardized consent form templates with clear language understandable to subjects;

e) Harmonize the Common Rule and existing regulations of the Food and Drug Administration, and require that all federal agencies conducting human subjects research adopt human subjects regulations that are consistent with the ethical requirements of the Common Rule; and

f) Work toward developing an interoperable or compatible data collection system for adverse event reporting across the federal government. 40

Most of these provisions were included in the revisions to the Common Rule that updated the original provisions from 1991 and were effective January 21, 2019, with the exception of staged implementation of single IRB review for multisite studies. Twenty federal agencies follow the Common Rule, with the notable exception of the FDA. So far, no official indication of the FDA's intent has been provided, although the expectation is that some effort will be made to harmonize the regulations—at least in a similar fashion as previous agreements.

OTHER HUMAN SUBJECTS PROTECTION FAILURES

This exposition of how we have arrived at the current rules and regulations for protecting human subjects who participate in research is lengthy but is at best an outline. Even this abbreviated history should elicit an appreciation of the complexity of the ethics surrounding protection of human subjects in research. A fair question is whether these provisions have significantly altered the landscape since Dr Beecher published his concerns in the New England Journal of Medicine in 1966. A cursory review turns up a few exceptions to the relative safety afforded by the current protections, with three that are particularly instructive.

Jesse Gelsinger

Jesse Gelsinger had just turned 18, the legal age for consent, when he volunteered in 1999 for a phase 1 gene therapy study designed for treatment of ornithine transcarbamylase (OTC) deficiency. Phase 1 studies are designed primarily to determine the appropriate dose of a drug. Gelsinger was born with a mild form of OTC that was well controlled by diet and drug therapy; he had minimal risk of serious complications from the disease as long as he followed his treatment protocol. He did not stand to benefit significantly from his participation in the phase 1 study but felt that he should volunteer because of the knowledge that might benefit others.

Gelsinger died 4 days after receiving an experimental therapy consisting of a gene attached to an adenovirus that would theoretically serve as a delivery system to insert the new gene into the DNA of his liver cells. The death was unexpected in a relatively healthy 18-year-old, and the outcome precipitated a long and contentious investigation into how the protections that should have prevented Gelsinger from participating in the study were circumvented or ignored. The investigation uncovered questions regarding (1) information that should have been included in the consent form, (2) the actual risk posed by the study based on complications from similar studies that were not disclosed in reports to regulatory bodies, (3) why Gelsinger was enrolled in the study in violation of the protocol's inclusion/exclusion criteria, (4) the potential risk/benefit analysis based on the mild nature of his disease that would argue against his participation, and (5) an undisclosed conflict of interest for the director of the gene studies program that may have clouded decisions at critical points during conduct of the study. 42 - 45

Examination of this study demonstrates that the protections afforded to subjects are well established but still depend on the assumption that the individuals responsible for every step of the evaluation and approval of studies and those who actually conduct the research all perform reliably in their roles.

Johns Hopkins Lead Abatement Study

Another notable case revolves around the issues of appropriate consent, appropriate risks for children (or any vulnerable population), and disclosure of results obtained in research studies. The Kennedy Krieger Institute (KKI), an affiliate of Johns Hopkins Children's Center, conducted a study evaluating the effectiveness of lead abatement programs in low-income housing in Baltimore, MD during the 1990s. The study recruited families to live in houses either untouched or treated with different abatement techniques to determine which processes were most effective in protecting children from the significant neurologic effects of elevated lead levels that were endemic among children living in low-income housing in Baltimore. The goal was “to find a relatively inexpensive and effective method for reducing—though not eliminating—the amount of lead in children's homes and thereby reducing the devastating effect of lead exposure on children's brains.” 46 A total of 108 families with young children were recruited to live in houses with lead levels ranging from none to levels just below the existing legal limit, and the children's serum lead levels were monitored. In two homes, the lead levels in the children crossed into toxic levels, but the families were not informed or advised to move out of the toxic environment. Eventually, a lawsuit was filed on behalf of the two children, and it raised significant ethical questions surrounding informed consent, appropriate risks, and disclosure of results that are reviewed at length in the article “With the Best Intentions: Lead Research and the Challenge to Public Health.” 46 The Maryland Court of Appeals opinion equated the multiyear lead study with the Tuskegee study in its egregious disregard for research ethics in a vulnerable population.

Ellen Roche

Ellen Roche was a healthy 24-year-old laboratory technician at the Johns Hopkins Asthma and Allergy Center. She volunteered to take part in a 2001 lung function physiology experiment in which normal pulmonary function in healthy volunteers would be manipulated by inhalation of hexamethonium, a compound that interferes with normal nervous system interaction with the lungs to mimic a mild asthma attack. Although it had been used in the 1950s to treat hypertension, hexamethonium fell into disuse as more effective drugs became available, and the FDA withdrew approval in 1972. Of note, hexamethonium was never approved as an inhaled medication. Roche was the fourth patient to receive hexamethonium in the trial. At least one previous subject had had mild persistent respiratory symptoms that the investigator dismissed as a cold. Roche became very ill, with significant pulmonary abnormalities presenting within 24 hours. The symptoms progressed to multisystem organ failure, and she died within a month. 47 , 48

The ensuing investigation turned up several concerns:

• The literature search relied on PubMed and one contemporary textbook of pulmonary medicine to explore the potential use of hexamethonium for the purpose proposed in the research plan. Neither source revealed any indication of concerns, although other databases and older textbooks warned of significant pulmonary complications associated with hexamethonium.
• No request was made to determine if the FDA required an investigational new drug application, even though the medication was no longer approved and had never been approved as an inhalational drug.
• The consent form referred to hexamethonium as a medication but failed to mention that FDA approval had been withdrawn.
• A few subjects included in previous studies used inhaled hexamethonium with no mention of problems in the subsequent publications, but two subjects did have significant difficulties that were not reported as the investigator did not consider them related to the drug.
• The hexamethonium used in the study was of chemical grade and was not prepared as a pharmaceutical agent. 47 , 48

This list is not complete and raises many concerns, but the focus of the investigation became the lack of adequate research to confirm that the compound used to induce asthma symptoms was safe. The responsibility for this failure primarily attached to the investigator, with additional concern focusing on a review process that failed to follow proper procedures for approval of the protocol. During the follow-up, several articles from the 1950s reporting that hexamethonium could cause fatal lung inflammation similar to the pulmonary complications leading to the demise of Ellen Roche were identified. PubMed's coverage of the literature starts in the mid-1960s. In addition, review of the FDA records related to the withdrawal of hexamethonium in 1972 cited the drug's “substantial potential toxicity” as one element leading to the decision. 48

The examples of ethical issues from history and the scarcity of contemporary examples demonstrate that regulations for the protection of humans participating in research have evolved in a way that minimizes the probability of harm to subjects choosing to participate in research. These examples also reinforce the importance of individual responsibility to faithfully execute the requirements of their assigned roles. Failure of IRBs to provide appropriate review and oversight can lead to severe consequences, as can abrogation by the investigator to place the well-being of the subjects as the primary responsibility in any research protocol. Furthermore, these examples support the argument that no amount of regulation or oversight can completely remove the variable of individual failures to adhere to the rules or accept the responsibility associated with their role in research that may precipitate serious unexpected consequences. The rules and expectations for those charged with the review, administration, and performance of research requiring human subjects can only minimize the probability that these instances will occur. The point at which the primary responsibility of protecting human subjects from preventable harm deviates to focus on some other aspect of the research that leads to harm is rarely predictable. Simplified to the world of Monty Python, “Nobody expects the Spanish Inquisition!”

ACKNOWLEDGMENTS

The author has no financial or proprietary interest in the subject matter of this article.

This article meets the Accreditation Council for Graduate Medical Education and the American Board of Medical Specialties Maintenance of Certification competencies for Patient Care, Medical Knowledge, and Systems-Based Practice.