Tangles of neurogenetics, neuroethics, and culture

Neurogenetics promises rich insights into how the mind works. Researchers investigating the range of topics from normal brain functioning to pathological states are increasingly looking to genetics for clues on human variability and disease etiology. Is it fair to assume this interest in neurogenetics is universal? How should researchers and clinicians approach ideas of consent to research or prediction of disease when a subject or patient understands the mind with concepts or language incompatible with neurogenetics? In this paper we consider how non-Western philosophies bring complexity to ideas of individual and community consent and confidentiality in the context of neurogenetics.     

Cultural values embodying universal norms: a critique of a popular assumption about cultures and human rights

In Western and non-Western societies, it is a widely held belief that the concept of human rights is, by and large, a Western cultural norm, often at odds with non-Western cultures and, therefore, not applicable in non-Western societies. The Universal Draft Declaration on Bioethics and Human Rights reflects this deep-rooted and popular assumption. By using Chinese culture(s) as an illustration, this article points out the problems of this widespread misconception and stereotypical view of cultures and human rights. It highlights the often ignored positive elements in Chinese cultures that promote and embody universal human values such as human dignity and human rights. It concludes, accordingly, with concrete suggestions on how to modify the Declaration.     

Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine,Mahidol University,Thailand

Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an “IRB Metrics” was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010–September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with positive outcomes for all parties involved in the conduct of human-subject research.     

Human subject protections in genetic research

The Certificate of Confidentiality (COC) is a voluntary tool to protect researchers from being compelled to release identifying information about their subjects. Institutional review board (IRB) review and informed consent (IC) procedures are mandatory tools to protect human subjects. Although many studies reveal poor documentation of IRB and IC procurement, most published research undergoes IRB review and has appropriate IC procedures. There are no empirical data about the use of COCs. We examined the procurement and documentation of all these human subject protections in the genetics literature. A total of 112 (55%) articles documented IRB review, 108 (53%) document IC, and 82 (41%) documented both. None documented the procurement of a COC. Returned surveys provided additional information that confirmed that at least 74% (n = 150) of research had received appropriate IRB review, at least 71% (n = 143) had procured IC, and at least 10% (n = 21) had obtained a COC. An additional 22 respondents had procured COCs for other research, whereas 17 respondents were unaware of them and their purpose. In this era of public scrutiny of medical research, we recommend greater familiarity with and documentation of all human subject protections.     

Isolation,Cryopreservation and Culture of Human Amnion Epithelial Cells for Clinical Applications

Human amnion epithelial cells (hAECs) derived from term or pre-term amnion membranes have attracted attention from researchers and clinicians as a potential source of cells for regenerative medicine. The reason for this interest is evidence that these cells have highly multipotent differentiation ability, low immunogenicity, and anti-inflammatory functions. These properties have prompted researchers to investigate the potential of hAECs to be used to treat a variety of diseases and disorders in pre-clinical animal studies with much success.hAECs have found widespread application for the treatment of a range of diseases and disorders. Potential clinical applications of hAECs include the treatment of stroke, multiple sclerosis, liver disease, diabetes and chronic and acute lung diseases. Progressing from pre-clinical animal studies into clinical trials requires a higher standard of quality control and safety for cell therapy products. For safety and quality control considerations, it is preferred that cell isolation protocols use animal product-free reagents. We have developed protocols to allow researchers to isolate, cryopreserve and culture hAECs using animal product-free reagents. The advantage of this method is that these cells can be isolated, characterized, cryopreserved and cultured without the risk of delivering potentially harmful animal pathogens to humans, while maintaining suitable cell yields, viabilities and growth potential. For researchers moving from pre-clinical animal studies to clinical trials, these methodologies will greatly accelerate regulatory approval, decrease risks and improve the quality of their therapeutic cell population.     

Reflections on the responsible conduct of cancer research

Most cancer researchers regularly practice the responsible conduct of research (RCR) without consciously considering it. As professional scientists, we simply do what we are trained to do. However, as we train a new generation of cancer researchers in our laboratories, we must be vigilant against undue complacency. In an age when misconduct in research is receiving more media attention than ever before, we should periodically take a moment of pause and reflect upon the meaning and practice of responsibly conducting research. Rather than meeting minimum standards in a compliance-driven manner, we should practice forethought and periodically consider how we can improve. We, as leaders in cancer research, must then push our peers to do the same. By embedding RCR into the culture of cancer research through a multilayer approach, including regular assessment at the levels of individual research groups, departmentally, and institutionally, we will become a model discipline in the responsible conduct of research.     

Transcultural Psychiatry: Cultural Difference,Universalism and Social Psychiatry in the Age of Decolonisation

In the mid-twentieth century, in the aftermath of WWII and the Nazi atrocities and in the midst of decolonisation, a new discipline of transcultural psychiatry was being established and institutionalised. This was part and parcel of a global political project in the course of which Western psychiatry attempted to leave behind its colonial legacies and entanglements, and lay the foundation for a more inclusive, egalitarian communication between Western and non-Western concepts of mental illness and healing. In this period, the infrastructure of post-colonial global and transcultural psychiatry was set up, and leading psychiatric figures across the world embarked on identifying, debating and sometimes critiquing the universal psychological characteristics and psychopathological mechanisms supposedly shared among all cultures and civilisations. The article will explore how this psychiatric, social and cultural search for a new definition of ‘common humanity’ was influenced and shaped by the concurrent global rise of social psychiatry. In the early phases of transcultural psychiatry, a large number of psychiatrists were very keen to determine how cultural and social environments shaped the basic traits of human psychology, and ‘psy’ practitioners and anthropologist from all over the world sought to re-define the relationship between culture, race and individual psyche. Most of them worked within the universalist framework, which posited that cultural differences merely formed a veneer of symptoms and expressions while the universal core of mental illness remained the same across all cultures. The article will argue that, even in this context, which explicitly challenged the hierarchical and racist paradigms of colonial psychiatry, the founding generations of transcultural psychiatrists from Western Europe and North America tended to conceive of broader environmental determinants of mental health and pathology in the decolonising world in fairly reductionist terms—focusing almost exclusively on ‘cultural difference’ and cultural, racial and ethnic ‘traditions’, essentialising and reifying them in the process, and failing to establish some common sociological or economic categories of analysis of Western and non-Western ‘mentalities’. On the other hand, it was African and Asian psychiatrists as well as Marxist psychiatrists from Eastern Europe who insisted on applying those broader social psychiatry concepts—such as social class, occupation, socio-economic change, political and group pressures and relations etc.—which were quickly becoming central to mental health research in the West but were largely missing from Western psychiatrists’ engagement with the decolonising world. In this way, some of the leading non-Western psychiatrists relied on social psychiatry to establish the limits of psychiatric universalism, and challenge some of its Eurocentric and essentialising tendencies. Even though they still subscribed to the predominant universalist framework, these practitioners invoked social psychiatry to draw attention to universalism’s internal incoherence, and sought to revise the lingering evolutionary thinking in transcultural psychiatry. They also contributed to re-imagining cross-cultural encounters and exchanges as potentially creative and progressive (whereas early Western transcultural psychiatry primarily viewed the cross-cultural through the prism of pathogenic and traumatic ‘cultural clash’). Therefore, the article will explore the complex politics of the shifting and overlapping definitions of ‘social’ and ‘cultural’ factors in mid-twentieth century transcultural psychiatry, and aims to recover the revolutionary voices of non-Western psychiatrists and their contributions to the global re-drawing of the boundaries of humanity in the second half of the twentieth century.

     

Geographic and Temporal Trends in Amazonian Knowledge Production

The presence of researchers from Western (i.e., developed world) institutions in Amazonia has frequently been contentious due to fears of ‘scientific imperialism’ or suspicions that they may be exerting undue influence over research agendas and knowledge production to the detriment of local researchers. Such negative perceptions are widespread, but not well substantiated. A more nuanced understanding of these issues requires information on who is conducting research in Amazonia and how knowledge production has changed over time. We performed a bibliometric analysis on Thomson Reuters'ISI Web of Science of all research articles about the Amazon published in three time periods: 1986–1989, 1996–1999, and 2006–2009. We found that the number of articles published and the diversity of countries involved in Amazonian research increased dramatically over the three time periods. The representation of several Amazonian countries—especially Brazil—increased, while the proportion of articles without a single author from an Amazonian country also increased. The results indicate that the research capacity of Amazonian countries has increased, but that leadership of high‐impact projects may still largely reside with researchers from developed countries.     

The challenge of cross-cultural clinical trials research: case report from the Tibetan Autonomous Region, People's Republic of China

Efforts to conduct Western clinical research in non-Western medical settings with little or no familiarity with such methodologies are on the rise, but documented accounts of the ways that biomedical science requires negotiation and translation across cultures are not plentiful. This article adds to this literature through analysis of an NICHD-funded collaborative research effort in women's health carried out in the Tibetan Autonomous Region of the People's Republic of China. The research involved a feasibility study for an eventual clinical trial comparing Tibetan medicine with misoprostol for preventing postpartum hemorrhage in delivering women. It explores strategies of negotiation and translation in and around notions of the scientific method, informed consent procedures, randomization, blinding, placebo, and concepts of medical standardization.     

Research Ethics and Intellectual Disability: Broadening the Debates

This article examines the ethical issues surrounding the inclusion of people with intellectual disabilities as research subjects. It explores subject selection, competence, risk and benefits, and authority through three tensions that emerge when considering these concepts in the context of the Disability Rights Movement and critical disability scholarship. These tensions are defined as the double dangers of inclusion and exclusion; the challenges of defining competence and risk in terms of individuals vs. groups; and the conflicts that arise when pursuing the dual goals of amelioration and elimination of disabilities. Though these tensions are not resolved, they underscore the importance of researchers engaging with critical disability perspectives in order to navigate these complex ethical questions.     

From a crisis to an opportunity: Eight insights for doing science in the COVID‐19 era and beyond

The COVID‐19 crisis has forced researchers in Ecology to change the way we work almost overnight. Nonetheless, the pandemic has provided us with several novel components for a new way of conducting science. In this perspective piece, we summarize eight central insights that are helping us, as early career researchers, navigate the uncertainties, fears, and challenges of advancing science during the COVID‐19 pandemic. We highlight how innovative, collaborative, and often Open Science‐driven developments that have arisen from this crisis can form a blueprint for a community reinvention in academia. Our insights include personal approaches to managing our new reality, maintaining capacity to focus and resilience in our projects, and a variety of tools that facilitate remote collaboration. We also highlight how, at a community level, we can take advantage of online communication platforms for gaining accessibility to conferences and meetings, and for maintaining research networks and community engagement while promoting a more diverse and inclusive community. Overall, we are confident that these practices can support a more inclusive and kinder scientific culture for the longer term.     

"Walking along beside the researcher": how Canadian REBs/IRBs are responding to the needs of community-based participatory research

Research ethics boards and institutional review boards (REBs/IRBs) have been criticized for relying on conceptions of research that privilege biomedical, clinical, and experimental designs, and for penalizing research that deviates from this model. Studies that use a community-based participatory research (CBPR) design have been identified as particularly challenging to navigate through existing ethics review frameworks. However, the voices of REB/IRB members and staff have been largely absent in this debate. The objective of this article is to explore the perspectives of members of Canadian university-based REBs/IRBs regarding their capacity to review CBPR protocols. We present findings from interviews with 24 Canadian REB/IRB members, staff, and other key informants. Participants were asked to describe and contrast their experiences reviewing studies using CBPR and mainstream approaches. Contrary to the perception that REBs/IRBs are inflexible and unresponsive, participants described their attempts to dialogue and negotiate with researchers and to provide guidance. Overall, these Canadian REBs/IRBs demonstrated a more complex understanding of CBPR than is typically characterized in the literature. Finally, we situate our findings within literature on relational ethics and explore the possibility of researchers and REBs/IRBs working collaboratively to find solutions to unique ethical tensions in CBPR.     

Ancillary care in public health intervention research in low-resource settings: researchers' practices and decision-making

Little is known about researchers' practices regarding the provision of ancillary care (AC) in public health intervention studies they have conducted and the factors that influence their decisions about whether to provide ancillary care in low-resource settings. We conducted 52 in-person in-depth interviews with public health researchers. Data analysis was iterative and led to the identification of themes and patterns among themes. We found that researchers who conduct their research in the community setting are more likely to identify and plan for the AC needs of potential research subjects before a study begins, whereas those affiliated with a permanent facility are more likely to deliver AC to research subjects on an ad hoc basis. Our findings suggest that on the whole, at least for public health intervention research in low-resource settings, researchers conducting research in the community setting confront more complex ethical and operational challenges in their decision-making about AC than do researchers conducting facility-based studies.     

Research in the ranks: vulnerable subjects, coercible collaboration, and the hepatitis E vaccine trial in Nepal

Concern over the diminished autonomy of members of the armed forces has resulted in the classification of these groups as "vulnerable" in many international codes of research ethics, a designation that places the onus on researchers to provide special justification for the inclusion of these persons in research. This paper examines the application of these ethical requirements to a recent trial carried out by U.S. Army researchers among soldiers of the Royal Nepal Army (RNA) and concludes that the requirements to justify conducting research in this population were not met. Furthermore, noting the human rights abuses rampant in the RNA, it is appropriate to question the choice of this institution as both a partner and a subject pool for U.S. state-sponsored research. This case study raises another important ethical question about the vulnerability to coerced collaboration of groups or institutions. In response, I propose the idea of "institutional vulnerability" as an extension of the idea of individual "juridic vulnerability." The recent military and financial assistance that the RNA received from the U.S. Army, in light of their partnership in this biomedical research trial, constitutes an appropriate and revealing context in which to ground this discussion.     

Metamorphosis in the Culture Market of Niger

The banner of authenticity is falling in the contemporary market for non-Western culture. Taking Tuareg artisanry in Niger as a case study, I show that the neocolonial Western habit of collecting "exotic" art objects is giving way to a more collaborative proclivity toward Western objects produced in "traditional" Tuareg style. While Tuareg artisans—adjusting to social and cultural upheavals attending the urbanization of their practice and the recent Tuareg separatist rebellion—are producing such hybrid "modern" objects, some Tuareg nobles, impoverished by those same changes, have begun painting representational images of a more "authentic" Tuareg culture. The nature of the competition between Tuareg artisans and nobles, as well as the complex cross-identification between Tuaregs and their Western expatriate customers, illuminate a general perplexity about modernity in the contemporary Third World and indicate a transformation in the terms of its encounter with the West. [Tuaregs, art and artisanry, authenticity, expatriates, and modernity and tradition]     

Certificates of confidentiality in research: rationale and usage

Certificates of confidentiality (COCs) are a tool to protect researchers from being compelled to release identifying information about their subjects. Whereas institutional review board (IRB) review and informed consent procedures are mandatory tools to protect human subjects, COCs are voluntary. There are limited data about who procures COCs and why, and whether they are useful. Three Institutes of the National Institutes of Health (NIH) provided data on 114 research projects that had received COCs. Eighty-three researchers had procured a single COC and 11 researchers had procured 31 COCs. One hundred and four (91%) of the COCs were obtained by researchers at academic sites, and 17 institutions collectively accounted for 82 COCs. The most commonly cited sources of information about COCs came from colleagues (n = 18, 35%) and previous experience (n = 17, 33%). The most common reasons for procuring a COC were that the research involved genetics (n = 28, 54%), the research could lead to social stigmatization or discrimination (n = 22, 42%), or the research could damage an individual's financial standing, employability, or reputation (n = 21, 40%). These findings show that COCs are often congregated within institutions and by particular individuals. This may be because others are unaware of COCs or because others do not believe they are necessary or useful.     

US IRBs confronting research in the developing world

Increasingly, US‐sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear. METHODS: I conducted in‐depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%). RESULTS: US IRBs face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long‐standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst‐case scenarios’. CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice.     

Institutional review boards' use and understanding of certificates of confidentiality

Certificates of Confidentiality, issued by agencies of the U.S. government, are regarded as an important tool for meeting ethical and legal obligations to safeguard research participants' privacy and confidentiality. By shielding against forced disclosure of identifying data, Certificates are intended to facilitate research on sensitive topics critical to the public's health. Although Certificates are potentially applicable to an extensive array of research, their full legal effect is unclear, and little is known about stakeholders' views of the protections they provide. To begin addressing this challenge, we conducted a national survey of institutional review board (IRB) chairs, followed by telephone interviews with selected chairs, to learn more about their familiarity with and opinions about Certificates; their institutions' use of Certificates; policies and practices concerning when Certificates are required or recommended; and the role Certificates play in assessments of research risk. Overall, our results suggest uncertainty about Certificates among IRB chairs. On most objective knowledge questions, most respondents chose the incorrect answer or 'unsure'. Among chairs who reported more familiarity with Certificates, composite opinion scores calculated based on five survey questions were evenly distributed among positive, neutral/middle, and negative views. Further, respondents expressed a variety of ideas about the appropriate use of Certificates, what they are intended to protect, and their effect on research risk. Nevertheless, chairs who participated in our study commonly viewed Certificates as a potentially valuable tool, frequently describing them as an 'extra layer' of protection. These findings lead to several practical observations concerning the need for more stakeholder education about Certificates, consideration of Certificates for a broader range of studies, the importance of remaining vigilant and using all tools available to protect participants' confidentiality, and the need for further empirical investigation of Certificates' effect on researchers and research participants.     

Cultural Variation in the Use of Overimitation by the Aka and Ngandu of the Congo Basin

Studies in Western cultures have observed that both children and adults tend to overimitate, copying causally irrelevant actions in the presence of clear causal information. Investigation of this feature in non-Western groups has found little difference cross-culturally in the frequency or manner with which individuals overimitate. However, each of the non-Western populations studied thus far has a history of close interaction with Western cultures, such that they are now far removed from life in a hunter-gatherer or other small-scale culture. To investigate overimitation in a context of limited Western cultural influences, we conducted a study with the Aka hunter-gatherers and neighboring Ngandu horticulturalists of the Congo Basin rainforest in the southern Central African Republic. Aka children, Ngandu children, and Aka adults were presented with a reward retrieval task similar to those performed in previous studies, involving a demonstrated sequence of causally relevant and irrelevant actions. Aka children were found not to overimitate as expected, instead displaying one of the lowest rates of overimitation seen under similar conditions. Aka children copied fewer irrelevant actions than Aka adults, used a lower proportion of irrelevant actions than Ngandu children and Aka adults, and had less copying fidelity than Aka adults. Measures from Ngandu children were intermediate between the two Aka groups. Of the participants that succeeded in retrieving the reward, 60% of Aka children used emulation rather than imitation, compared to 15% of Ngandu children, 11% of Aka adults, and 0% of Western children of similar age. From these results, we conclude that cross-cultural variation exists in the use of overimitation during childhood. Further study is needed under a more diverse representation of cultural and socioeconomic groups in order to investigate the cognitive underpinnings of overimitation and its possible influences on social learning and the biological and cultural evolution of our species.     

Why IRBs should protect bystanders in human research

Many types of human research activities present risks and burdens to third parties (e.g., bystanders). Few human protection policies directly address the protection of research bystanders, though some address it in passing. In what follows, I re-iterate reasons why bystanders are entitled to protections. I also argue that Institutional Review Boards (IRBs) are in the best position to signal to researchers and sponsors that bystanders should be protected in research. In some cases, IRB review would consist of evaluating bystander protection strategies directly; in other cases, this might entail merely certifying that another institutions, like a drug regulator, has taken adequate measures to protect the welfare of research bystanders.