Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. Principal investigators should build ‘true research teams’ where (...) members of the team are meaningfully involved in decisions regarding the protocol and its implementation. There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions and look for means to negotiate appropriate protections for those willing to participate. In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

For decades, scholars in the social sciences and humanities have questioned the appropriateness and utility of prior review of their research by human subjects' ethics committees. This essay seeks to organize thematically some of their published complaints and to serve as a brief restatement of the major critiques of ethics review. In particular, it argues that 1) ethics committees impose silly restrictions, 2) ethics review is a solution in search of a problem, 3) ethics committees lack expertise, 4) ethics committees (...) apply inappropriate principles, 5) ethics review harms the innocent, and 6) better options exist. (shrink)

People engaged in international research projects – whether sponsors, researchers or participants – have different cultural and religious backgrounds. This can lead to quandaries over whose values should dictate the ethical basis for research. This paper addresses this issue by claiming that four core values are integral to the nature and justification of valid research and that to have integrity researchers must be committed to these values. Since the values are not specific to any particular culture or religion they constitute (...) a neutral ethical framework for the conduct of international research. It then claims that if researchers understand these values they can take responsibility for applying them to their own situation. This can help overcome problems which currently arise when researchers are not certain what to do because the specific ethical requirements of sponsors would be impractical or damaging if implemented in the circumstances in which the researchers operate. Finally, it is suggested that the four values outlined in the paper may be a basis for further work – such as developing awareness training and evolving guidance for specialist areas of research. (shrink)

The concept of “ethical research” holds considerable sway over the ways in which contemporary biomedical, natural, and social science investigations are funded, regulated, and practiced within a variety of countries. Some commentators have viewed this “new” means of governance positively; others, however, have been resoundingly critical, regarding it as restrictive and ethics bodies and regulations unfit for the task they have been set. Regardless, it is clear that science today is an “ethical” business. The ways in which formal and informal (...) ethical discourses and practices—what might be called “regimes of normativity”—structure scientific work and the meanings it is ascribed with have, however, been underexplored. This article attends to how science and ethics articulate; how they are, in many ways, co-produced. Exploring these processes of co-production casts into sharp relief the essential emotionality of science; the relationships investigators have with their colleagues, work, and research participants pulse with emotion, potentially shaping in important ways the very kinds of knowledge that laboratories produce. (shrink)

The current ethical structure for collaborative international health research stems largely from developed countries' standards of proper ethical practices. The result is that ethical committees in developing countries are required to adhere to standards that might impose practices that conflict with local culture and unintended interpretations of ethics, treatments, and research. This paper presents a case example of a joint international research project that successfully established inclusive ethical review processes as well as other groundwork and components necessary for the conduct (...) of human behavior research and research capacity building in the host country. (shrink)

This article parallels a debate similar to the one in Canada and elsewhere where researchers whose work involves humans now operate under a single ethics policy, with a strong biomedical emphasis. The institution of research ethics committees for humanities and social sciences in South Africa are relatively recent, posing unique challenges to researchers and academicians. These factors contribute to the complexity of conducting ethically sound research in the humanities and social sciences. The article explores this specific context and how a (...) research ethics committee in the humanities and social sciences can meet the challenge of the unique South African context. (shrink)

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. (shrink)

The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed (...) by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review. (shrink)

We aim, in this paper, to discuss how far the ethical framework for assessing medical research, generalized into other institutional settings, is also appropriate for social science research, particularly qualitative research. Recently, researchers have raised concerns about ‘ethics creep’, incompatibility with participatory methodologies and the exclusion of service users. Researchers are increasingly raising questions as to whether the processes of governance and the paradigmatic assumptions pervading research ethics committees are fit for purpose when they deliberate on non-clinical research that uses (...) social science methods. We review whether ethical scrutiny by research ethics committees is asking the wrong questions and holding research to the wrong standards. (shrink)

This article is a response to the challenge with which Zachary Schrag concluded his article, ‘The case against ethics review in social sciences’ − that ‘the burden of proof for its continuation rests on its defenders’ (Schrag, 2011). This article acknowledges that there is substance in the charges he lays against some reviews of social sciences and that these are of sufficient quantity and seriousness to justify his challenge. Instead of favouring abandonment of ethical review of social sciences, the author (...) of this article draws upon his experience as Research Ethics Officer for Social Sciences and Law in a research intensive UK university to identify the sources of some of the problems and suggest potential remedies. These start with reviewing the warrant for ethical review as the basis for understanding reviewer’s role concerning the core ethical issues of rigour, respect and responsibility in the proposed research. This response concludes by considering the implications of a warrant for enhancing trust between scientists and the public as the context in which ethical review is only one component in a number of ethical strategies designed to promote ethical mindfulness as integral to social science research. (shrink)

This paper discusses the issue of informed consent from an African perspective with a particular emphasis on the problems posed by the documentation of consent in the African socio-cultural environment. The paper presents two small-scale surveys which typify and exemplify the African perspective with regard to procedures for obtaining consent (agreement) and for documenting it. To avoid causing moral pain to African research participants and the feeling of having been used as mere sources of data, this paper suggests, as a (...) short-term solution, that African cultural values be incorporated in the procedures and regulations aimed at protecting their human rights. As a long-term solution, the paper encourages universities and research institutions operating in Africa to come up with clear guidelines of ethical conduct which would satisfy both the interests of ordinary Africans (particularly the rural and uneducated population) and legal requirements to which Western research institutions and funding agencies are subjected. (shrink)

Research on sexual violence is fraught with ethical and methodological challenges due to its sensitive nature. This paper describes the ethical and methodological challenges encountered in planning and conducting two exploratory studies on sexual violence that included in-depth interviews of eight female adolescent rape survivors in Ibadan and four married women in Lagos Nigeria who were raped, forced to perform sexual acts and sexually deprived. The first challenge encountered was an Institutional Review Board requirement to obtain parental permission from adolescents, (...) when such a requirement may place the adolescent at risk if a parent was a perpetrator of sexual violence. Using arguments emphasizing the Council for International Organization for Medical Sciences guidelines helped convince the IRB to provide a waiver of parental consent. Second, the privacy required to conduct in-depth interviews for rape survivors was difficult to achieve because five of the rape survivors were apprentices who work in public settings which are typically used to conduct business in the informal sector. To overcome this challenge, interviews were conducted in safe locations, investigator's offices and homes of survivors. The culture of silence associated with sexual violence posed a challenge because it encourages perpetration of violence with impunity causing rape survivors to suffer in silence. None of the affected adolescents had sought judicial redress for rape despite availability of stringent punishment for this behaviour. Referral information was provided on where survivors could seek care. Interviews with the women could not be recorded on audio-tapes because of concerns that their partners might identify their voices from the tapes and punish them for this. Although research on sexual violence poses ethical and methodological challenges, it is not only desirable but also feasible to conduct such research in ways that ensure safety of participants. (shrink)

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards .Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. (...) A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research. (shrink)

Modern bioethics was born in the West and thus reflects, not surprisingly, the traditions of Western moral philosophy and political and social theory. When the work of bioethics was confined to the West, this background of socio-political theory and moral tradition posed few problems, but as bioethics has moved into other cultures – inside and outside of the Western world – it has become an agent of moral imperialism. We describe the moral imperialism of bioethics, discuss its dangers, and suggest (...) that global bioethics will succeed only to the extent that it is local. (shrink)