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)

Contemporary bioethics education has been developed predominately within Euro-American contexts, and now, other global regions are increasingly joining the field, leading to a richer global understanding. Nevertheless, many standard bioethics curriculum materials retain a narrow geographic focus. The purpose of this article is to use local cases from the Asia-Pacific region as examples for exploring questions such as ‘what makes a case or example truly local, and why?’, ‘what topics have we found to be best explained through local cases or (...) examples?’, and ‘how does one identify a relevant local case?’ Furthermore, we consider the global application of local cases to help extend the possible scope of the discussion, opening new avenues for the development of practical bioethics educational materials. We begin with a background description and discussion of why local cases enhance bioethics education, move to an overview of what is currently available and what is not for the region, and then outline a discussion of what it means to be local using example cases drawn from Hong Kong, Australia, Pakistan, and Malaysia. We are not creating a casebook but rather constructing by example a toolbox for designing active and dynamic learning cases using regional diversity as contextualised cases with generalised principles. (shrink)

The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that (...) acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved. (shrink)

Internet-based health research is increasing, and often offers financial incentives but fraudulent behavior by participants can result. Specifically, eligible or ineligible individuals may enter the study multiple times and receive undeserved financial compensation. We review past experiences and approaches to this problem and propose several new strategies. Researchers can detect and prevent Internet research fraud in four broad ways: through the questionnaire/instrument ; through participants' non-questionnaire data and seeking external validation through computer information,, and 4) through study design. These approaches (...) each have pros and cons, and raise ethical, legal, and logistical questions, given that ethical tensions can emerge between preserving the integrity of research vs. protecting the privacy and confidentiality of study respondents. While past discussions concerning the ethics of online research have tended to focus on the participants' ability to trust the researchers, needs now arise to examine researchers' abilities to trust the participants. This analysis has several critical implications for future practice, policy, and research. (shrink)

Reply to a commentary by Felicitas Holzer and Ignacio Mastroleoon “Models of Consent to Return of Incidental Findings in Genomic Research.”.

Several films, including Three Identical Strangers, examined ethical problems in an experiment that involved identical siblings who were adopted as infants and separated into different families to examine the effects of nature versus nurture. The study was primarily designed and directed by Dr Peter Neubauer. The experiment, conducted in the 1960’s through 1980’s, serves as an important cautionary case study, raising several critical and ongoing ethical issues faced by researchers, universities and archives today. The organisation coordinating the study donated the (...) research records to Yale University under the condition that they remain sealed until 2065, and has impeded study participants’ full access to research material. This case raises questions of what investigators, their descendants, research ethics committees or institutional review boards, universities and archives should do with study records when researchers retire or die—whether universities should accept researchers’ donations of archival records that may contain patient or participant data, and if so, under what conditions. This study also poses crucial issues for IRBs—for example, whether researchers themselves or their designates should control all access to study records, particularly if controversy or lawsuits ensue. These questions will become increasingly crucial since the amount of research has burgeoned over recent decades, and investigators, on retirement or death, may want to donate their archives to universities. This experiment thus highlights ethical questions to which researchers, IRBs, universities, healthcare institutions, archivists and libraries should attend. (shrink)

While attention has focused in many states and countries on the initial acute phase of the COVID-19 pandemic and on lowering rates of infection and deaths, evidence suggests that among many survivo...

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = (...) 0.001), more sponsor-country authors (P = 0.003), sponsor-country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host-country involved (P = 0.002), journals having sponsor-country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor-country editors and research being biomedical.Conclusions: One-third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = (...) 0.001), more sponsor‐country authors (P = 0.003), sponsor‐country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host‐country involved (P = 0.002), journals having sponsor‐country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor‐country editors and research being biomedical.Conclusions: One‐third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)