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  1. Us irbs confronting research in the developing world.Robert L. Klitzman - 2012 - Developing World Bioethics 12 (2):63-73.
    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 (...)
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  • Stakeholder views of ethical guidance regarding prevention and care in HIV vaccine trials.Rika Moorhouse, Catherine Slack, Michael Quayle, Zaynab Essack & Graham Lindegger - 2014 - BMC Medical Ethics 15 (1):51.
    South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders’ perspectives on ethical guidance related to prevention and care in HIV vaccine trials.
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  • Peruvian Female Sex Workers’ Ethical Perspectives on Their Participation in an HPV Vaccine Clinical Trial.Brandon Brown, Mariam Davtyan & Celia B. Fisher - 2015 - Ethics and Behavior 25 (2):115-128.
    This study examined female sex workers’ evaluation of ethically relevant experiences of participating in an HPV4 vaccine clinical trial conducted in Lima, Peru. The Sunflower Study provided all participants with HPV testing, treatment for those testing positive, and access to the vaccine for all testing negative. Themes that emerged from content analysis of interviews with 16 former participants included the importance of respectful treatment and access to healthcare not otherwise available and concerns about privacy protections, the potential for HIV stigma, (...)
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  • Reviewing HIV‐Related Research in Emerging Economies: The Role of Government Reviewing Agencies.Patrina Sexton, Katrina Hui, Donna Hanrahan, Mark Barnes, Jeremy Sugarman, Alex John London & Robert Klitzman - 2014 - Developing World Bioethics 16 (1):4-14.
    Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi-structured, in-depth telephone interviews with 15 researchers, Research Ethics Committees personnel, and a government agency member involved in multinational HIV Prevention Trials Network research in emerging economies. Ministries of Health or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can (...)
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  • National Human Research Ethics: A Preliminary Comparative Case Study of Germany, Great Britain, Romania, and Sweden.Bernard Gallagher, Anne H. Berman, Justyna Bieganski, Adele D. Jones, Liliana Foca, Ben Raikes, Johanna Schiratzki, Mirjam Urban & Sara Ullman - 2016 - Ethics and Behavior 26 (7):586-606.
    Although international research is increasing in volume and importance, there remains a dearth of knowledge on similarities and differences in “national human research ethics”, that is, national ethical guidelines, Institutional Review Boards, and research stakeholder’ ethical attitudes and behaviors. We begin to address this situation by reporting upon our experiences in conducting a multinational study into the mental health of children who had a parent/carer in prison. The study was conducted in 4 countries: Germany, Great Britain, Romania, and Sweden. Data (...)
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  • The reporting of irb review in journal articles presenting hiv research conducted in the developing world.Robert L. Klitzman, Kelly Kleinert, Hoda Rifai-Bashjawish & L. E. U. Shiung - 2011 - Developing World Bioethics 11 (3):161-169.
    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 = (...)
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