Research ethics

I have been primarily interested in ethical issues raised by research sponsored by rich countries in resource poor countries. The issue started to get international attention in the mid-1990s, when WHO/UNAIDS decided to endorse a trial of an HIV vaccine candidate that was rejected in the US. According to the guidelines in effect at that time, this was not permissible: Trials that could be done in both rich and poor countries should primarily be done in resource rich countries, and as a minimum be done simultaneously in both settings. The justification for this prohibition against doing trials only in research poor settings was to avoid exploitation of poor countries. Many representatives from these countries, such as Thailand, argued that this standard was inherently paternalistic and unjustifiable. As a result a process of discussion of the international guidelines was initiated by UNAIDS. I had been interested in this issue in relation to Brazil, and was asked by UNAIDS to produce a working paper.

    1. Fonseca OQ, Lie RK. Informed consent to preventive AIDS vaccine trials in Brazil: a pilot study. AIDS and Public Policy Journal 1995; 10:22-26
    2. Lie RK. Ethical issues in clinical trial collaborations with developing countries - with special reference to preventive HIV vaccine trials with secondary endpoints. UNAIDS Working Paper, 1997

At the same time as this deliberation was going on, the controversy erupted over the perinatal HIV transmission trials with the publication of a Sounding board article and editorial in the New England Journal of Medicine. This controversy was about whether it sometimes would be justifiable to allow trials in resource poor settings that would be unacceptable in rich countries. I have argued in several articles that under certain very specific conditions this should be acceptable. In an article I published with Seema Shaw we argue that standard of care may change as a research project progresses and this creates challenges for the conduct of clinical trials.

    1. Lie R.K. The perinatal HIV transmission studies. Bioethics 1998:12:307-311
    2. Wendler D, Lie RK, Emanuel E. The standard of care debate: Can researchers be ethical and helpful. American Journal of Public Health 2004:94; 923-9
    3. Lie RK. The HIV perinatal transmission studies and the debate about the revision of the Helsinki Declaration. In Lie RK, Schotsmans P, eds Healthy thoughts: European Perspectives on Health Care Ethics. Peeters Verlag, Leuven, 2002. pp 189- 206
    4. Lie RK. Standard of care owed to participants in trials: Different standards in different countries? In: Ashcroft R, Angus Dawson, Heather Draper and John McMillan, eds. Principles of Health Care Ethics, John Wiley, London, 2007, pp. 729-734
    5. Lie RK, Emanuel E, Grady C, Wendler D. The standard of care debate: The international consensus opinion versus the Declaration of Helsinki Journal of Medical Ethics 2004: 30: 190-
    6. Shah S, Lie RK. Aiming at a moving target: Research ethics in the context of evolving standards of care and prevention. Journal of Medical Ethics 2013; 39: 699-702

As a result of these discussions, I was part of a group that developed what has been called the Fair Benefits Framework. This framework rejects the requirement that a particular type of benefit should be required in international collaborative research. Specifically, it rejects the requirement that reasonable availability should always be required. Some have interpreted this to be that only the amount of benefits matters, and no restrictions should be placed on the types of benefits, and that there are no independent standards by which benefit agreements can be evaluated: whatever parties to the negotiations agree is fair should be accepted. I have rejected this interpretation of the Framework.

    1. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Moral Standards for Research in Developing Counties: From "Reasonable Availability" to "Fair Benefits” Hastings Center Report 2004: (May-June, No 3): 17-26
    2. Participants in the 2001 Conference on Ethical Aspects of Research in Developing Countries. Fair benefits for research in developing countries. Science 2002:298; 2133-2134
    3. Lie RK. The Fair Benefits Approach Revisited. Hastings Center Report 2010,July-August, 3