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Abstract
Commentators on the ethics of translational research find it morally problematic. Types of translational research are said to involve questionable benefits, special risks, additional barriers to informed consent, and severe conflicts of interest. Translational research conducted on the global poor is thought to exploit them and increase international disparities. Some commentators support especially stringent ethical review. However, such concerns are grounded only in pre-approval translational research (now called T1). Whether or not T1 has these features, translational research beyond approval (T2: phase IV, health services, and implementation research) is unlikely to and, when conducted on the global poor, may support development. Therefore, insofar as T1 is morally problematic, and no independent objections to T2 exist, the ethics of translational research is diverse: while some translational research is problematic, some is not. Funding and oversight should reflect this diversity, and T2 should be encouraged, particularly when conducted among the global poor.
Winner of the 2010 Mark S. Ehrenreich Prize in Healthcare Ethics Research, presented by the International Association of Bioethics and USC's Pacific Center for Health Policy and Ethics at the 10th World Congress of Bioethics.
For helpful comments, we extend our warm thanks to Richard Ashcroft, as well as to Paul Bain, Edison Bicudo Junior, Vishnu Jejjala, Ann Kelly, Jonathan Kimmelman, Larry Lessig, Penney Lewis, Joia Mukherjee, Julian Sofaer, Reuben Thomas, Robert Truog, Angelo Volandes, Leif Wenar, Dan Wikler, and AJOB's anonymous reviewers. We also thank the Medical Law and Ethics Seminar group at King's College London, and the Medical Anthropology Seminar group at the London School of Hygiene and Tropical Medicine.
Notes
1. We are grateful to Jonathan Kimmelman for this example.
“First-in-human trials” that administer subtherapeutic doses of the trial drug to a small number of participants.
To be precise, Phase IIIb trials can overlap with the lengthy process of gaining regulatory approval.
Likewise, the website of the World Health Organization Department of Essential Health Technologies laments that “despite the exponential growth of scientific and technological development, availability of and access to appropriate and affordable health technologies in low- and middle-income countries are still insufficient.” The department encourages the “[adaptation of] innovative technologies to address global health concerns” (CitationWHO Staff 2009a).
During a discussion that followed a 2009 seminar at Harvard Medical School.
However, studies observing bad practices may be ethically problematic even if these studies do not generate new risks for patients. Consider a study to determine the frequency with which dirty needles are re-used without being sterilized. Such a study cannot achieve statistical significance if researchers intervene to prevent the re-use of needles whenever it takes place, as perhaps they should. (We thank Dan Wikler for this example.)
The title of the source “Development attrition rates for selected therapeutic categories” (our italics) is misleading in that one of the therapeutic categories is called “all drugs” and the increase in success rate with successive phases is seen in all of the 10 given categories.
Particularly phase IV trials have very many participants, significant lapses of time—sometimes years—can separate the end of an individual's participation and the time when such information can be disclosed without compromising scientific integrity. Focus groups with U.S. participants in clinical trials for chronic diseases found that some participants greatly valued such information and wanted the time lapse to be shorter (CitationSofaer et al. 2009).
We thank an anonymous referee for this point.
The press often reports on research that investigates the approved drugs and health systems that its readers use, and thereby provides an additional source of information for potential participants. Such reports comprise additional oversight of that category of research, admittedly inferior to the oversight provided by ethics committees in some respects, but superior in others. Such reports decrease the urgency of amplifying oversight of research beyond approval.
In principle, drug manufacturers might use patent protections to try to limit such experimental use. But recent setbacks to the so-called “experimental use exception” of American patent law do not affect this particular experimental use of drugs. See Citation Merck KGaA v. Integra Lifesciences I, Ltd. (2005) and, regarding medical devices, Citation Madey v. Duke Univ., 307 F.3d 1351 (2002). Moreover, in practice, drug manufacturers normally do not seek to delimit this type of experimental use. We are grateful to Larry Lessig for these citations and for a helpful discussion.
Consider also Alan Wertheimer's case of the lecherous millionaire (CitationWertheimer 2008). A child needs lifesaving surgery. The mother cannot afford to pay for it. A lecherous millionaire proposes to pay for the surgery if she sleeps with him. She consents, and the child's life is consequently saved. The mother benefits from the interaction to a greater extent than the millionaire, yet she is objectionably exploited. Indeed, she is still exploited if the millionaire increases the benefit to her, by paying also for the lifesaving surgery of her other child, and requesting no additional benefit to him. This is the case even though the distribution of benefits arising from the interaction thereby becomes even more favorable to the exploited mother. By analogy, the argument continues, large net benefits to the global poor in some translational studies provide no assurance against objectionable exploitation.
For example, resource-rich countries often set the agenda for translational research done in resource-poor countries, including research beyond approval. That agenda-setting might be considered offensive to host countries’ sovereign dignity.
Our recommendation is in line with a recent report from The Academy of Medical Sciences in the UK that claims that “the UK … should lead the world in creating a proportionate, risk-based regulatory framework for medical research involving patients” (AMS staff 2010, 6).