Editor's Note: This is a commentary on the following article, which appears in this issue of Academic Medicine: Dubois JM, Dueker JM, Anderson EE, Campbell J. The development and assessment of an NIH-funded research ethics training program. Acad Med. 2008;83:596-603.
The National Institutes of Health (NIH) has had a long tradition of engagement with bioethics. At the opening of the Clinical Center in 1953, there was discussion about how to obtain informed consent from research participants. In the 1960s, the Clinical Center became one of the first biomedical research institutions to have independent review of research protocols-long before IRB review became a regulatory requirement. And, in 1977, the NIH hired a staff bioethicist to help review the ethics of research trials.
During the last 15 years, the NIH has substantially expanded it support of bioethics. In the mid-1990s, after his appointment as director of the clinical center, John Gallin created and supported a large intramural bioethics department. After President William Clinton's 1997 apology for the Public Health Service's Tuskegee study, the NIH expanded its extramural support for bioethics with grants for training in bioethics-T15 awards-and career development awards in bioethics-K awards. In addition, the Fogarty International Center began an important program of supporting training in international bioethics. The article by DuBois and colleagues1 in this issue of Academic Medicine is a snapshot of the efforts and outcomes of one such T15 award, with a focus on ethical decision making in mental-health-related research.
Despite these initiatives, the NIH's overall support of bioethics can be described as small, if not miniscule. By the best available estimate, less than 0.1%, and closer to 0.05%, of the NIH's budget is devoted to supporting bioethics training and research. And, as Salerno notes, nearly 40% of that support is devoted to Fogarty's international training initiative.2 Support by charitable foundations is similarly small. Only one foundation is devoted to bioethics, and, optimistically, there may be just five other foundations that support research and training that could be classified as bioethics.
The consequence is all too obvious. The NIH's Clinical and Translational Science Awards (CTSA) require a bioethical component, yet many of the institutions that have won CTSAs lack trained bioethics researchers to fulfill this component. Other institutions have designated individuals whose previous research has not encompassed the research ethics issues that are at the heart of the CTSA initiative. Concomitantly, there are many fundamental bioethical issues important to the NIH's mission that have gone unexplored or that have been explored only superficially. Consider issues such as posttrial benefits, what research procedures should qualify as minimal risk, what ancillary care services do researchers owe participants, or how should the risks of research and the social value of research be compared in trials that offer no benefits to participants. In addition, there is woefully little research evaluating different ways to improve the understanding of research participants, whether paying participants undermines or enhances their understanding, and how safe research is overall and whether it is getting safer.
What should be done? First, the goals of any initiative in bioethics need to be clearly specified. To ensure that research is conducted in the most ethical manner, to protect research participants, and to reassure the public about the ethical conduct of biomedical research, the research community needs bioethicists who can train researchers and future bioethicists, as well as bioethicists who conduct research, to answer fundamental questions such as those noted above. There is a need for what might be called bioethicists who are producers; that is, bioethicists who undertake innovative research projects, who collaborate with other biomedical researchers, and who can educate the next generation of bioethicists and research scientists. Without these producer bioethicists, there is no way to train research scientists and other research personnel in the proper conduct of research, especially that involving human participants, and no way to answer the pressing bioethical questions that currently confront researchers as well as thosethat will inevitably arise in the future.
To fulfill these goals, the NIH would have to undertake four distinct initiatives. Producer bioethicists do not arise through spontaneous generation; they must be educated and mentored in well-designed postdoctoral programs. As is true in every other scientific area, this requires multidisciplinary centers of excellence that are devoted to both research and training. These centers need a critical mass of bioethicists drawn from many relevant disciplines-medicine, biomedical science, philosophy, law, public health, and related disciplines. These faculty must conduct original research and must provide high-quality mentorship for physicians, philosophers, lawyers, and social scientists who are training to become bioethicists.
Second, like biomedical researchers at the start of their careers, young bioethicists need support for the transition between postdoctoral fellowships and junior faculty positions. Therefore, established K awards targeted at bioethics need to be developed and made available. How many bioethicists should be trained? One factor to consider is that during the next few years, many of the leading bioethicists who entered the field in the late 1970s and early 1980s will be retiring and will need to be replaced. Further, a bioethics workforce sufficient to satisfy the demands at the soon-to-be-60 CTSA sites, other major research institutions, and centers of excellence is necessary. As Salerno notes,2 on the basis of these estimates, 19 bioethics K awards to junior faculty during a period of five years is insufficient. A more realistic estimate is 20 to 30 K awards per year for the foreseeable future. That would require at least a fivefold increase in NIH support for bioethics-related K awards.
Third, although bioethics research is inexpensive, especially compared with laboratory or clinical research, it is not free. Rigorous empirical studies, whether examining existing databases or collecting data on research participants, researchers, or the public, require resources. Akin to theoretical physics, even clear and precise conceptual analysis of bioethical issues-such as whether it is ethical to enroll uninsured patients in research, the meaning of coercion, or what the appropriate posttrial benefits should be-is labor intensive, requiring support for salaries and collaboration among researchers. Thus, there needs to be reliable grant support for bioethics research. Importantly, whereas traditional R-01-type research awards may be appropriate mechanisms for empirical bioethical research, different types of grants-and grant applications-may be necessary to properly support more theoretical and analytic research.
Fourth, bioethics is a distinct discipline with an extensive literature and knowledge base. Just as we would not expect hepatologists to review cardiology grants or oncologists to review mental health awards, we should not expect laboratory or clinical researchers to review bioethics K or R awards. Competent review of bioethics grant proposals will require dedicated study sections composed of qualified bioethicists. Furthermore, these grants should not compete with grants elucidating basic biochemical pathways or clinical trials of new treatments.
A final question is whether such bioethics-related initiatives can be accomplished inside the NIH without creating an office, a center, or some other official body that is responsible and accountable for ensuring their fulfillment. No doubt, such an office or center would require both dedicated and reliable funding and expertise in bioethics. And though there are many individuals within the NIH who view bioethical issues as important, are supportive of their being addressed, and are thoughtful about them, bioethics is an orphan. Bioethical issues transcend all of the NIH's institutes and centers, yet bioethics does not belong to any single institute or center. No institute or center has developed an institutional expertise in bioethics. Furthermore, when it comes to funding, institutes and centers will put priority on their core research topics and not something that may be deemed peripheral. This is especially true during the current tight budget.
The absence of an accountable body also means there is no strategic plan for supporting bioethics at the NIH. No one has clearly articulated-and periodically revised-research priorities to ensure that issues relevant to the NIH mission are addressed. Similarly, no one is accountable for ensuring that the research is of high analytic and empirical quality. It is very difficult to imagine how bioethics can be properly supported by the NIH without some accountable body-be it an office, a center, or some other official something-that has knowledge of the discipline, appropriate topics, and scholars.
Researchers and NIH officials often complain, and rightly so, about the absence of bioethics research on key issues and the uneven quality of the research that exists. The historically limited support for bioethics training and research by the NIH and charitable foundations is a large part of the reason these issues go unaddressed in any sustained and systematic manner.
Obviously, support is necessary but not sufficient to guarantee high-quality bioethics research. Promoting an appropriately high quality of research would require a strategic plan to attract bright new scholars into the field, as well as the appropriate commitment to K and R awards-and study sections- to support their training and future research throughout a career. This must be a long-term commitment, not something that is here today but has a limited or uncertain future. In today's context, what talented young scholar would commit his or her career to such an ephemeral discipline? If the NIH wants to ensure that the research it funds is ethical, that researchers are trained in ethics, and that pressing ethical questions are thoughtfully analyzed and properly addressed, then it must assume responsibility for supporting the field. If the current situation continues, it is fairly certain that the quality of bioethics research and training will not improve. This greatly increases chances of some ethical violation that might ignite public suspicions.
The views presented in this article are the personal opinions of the author and do not represent the official views or policies of the Department of Health and Human Services, National Institutes of Health, or U.S. Public Health Service.