Salerno, Judith A. MD, MS
Dr. Salerno is executive director, Institute of Medicine, The National Academies, Washington, DC.
Correspondence should be addressed to Dr. Salerno, 500 5th St., NW, Washington, DC 20001; e-mail: (firstname.lastname@example.org).
Ethically conducted research involving human participants is a cornerstone of the academic medical research establishment. However, there is public mistrust of clinical research and, as a result, low participation rates in research studies among minorities and in communities where health disparities are glaring. Specific initiatives have been undertaken by the National Institutes of Health (NIH) to restore public confidence in biomedical research and to ensure that research is conducted ethically and responsibly. The T15 program, instituted in 1997, made awards beginning in 1998 to institutions for up to three years to develop, conduct, and evaluate short-term courses on ethical issues in research. A companion solicitation (K01 program) targeted the career development of independent investigators in applied research ethics through mentored scientist development awards in research ethics. Both programs emphasized ethical research involving human participants and outreach to minority scientists.
The author asks how the success of these programs should be gauged, especially in light of new—and often unforeseen—ethical challenges that are likely to confront the research community. Participation in some T15 programs indicates that few researchers and practitioners perceived the need to increase their proficiency in analyzing the ethical dimensions of their work. To improve participation and, ultimately, ethical approaches to human participants research, the NIH should foster appreciation for the centrality of bioethics in the biomedical research enterprise. The author calls on the NIH to provide leadership for bioethics by further developing a national agenda for bioethics training and research.
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.
On May 16, 1997, President William Clinton issued an apology on behalf of the American people to the survivors of the shameful Tuskegee experiment and their families. The Tuskegee Syphilis Study was a U.S. Public Health Service study, spanning four decades (1932–1972), in which 399 poor African American men with syphilis in Macon County, Alabama, were studied without being informed about their disease or available treatment, or even that they were participating in medical research. Many died of the complications of syphilis. The scars of Tuskegee have been long lasting; there continues to be widespread mistrust of clinical research among African Americans and, as a result, low participation rates in research studies among minorities and in communities where health disparities are glaring.
Understanding that the apology was only “the first step … to rebuild the broken trust,”1 President Clinton proposed a number of specific initiatives to restore public confidence in biomedical research and to ensure that research is conducted ethically and responsibly. A cornerstone of his promise was to “strengthen researchers’ training in bioethics” and to provide “postgraduate fellowships to train bioethicists especially among African Americans and other minority groups.”1 The then-Secretary of Health and Human Service (HHS) Donna Shalala directed HHS agencies to establish a program to facilitate Clinton’s commitment. In response to Shalala’s directive, the National Institutes of Health (NIH), with participation by other HHS agencies, developed several initiatives to train biomedical researchers in research ethics and to support the career development of academic bioethicists. One of the tangible results was the issuance in November 1997 of two new tandem program announcements (PA). The T15 PA program made awards to institutions for up to three years “to develop, conduct and evaluate short-term courses on ethical issues in research” (first issued as NIH PAR-98-005). The companion solicitation targeted the career development of independent investigators in applied research ethics through mentored scientist development awards (the K01 mechanism) in research ethics. Both programs emphasized research involving human participants and outreach to minority scientists, but they did not exclude other topics and nonminority scientists.
Under the T15 program, 26 new awards were made by the NIH between FY1998 and FY2003, with an investment totaling approximately $10 million for new and noncompeting awards. In that same time period, 19 K01 awards were made at a cost of about $5.4 million. More recently (FY2005), the NIH supported nearly $18 million for bioethics training across 15 different mechanisms, including the largest program, the Fogarty International Center’s international bioethics education awards (R25), at $7.1 million. When these dollar amounts are viewed in relation to the NIH’s multibillion-dollar investment in clinical research, investment in bioethics education and research has remained small.
How should we gauge the success of these programs? Has the investment been adequate to spur bioethics education and training in the United States? Do the T15 and K01 bioethics programs add value for the size of the investment? Although these are difficult questions to answer directly, the NIH, as the world’s largest funder of biomedical research, has an abiding interest and a special responsibility to ensure that the research it supports is conducted in accordance with the highest ethical standards, from the protection of human participants to the responsible conduct of research. The explosion of research and biotechnical advances, the fresh emphasis on translating research findings into practice, the new frontiers of personalized and predictive medicine, and the compelling need for research involving vulnerable populations (e.g., the frail elderly, children) represent only a few of the areas where new—and often unforeseen—ethical challenges are likely to confront the research community at academic health centers and teaching hospitals. Thus, the need for an ethically trained workforce that is ready to meet emerging challenges will increase as science advances.
In this issue, DuBois and colleagues2 report on an evaluation of an NIH-supported T15 program that was funded from 2002 to 2006. The program, jointly based at St. Louis University and the Missouri Institute for Mental Health, was designed to train mental health researchers in ethics problem solving and to develop training resources that would be made widely available through a train-the-trainer approach. A special emphasis of the program was the incorporation of mental health services consumer perspectives into cases and scenarios, thus integrating the voices of those who had served as participants in research. The Web site, case scenarios, textbook, and DVD developed for the course have been used by the course directors in other training venues. Yet, despite broadly based advertising of the program and the availability of a distance-based learning component, an average of only 20 participants participated in each course—noteworthy because so few researchers and practitioners perceived the need to increase their proficiency in analyzing the ethical dimensions of their work.
Like the program described by DuBois and colleagues, most T15 programs use a variety of methods to evaluate the impact of their training programs, including pre and post knowledge assessments, qualitative evaluations of course content and instruction, and quantitative measures such as tracking the number of visits to the training Web site; many have made their products available online. These are important, if small, steps in reconstructing the public trust that past missteps have eroded. Despite these efforts, the larger question of whether the T15 programs have had a sustained impact and whether they have enhanced the ability of biomedical researchers to recognize the ethical dimensions of an issue and resolve ethical conflicts is largely unknowable. Evaluations aimed at the specific effects of specific interventions cannot adequately capture more fundamental matters of attitude and ethical questioning that should infuse and inform every aspect of biomedical research. The problems do not lie in the design, implementation, or evaluation of the T15 program, but in a lack of appreciation for the centrality of bioethics across the biomedical research enterprise nationally.
In addition to the T15 program, there are numerous high-quality tutorials, case studies, and Web pages available as resources for students, trainees, and researchers to explore bioethics issues. However, these efforts, too, remain marginalized in the absence of a broad national agenda for bioethics and with the lack of recognition that bioethics is one of the foremost interdisciplinary issues in research. The establishment of such recognition is another key step in fostering the public’s tenuous trust of bioethical research practices.
The opportunity currently exists for the NIH to provide leadership for bioethics by developing a national agenda for bioethics training and research. Doing so would provide the context to make sense of the existing crazy quilt of programs and courses in bioethics and would allow the incorporation of training for ethical action throughout the biomedical research community. To be successful, such an agenda should strengthen bioethics scholarship to support the development of teachers and consultants for the research community. Currently, there are at least eight major institutions recruiting and vying for academic bioethicists to fill vacant faculty positions from a very small pool of candidates (E. Emanuel, National Institutes of Health, personal communication, June 2007). The K01 program alone, supporting fewer than 20 academic careers during a period of five years, will not be the engine for academic scholarship in bioethics.
A recent innovation, launched as part of the NIH Roadmap for Medical Research, is the Clinical and Translational Research Award (CTSA) program. This program seeks to create a “definable academic home for the discipline of clinical and translational science at institutions across the country.”3 Currently, the CTSA consortium includes 24 academic health centers in 18 states; by 2012, the consortium will link approximately 60 institutions engaged in clinical and translational science. The CTSA solicitation requires applicants to address bioethics through the program’s Research Design, Epidemiology, Biostatistics and Clinical Research Ethics component. The scope and potential influence of the CTSA program is an extraordinary opportunity for the NIH to engage in the focused agenda setting and integration of bioethics into research training and practice that is warranted. This will need to be done deliberately and thoughtfully, with wide buy-in from the research community, so that bioethics is given the prominence it deserves and is not, once again, lost in translation.
Public concerns about ethic matters have become widespread, in topics ranging from the conduct of public officials, to plagiarism in academia, to professional and personal ethics (e.g., the New York Times Magazine’s popular ethics column). The T15 and K01 programs generated by the response to the Tuskegee experiment were small steps in restoring the public trust. They should not be abandoned but, instead, strengthened and integrated into a larger bioethics training agenda. Progress in clinical science will depend on repairing and maintaining the public trust to sustain public participation in clinical research and encourage public understanding of the importance of biomedical research.
The views expressed in this article are those of the author and do not necessarily represent those of the Institute of Medicine or the National Academies.