Posted on July 27, 2015 at 11:41 AM
(This post also appears on the Penn Wharton Public Policy Initiative)
In December 2011, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) released its report Moral Science: Protecting Participants in Human Subjects Research. In it, the Commission responded to a charge from the President to determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the federal government. Although the Bioethics Commission noted the substantial protections for the health, rights, and welfare of research participants under the existing U.S. system, it also found room for improvement in several areas.
One such area identified by the Bioethics Commission was the treatment and compensation of participants who sustain research-related injuries. Over the last several decades, almost every developed country has instituted policies requiring researchers or sponsors to provide treatment and compensation for research subjects’ injuries. Despite recommendations from the Presidential Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research in 1982, the National Bioethics Advisory Commission (NBAC) in 2001, and the Institute of Medicine (IOM) in 2002 that the federal government either explore the issue further or implement a system of its own, U.S. action has been minimal.
In Moral Science, the Bioethics Commission argued that the absence of such a system was ethically unjustified. Rooted in longstanding ethical principles the Bioethics Commission wrote that “treatment or compensation… is appropriate as an act of benevolent regard for an individual’s willingness to participate in an enterprise of important benefit to the public.” Offering arguments based in justice, professional obligations, and utility, the Bioethics Commission recommended that the federal government evaluate the need for a national system of compensation for research-related injuries and study possible program mechanisms. Just over one year later, the Bioethics Commission took up this issue again in its report Safeguarding Children: Pediatric Medical Countermeasure Research. In this report, the Bioethics Commission reviewed the ethical considerations of conducting clinical trials of medical countermeasures—interventions used in the event of a terror attack—with children. When considering ethical requirements for these studies, the Bioethics Commission reaffirmed its ethical argument for research-related injury compensation from Moral Science and recognized the additional need in the context of pediatric MCM research.
Since the release of these reports, several developments have highlighted the importance of the Bioethics Commission’s recommendations to study and evaluate different approaches to designing a system for compensation. These developments include:
- New evidence that suggests that, without government intervention, some private institutions have yet to develop their own compensation policies. As of 2012, there has been no substantial change in research-related injury compensation policies among U.S. institutions since 2000 despite the calls for change from NBAC, the IOM and the Bioethics Commission during that time. In addition, over ten percent of U.S. research institutions actually changed their consent forms to include exculpatory language as of 2012 despite having had none in 2000.
- A 2013 strengthening of India’s legal protections for injured research subjects that prompted the National Institutes of Health (NIH) to halt as many as 40 clinical trials in light of what many industry experts considered to be an “unstable regulatory climate.”, Despite making a reluctant return to India when the law was further clarified, the NIH faces continued legal challenges to providing appropriate compensation., The situation in India is not an isolated incident. On other occasions, the lack of a systematic compensation system has forced U.S. research teams abroad to work around existing regulations or in some cases, even stop clinical trials.
- A 2013 study demonstrating the possibility that costs of treatment for research-related injury might be shifted to local health care systems within developing countries where research takes place. The study of NIH HIV/AIDS clinical trials in Africa found that although many investigators use portions of their funding to cover treatment or reparation for research-related injuries, data from one African country suggest that “overburdened and under-resourced health systems may be forced to provide care and treatment for injuries caused by research when sponsors fail to do so.”
- A 2013 revision to the World Medical Association’s Declaration of Helsinki adding that “appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.” The revision represents growing consensus on the issue of research-related injury compensation within the international community. The update has resulted in rising acknowledgement among scholars and physicians that the United States remains an outlier on this issue.
In Moral Science, the Bioethics Commission presciently observed that, among other ethical arguments, general utility supports such a system, noting “if there is a growing commitment toward harmonization of policies and recognition of equivalent protections, the fact that federally sponsored human subjects research differs substantially in this policy toward compensation for humans subjects who are harmed in the course of research could prove a significant barrier [to recruitment of participants].”
As the United States remains one of the few industrialized countries without a strong legal infrastructure providing for research-related injury compensation, recent events further highlight the strategic and ethical imperative for federal action. Amidst continued attention within the international community, the need for a systematic approach to compensation continues to grow.
 Presidential Commission for the Study of Bioethical Issues (PCSBI). (2011, December). Moral Science: Protecting Research Participants in Human Subjects Research. Washington, DC: PCSBI, p. 58.
 Resnik, D.B., et al. (2014). Research Related Injury Compensation Policies of U.S. Research Institutions. IRB 36 (1), 12-19.
 Gupta, Y.K. et al. (2014). Compensation for Clinical Trial-Related Injury and Death in India: Challenges and the Way Forward. Drug Safety, 37 (12), 995-1002.
 Krishnan K. and J.P. Koshy. (2013, 11 July). US agency NIH scraps nearly 40 clinical trials in India. Livemint. Retrieved on June 24, 2015 from http://www.livemint.com/Politics/zwG7cCA7nFYFdpzYLXcCVM/US-agency-NIH-cancels-nearly-40-ongoing-clinical-trials-in-I.html.
 Reardon, S. (2014). NIH makes wary return to India: Some clinical trials funded by US agency resume, but strict regulations have put off others. Nature, 506 (7487), 143-144.
 Marwick, C. (1998). Compensation for Injured Research Subjects. Journal of the American Medical Association, 279 (23), 1853-1855.
 Pike, E.R. Recovering from Research: A No-Fault Proposal to Compensate Injured Research Participants. American Journal of Law and Medicine, 38 (1), 42-43.
 Mamotte N., Wassenaar D. and N. Singh. (2013). Compensation for Research-Related Injury in NIH-Sponsored HIV/AIDS Clinical Trials in Africa. Journal of Empirical Research on Human Research Ethics, 8 (1), 45-54.
 World Medical Association (WMA). (2013). World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Journal of the American Medical Association, 310 (20), 2191-2194.
 Many who covered the revision to the declaration or who were quoted in articles that followed it expressed doubts about whether or not US regulators would enact changes following the statement from the WMA. For more see: Kurihara, C. and Takeo S. (2013). Discussion toward he 50th anniversary of the Declaration of Helsinki: Interview with Dr. Otmar Kloiber, Secretary General, World Medical Association. Rinsho Hyoka (Clin Eval), 41 (2), 351-372; Morris, K. (2013). Revising the Declaration of Helsinki. The Lancet, 381 (9881), 1889-1890; Lynch, H.F. (2013) Bill of Health: Revisions to the Declaration of Helsinki. Retrieved on July 2, 2015 from http://blogs.law.harvard.edu/billofhealth/2013/04/18/revisions-to-the-declaration-of-helsinki/.
 PCSBI, (2011, December), op cit, p. 62.