Determining the Scope of Research-Related
Injuries: A Study Worth Conducting

Alice M. Maples, J.D., LL.M. candidate

Research-related mishaps have captured the publicís attention through widespread coverage of incidents such as those involving Jesse Gelsinger and Ellen Roche, both of whom died while serving as subjects of research. The reporting of these two unfortunate examples of research-related deaths makes one wonder how often subjects are injured or lose their lives in research without the incidents coming to the attention of the public.

The National Bioethics Advisory Commission (NBAC), whose charter recently expired, issued a report in August of this year addressing human subjects research. Natíl Bioethics Advisory Commín, Ethical and Policy Issues in Research Involving Human Participants, Vol. 1 (2001) (available at http://bioethics.georgetown.edu/nbac/human/overvol1.html). In the context of this report, the NBAC proposed many changes to the system of regulation regarding human subjects research. Id. Two recommendations included developing a system of "compensation for research-related injuries" and improving the way in which ongoing research is monitored. Id. at 111.

Currently, if "more than minimal risk" is involved in the research, subjects must be told during the process of informed consent whether compensation and/or medical treatment will be provided in the event of injury, the extent of compensation and medical treatment, and the location of further information. Id. at 123 (citing 45 CFR § 46.116(a), 21 CFR § 56.116(a)). Informed consent cannot include exculpatory language. Natíl Bioethics Advisory Commín at 123 (citing 45 CFR § 46.116, 21 CFR § 50.20). Research subjects must seek recourse through the legal system to redress their injuries, unless the subjects are privately insured or are participating in research at an institution with a voluntary compensation program. Natíl Bioethics Advisory Commín at 125 (citing Charles Marwick, Compensation for Injured Research Subjects, 279 JAMA 1854 (1998)). Marwick observed that "the University of Washington School of Medicine in Seattle" used a "self-insured liability program" that paid for "any amount appropriate for medical care, as well as for such other expenses as transportation or needed attendants." Marwick, supra.

The NBAC concluded that "[t]he federal government should study the issue of research-related injuries to determine if there is a need for a compensation program. If needed, the federal government should implement the recommendation of the Presidentís Commission . . . to conduct a pilot study to evaluate possible program mechanisms." Natíl Bioethics Advisory Commín at 126. In 1982, this Presidentís Commission specifically recommended that the federal government conduct a "modest social policy experiment . . . to determine the need for, and feasibility of, comprehensive or partial programs to compensate injured subjects." Presidentís Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Compensating for Research Injuries: The Ethical and Legal Implications of Programs to Redress Injured Subjects, Vol. One (1982) at 105. Based on limited studies conducted on behalf of the Presidentís Commission at institutions with compensation mechanisms, the Presidentís Commission concluded in 1982 that there were few serious injuries, that most injuries requiring medical intervention were "only temporarily disabling," that serious injuries and deaths were more often attributable to the subjectís underlying condition than to research, and that having a mechanism for compensation did not result in "excessive or unmerited claims of injury." Id. at 65. Despite the Presidentís Commissionís recommendations, the NBAC noted that there is no sufficient compilation of data regarding the prevalence of research injuries. Natíl Bioethics Advisory Commín at 125. The NBAC recommended that such data be collected through existing mechanisms, such as "reports to FDA of serious adverse events." Id. at 126.

Interestingly, the NBAC also addressed the need for improvements in the system of continuing reviews of research by institutional review boards, noting that federal regulations require institutional review boards to review ongoing research at least once a year, but that these regulations provide insufficient guidance as to the nature of such review. Natíl Bioethics Advisory Commín at 112 (citing 45 CFR § 46.109(e), 21 CFR § 56.109(f)). The NBAC reviewed regulations pertaining to adverse event reports, noting that "evaluation of reports and distribution of findings to all relevant parties are also critical." Natíl Bioethics Advisory Commín at 113-114. The NBAC ultimately favored creation of "a uniform system for reporting and evaluating adverse events occurring in research, especially in multi-site research." Id. at 117.

The implementation of this recommendation would, in and of itself, have a positive impact on the protection of human subjects, by clarifying the role of the various parties to the research and by ensuring better compliance with reporting of adverse events. In addition, the uniform system could be crafted in a way that would provide a better opportunity to compile data regarding the overall scope of injuries resulting from research involving more than minimal risk, thus facilitating a study of the need for compensation.

The NBAC seems to take the position that, regardless of the frequency with which research-related injuries occur, the risks of research should not fall to the subjects, but should instead be allocated to those who will reap the rewards of the research. Id. at 125. The NBAC suggested that institutions and sponsors could fund a compensation system through insurance mechanisms or payment of premiums to a central fund. Id. at 126. The non-fault compensation system would include medical and rehabilitative costs. Id. The NBAC suggested that such a system would operate in "coordination with, but not replacement of, the existing fault-based liability system." Id.

One scholar observed that "[a] huge disparity in power and resources exists between test sponsors and test subjects." James T. OíReilly, Elders, Surgeons, Regulators, Jurors - Are Medical Experimentationís Mistakes Too Easily Buried, 31 Loy. U. Chi. L.J. 317, 363 (2000). OíReilly suggested that "[a]s a safeguard for patients, a statutory or common-law tort standard of strict liability to fully compensate test subjects for physical harm resulting from the experimentation seems particularly sensible." Id.

It is certainly possible to debate the feasibility of a compensation program, especially in the situation of therapeutic research. It is also possible to debate the question of who should bear the risk of injuries resulting from research. However, the federal government has not acted adequately to address the issue of research-related injuries. At a time when human subjectsí risks of injuries have become manifest to the general public, a study of the prevalence of research injuries would represent an important first step in determining whether such a system is ethically required and feasible to administer. Perhaps our hesitance to take this step is due to a fear that once the data is marshaled, the need for a compensation system will become immediate and compelling.

12/19/01