In its recent report, Safeguarding Children: Pediatric Medical Countermeasure Research, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) revisited the issue of compensation for research-related injury—an issue first addressed in its December 2010 report, Moral Science: Protecting Participants in Human Subjects Research.
In Safeguarding Children, the Bioethics Commission reaffirmed the conclusion reached in Moral Science that those “harmed in the course of human subjects research ought not individually bear the costs of care required to treat qualified harms resulting directly from that research.” The Bioethics Commission noted that the principles of justice—which requires that the benefits and burdens of research be distributed equitably—and beneficence and respect for persons—which together require that ameliorable risks to participants be minimized—support compensating injured research participants.
In the context of pediatric medical countermeasure (MCM) research, the ethical case for compensation is particularly acute. Children who enroll in pediatric MCM research cannot legally or ethically provide informed consent for participation. These children could also be asked to bear greater risk than ordinarily permitted in pediatric research—although no more than a minor increase over minimal risk—for the benefit of children exposed to a potential future attack. For these reasons, children injured as a result of their participation in pediatric MCM research should receive necessary medical care and appropriate compensation for their injuries. Reviewers of pediatric MCM research have a corresponding obligation to ensure that researchers have a plan to treat or compensate those participants who are injured.
As acknowledged by the Bioethics Commission in Moral Science, there is, as yet, no overarching federal policy to ensure that all injured research participants receive treatment or compensation. There are, however, two systems that provide some compensation for research-related injuries, although they do not provide sufficient protection in the pediatric MCM context. The first system is the National Vaccine Injury Compensation Program, a national system that compensates those injured by vaccines listed in the Vaccine Injury table (available here) or that are recommended by the U.S. Centers for Disease Control and Prevention for routine administration. Most MCM vaccines are not listed in the Vaccine Injury Table, and not all MCMs are vaccines. Injured pediatric MCM research participants would therefore not be eligible for compensation under this program.
A second, and potentially more suitable, alternative is the Public Readiness and Emergency Preparedness (PREP) Act, which provides limited access to compensation for those injured as a result of receiving an MCM. The PREP Act permits those who suffer “serious physical injury or death” to recover from the “Covered Countermeasure Process Fund,” a pool of funds that comes into existence once the Secretary of HHS declares an emergency. Those who suffer minor injuries, however, or those whose injuries arise after the expiration of the PREP Act’s one year statute of limitations, will be unable to receive compensation.
Ultimately, the Bioethics Commission concluded that, in both pre- and post-event pediatric MCM research, those conducting research must ensure that there is a sufficient treatment and compensation plan in place so that the costs of any resulting harm or injury do not fall on pediatric research participants or their families.
