(Philadelphia, PA) -- Regulations governing the use of human subjects in biomedical research in the United States must be updated to keep pace with rapid changes in the medical practice to which they are meant to apply, recommend bioethicists at the University of Pennsylvania Health System. They suggest that, even though current practices have worked well for the past two or three decades, the pace of research today is outdistancing the present system. The team's recommendations, which will appear in today's Journal of the American Medical Association (JAMA), also include specific key guidelines based on research done by the Project on Informed Consent of the Human Research Ethics Group at Penn's Center for Bioethics. "Change is essential if the same level of protection is to be afforded human subjects who participate in research in the future," notes co-author Paul Root Wolpe, PhD.
The model of research for which existing regulations were designed evolved around a single investigator funded by the National Institutes of Health or other governmental sources, using subjects at a single location. Today's research, however, often involves private funding at multiple institutions by many investigators. "One of the most important recommendations made by the Human Research Ethics Group," states Arthur L. Caplan, PhD, director of Penn's Center for Bioethics and a co-author of the study, "is the extension of any existing and future protections for human research in the United States -- regardless of whether they are publicly or privately funded, or whether the research is aimed at producing commercial products."
Moreover, in recent years, some members of vulnerable groups, including those with mental illnesses, soldiers, institutionalized children, and pregnant women have been subjected to abuse or misconduct in the research setting. "These problems also reveal the need to revisit the policies in place for the protection of human subjects," states Wolpe.
Penn's Human Research Ethics Group took a comprehensive look at the system rather than examining it from the standpoint of individual populations of potential research subjects. They put forth many recommendations as to how to best update and revamp existing protections for human subjects. Changes to the current system suggested by the Group include: protecting the rights of the mentally ill through durable power of attorney and advance directives; tighter monitoring of studies involving persons with cognitive impairment; creating clearer and more specific consent forms for cases where there is no expected benefit from participation for subjects; and fortification of local peer review boards. In addition, it is recommended that Institutional Review Boards (IRBs) should be directly informed of all potential conflicts of interest that exist for investigators and institutions.
The study was also co-authored by Jonathan D. Moreno, PhD, of the Center for Biomedical Ethics, University of Virginia.
Editor's note: Drs. Wolpe and Caplan may be reached directly by calling 215-898-7136.
Journal
JAMA