PerspectivesAre you interested in submitting a Perspective Article? Be sure to read The Science Advisory Board's Editorial Guides for Perspective Articles. Click here. Reducing the Incidence and Impact of Clinical Trial Litigation by Katrina A. Bramstedt, Ph.D.  The past five years has seen an upsurge in clinical trial litigation in the United States. Reasons for this include the fact that investigators have a history of poor compliance with the Code of Federal Regulations, widespread public knowledge of problems in clinical trials (e.g., Tuskegee, Gelsinger, AbioCor), greater media exposure of the field of bioethics, increasing and more significant relationships between industry sponsors and clinical investigators, overburdened Institutional Review Boards (IRB), and the fact that trials are getting more risky due to increasingly complex technology (e.g., gene therapy, artificial organs). In addition to clinical investigators being named as defendents, IRB members and consulting bioethicists, are also being sued.As evidenced by the volume of legal services advertising, the practice of contingency-based attorney fees, and the number of lawsuits filed, the US is a litigious society. Even if the number of lawsuits filed cannot be reduced, there may indeed be ways to weaken the legitimacy of the allegations by frontloading the clinical trial process with integrity and research subject protections. To this end, a role emerges for Research Subject Advocates (RSA). Currently, the National Institutes of Health (NIH) funds the salary of approximately 140 RSAs across the US. Other RSAs are funded by their hospital/research center employer, or the study sponsor (the later is most poised for allegations of conflict of interest). These RSAs, usually MD or PhD educated, have training in research ethics, compliance, and regulatory affairs and assist clinical investigators with the design and conduct of clinical trials, monitor adverse events and conflict of interest, draft consent forms, and witness the consent process. Additionally, an RSA serves as a go-to person for research subjects when subjects have questions or concerns about the study, their safety and welfare, or their rights as volunteers in the research process. Another key part of the RSA role is education. RSAs teach research ethics to clinical investigators and the research team. In addition to routine seminars, they arrange Grand Rounds sessions in which prominent leaders in the field present novel information on the conduct of clinical trials, new or proposed regulations, techniques to enhance the protection of research subjects, tools to improve the quality of informed consent, etc. The time is ripe for widespread use of RSAs in the practice of clinical research. IRBs are overworked, understaffed, and generally lack training in the field of research ethics. Additionally, with nearly 44 million Americans lacking health insurance, many of these seek out clinical trials as a form of health care, thus fueling the notion of therapeutic misconception. Research subjects (and clinical investigators) must be reminded that clinical research is not medical therapy, and that the goal of research is to gain scientific knowledge that will be generalizable so as to help future patients (not the research subject him/herself). The integrity of the clinical research profession is at stake each time litigation occurs. If society’s perception of research is negative, this can potentially affect future research funding and the development of medical breakthroughs for future patients. The safety and welfare of research subjects needs to be protected, and the integrity of the research process needs to be ensured. Enter the RSA. ### Katrina A. Bramstedt, PhD Director, Research Subject Advocacy Program Associate Staff, Department of Bioethics Cleveland Clinic Foundation (Cleveland, OH) Dr. Bramstedt has been a member of The Science Advisory Board since November 1997 and currently is serving on the Board's steering committee for 2003-2004. ### << Previous Next >> [ View All Perspectives ] |
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