Recombinant DNA Advisory Committee - 09/14-15/92 
PATIENTS/DR. MCCARTHY 
Dr. Wivel said that recently the RAC has had numerous discussions regarding the limits 
of liability on the part of sponsoring institutions that support human gene therapy 
protocols. Many of the issues that have been raised are generic to all clinical research, 
focusing of the phraseology of informed consent documents. In light of these discussions, 
Dr. Charles McCarthy, former Director of the Office of Protection from Research Risk, 
NIH, was asked to provide background information regarding the Code of Federal 
Regulations and the process of liability with regard to clinical research. 
Presentation-Dr. McCarthy 
Dr. McCarthy explained that much of the RAC's concern with regard to gene therapy is 
about injury that may occur to research subjects, not as a result of negligence, but as the 
result of unforeseen consequences of the research. In the history of clinical research to 
date, there have been virtually no cases of this kind although there have been several 
lawsuits relating to negligence. 
Dr. McCarthy said that due to concerns about this issue, the Secretary's Task Force on 
Compensation of Injured Research Subjects was established as an advisory body to the 
Secretary of the Department of Health and Human Services (DHHS) for several years. 
The conclusion of the Task Force was that there is an obligation to provide 
compensation for subjects injured in the course of research where the injury itself is not 
related to the disease or condition from which the subject is suffering. Under Secretary 
Califano, legislation was proposed whereby injured subjects would be compensated under 
the Worker's Compensation Act. Individuals injured as a result of Federally funded 
research would be considered Federal employees for the purposes of compensation. 
However, the same week that the legislation was to be signed, Secretary Califano was 
fired. The proposed legislation was never signed. This issue was then taken up by the 
Ethics Advisory Board which also disbanded before a recommendation was developed. 
Next, the issue was passed to the President's Commission for the Study of Ethical 
Problems in Medicine and Biomedical and Behavioral Research. The Commission was 
also of the opinion that there is an ethical obligation to compensate injured research 
subjects. Nevertheless, the obligation was viewed as a consideration, not an absolute 
obligation. The Commission recommended that NIH should conduct a study to 
determine the cost of such a program. The NIH committee found that because the 
incidence of research related injury not attributable to negligence was so low, it was not 
possible to obtain data regarding the proposed cost of a nationwide program in a 
reasonable period of time. Therefore, the statistics on this issue are largely lacking. The 
prevailing opinion of experts today is that injuries can and do occur on rare occasions 
where the injury is not the result of direct negligence, but rather of unforeseen 
consequences of the research. Since it is not likely that DHHS will develop a program 
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Recombinant DNA Research, Volume 16 
