Recombinant DNA Advisory Committee - 12/3-4/92 
Dr. Murray welcomed Ms. Abbey Meyers of the National Organization of Rare 
Disorders and Dr. Harold Ginsberg of Columbia University as ad hoc consultants to the 
RAC. 
IV. DISCUSSION REGARDING COST ASSOCIATED WITH TREATMENT FOR NON- 
NEGLIGENT RESEARCH-RELATED INJURY/DR. ZALLEN AND MS. MEYERS 
Presentation-Dr. Zallen 
Dr. Murray called on Dr. Zallen to initiate discussion on the issue of costs associated 
with the treatment of non-negligent research-related injury. Dr. Zallen explained that 
the informed consent documents of many previously approved human gene therapy 
protocols include the following language, You or your insurance company are expected to 
pay the medical costs arising out of any research-related injuries. If this statement is a 
trend for future protocols, then the only patients who would be able to cover the costs 
associated with untoward research-related injuries would be those individuals who 
possess high-level medical coverage or have substantial personal financial resources. 
This trend is in direct conflict with NIH policy, namely, the inclusion of women and 
minorities in study populations. Traditionally women and minorities have had less access 
to jobs that provide health care benefits. 
Dr. Zallen noted that Dr. Charles McCarthy, formerly Director of the Office for 
Protection from Research Risks, NIH, presented a historical review during the 
September 1992 RAC meeting regarding the political factors and institutional events that 
resulted in a failure to act on either the 1977 Health, Education, and Welfare report or 
the subsequent President's commission report that recognized an obligation to 
compensate subjects for research-related injury. 
Gene therapy is a novel area in which the potential risk to patients is not entirely 
understood. As time and experience are gained, the risks will be more clearly 
understood. However, sufficient knowledge has not been gained regarding the possible 
adverse effects associated with gene transfer. If injury is incurred to patients 
participating in these protocols, it is unlikely that insurance companies will compensate 
for medical costs associated with such injury. The RAC should propose that the NIH 
Director convene a panel to examine this issue and to create policy that will guide 
Institutional Review Boards (IRBs) and the RAC in future decisions. 
Dr. Zallen and Ms. Meyers submitted a draft letter to the NIH that addressed the 
aforementioned issue, Dr. Zallen suggested that the RAC should make additions or 
changes to the letter as appropriate. 
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