Recombinant DNA Advisory Committee - 12/3-4/92 
Dr. Chase expressed concern regarding the revised letter because of the implication that 
gene therapy is inherently more dangerous than any other type of experiment. He 
objected to the recommendation that the NIH Director should convene a panel to 
discuss this issue. If the RAC decides that patients should receive compensation for non- 
negligent research-related injury, then they should make a specific recommendation. 
What is the necessity for creating a panel? Dr. Chase said that he does not support the 
revised letter. 
Dr. Geiduschek supported Dr. Chase's comments and suggested that the RAC 
recommend a course of action, not a panel to study the issue. However, Dr. Geiduschek 
disagreed that the letter suggests that there is an inherent danger associated with gene 
therapy, which is greater than any other experimental treatment. 
Dr. Zallen suggested the inclusion of the following sentence in the first paragraph, This 
situation occurs in most areas of medical research. Dr. Walters suggested removal of the 
paragraph that specifically recommends the formation of a panel. If the RAC wants to 
bring this matter to the attention of the NIH Director, perhaps the letter should simply 
state that the RAC has encountered this problem and is asking that the Director find a 
way to respond to the problem. 
Dr. H. Miller stated that it is the position of the FDA that the current requirements of 
the Federal regulations, namely that, ...an explanation as to whether any medical 
treatments are available if injury occurs, and if so what they consist of..., is adequate. RAC 
members who feel strongly about this issue should submit their views to the NIH 
Director outside of the RAC since the issue does not specifically involve recombinant 
DNA or gene therapy. 
Dr. Parkman said that the sentence that describes a divergence in policy is inflammatory. 
The reality is that policies have been very consistent; namely, that the compensation for 
non-negligent research is not the responsibility of the research institution. He quoted 
the following statement from the letter, If the benefit of this is to society as a whole, then 
the responsibility for payment is of the society as a whole. It is not the responsibility of the 
investigator or the institution in which they are found. He said that this statement confirms 
the necessity that compensation for non-negligent injury should be addressed as part of 
the administration's revised health care plan. The RAC should propose that the NIH 
Director recommend that it is not the right of an insurance company to deny payment to 
an individual because of the fact of non-negligent involvement in a research protocol. 
The ongoing concern is that insurance companies are going to deny payment because 
research is involved. Compensation should be applicable to research that has been 
approved by any legally constituted IRB, not just NIH funded research. 
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Recombinant DNA Research, Volume 16 
