Recombinant DNA Advisory Committee- 9/12-13/94 
opinion, RAC has conducted a good job in bringing out all of the salient points of 
reviewed protocols. He agreed with Dr. Motulsky that the RAC occasionally gets bogged 
down by the informed consent issues. It was pointed out that proposals previously 
approved by the IRBs still contain serious problems that demand RAC attention. FDA 
provides more of a technical decision point in the final review process, while RAC reviews 
provide protocol evaluation within a larger context. Dr. Miller said when a good protocol 
is submitted, it goes through the RAC process very quickly. 
Dr. Varmus was concerned about review criteria by which the decisions are made, and the 
timing of RAC review vis-a-vis NIH peer review and IRB approval. 
Dr. Smith commented that management of data reporting will be expanded in the future 
since all protocols, even those that bypass RAC review, will have to report their progress 
to the RAC. He asked if there are other functions that are not performed by FDA that 
need to be addressed by the RAC. 
Dr. Straus said that from his experience of chairing both an IRB and the Institutional 
Biosafety Committee (IBC) of NIH, he realized that each committee cannot succeed by 
confining itself strictly to ethical or safety issues alone. The RAC should deal with both 
aspects of protocols. There is a place for a public debate about the nature of new 
approaches, and this aspect of public safety debate is not readily available from FDA Dr. 
Straus said that the RAC is already moving in the direction of redefining itself, and he 
does not object to the idea that the RAC would confine itself to safety issues. 
Dr. Parkman said that 80% of RAC reviewed protocols have yet to pass the NIH initial 
peer review. RAC review usually is the first scientific review outside the protocol’s 
sponsoring institution. He noticed that Pis very often are the only experts in the field of 
gene therapy in their local institutions, and they have to exclude themselves from 
reviewing their own protocols. As a matter of fact, RAC is the first place that all facets of 
a protocol are closely scrutinized, even though the protocol has been administratively 
approved by the local committees. 
Dr. Dronamraju said that scientific and ethic issues are interconnected, and he would 
favor RAC to be concerned with both type of issues. 
Ms. Meyers was concerned about deleting the Points to Consider from the NIH Guidelines, 
particularly since the RAC has just revised the informed consent portions of the 
document. RAC review of human gene transfer experiments is to assure public 
accountability and to protect patients’ rights. She has been very concerned about the 
Informed Consent documents. NIH has been sued by families of patients who died in 
recent FIAU or fialuridine hepatitis drug trials for inadequate disclosure in the Informed 
Consent documents. Ms. Meyers said that the Informed Consent document is an 
important part of the protocol, and the RAC as a public body is responsible for assuring 
patient protection. More than 50% of Informed Consent documents submitted to the 
RAC are inadequate. The AIDS community now realizes that it was a mistake to 
accelerate approval of the class of drugs known as reverse transcriptase (RT) inhibitors 
[ 22 ] 
Recombinant DNA Research, Volume 20 
