Recombinant DNA Advisory Committee - 12/2-3/93 
for the protection of human subjects and oversees approximately 1,000 IRBs in the 
United States. OPRR discharges its responsibility through a process of assurance 
negotiation. For large institutions, multiple project assurances are franchised by OPRR. 
Each institution is responsible for the review of all Informed Consent documents and 
oversight of the consent process. For smaller institutions, the local IRBs work in tandem 
with the OPRR through single project assurances. The only Informed Consent 
documents routinely reviewed by OPRR are those from small institutions. 
Dr. Ellis said that a very important component of the oversight system is vesting the IRB 
with the authority for oversight of the Informed Consent process at the local level since 
the IRB is in the best position to reflect the local and state laws, institutional policies 
and responsibilities, and diversities in patient population. OPRR provides informal 
guidance through periodic contact with the institution, informational conferences, and 
through the newsletter, OPRR Reports. 
OPRR assures compliance through a formal mechanism. The Federal regulations 
include eight elements that must be considered when drafting an Informed Consent 
document. The RAC can forward recommendations (e.g., specific to gene transfer) to 
OPRR for inclusion in Informed Consent documents. If endorsed by OPRR, the 
recommendation would be transmitted to the local IRBs through OPRR Reports. Dr. 
Ellis suggested the RAC could amend the Points to Consider in the Design and 
Submission of Protocols for the Transfer of Recombinant DNA into the Genome of Human 
Subjects ( Points to Consider) to include pertinent issues that need to be addressed in the 
Informed Consent document and would work in tandem with the IRBs to educate 
investigators with regard to the preparation of Informed Consent documents for human 
gene transfer protocols. 
Ms. Meyers asked who has the final authority over Informed Consent documents, the 
RAC or the IRB. Dr. Ellis explained that while the IRB has purview over these 
documents, the RAC is in a position to recommend necessary changes. Dr. Zallen asked 
if the NIH Director has the authority to overrule the local IRB. Dr. Ellis said that the 
Director has ultimate authority over NIH research grant awards. Since the NIH Director 
can withdraw grant monies, IRB's tend to comply with NIH regulations and 
recommendations so their funds will not be jeopardized. 
Dr. Parkman said that Dr. Ellis has suggested a very clear two-prong approach with 
regard to Informed Consent documents; therefore, the working group should now be 
charged with developing suggested language for recommendation to OPRR and the Points 
to Consider document. 
A lengthy discussion ensued about compensation for costs associated with research- 
related injuries, an issue that frequently remains unresolved between the RAC and local 
IRBs. Dr. Ellis agreed that there are serious ethical considerations if patients were 
required to pay for such costs; however, these issues are beyond the scope of OPRR. 
The issue of compensation for research-related injury has previously been addressed by 
the RAC and has been brought to the attention of the Health Care Reform Task Force 
[540] 
Recombinant DNA Research, Volume 18 
