fnn f r»t/ 
XXVI. 
XXVII. 
Recombinant DNA Advisory Committee - 06/7-8/93 
production of viral materials and allow for the inexpensive disposal of vaccinated 
animals. If these vectors are reclassified for use at BL1, there would be substantial 
commercial benefit. Dr. Post suggested one possible problem associated with the use of 
NYVAC (the vaccinia-derived vector) in patients with eczema. Such a vector may cause 
disseminated disease in these individuals. Dr. Paoletti said that in immune compromised 
animal models, no evidence of disseminated infection has been observed. The vector 
will probably be administered by subcutaneous or intramuscular routes as opposed to 
dermal scarification for the parental vaccinia virus. 
Committee Motion 
A motion was made by Dr. Straus and seconded by Dr. Carmen to approve the request. 
The motion was passed by a vote of 15 in favor, 0 opposed, and 1 abstention. 
REPORT FROM THE WORKING GROUP ON EXEMPT REVIEW OF HUMAN GENE 
TRANSFER PROTOCOLS/DR. PARKMAN 
Dr. Parkman submitted a draft document entitled: Cover Sheet for Exempt Review of 
Human Gene Marking Protocols. The RAC submitted several changes to the proposed 
document which might be used for the decentralized review of human gene transfer 
protocols that are identical to studies previously reviewed and approved by the RAC. 
The working group will continue to refine the draft document for discussion at the next 
RAC meeting. 
A DRAFT LETTER TO THE NIH DIRECTOR REGARDING COMPENSATION FOR 
RESEARCH-RELATED INJURIES 
Dr. Walters resumed discussion on a letter circulated earlier by Dr. Parkman regarding 
the issue of compensation for research-related injuries. This letter would be forwarded 
to the NIH Director as a follow-up to the January 6 letter. 
Dr. Parkman suggested that compensation be incorporated in the forthcoming President's 
health care reform proposal. The following statement was approved by the RAC as 
follows: 
"The sense of the Recombinant DNA Advisory Committee (RAC) is that the 
present discussions about national health care reform provide an opportunity for 
the NIH Director to address the issues relating to providing health care for 
patients who are injured as a result of participating in clinical research approved 
by NIH-mandated IRBs. A report of the President's Commission for the Study of 
Ethical Problems in Medicine and Biomedical and Behavioral Research, 
Compensating for Research Injuries (1982), demonstrated that other nations which 
[594] Recombinant DNA Research, Volume 17 
