Recombinant DNA Advisory Committee - 12/3-4/92 
Dr. Carmen stated that he is in support of the letter; however, the deletion of the phrase 
NIH funding is inappropriate. The NIH Director speaks only for NIH, which has certain 
funding obligations. The RAC is an NIH committee. He proposed the following 
substitute language, ...but all types of research carried out at institutions receiving NIH 
support. Mr. Barton accepted Dr. Carmen's revision as a friendly amendment. The 
letter reads as follows: 
In reviewing protocols for human gene therapy, we as RAC members have 
become increasingly concerned about the divergence in policy among various 
research institutions on the issue of providing medical care to subjects who may 
suffer injury in the course of their participation in research. This situation occurs 
in most areas of medical research. In some cases, the institution promises to 
cover the costs of immediate care but hedges on long-term care arrangements. In 
other cases, the costs of medical care for such injuries are, according to the 
consent forms, to be paid by the subjects themselves, or by their insurance 
companies if the subjects are insured and the insurance companies will pay. 
In any area of biomedical research, the consequences of the research for subjects 
are not fully known. In our view, it is unfair to expect individuals, their families, 
or their insurers to absorb unpredictable and potentially substantial medical costs 
arising out of these individuals' participation as research subjects. 
We as RAC members, have reviewed this matter at considerable length. On the 
basis of our deliberations, we recommend that you create a panel to study the 
question of how the medical costs of research-related non-negligent injuries 
should be covered. Such a panel should make policy recommendations that would 
apply, not only to gene therapy research, but to all types of research involving 
human subjects. We believe that a uniform policy on this question would be 
welcomed by investigators, who are concerned about the welfare of the patients 
whom they invite to participate in research, as well as by the research subjects 
themselves. 
A motion to call the question was made by Dr. Secundy and seconded. The motion to 
call the question passed by a vote of 9 in favor, 0 opposed, and 2 abstentions. 
The motion to approve the letter with the aforementioned changes was approved by a 
vote of 9 in favor, 4 opposed, and no abstentions. 
XIII. AMENDMENT TO THE POINTS TO CONSIDER REGARDING SAFETY OF 
DELIVERY/EXPRESSION SYSTEMS AND REPORT OF MURINE REPLICATION- 
COMPETENT RETROVIRUS (RCR) ASSAYS (CONTINUED) 
[592] 
Recombinant DNA Research, Volume 16 
