Recombinant DMA Advisory Committee - 6/9-10/94 
The Council for International Organization of Medical Sciences, Geneva, Switzerland, 
has published the International Ethical Guidelines for Biomedical Research Involving 
Human Subjects. These guidelines specify therapies that are provided free of charge for 
specific research-related injuries, and asserts the right of subjects to compensation in the 
event of disability or death. 
On February 24, 1990, the U.S. Department of Defense (Army) issued regulations on the 
Use of Volunteers as Subjects of Research. According to these regulations, subjects who 
receive research-related injuries while in uniform receive compensation comparable to 
subjects who have been injured in combat. Civilian employees are covered under 
Worker's Compensation. Medical insurance and direct costs for contracting personnel 
are provided as part of the contract cost negotiated between the U.S. Department of 
Defense (Army) and the contractor. 
Documents are included from the Royal College of Physicians and the Association of the 
British Pharmaceutical Industry that detail Great Britain’s National Health System in 
which all medical costs are covered for subjects injured during the course of their 
participation in research. 
Dr. Zallen inquired about the current status of legislation relating to U.S. Health Care 
Reform and coverage for research-related injuries. Dr. Wivel explained that there are 
several health care proposals pending consideration at different Congressional 
committees and that specific language regarding compensation for research-related 
injuries has not been finalized in the legislation. 
Temin Letter Regarding Potential for Recombination of Retroviral Vectors 
Dr. Walters noted a letter dated December 2, 1993, from Dr. Howard M. Temin 
requesting that the RAC consider a specific safety issue regarding the potential for 
recombination of retroviral vectors. TTie letter states: 
"I would like you to consider the following safety point relative to retrovirus 
vectors. Recombination, which could form replication-competent virus by 
recombination between the vector and packaging cell RNAs, only takes place 
upon infection of sensitive cells. Thus, even if there is no replication-competent 
virus in a vector inoculum, replication-competent virus could be formed upon 
infection. Does the testing now used for vector preparations used in patients 
adequately test for this possibility?" 
Included in the meeting materials were comments by RAC members and representatives 
of industry responding to Dr. Temin's letter. Since this item was not included in the 
meeting agenda announced in the Federal Renter, the discussion remained informal. Dr. 
Walters suggested that a working group should be established prior to the next RAC 
meeting to determine the RACs plan of action with regard to this issue and invited 
suggestions for ad hoc consultants who could provide their expert comments on this 
issue. 
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Recombinant DNA Research, Volume 19 
