Recombinant DNA Advisory Committee - 3/3-4/94 
RAC that suggested revisions to Dr. Richard Haubrich's Informed Consent document 
(Protocol #9312-062) were incorporated and approved by the IRB of the University of 
California at San Diego. 
No response was received to a December 9, 1993, letter to the IRB of the University of 
Iowa College of Medicine, Iowa City, Iowa, regarding suggested revisions to Dr. Michael 
Welsh's Informed Consent document (Protocol #9312-067). 
At the request of the NIH Office for the Protection from Research Risk, Dr. Walters 
will address the Federal Coordinating Council for Science, Engineering and Technology, 
Human Subjects Review Committee regarding the issue of provision of medical care to 
patients injured in the course of their participation in biomedical research and 
compensation for research related injury. Dr. Walters noted that in 1976 the University 
of Washington, Seattle, Washington, adopted a self-insurance program for normal 
volunteers who participate in "non-clinical research." Dr. Parlman inquired whether a 
Phase I study would be encompassed as "non-clinical research." Dr. Walters responded 
that subjects injured in a Phase I study would not be covered. There have been a total 
of 21 claims since 1976 with the largest claim being $6,000. Dr. Walters said that in the 
United Kingdom, compensation for research related injuries is not a problem since most 
of the costs are covered by the National Health System. Dr. Walters will provide an 
update on this issue at the next RAC meeting. 
Dr. Parkman remarked that the compensation issue should be addressed in terms of all 
clinical research not just for human gene therapy. Dr. Wivel added that inclusion of the 
language in the proposed health care reform benefits package will be followed up 
through the NIH Office of Legislative Policy Analysis. Dr. Motulsky said that a bipolar 
system might evolve since the industry sponsored research is more likely to provide the 
coverage for medical costs of research injuries than research sponsored by the 
universities. Dr. Walters said that he has noticed a similar trend in the United Kingdom. 
II. RAC WORKING GROUP REPORT - DATA MANAGEMENT/DR SMITH 
Dr. Brian Smith, Chair of the RAC Working Group on Data Management, provided a 
summary of the responses that were submitted by Principal Investigators in response to 
ORDA's December 27, 1993, request for additional information. He noted that 
subsequent information provided by the Principal Investigators adequately addressed the 
concerns of the RAC. However, Dr. Smith noticed a few problems in the data reporting. 
In his written comments, Dr. Deisseroth (Protocol #9105-007) questioned the RAC's 
classification of failure to engraft following bone marrow transplant as an adverse effect. 
Dr. Smith said that failure to engraft should be considered an adverse effect if the 
frequency of occurrence is not within the statistical range of the expected outcome. Dr. 
Smith asked whether the RAC has approved the change of vector in Dr. Rosenberg's 
study (Protocol #9007-003). 
Dr. Smith said that responses were not received from either Dr. Cornetta (Protocol 
#9202-014) or Drs. Galpin and Casciato (Protocol #9306-048). Dr. Parkman said that 
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Recombinant DNA Research, Volume 19 
