Recombinant DMA Advisory Committee - 6/9-10/94 
1. CALL TO ORDER/DR, WALTERS 
Dr. Walters (Chair) called the meeting to order and stated that notice of the meeting 
was published in the Federal Register on April 22, 1994 (59 FR 19200), and the proposed 
actions were published in the Federal Register on May 11, 1994 (59 FR 24618), as 
required by the NIH Guidelines for Research Involving Recombinant DMA Molecules (NIH 
Guidelines). He noted that a quorum was present and outlined the order in which 
speakers would be recognized. The primary and secondary reviewers will present their 
comments regarding the proposal, followed by responses from the principal investigators 
(Pis). The Chair will then recognize other committee members, ad hoc consultants, 
other NIH and Federal employees, the public who have submitted written statements 
prior to the meeting, and followed by the public at large. 
New Members 
Dr. Walters said that three new RAC members will participate in this meeting: (1) Gail 
S. Ross, Ph.D., Research Director, High-risk Infant Follow-up Program, New York 
Hospital, Perinatology Center, Cornell University, New York, New York; (2) Bratin K. 
Saha, Ph.D., Assistant Professor, Department of Pathology, Winship Cancer Center, 
Emory University, Atlanta, Georgia; and (3) David Ginsburg, M.D., Professor, 
Department of Internal Medicine and Human Genetics, Howard Hughes Medical 
Institute, University of Michigan, Ann Arbor, MichigaiL 
Overview 
Dr. Walters noted that 10 human gene transfer protocols will be reviewed at this 
meeting, 8 gene therapy protocols (6 cancer, 1 rheumatoid arthritis, and 1 Fanconi 
anemia) and 2 gene marking studies (1 autologous bone marrow marking and 1 tumor 
infiltrating lymphocyte marking). 
Discussion-Compensation for Research-Related Injuries 
Dr. Walters summarized the meeting material regarding compensation for research- 
related injuries that was provided as a supplement to the RACs previous discussions 
regarding provision of medical care to subjects who may be injured during the course of 
their participation in research. 
Robert Levine's book entitled. Ethics and Regulation of Clinical Research, includes a 
discussion of the Yale University program on compensation for research-related injuries. 
The University of Washington has a self-insured Human Subjects Compensation plan for 
research protocols that are not beneficial or therapeutic. Since 1979, the University of 
Washington plan has received 21 requests for payment resulting in a total outlay of 
$4,110.70. lie most costly incident involved an elderly subject who broke her leg while 
participating in a fall prevention study. The injured subject required treatment costing 
$1,639.04. Most other requests averaged less than $600. 
Recombinant DNA Research, Volume 19 
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