Recombinant DNA Advisory Committee - 09/9-10/93 
I-A. CALL TO ORDER 
Dr. Walters (Chair) called the meeting to order and stated that notice of the meeting 
was published in the Federal Register on August 18, 1993 (58 FR 44098), as required by 
the National Institutes of Health Guidelines for Research Involving Recombinant DNA 
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 protocol, 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, followed by the public at large. 
I-B. UPDATE ON THE LETTER SENT TO THE NIH DIRECTOR REGARDING 
COMPENSATION FOR RESEARCH-RELATED INJURIES/DR, WALTERS 
Dr. Walters summarized the events surrounding the RACs recommendations to the NIH 
Director regarding the provision of medical care to subjects who may be injured in the 
course of their participation in clinical research. Dr. Walters explained that at the time 
of the June 7-8 RAC meeting, he had not received a response to his letter sent to 
Bemadine Healy, former NIH Director on January 6, 1993; therefore, the committee 
recommended that a follow-up letter should be sent to the NIH Director regarding this 
issue. 
Dr. Walters described the correspondence that had been received since the June 7-8 
meeting: (1) a letter from Dr. Bemadine Healy dated June 3, and (2) a letter from the 
Acting NIH Director, Dr. Ruth Kirschstein, dated August 6. Dr. Healy's letter stated the 
following: 
"I understand the RACs present interest in seeing greater policy consistency 
among research institutions in this area, but I do not believe we can achieve a 
more uniform approach without also addressing the central issues involved in an 
expanded Federal role. Consequently, before another panel is formed to study 
this issue anew, I believe it is necessary to establish that the need in this area is 
greater today than 10 years ago. Have the frequency and incidence of non- 
negligent injuries increased? Is the number of research subjects who are not 
being treated or compensated on the rise? Are research subjects more concerned 
about and reluctant to participate in research today? 
"Further review of the compensation question will be included in the 
responsibilities of the NIH Science Policy Studies Center. Recently established to 
enhance NIH's capacity to identify and analyze the social, legal, ethical, and 
economic implications of biomedical and behavioral research, the Center is 
planning a priority setting conference in the fall to establish criteria for addressing 
pending and emerging issues. This broad assessment of current issues may give 
the NIH a better understanding of the compensation issue's relative pervasiveness 
and importance. By the end of the year, we may also have a clearer picture of 
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Recombinant DNA Research, Volume 18 
