ATTACHMENT B 
EXCERPTS FROM THE JUNE 1, 1990, HUMAN GENE THERAPY 
SUBCOMMITTEE 
PRESENTATION AND DISCUSSION OF PROPOSED ADDITION TO APPENDIX D 
OF THE NIH GUIDELINES (HUMAN GENE THERAPY CLINICAL PROTOCOL - 
ADENOSINE DEAMINASE DEFICIENCY): 
Dr. Walters thanked Drs. Parkman, Neiman, Childress, and R. Murray for their excellent 
reviews of the protocol and thanked the investigators for their responses and for putting 
the proposal into the format of the "Points to Consider" document. He also 
acknowledged the thorough review submitted by Dr. Louise Markert who has served as 
an ad hoc consultant to the subcommittee. He asked if all members had received the 
written materials prior to the meeting. Dr. Gellert said he received his materials only 
the day before the meeting. Dr. Walters noted there was substantial material to process 
and said he hoped all members of the subcommittee had a chance to read through it. 
Dr. Walters said that the general format of the previous meeting would be followed and 
that the primary reviewer would present, followed by secondary reviewers and 
subcommittee discussion of the protocol. Then the investigators would be allowed to 
respond to questions. Dr. Walters then called on Dr. Parkman to present general 
comments relating to bone marrow transplantation and to comment on what are 
perceived as major changes in the revised protocol. Further, Dr. Walters said he and Dr. 
Parkman had discussed the question of new material being presented to the 
subcommittee at this meeting and how it would be dealt with and in what form it should 
be presented. 
Dr. Parkman said that he felt the subconunittee had already come to closure at its last 
meeting on the subject of material not made available to the subcommittee in hard copy 
prior to its meetings, and that the subcommittee had determined they would not consider 
such data. Drs. Childress and Neiman said a distinction should be drawn between new 
data and data which fleshes out or responds to issues raised by the review, which they 
felt were necessary to the understanding of the protocol by the subcommittee. 
Dr. Epstein asked about the timing of the entire process. He questioned why the 
material arrived to the members only two days before the meeting and asked Dr. Wivel 
if progress had been made on setting up a timetable for submissions in the review 
process as had been discussed at the last meeting. Dr. Wivel said he believed the 
schedule would be dictated by the restrictions under which the subcommittee operates 
and schedules can only be set according to how and when materials are received by the 
Office of Recombinant DNA Activities (ORDA). 
Dr. Anderson said that because of the many issues raised by the subcommittee, it was 
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