Recombinant DNA Advisory Committee - 6/9-10/94 
between these genes. Dr. Miller expressed his dissatisfaction with the Southern blot data 
provided in response to his concerns about vector rearrangement. Drs. Saha and Post 
suggested that additional data should be requested as a stipulation for approval. Dr. 
Miller stressed that the vector construct to be administered to the patients should be 
adequately characterized. There were several statements that failure of the investigators 
to comply with the RAC timetable for submission of data made the approval 
questionable. Dr. Parkman suggested that the NIH Guidelines should be amended such 
that data submitted less than 2 weeks before the meeting at which the protocol will be 
reviewed should not be permitted. Ms. Wilson explained that such a provision is 
included in Appendix M-III-B-3 of the NIH Guidelines. Several RAC members stated 
that it is RACs obligation to proceed with the review of the late data. The consensus of 
the RAC was that the protocol should be reviewed since it was on the table. 
Committee Motion 
The RAC approved a motion made by Dr. Post and seconded by Dr. Motulsky to 
approve the protocol submitted by Dr. Michael Lotze of the University of Pittsburgh, 
Pittsburgh, Pennsylvania, by a vote of 10 in favor, 0 opposed, and 3 abstentions. 
Approval of the protocol is contingent on the review and approval of the following by 
Drs. Miller and Parkman: (1) complete vector sequence, including a detailed restriction 
enzyme digestion map relevant to the vector backbone; and (2) Southern blot analysis of 
cells transduced with the vector constructs with and without the gene inserts, 
demonstrating concordance with the restriction enzyme analysis and sequence data. 
XVIII. CONTINUED DISCUSSION OF THE AMENDMENT TO PART I-D, INFORMED 
CONSENT, OF THE POINTS TO CONSIDER OF THE NIH GUIDELINES 
ZALLEN 
Dr. Walters stated that the RACs previous comments and suggestions on the draft 
revision of Part I-D, Informed Consent, of the NIH Guidelines, have been incorporated 
into a revised document. Under the section on Reproductive Considerations, the 
statement about pregnant and lactating women has been moved from last to the first 
sentence. Dr. Motulsky suggested that this section be revised to include male 
contraception. Dr. Smith suggested that the first sentence should become the last 
sentence for clarity. Dr. Smith suggested that Section I-D-2-a-(5) should be revised to 
clarify the use of descriptors. The consensus of the RAC was that the revised language 
will read: 
"If verbal descriptors (e.g., rare, uncommon, or frequent) are used to express 
quantitative information regarding risk, these terms should be explained." 
Committee Motion 
The RAC approved a motion made by Dr. Parkman and seconded by Dr. Miller to 
accept minor editorial changes to Part I-D, Informed Consent, by a vote of 13 in favor, 0 
opposed, and no abstentions. 
[362] 
Recombinant DNA Research, Volume 19 
