Recombinant DNA Advisory Committee - 06/7-8/93 
and that females not be pregnant or plan to become pregnant while participating in the 
study, an explanation of long-term follow-up, and a request for autopsy. The motion 
passed by a vote of 18 in favor, 0 opposed, and 2 abstentions. 
IX. WORKING GROUP REPORT ON SUBMISSION OF HUMAN GENE TRANSFER 
PROTOCOLS/DR. BRINCKERHOFF 
Dr. Walters called on Dr. Brinckerhoff to present the report on the Working Group on 
the Submission of Protocols. The working group consisted of Drs. Brinckerhoff, Miller, 
Krogstad, and Ms. Meyers. A telephone conference call was held on May 28, 1993. The 
working group discussed whether investigators submitting human gene transfer protocols 
for RAC review should continue to be required to submit both the clinical protocol and 
the Points to Consider as part of their submission. Due to a substantial increase in the 
number of protocols submitted for RAC review, many committee members expressed 
concern about the volume of paperwork that is required; stating that the submission 
materials have reached an unmanageable level. 
Committee motion 
A motion was made by Dr. Chase and seconded by Dr. Krogstad to endorse the 
recommendations of the Working Group on Submission of Human Gene Transfer 
Protocols and to amend the Points to Consider of the NIH Guidelines as appropriate. 
The motion passed by a vote of 22 in favor, 0 opposed, and no abstentions. The 
recommendations of the working group are as follows: 
1. The RAC should more strictly enforce the page limits for the protocol (20 pages) 
and Points to Consider (4-5 pages) as required by the Guidelines for the Submission 
and Review of Human Gene Transfer Protocols by the RAC of the Points to 
Consider. References may be made to supplemental materials. Discretion should 
be used on the part of investigators about the amount of supplemental materials 
that are included in their submissions. Materials will not be accepted if typed in a 
font that is more than 15 characters per inch. 
2. The Points to Consider should remain a free standing document because protocols 
are not always succinct. The Points to Consider assists investigators in focusing 
their answers to specific questions. The investigators should provide complete 
responses to each question and if necessary, specifically refer the reviewers to 
portions of the protocol that address certain issues more fully. 
3. The investigators should focus on following the Informed Consent Section of the 
Points to Consider. The working group will develop a guidance document for 
investigators to use in developing appropriate Informed Consent documents. 
Recombinant DNA Research, Volume 17 
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