Recombinant DNA Advisory Oammittcc - 
D. LOCAL COMMITTEE APPROVALS 
1. Has the proposed study been unconditionally approved by your Institutional Biosafety Committee? If so, 
provide a copy of the approval. 
2. Has the projxjsed study been unconditionally approved by your Institutional Review Board? If so, provide a 
copy of the approval. 
E. INFORMED CONSENT DOCUMENT 
1. Provide a copy of the IRJB-approved Informed Consent document, consistent with the Points to Consider. 
and underline the text addressing the following specific items: 
NOTE: If any of these items are not addressed in the Informed Consent document, provide an explanation as to the 
reason for their omission. 
a. Any requirement for use of birth-control by male and female participants during the course of the 
experiment; 
b. Financial costs for which the individual research subject will be responsible; 
c. Need for long-term follow-up and the arrangements for such follow-up; 
d. Statement indicating that a request for permission to perform an autopsy will be made of the 
family, regardless of the immediate cause of death; 
e. Arrangements in place at the research institution for sharing information with the new media and 
the public, 
f. Provisions for protecting patient privacy and the confidentiality of data obtained from individual 
participants in the research. 
F. ADDITIONAL INFORMATION 
1. Provide curricula vitae (2 page Biosketch format) for principal investigators and key personnel. 
2. Provide relevant publications only. 
XIX. CLOSING REMARKS 
Dr. Walters sisked the RAC members if there were any outstanding issues that should be 
addressed prior to adjournment of this meeting. Dr. Hirano questioned the time-frame 
from publication of an incorporated version of the NIH Guidelines. Dr. Wivel responded 
that such document is in final format and is awaiting completion of the pending 
environmental assessment for Appendices P and Q. 
Dr. Motulsky said that the RAC has extensively discussed the informed consent issues 
related to gene therapy. These are very important issues in clinical medical research. If 
the conclusion of this discussion is published in a research journal, it will benefit 
investigators in other areas of clinical research and will save the RAC a great deal of 
time without having to revisit the same issue in deliberation of each protocol. 
Recombinant DNA Research, Volume 19 
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