Recombinant DMA Advisory Committee - 3/3-4/94 
deliberated whether these exceptions should be specified or determined on a case-by- 
case basis when protocols are submitted for review. Dr. Parkman said that it is 
impossible to list all acceptable cDNA inserts for this category; therefore, the definition 
should be limited to RAC-approved vector constructs and RAC-approved vector 
constructs with minor modifications. Dr. Carmen expressed his support for this 
definition. Dr. Parkman suggested that RAC-approved protocols involving modification 
of the tumor type should qualify as a Minor Action; however, the issue of risk is always a 
consideration. Dr. Wivel assured the RAC that risk would be considered on a case-by- 
case basis at the time of submission. 
Committee Motion 1 - Proposed Categories 
A motion was made by Dr. Carmen and seconded by Dr. Dronamraju to modify the 
lethally irradiated tumor cell category as follows: lethally irradiated tumor cells/no 
replication-competent virus, RAC-approved vector constructs with minor 
modifications/additional tumor cells. The motion to accept this modification passed by a 
vote of 13 in favor, 0 opposed, and no abstentions. 
Committee Motion 2 - Proposed Categories 
A motion was made by Dr. Post and seconded by Dr. Straus to approve the following 
categories of Minor Actions: (1) non-exempt vaccines, (2) new site/original Principal 
Investigator, (3) new site/new Principal Investigator, (4) "umbrella" protocols, and (5) 
modifications not related to gene transfer. The motion passed by a vote of 13 in favor, 0 
opposed, and no abstentions. 
Dr. Merchant asked the RAC to consider Phase 11 and Phase III trials for consideration 
as Minor Actions. Dr. Straus stated that the RAC has considered very few Phase II gene 
transfer studies; therefore, it is premature to include such experiments as Minor Actions. 
Ms. Grossman and Dr. Parkman agreed with Dr. Straus' statement. 
Committee Motion 3 - Proposed Categories 
A motion was made by Dr. Smith and seconded by Dr. Post to amend the proposed 
categories of Minor Actions to include gene marking protocols involving RAC-approved 
vector constructs or RAC-approved vector constructs with minor modifications and/or 
additional target cells. The motion passed by a vote of 13 in favor, 0 opposed, and no 
abstentions. 
Summary 
The Proposed Categories for Minor Actions to the NIH Guidelines Involving Human 
Subjects, as approved by the RAC, reads as follows: (1) Vaccines -- Recombinant DNA 
vaccines not covered by Footnote 21, (2) Lethally irradiated tumor cells/no replication- 
competent virus - RAC-approved vector constructs with minor modifications/additional 
tumor cells, (3) New site/original Principal Investigator - RAC-approved protocol 
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