Recombinant DMA Advisory Committee - 3/3-4/94 
Dr. Parkman introduced the checklist to be submitted by the Principal Investigators with 
their protocols for Accelerated Review. The purpose of the checklist is to have the 
Principal Investigators answer the pertinent questions in order to aid the ORDA staff in 
determining eligibility for Accelerated Review. The checklist is very similar to the one 
approved for the single-patient Expedited Review except for item B-11. Item B-11 asks 
the question whether the vector has been reviewed and approved for clinical 
investigation by the Food and Drug Administration. It is certain that the vector will be 
available for single-patient expedited trial, and the question is not relevant for the 
present Accelerated Review. Dr. Parkman suggested the deletion of this item from the 
proposed check list. 
Ms. Grossman asked to clarify item C-4 on the question of whether the proposed study is 
similar to another RAC-approved protocol. The Principal Investigator needs to identify 
the major differences in the checklist. 
Dr. Secundy asked for clarification of item E dealing with the Informed Consent 
document. Dr. Parkman explained that these listed elements for Informed Consent are 
frequently overlooked by the Principal Investigators, and the listing is to assure that the 
Principal Investigators have included these elements. Dr. Parkman said that submission 
for Accelerated Review should be a complete document similar to that required for 
regular review including an IRB-approved Informed Consent document. Points to 
Consider, etc. Drs. Straus and Zallen agreed with Dr. Parkman that a listing of required 
Informed Consent elements will aid the ORDA staff in determining whether all 
important questions have been addressed by the Principal Investigators in their Informed 
Consent. Dr. Secundy noted that the language should be clarified to indicate that these 
elements are essential but not the only required elements for the Informed Consent 
document. Dr. Straus said that these additional elements are already incorporated into 
the revised Points to Consider. Dr. Parkman explained that the purpose of highlighting 
these elements is to aid ORDA staff in determining whether they are addressed by the 
Principal Investigators. Dr. Straus suggested language to ask Principal Investigators to 
provide a copy of the IRB-approved Informed Consent document, consistent with the 
Points to Consider, and to underline the text addressing the listed specific items. Dr. 
2Lallen remarked that there are circumstances in which a particular element is not 
appropriate for inclusion in a particular Informed Consent document. She cited an 
example where the Principal Investigators might avoid mentioning an autopsy in the 
Informed Consent document to be prepared for children. Dr. Zallen said that if a 
particular item is not addressed in the Informed Consent document, the Principal 
Investigators should provide an explanation as to the reason for its omission. 
The RAC approved a motion made by Dr. Parkman and seconded by Dr. Secundy to 
accept the proposed cover sheet with the incorporation of minor modifications by a vote 
of 13 in favor, 0 opposed, and no abstentions. The current document will be divided into 
2 separate documents: (1) Accelerated Review cover sheet, and the (2) Cover Sheet for 
Expedited Review of a Single Patient Human Gene Transfer Experiment (Expedited Review). 
The difference between these two documents is that the Expedited Review cover sheet 
will include the following addition questions: "Has the vector been reviewed and 
Recombinant DNA Research, Volume 19 
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