Recombinant DMA Advisory Committee - 3/3-4/94 
Dr. Walters said that it is not feasible to do detailed editing around the table about the 
revision, and he suggested focusing on the specific amendments contained in the Part I- 
D-2 regarding the Informed Consent document for the present discussion. Dr. Parkman 
said that Part I-D-2-b-(9), Explanation to Participants of the Specific Requirements of Gene 
Transfer Research, furnishes the Principal Investigators specific information on how the 
participants should be informed. If specific language for each required element is not 
written, the investigators may not satisfactorily address these elements in their Informed 
Consent document. Dr. Zallen said that these specific languages can be provided by the 
ORDA on a list apart from the Points to Consider. Dr. Parkman suggested that 
questions in Part I-D-2-b-(9) should be prefaced with an explanation as to the necessity 
for the requested information. 
Dr. Straus said that Part I-D-2-b-(3) regarding possible risk, discomfort, and side effects 
should be written more explicitly to inform patients about risks in gene transfer studies. 
Dr. Straus will provide a sentence for this section. Dr. Secundy suggested inclusion of a 
statement to require the Informed Consent document should be written in a language 
understandable to laypersons. Dr. Walters suggested to condense Part I-D-1 through I- 
D-l-a-(2), and to rearrange sections dealing with patient selection, privacy and 
confidentiality, and special issues. Drs. Zallen and Secundy said that questions contained 
in these sections are designed to ensure that no conflict of interest or coercion is 
involved in the informed consent process. Dr. Walters suggested to revise the Part I-D- 
1-a on communication of the study with potential participants in a procedural manner. 
Dr. DeLeon suggested to preface those questions in terms of why the questions were 
asked. 
The RAC recommended that the working group should develop a consolidated version 
of Part I-D, particularly Part I-D-2-b-(9), Explanation to Participants of the Specific 
Requirements of Gene Transfer Research, which includes language from both proposed 
documents. The RAC suggested that questions should be prefaced with an explanation 
as to the necessity for the requested information. Dr. Walters stated that since a broad 
consensus have been made on how to revise the informed consent section in Part I-D, 
the working group will be able to use these recommendations and submit a revised 
document to the next meeting. 
XVIII. CONTINUATION OF THE RAC WORKING GROUP DISCUSSION ON 
ACCELERATED REVIEW - AMENDMENTS TO THE NIH GUIDELINES AND THE 
POINTS TO CONSIDER/DYL PARKMAN 
Dr. Parkman presented an overview of the Proposed Cover Sheet for Accelerated Review 
of Human Gene Transfer Experiments (Accelerated Review). The proposed cover sheet 
could be adopted as a preliminary mechanism for screening human gene transfer studies 
that may qualify for the accelerated review process previously approved by the RAC. 
Principal Investigators requesting consideration of their protocol for the Accelerated 
Review process must complete the cover sheet. Based on the information provided by 
the Principal Investigator, NIH/ORDA in consultation with the RAC Chair and one or 
more RAC members, as necessary, will make a determination regarding eligibility for 
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