3 
Dr. Walters called the meeting of the Working Group on Human Gene Therapy to 
order at 9:15 a.m. on November 16, 1984. He wel caned two new members of the 
working group: Mrs. Anne Witherby of Boston, Massachusetts, and Dr. Robert Rich 
of Camegi e-Mel Ion University. He also we leaned two new liaison members: 
Dr. Stuart Nightingale of the Pood and Drug Administration (FDA) and Dr. Lowell 
Harmison of the Office of Assistant Secretary for Health, Department of Health 
and Human Services (DHHS). 
Dr. Walters said the purpose of the November 16, 1984, working group meeting 
was to continue to develop a "points to consider" document for human gene 
therapy applications. He called the attention of the working group to the 
document (Attachment II) developed from the October 12, 1984, meeting of the 
Working Group on Human Gene Therapy. He asked whether the following title of 
the document was acceptable: 
"Points to Consider in the Design and Submission of Scmatic Cell Gene 
Therapy Protocols" 
Dr. Grobstein suggested the word "human" should be included in the title. The 
workina group agreed. 
Dr. Grobstein indicated he had written an alternative preamble (Attachment III). 
He thouoht the only substantive difference between his version and the preariole 
included in Attachment II was that his version did not require the proposal be 
published in the Federal Register prior to review. 
Dr. Gottesman said the NIH Guidelines for Research Involving Recombinant ENA 
Molecules currently require announcement of all major actions in the Federal 
Register prior to RAC review. An announcement that a proposal would be reviewed 
would, thus, have to be made prior to the RAC meeting. The working group might, 
however, discuss the appropriate time to announce working group review of a 
proposal: (1) working group review might be announced before the RAC meeting 
but after the working group meeting; or (2) before the RAC and the working 
group meetings. 
Mr. Capron said human gene therapy protocols should be announced in the Federal 
Register prior to working group review. The working group might then have the 
opportunity to consider public comment in its review. He preferred a single 
Federal Register announcement notifying the public of both the working group 
meeting and the RAC meeting. 
Dr. Walters asked whether the working group agreed announcements of review 
of human gene therapy protocols will be published in the Federal Register 
prior to the working group meeting. The working group agreed in principle. 
Dr. Grobstein pointed out that the public would have access on request to the 
proposal after the Federal Register announcement appeared. Dr. Miller said the 
working group should discuss how this access would affect confidentiality and 
proprietary information issues. The working group agreed to discuss this issus 
later in the meeting. 
[ 217 ] 
