The subcommittee recommended that the following sentences be inserted after 
the first sentence in (d) on page 14: 
"Are there objective and quantitative measurements to assess the natural 
history of the disease? Will such measurements be used in following 
your patients?" 
The subcommittee recommended that question c. on page 15 be reworded as follows: 
"c. Vhat precautions will be taken against such spread (e.g., to patients 
sharing a roam, health-care workers, or family members)?" 
The proposed revised Points to Consider document, which is to be considered by 
the full Recombinant DNA Advisory Committee (RAC) on September 29, 1986, appears 
in Attachment III. 
PROPOSAL BY COMMITTEE FOR RESPONSIBLE GENETICS 
The subcommittee considered a proposal by the Committee for Responsible Genetics 
to amend the NIH Guidelines for Research Involving Recombinant ENA Molecules 
(Attachment IV). Drs. Capron, Grobstein, and Motulsky began the discussion of 
this proposal. Dr. Capron addressed the effects of the proposed restrictions 
and the persuasiveness of the rationale. Dr. Grobstein said that the proposed 
language was unfortunate in several respects, but that a modified version of 
the proposal might serve as interim public policy. Er. Motulsky said that it 
would be unwise to prohibit categorically any DNA manipulation with human germ 
line cells or early zygotes since such work may lead to scientific insights 
and/or approaches to prevention or management of birth defects or genetic 
disease in the future. Many members of the subcommittee shared the view that 
the proposal is unduly restrictive. 
After extensive discussion of the issues raised by this proposal, the subcommittee 
prepared the following statement and recommendation to the RAC: 
"1. The Committee for Responsible Genetics (CRG) in a letter dated March 26, 
1986, has expressed concern about human gene therapy that is not aimed 
solely at the relief of a life-threatening or severely disabling condition, 
or that could alter germ line cells. The subcommittee has expressed 
its concerns about such gene therapy in the introduction to the 'Points 
to Consider in the Design and Submission of Human Somatic-Cell Gene 
Therapy Protocols': 
'(7). ..The RAC and its subcommittee will not at present entertain 
proposals for germ-line alterations but will consider for approval 
protocols involving scmatic-cell gene therapy,' and 
'(11) In recognition of the social concern that surrounds the general 
discussion of human gene therapy, the subcommittee will continue to 
consider the possible long-range effects of applying knowledge gained 
from these and related experiments. Vhile research in molecular 
bioloav could lead to the development of techniques for gem line 
[38] 
Recombinant DNA Research, Volume 1 1 
