Attachment VI - Page 4 
- 3 - 
I’olnts l- r > are a partial listing of the elements of 
Informed consent and may be misleading to applicants. If a 
listing of details of elements of Informed consent Is 
deemed necessary, we believe It shhould Include all of the 
basic and additional elements of Informed consent contained 
In the regulations. 
13. In section I.E., the Initial paragraph under "Privacy and 
Confidentiality" would, we believe, provide sufficient 
information, without points 1 and 2. 
14. We believe that section II. B. Is irrelevant to a Judgement 
of the appropriateness of a clinical trial. 
15. We are concerned that the Interrogatory style of the 
document may be Interpreted as strident or even adversary. 
Furthermore, the document does not provide the rationale 
for many of the questions although arguably the rationale 
could be Invaluable for the formulation of responses. We 
believe that both the tone of the document and the quality 
of communication between NIH and investigators would be 
improved by a more explicative, collaborative approach. As 
a n example of this. Attachment A Is the FDA's draft 
"Points to Consider in the Production and Testing of New 
Drugs and Biologicals Produced by Recombinant DNA 
Tec hnology . " 
16. We have one additional major concern. There exists virtual 
unanimity among those conversant with human gene therapy 
tliat somatic-cell gene therapy is analogous to other 
conventional medical interventions, such as vaccination, 
exogenous replacement of insulin in diabetics, or 
heterologous organ transplantation for genetic disease 
(see, for example, Barranger, New Eng. J. Med. 311, 
1629-30, 1984). The conclusion of the recent OTA report, 
Human Gene ■ The rapy-B ackg round Pa pe r , which Is In fact cited 
in the "Points'^ document, Is Instructive: 
Civic, religious, scientific, and medical groups have 
all accepted, in principle, the appropriateness of 
gene therapy of somatic cells In humans for specific 
genetic diseases. Somatic cell gene therapy Is seen 
as an extension of present methods of therapy that 
might be preferable to other technologies. 
The FDA has also endorsed this view In principle and has 
made known Its Intention to subject appropriate products 
employed lor human gene therapy to an adm l ns t ra t 1 ve review 
similar to that for analogous biological drug products. 
Since as Implied above;, most of the critical decisions on 
l nd l v Idua 1 
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