Recombinant DNA Advisory Committee - 6/9-10/94 
transfer. Dr. Walters commented that this exclusion will prevent inadvertent gene 
transfer to the fetus. Dr. Parkman added that the recommended duration of barrier 
contraception should be specified. Dr. Chase said that this exclusion is a balance 
between the females right to treatment versus the desire to protect the nascent field of 
gene transfer research. Dr. Motulsky concurred with Dr. Chase's comments. 
Regarding the statement, "In the consent form, subjects should be informed about...any 
costs for medical treatment...as a direct result of research-related injury". Dr. Parkman 
said that the word direct is problematic based on variable interpretation and 
recommended that the term direct be deleted. Ms. Buc suggested that the phrase, "In the 
consent form" is redundant and should be deleted. 
Dr. Walters suggested that the RAC empower Dr. Zallen and the ORDA staff to 
incorporate the suggested editorial changes. 
Ms. Buc reiterated her concern about excluding women from participation in Phase I/n 
gene therapy trials since such studies are often the last hope of benefit for terminally ill 
patients. Dr. Chase said that the issue is the right of pregnant women to a treatment 
versus a collective right to safeguard a new form of medical experimentation. Both men 
and women are urged to practice barrier contraception with no reference to gender. Dr. 
Parkman suggested that the statement, "female subjects should be informed..." should be 
eliminated to avoid gender discrimination. Dr. Miller noted that most investigators 
would be reluctant to perform such a novel treatment on pregnant women. Ms. Buc 
stated that due to the controversial nature of this issue, the RAC should not take a 
position on the exclusion of pregnant women. Drs. Ross and Smith said that participants 
should be informed of the possible risk rather than outright exclusion. Dr. Parkman 
asked whether the FDA has a policy on this issue. Dr. Noguchi said that the FDA would 
not dismiss such a protocol outright unless there was clear scientific reason as to why 
women of child bearing age or pregnant women should not be included in the protocol. 
Dr. Parkman concluded that the investigators should; (1) describe whether pregnant 
women will be included in the study, and if not, provide an explanation for their 
exclusion, (2) describe possible risks to the fetus, and (3) include specific 
recommendations regarding contraception. Dr. Parkman suggested a new title for Part I- 
D-2-b-(l) entitled: "Reproductive Considerations." Dr. Noguchi said that Dr. Parkman's 
recommendations are consistent with FDA policy. 
Committee Motion 1 
The RAC approved a motion made by Dr. Chase and seconded by Dr. Haselkorn to 
accept the proposed amendments to Part I-D, Informed Consent, of the Points to 
Consider by a vote of 13 in favor, 0 opposed, and no abstentions. These amendments 
were approved with the exception of Parts I-D-2-b-(l) (Barrier Contraception) and I-D- 
2-b-(3) (Request for Autopsy), deletion of the words "in the Informed Consent 
document" where appropriate, and the inclusion of minor editorial changes. 
As to the use of verbal descriptors for possible risks. Dr. Chase suggested that if these 
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