Recombinant DNA Advisory Committee - 6/9-10/94 
previously used in relatively few or no humans, unforeseen risks are possible, 
including ones that could be severe." 
"The Informed Consent document should indicate any possible adverse medical 
consequences that may occur if the subjects withdraw from the study once the 
study has started." 
"Part I-D-2-a-(6). Costs" 
"The subjects should be provided with specific information about any financial 
costs associated with their participation in the protocol and in the long-term 
follow-up to the protocol that are not covered by the investigators or the 
institution involved." 
"Subjects should be provided an explanation about the extent to which they will be 
responsible for any costs for medical treatment required as a result of research- 
related injury." 
"Part I-D-2-C. Specific Requirements of Gene Transfer Research" 
"Part I-D-2-c-(l). Reproductive Considerations" 
'To avoid the possibility that any of the reagents employed in the gene transfer 
research could cause harm to a fetus/child, subjects should be given information 
concerning possible risks and the need for contraception by males and females 
during the active phase of the study. The period of time for the use of 
contraception should be specified." 
"The inclusion of pregnant or lactating women should be addressed." 
"Part I-D-2-c-(2). Long-Term FoUow-Up" 
'To permit evaluation of long-term safety and efficacy of gene transfer, the 
prospective subjects should be informed that they are expected to cooperate in 
long-term follow-up that extends beyond the active phase of the study. The 
Informed Consent document should include a list of persons who can be 
contacted in the event that questions arise during the follow-up period. The 
principal investigator should request that subjects continue to provide a current 
address and telephone number." 
"The subjects should be informed that any significant findings resulting from the 
study will be made known in a timely manner to them and/or their parent or 
guardian including new information about the experimental procedure, the harms 
and benefits experienced by other individuals involved in the study, and any long- 
term effects that have been observed." 
Recombinant DNA Research, Volume 19 
[365] 
