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omitted from the consent process or the Informed Consent document." 
"Part I-D-2-a. General Requirements of Human Subjects Research" 
"Part I-D-2-a-(l). Description/Purpose of the Study" 
"The subjects should be provided with a detailed explanation in non-technical 
language of the purpose of the study and the procedures associated with the 
conduct of the proposed study, including a description of the gene transfer 
component." 
"Part I-D-2-a-(2). Alternatives" 
"The Informed Consent document should indicate the availability of therapies and 
the possibility of other investigational interventions and approaches." 
"Part I-D-2-a-(3). Voluntary Participation" 
"The subjects should be informed that participation in the study is voluntary and 
that failure to participate in the study or withdrawal of consent will not result in 
any penalty or loss of benefits to which the subjects are otherwise entitled." 
"Part I-D-2-a-(4). Benefits" 
"The subjects should be provided with an accurate description of the possible 
benefits, if any, of participating in the proposed study. For studies that are not 
reasonably expected to provide a therapeutic benefit to subjects, the Informed 
Consent document should clearly state that no direct clinical benefit to subjects is 
expected to occur as a result of participation in the study, although knowledge 
may be gained that may benefit others." 
"Part I-D-2-a-(5). Possible Risks, Discomforts, and Side Effects" 
"There should be clear itemization in the Informed Consent document of types of 
adverse experiences, their relative severity, and their expected frequencies. For 
consistency, the following definitions are suggested: side effects that are listed as 
mild should be ones which do not require a therapeutic intervention; moderate 
side effects require an intervention; and severe side effects are potentially fatal or 
life-threatening, disabling, or require prolonged hospitalization." 
"If verbal descriptors (e.g., "rare", "uncommon", or "frequent") are used to express 
quantitative information regarding risk, these terms should be explained." 
"The Informed Consent document should provide information regarding the 
approximate number of people who have previously received the genetic material 
under study. It is necessary to warn potential subjects that, for genetic materials 
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