Recombinant DNA Advisory Committee - 6/9-10/94 
The amended version of Part I-D, Informed Consent, of the Points to Consider of the 
NIH Guidelines reads: 
"Part I-D. Informed Consent" 
"In accordance with the requirements of DHHS regulations for the Protection of 
Human Subjects (45 CFR Part 46), investigators should indicate how subjects will 
be informed about the proposed study and the marmer in which their consent will 
be solicited. They should also indicate how the Informed Consent document 
makes clear the special requirements of gene transfer research." 
"Part I-D-1. Communication About the Study to Potential Participants" 
"Part I-D-l-a. Which members of the research group and/or institution will be 
responsible for contacting potential participants and for describing the study to 
them? What procedures will be used to avoid possible conflicts of interest if the 
investigator is also providing medical care to potential subjects?" 
"Part I-D-l-b. How will the major points covered in Parts I-A through I-C be 
disclosed to potential participants and/or their parents or guardians in language 
that is understandable to them?" 
"Part I-D-l-c. What is the length of time that potential participants will have to 
make a decision about their participation in the study?" 
"Part I-D-l-d. If the study involves pediatric or mentally handicapped subjects, 
how will the assent of each person be obtained?" 
"Part I-D-2. Informed Consent Document" 
"Investigators submitting human gene transfer proposals for Recombinant DNA 
Advisory Committee review must include the Informed Consent document as 
approved by the local Institutional Review Boards. A separate Informed Consent 
document should be used for the gene transfer portion of a research project when 
gene transfer is used as an adjunct in the study of another technique, e.g., when a 
gene is used as a "marker" or to enhance the power of immunotherapy for 
cancer." 
"Because of the relative novelty of the procedures that are used, the potentially 
irreversible consequences of the procedures performed, and the fact that many of 
the potential risks remain undefined, the Informed Consent process should 
include the following specific information in addition to any requirements of the 
DHHS regulations for the Protection of Human Subjects (45 CFR 46). Indicate if 
each of the specified items appears in the Informed Consent document, or, if not 
included in the Informed Consent document, how those items will be presented to 
potential subjects. Include an explanation if any of the following items are 
Recombinant DNA Research, Volume 19 
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