"Submission of a human gene transfer experiment to NIH OBA must include a copy of the proposed informed
consent document. 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 document 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 omitted
from the consent process or the informed consent document."
Appendix M-III-B strongly encourages use of a separate consent form for the gene transfer component
of a study in which either additional investigational interventions or standard treatments are also used.
This can help potential participants assess the potential benefits and harms of gene transfer when it is
combined with other interventions.
If a separate consent form for the gene transfer component of the study is not possible, the single
consent form should describe the gene transfer component separately whenever possible, in order to give
adequate attention to gene transfer's unique features. For example, separate sections or subsections
addressing gene transfer aspects of the study may be placed throughout the consent form in such a way
as to enable potential research participants to distinguish among the various components of the study.
The NIH Office of Biotechnology Activities (OBA), which staffs the
Recombinant DNA Advisory Committee (RAC) and administers the
NIH Guidelines, can be a resource
for development and review of gene transfer research consent forms. Among the valuable resources available on
the OBA website are a number of sources of information, data, and descriptions
applicable to different gene transfer interventions, vectors, diseases and conditions, including:
- GeMCRIS Database - provides information on gene transfer trials. This resource may be useful to Investigators in the development of their consent form and to potential participants seeking information about trials similar to the one in which they are contemplating enrollment.
- Proceedings from Gene Transfer Safety Symposia and Policy Conferences
- Reports and Other Documents of Interest
- Minutes and webcasts of past RAC meetings