HOW TO PRINT To print this page, use your browser's print button. To print the entire document, download the PDF or click here and use your browser's print button. TOOLS & BACKGROUND MATERIALS NIH Office of Biotechnology Activities NIH Recombinant DNA Advisory Committee Appendix M of the NIH Guidelines FDA Guidance on Consent Forms
MAIN POINTS There should be a separate consent form for the gene transfer component when possible. If a separate consent form is not possible, the gene transfer component should be described separately within the consent form.

NIH GUIDELINES: "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."

DISCUSSION
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
• Safety Considerations in Cardiovascular Gene Transfer Clinical Research, December 2000
• Safety Considerations in the Use of AAV Vectors in Gene Transfer Clinical Trials, December 2000
• Internally Deleted, Helper-Dependent Adenoviral Vectors, March 2000
• Lentiviral Vector for Gene Delivery, March 1998
• Prenatal Gene Therapy: Scientific, Medical, & Ethical Issues, January 1999
• Reports and Other Documents of Interest
• Letter to principal investigators conveying RAC recommendations regarding adverse events in a gene transfer trial studying X-linked SCID, March 2003
• Assessment of adenoviral vector safety and toxicity, January 2002
• Enhancing the protection of human subjects in gene transfer research at the National Institutes of Health, July 2000
• Requirements for reporting serious adverse events: request for institutional review, November 1999
• FDA letter to IND sponsors/principal investigators of gene transfer clinical trials regarding protocol submission and adverse event requirements, November 1999
• RAC statement regarding in utero gene transfer research, March 1999
• Minutes and webcasts of past RAC meetings