Appendix I The National Cancer Institute Tiered Consent Form The National Cancer Institute (NCI), in cooperation with the National Action Plan for Breast Cancer, has developed a model informed consent document for future unspecified research use of specimens collected during routine medical care. The NCI databases currently use this consent form and an accompanying educational brochure for patients. A great deal of thought and testing went into formulating the form and accompanying brochure to ensure their utility and effectiveness. The form contains three statements to which patients must respond affirmatively: My tissue may be kept for use in research to learn about, prevent, or treat cancer. My tissue may be kept for use in research to learn about, prevent, or treat other health problems (i.e., diabetes, Alzheimer’s disease, or heart disease). Someone from XYZ may contact me in the future to ask me to take part in more research. Deleting the third statement would seem to realize the broadest type of consent. However, most institutional review boards (IRBs) require that permission be obtained to recontact a research subject. The third statement effectively protects researchers and presumably allows them more options, given changing guidelines and policies. Tiered consent, although presenting some complexities for the private sector, provides the most flexibility for patients. It is important to note that there are many examples of the successful use of the tiered consent process with IRB approval.

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