CHTN Policy for IRB Approval

The CHTN requires researchers to agree to follow the provisions of the "Common Rule" (45CFR46) federal human subjects regulations and obtain Institutional Review Board (IRB) approval before receiving specimens for their research. While these regulations currently do not apply to institutions that do not receive federal support, the CHTN policy requires all researchers using CHTN tissue to follow the Common Rule. This is consistent with the recommendations of a recent Presidential Commission report, Research Involving Human Biological Materials. That National Bioethics Advisory Commission report recommended that specimen resources should be responsible for assuring that users are following the Common Rule and that specimens are being used appropriately. The CHTN does not provide patient identity or other identifiers to investigators. This ensures complete confidentiality regarding medical information of patients.

Researchers at academic institutions and commercial companies are required to obtain IRB approval of their projects before receiving specimens from the CHTN. This may be accomplished in several ways. A researcher can use the established IRB at their institution/commercial organization. If the researcher does not has an established IRB at their institution/organization, the researcher may request that an IRB at another organization (e.g. university, college, hospital, other company) review their research proposal; or, alternatively, a researcher may use the services of an independent IRB. (See Listing of Independent IRBs).

All researchers should be aware of how the federal human subjects regulations apply to the use of human specimens. These are detailed in an NIH brochure, Research on Human Specimens: Are You Using Human Subjects?. Other information about use of human specimens and ethical issues are available on the NCI Cancer Diagnosis Program website.

For comments or concerns about this web site please contact: Steve Marroulis at marrouliss@imsweb.com