IRB Policy

The CHTN requires investigators to obtain Institutional Review Board (IRB) review and approval (if deemed necessary by their local IRB) before receiving specimens for their research. IRB review can be achieved by one of the following:

Utilization of the established IRB at their institution/commercial organization.
Utilization of a local institution/organization if the investigator does not have an established IRB at his/her institution/organization.
Utilization of the services of the Association for the Accreditation of Human Research Protection Program (AAHRPP). For an accredited list of IRBs refer to AAHRPP's accredited organizations.

Investigators, who do not have access to an IRB should contact the CHTN.

All investigators should be aware of how the federal human subjects' regulations apply to the use of human specimens. For example, specifically, the OHRP has indicated that research using anonymized or de-identified specimens does not constitute human research and thus is not regulated by the Code of Federal Regulations (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html ).