VCOM Institutional Policy and Procedure Manual

The corresponding IRB application must address, and provide justifications for, each of the Federal Policy and HIPAA Privacy Rule criteria for granting a waiver of informed consent/HIPAA authorization. Applicable PIs of the retrospective medical record research studies need to incorporate waiver criteria and model justifications into their IRB application. Since the VCOM IRB has pre approved the model justifications for the waiver criteria under this circumstances (i.e., the PI provides care to the respective patients), the application can be reviewed via expedited review and does not require consideration at a convened meeting of an IRB committee. If the PI of the retrospective medical record research study does not provide related care to the respective patients, there are obvious concerns that investigator access to, and the recording of, patients’ identifiable medical record information may adversely affect the patients’ rights to privacy and confidentiality of this information. Thus, in this situation, the PI must address, in the corresponding IRB application, each of the Federal Policy and HIPAA criteria for granting a waiver of informed consent/HIPAA authorization and must provide clear and thorough justifications regarding the applicability of these criteria to the proposed research. Since the VCOM IRB holds informed consent as a primary principle governing the ethical conduct of human subject research, all such requests for a waiver of informed consent/HIPAA authorization will require review and approval by a convened IRB committee (i.e., full board IRB review). D URATION OF P OLICY The VCOM IRB Guidance on Research Limited to Retrospective Medical Reviews established by the Institutional Review Board is effective as of the date above and shall remain effective until amended or terminated by the President and the Dean. 5.