Purpose of the Institutional Review Board
Saint Joseph Mercy Health System houses two Institutional Review Boards, IRB#1 and IRB#2, the Oncology Research IRB. They are established and empowered under the auspices of Saint Joseph Mercy Health System’s executive authorities, and, if federal funding is used to support human subject research in whole or in part, by the Institution’s Assurance with the federal Office for Human Research Protections (OHRP).
The primary responsibility of the IRB is to protect the rights and welfare of human subjects in research. In doing so, the IRB monitors human subject research to determine that it is conducted ethically and in compliance with institutional and Federal regulations, the requirements of applicable law, Saint Joseph Mercy Health System’s Assurance, and Saint Joseph Mercy Health System’s policies and procedures. The IRB fulfills these responsibilities by conducting prospective and continuing reviews of human subject research, including review of the protocol and funded grant applications or proposals (for Federally-supported research), the informed consent process, procedures used to enroll subjects, and any Adverse Events or unanticipated problems reported to the IRB.
Except for research activities involving minimal risk to human subjects, all research protocols under the auspices of Saint Joseph Mercy Health System, including protocols conducted through the Michigan Cancer Research Consortium, that involve human subjects must be reviewed by, and receive the approval of the IRB, prior to initiation of the protocol. All protocols are subject to continuing review, which must be carried out at least on an annual basis.
Oncology Central IRB (OCIRB)
Saint Joseph Mercy Health System established a second IRB on August 18, 2005 to handle the growing volume of research studies and to provide for review of oncology related studies conducted through the Michigan Cancer Research Consortium. The Saint Joseph Mercy Health System IRB has a written agreement with the member institutions of the Michigan Cancer Research Consortium (MCRC) for the purpose of providing central IRB review of National Cancer Institute-funded Community Clinical Oncology Program (CCOP) protocols, other National Cancer Research study group protocols, industry sponsored research protocols, and investigator initiated research protocols.
The OCIRB reviews and approves all Michigan Cancer Research Consortium trials and is the exclusive IRB approving Michigan Cancer Research Consortium trials. The member institutions of the Michigan Cancer Research Consortium have agreed that no MCRC trial shall be conducted unless and until the OCIRB has reviewed and approved the applicable protocols.