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.