Advances in medicine would not be possible without the participation of patients
in clinical research. The safety and welfare of patients participating in research
is the highest priority of investigators, staff and others involved in the conduct
of studies at Saint Joseph Mercy Health System (SJMHS). The institution is committed
to the ethical conduct of research in accordance with the Mission and values
of the hospital, and in accordance with national guidelines and standards.
The Institutional Review Board (IRB) is an independent committee designated
by SJMHS to safeguard the rights and welfare of human participants in all research
activity conducted under the sponsorship of SJMHS. All members of the IRB are
volunteers and include physicians, scientists, pharmacists, social workers,
clergy, community representatives and former patients.
Under federal law, the IRB must approve all research involving human subjects.
The IRB has legal authority to suspend or close any research study that presents
an unacceptable risk to the patients who are participating in the study. The
IRB meets monthly to consider approval of new studies and to monitor the conduct
of studies that are in progress.
A key concern for the IRB is the process for assuring that all patients who
are interested in participating in a study are fully informed of the risks and
benefits of participating, are aware of their right to withdraw from participation
at any time, and know that participation is an entirely voluntary process without
coercion of any kind.