Employees and students of the university of Cincinnati conduct
human subjects' research ethically and in accordance with this rule, with the
ethical principles stated in the "Belmont" report and with all applicable
federal, state, and local law and regulations, including regulations of the
department of health and human services (DHHS) regulations for the protection
of human research subjects, 45 C.F.R. part 46 subpart A, and FDA regulations
governing research with drugs, devices, and biologics, C.F.R. title 21 (food
and drugs), parts 50 (protection of human subjects) and 56 (institutional
review boards).
(A) To assure such
compliance, the university has a federal wide assurance with DHHS regulations
certifying that procedures will be followed that
will assure the protection of all human subjects involved in research projects.
This certification applies anyone engaged in human
subjects research on the premises of the university of Cincinnati,
and to faculty, students, staff, or other
representatives of the university engaged in human subjects research conducted
elsewhere on behalf of the university of Cincinnati.
(B) The university has established
institutional review boards
("IRB") to review
research involving human subjects. The IRB reviews research involving
investigational drugs, biologics, devices, and medical treatments and other
research involving human subjects. All research to which this rule applies must
be reviewed
and approved by a university IRB
before research begins.
(1) The IRB shall establish policies and
procedures for membership, regular meetings, review and approval of protocols
and consent forms, modifications to approved research, the risk/benefit ratio
of the research to the subjects involved, protection of the confidentiality of
the subjects' private information, and the reviews of approved research
protocols at timely intervals.
(2)
The IRB may suspend or terminate approved research if it is not being conducted
in accordance with this policy, with IRB requirements, or if it may pose the
risk of serious harm to human subjects.
(3) The IRB has authority, as a condition of
approval of a protocol, to observe, or have a third party observe, the consent
process; and to observe, or have a third party observe, the conduct of the
research at any time.
(4) The IRB
shall act independently of university officials. No university official shall
attempt to influence the IRB inappropriately on any matter before the IRB or
within the IRB's jurisdiction.
(C) The vice president for research
or designee shall serve as the institutional
official for human subjects' research and is responsible for administering this
rule. Any violation of this policy should be reported to the institutional
official who shall have the authority to take such action as required to bring
the university into compliance.
