(D)
Authority and
responsibility.
(1)
The IRBs designated under the university's FWA are the
principal mechanism by which the university reviews proposed research to ensure
that it is planned and conducted in a manner consistent with applicable law and
policy, and that the rights and welfare of human research participants are
adequately protected. The responsibilities of the IRB include, but are not
limited to:
(a)
Reviewing, approving, exempting, requesting modifications
to, or denying proposed research involving human subjects to ensure that it is
planned and conducted in a manner consistent with applicable law and policy,
and that the rights and welfare of human subjects are adequately protected.
Notwithstanding the preceding, research that has been approved by the IRB may
be subject to further review and approval or disapproval by the provost or the
provost's designee. No university official, however, may approve research that
has not been approved by the IRB.
(b)
Conducting
continuing review of research approved by the IRB, at intervals not less than
once per year, including as necessary, observing, or having a third party
observe, the consent process and investigational activity; or requesting and
inspecting information related to human participant research
activity.
(c)
Suspending or terminating approval of research activity
that is not being conducted in accordance with the requirements established by
the IRB for a particular research activity, has been associated with serious
harm to research participants, or that is not otherwise in accordance with
federal human subject research regulations or university
policy.
(d)
Reporting to appropriate university and federal
officials, and as applicable, any department or agency head:
(i)
Unanticipated
problems involving risks to research participants or others and serious or
continuing noncompliance with this policy or the requirements or determinations
of the IRB.
(ii)
Any suspension or termination of IRB
approval.
(e)
Contributing to the development and implementation of
administrative policies and procedures consistent with federal regulations and
best practices.
(2)
Sponsored
projects involving human subjects are subject to rule
3342-3-04.1 of the
Administrative Code.
(3)
The institutional official, by appointment from the
provost, shall represent the university in providing assurance to the federal
government that the university will comply with federal human subject research
regulations, and shall be responsible for ensuring that all regulatory and
programmatic requirements for the conduct of human participant research at the
university are met.
Replaces: 3342-3- 03.2