General Information
I. IRB Structure and Functions
The IRB consists of individuals with the various experiences and
skills necessary to evaluate human subject research and its
institutional, legal, scientific and social implications. The Vice
President for Academic Affairs appoints IRB members for a minimum of
three years. The IRB works in close relationship with the Vice President
for Academic Affairs, who provides final enforcement of the actions of
the IRB.
II. Responsibilities of the IRB
- Development of policy and procedures for review of activities
involving human subject research.
- Development of information and instructions for investigators,
reviewers, and subjects involved with human subject research.
- Initial and continuing review of such activities.
- Ascertaining acceptability of proposed research in terms of
institutional commitments, applicable law, and standards of
professional conduct and practice.
- Documentation of review of such activities in conformity with
applicable law, regulations, and policies.
- Provision of advice and counsel to investigators engaged in such
activities.
- Adjudication of differences and review of problems arising out
of such activities.
- Assuring compliance with externally imposed policies and
regulations.
- Reporting to the Secretary of Health and Human Services
unanticipated problems involving risks to subjects and others, in
work funded by HHS.
- Reporting to the appropriate institutional officials, and for
research funded by HHS regulations, to the Secretary of HHS, any
serious or continuing noncompliance by investigators with the
requirements and determination of the IRB.
III. Composition of the IRB
The IRB is required to have a minimum of at least five members with
varying backgrounds. One member's primary concern will be in
nonscientific areas, such as law or religion.
- One member shall be a person who is not affiliated with the
University and who is not part of the immediate family of a person
affiliated with the University.
- Members will consist of both men and women.
- Members will serve staggered three-year terms.
- The IRB may not have a member participating in the IRB's initial
or continuing review of any project in which the member has a
conflicting interest, except to provide information requested by the
IRB.
- The IRB may, at its discretion, invite individuals with
competence in special areas to assist in the review of complex
issues which require expertise beyond or in addition to that
available on the IRB. These individuals may not vote with the IRB.
IV. Operation of the IRB
- The IRB will determine that the criteria for IRB approval are
met and will recommend the frequency of continuing review and the
nature and extent of any monitoring of the research or consent
process.
- The IRB will provide for expedited review of certain categories
of research which it will designate with due consideration of
applicable regulations of sponsoring agencies.
- The IRB will provide written notice to principal investigators
of the disposition of their proposals.
- The IRB will maintain adequate documentation of all IRB
activities, including minutes of the IRB meetings.
V. IRB Meetings
The IRB meets twice a month during the academic semester. Meeting
times are announced each semester by the Grants Office, and can be found
on the IRB website. Proposals
are due one week prior to the IRB meeting.
VI. Establishing A Peer Review Committee
Divisions/disciplines with a significant number of minimal risk
research activities, which fall within one of the eligible categories
defined by the IRB, may establish a Peer Review Committee.
Divisions/disciplines which wish to establish a peer review committee
must develop division/discipline written guidelines on the basis of
recurring types of minimal risk activities and relevant well-established
and accepted professional guidelines (i.e. Ethical Principles of
Psychologists or those adopted by the American College of Sports
Medicine). When such guidelines have been approved by the Institutional
Review Board, the peer review process may be used.
The following written information must be provided to and approved by
the IRB before the division/discipline Peer Review Committee can review
research. The "Application to Establish A Peer Review Committee" should
be completed within the division. Any division/discipline which does not
have sufficient research activity to warrant establishing a peer review
committee, or does not wish to establish a peer review committee for any
other reason, should refer all research projects involving human
subjects to the Institutional Review Board for review.
The following information must be submitted to the IRB in the
"Application to Establish A Peer Review Committee" before the
divisional/discipline review process can be approved.
- The names of faculty who will be reviewing research involving
human subjects;
- The qualifications of each faculty member including academic
rank, research experience, and other pertinent information;
- The name(s) of the faculty member(s) who will be responsible for
assigning research projects involving human subjects to review
committee members, and who will assure that the "Application for
Approval of Investigations Involving the use of Human Subjects,"
along with a copy of the research proposal (if appropriate) and the
completed "Peer Review Form" are filed within a central location
within the division/discipline.
- A description of the location where the above information will
be filed within the division.