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 five members with varying backgrounds. One member’s primary concern will be in nonscientific areas, such as law or religion.
- 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 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.