Institutional Review Board (IRB)
Purpose
The Institutional Review Board (IRB) is an administrative body of Mount Saint Mary College, and it reports directly to the Vice President for Academic Affairs (VPAA), who is the Authorized Institutional Official required by Health and Human Services (HHS) guidelines to oversee the work of the IRB. The VPAA reports to the President of the College, who has the final jurisdiction in any question arising concerning the work of the IRB, subject to the HHS guidelines.
The Institutional Review Board for the Protection of Human Research Participants is an independent compliance committee mandated by the U.S. Department of Health and Human Services. (See Title 45, Part 46 of the Code of Federal Regulations.)
Responsibilities
The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within the definition of ‘research’ in this policy. In accord with the HHS guidelines, research that has been approved by Mount Saint Mary College’s IRB may still be subject to review and disapproval by the Vice President and President of Mount Saint Mary College, but those officials may not approve research that the IRB has disapproved.
In general, the responsibilities of IRBs are: (1) to review initial research proposals to ensure that the researchers’ plans provide subjects with adequate opportunity to provide informed consent for procedures and (2) to ensure that subjects are not exposed to unreasonable risks. IRBs also conduct continuing review of approved long-term projects to make certain that subject protections remain in place. These purposes also support Mount Saint Mary College’s mission values and curricular goals.
Membership
The IRB will consist of at least five committee members with 4 faculty members, at least two members with concerns in the scientific area (e.g., biomedical, behavioral sciences), at least one with concerns in the non-scientific area, and one external member not affiliated with the College. The committee should reflect expertise in the kinds of research that would be the most likely, most frequent cases.
The committee may select a pool of up to three external members not otherwise affiliated with the College, where for each meeting one of these members would attend and have voting privileges.
Terms of Office
The term of membership will normally be for three years (subject to term limits) and each year no more than two faculty members will be elected.
A pool of up to three non-affiliated members will be selected by the following process: During the last year of the non-affiliated members’ terms, the IRB Chairperson will open a public search for candidates that will include recommendations from the faculty. The IRB committee faculty members will vote to elect the non-affiliated members to three year renewable term limits.
The following criteria are to be used as guidelines for selecting the non-affiliated member for IRB: Knowledge of the US Department of Health and Human Services (HHS) and Office for Human Protections Research (OHPR) Regulations and successful completion of the OHRP training tutorial, knowledge about local communities, and experience reviewing human subject research for the protection of rights and welfare of subjects/participants.
More information on Institutional Review Board Policies and Protocols can be found on the IRB site on the MSMC portal.