The primary responsibility of the Alverno College Institutional Review Board (IRB) is the review of research for the protection of human subjects who are participants in research. Review by an IRB is the cornerstone of an institution’s program for the protection of human subjects participating in research. IRBs are responsible for ensuring that the rights and welfare of the participants in research are adequately protected. IRB means an institutional review board established in accord with and for the purposes expressed in Office for Human Research Protections policy (45 CFR 46.102(g)).
To minimize risks, the IRB ensures that the ongoing conduct of the research protects subjects at Alverno College and at other sites as negotiated through Federal Assurances. These protections ensure that human subjects participate in research only after providing legally effective, fully informed consent when consent is required by law for the ethical and legal conduct of the research. The IRB operates under the rules of conduct established from the Code of Federal Regulations, most frequently 45 C.F.R. § 46 subpart A (PDF), as well as Wisconsin state laws, and policies established by Alverno College. The IRB’s decisions are based on the ethical principles in the Belmont Report.
The IRB reports directly to the Alverno College President, who officially serves as the Institutional Official (IO) with oversight of the Alverno IRB and Human Research Protections Program. The IRB exercises full autonomy in deciding whether human subjects research reviewed under its auspices meets ethical requirements.
The IRB is constituted by the IO and is registered with Department of Health and Human Services, Office for Human Research Protections (OHRP) under Alverno College’s Federal Wide Assurance (FWA#FWA00012561). The IRB has the following authority:
The IRB ensures the adequacy of human subject protections by taking the following actions:
The IRB has jurisdiction only over the following categories of research when that research involves the use of human subjects or identifiable data or tissues derived from human subjects:
For research conducted on Alverno premises or on an identified population of Alverno students, faculty, or staff, Alverno College is the local IRB and, accordingly, acts as an IRB of record with its required approval of the final design of the research protocol and its specified procedures for the protection of human subjects, unless the Alverno College IRB Chair provides a written letter that officially delegates this final authority (or some portion of it) to another IRB. Alverno has articulated policies that address circumstances when multiple IRBs have shared jurisdiction. These policies may assist a researcher to avoid unnecessary duplication of effort. However, Alverno affiliated students should always begin with the Alverno IRB’s standard submission forms and processes.