Purpose

Ohio Wesleyan University is responsible for ensuring that research activities conducted under its auspices do not violate the rights and welfare of human subjects. These protections are derived from the ethical principles articulated in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research). The Institutional Review Board (IRB) is the body charged with ensuring the protection of human subjects in research conducted at the University or by an employee or student of the University. The IRB policy is designed to conform with the Department of Health and Human Services (HHS) Code of Federal Regulations (CFR) Final Common Rule (45 CRF §_.101-124; effective January 19, 2018) and Subparts B – E of the Common Rule (45 CRF §46.201-505; effective July 14, 2009).

Investigators must obtain IRB approval prior to the commencement of all human subject research (i.e., before announcing the research to prospective participants, recruiting participants, or collecting information from participants). The IRB shall review and have authority to approve, require modifications (in order to secure approval), or disapprove all research that involves human subjects. No one other than the IRB can approve human subject research.

Does the IRB policy apply to my work?

The IRB policy applies to all human subject research, which involves information from or about living human beings. Any discipline may involve human subject research. On the research proposal form, investigators will provide the IRB with information that is relevant to the determination of review status, however, the IRB is solely responsible for determining the review status of all research.

Exempt review. The IRB may determine that research is Exempt under this policy if the research is free of foreseeable risk to participants (additional requirements can be viewed in the full policy). When the IRB determines that research is Exempt, approval waives the need for Expedited or Full review, but it does not remove the need for investigators to protect participants according to the guidelines set forth in the Belmont Report.

Expedited review. The IRB may give research Expedited review if the research presents no more than minimal risk to participants (additional requirements can be viewed in the full policy). Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Full review. The IRB may give research Full review if the research does not meet the requirements of Exempt or Expedited review.