Institutional Review Board (IRB)

HSR Policy

• OWU's Human Subject Research (HSR) Policy

• Federal Policy - Protection of Human Research Subjects (45 CFR 46)

• The Belmont Report - Ethical standards for human subject research

Guidance

Does the HSR Policy Apply to My Work? The HSR policy applies to all human subject research, which involves collecting information from or about living human beings. Such activities are considered research when it is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Any discipline may involve human subject research.

• Interpreting the definition of "Human Subject" and "Research" in the HSR policy

What level of review will my project receive? The IRB makes the final decision about review status, but investigators are encouraged to review the factors used by the IRB to make this determination. Sections III and IV of the HSR policy describe the criteria and procedures for exempt, expedited, and full review. See also:

• Benign behavioral interventions (HHS Guidance)

• Federal Register - Expedited review categories

• Changes in the HHS Common Rule (effective 2019)

What should I do if unanticipated problems arise during my study? Investigators are responsible for immediately reporting certain problems and adverse events to the IRB. Use the following guidance document to determine when reporting is required.

• Reporting unanticipated problems and adverse events (HHS Guidance)

Other Resources

• Use of electronic informed consent (HHS Guidance)

• Use of subjects from vulnerable populations (HHS Guidance)