Review Criteria

 

In any review (Exempt from Full Board review, Expedited review, or Full Board review), the IRB will determine if:

1. Participation of human subjects in the project is justified;
2. Risks to subjects are minimized by using appropriate procedures that are consistent with sound research design (45 CFR 46.111(a)(1)(i));
3. Risks are justified in view of anticipated benefits, if any, to the subjects;
4. Selection of subjects is equitable (justification is required if the subject population is restricted to one gender or ethnic group or age);
5. Adequate provision is made for confidentiality of data and anonymity of subjects in any published record;
6. Adequate provision is made for the rights and welfare of subjects who are mentally, physically, economically, or educationally disadvantaged; and
7. Adequate provision is made for obtaining informed consent of the subjects, including those for whom English is not their first language.

The IRB has the authority to approve, require modifications in, or disapprove all human subjects research (45 CFR 46.109(a)). Research that has been approved by the OSU IRB may be subject to further review and approval or disapproval by officials of OSU. However, those officials may not approve research if it has not been approved by the OSU IRB (45 CFR 46.112).