1. Institutional Authority for Human Research Protection
Any institution engaged in human subject research supported or conducted by any federal department or agency must provide written assurance that it will comply with the requirements in the Code of Federal Regulations, under DHHS Protection of Human Subjects at 45CFR46 .
The University provides this assurance through a DHHS FWA (FWA00002306).
As part of its FWA, for research conducted by University and affiliate researchers, the University agrees to
- apply the Common Rule (i.e., 45 CFR 46 Subpart A) to human subject research conducted or otherwise supported by a federal department or agency (AKA: federally-funded research);
- apply Subparts B, C, and D for research involving pregnant women, fetuses, neonates of uncertain viability, or nonviable neonates; prisoners; and children; respectively, to federally-funded research ; and
- via the University IRB Flexibility Policy (IRB-Flex policy), provide equivalent protections for human subject research that is not conducted or otherwise supported by a federal department or agency.
The University's Research Integrity Office (RIO) and the IRB have the authority to ensure
- the rights and welfare of research participants are protected and
- human subject research meets regulatory and institutional requirements.
The federal regulations for the protection of human subjects exempt some research activities from the requirements for IRB review (§46.101(b)) . The University has designated the RIO to review and authorize exempt research. For more information about exempt categories of research, see the exempt research policy sections.
University IRB Flexibility Policy
At the discretion of the RIO and the IRB, the IRB-Flex policy may be applied to human subject research under these two conditions:
- The research involves no more than minimal risk.
- The research is not conducted or otherwise supported by a federal department or agency.
The IRB-Flex policy includes the following:
- addition of Flex-Exempt Review (see IRB Review Types) for minimal risk research that is neither conducted/supported by a federal agency; nor involves prisoners, or incomplete disclosure or deception.;
- relaxation of requirements for prior approval for minor amendments for all exempt research;
- option for administrative review by RIO staff of changes to personnel (not PI) and study sites for research approved by expedited procedures or at a convened IRB meeting;
- option for expedited review by IRB members of minor amendments to research approved at a convened IRB meeting (see IRB Review Types);
- flexibility related to requirements for informed consent (see Informed Consent Requirements, Informed Consent for Federally-Funded Minimal Risk Research, and Informed Consent for Exempt and Select Minimal Risk Research).
- flexibility related to requirements for additional protections for select vulnerable populations (see Research Involving Pregnant Women..., Research Involving Children; and
- flexibility related to requirements for obtaining parent permission and assent (see Research Involving Children.