1. Institutional Authority for Human Research Protection

Institutions 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 45 CFR 46.

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* C, and D for research involving 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 opted out of Subpart B because the only research conducted by University or affiliate researchers that may include pregnant women (and potentially, fetuses) is minimal risk research involving surveys, existing records or specimens and the additional protection do not apply.

The University's Research Integrity Office (RIO) and the IRB have the authority to ensure

  1. the rights and welfare of research participants are protected and
  2. 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:

  1. The research involves no more than minimal risk.
  2. The research is not conducted or otherwise supported by a federal department or agency.

The IRB-Flex policy includes the following:

  • addition of two exempt categories, Flex-Exempt 7 and Flex-Exempt 8;
  • relaxation of requirements for prior approval for minor amendments for all exempt research;
  • option for RIO staff to review minor amendments to approved research previously reviewed by expedited procedures or at a convened IRB meeting;
  • flexibility related to requirements for additional protections for vulnerable populations; and
  • flexibility related to requirements for obtaining parent permission and assent.

Refer to the relevant policies for information about the application of the IRB-Flex Policy under the aforementioned conditions.

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