6. Flexibility Policy
Updated July 1, 2019
The University has chosen to limit the scope of its Federal wide Assurance (FWA) to federally funded research, the terms of which allow an appropriate level of flexibility for research involving no greater than minimal risk. Unfunded research projects outside the scope of the FWA and reviewed under the flexibility policy will be afforded protections commensurate with risk as determined by the IRB. This policy is limited to unfunded studies involving no greater than minimal risk. Should the funding status of a study reviewed under this policy change, it is the responsibility of the Principal Investigator to notify the IRB. Under no circumstances will federally funded or FDA of VA regulated research be reviewed under this policy.
All human subjects research projects conducted or supported at the University remain subject to IRB policies and review, whether they qualify for this policy or not. When questions of applicability arise, studies will be reviewed on a case by case basis. The IRB may make exceptions to this policy for funded research that is not federally funded.
University IRB Flexibility Policy
At the discretion of the RI 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 supported by a federal department or agency.
The IRB-Flex policy includes the following:
- relaxation of requirements for prior approval for minor amendments for all exempt research;
- administrative review by RI staff of changes to personnel (not PI) and study sites for research approved by expedited procedures or at a convened IRB meeting;
- expedited review by IRB members of minor amendments to research approved at a convened IRB meeting (see IRB Review Types);
- expanded list of types of research that qualify for expedited review (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.