6. Flexibility Policy

Updated June 23, 2021

The University has chosen to limit the scope of its Federalwide Assurance (FWA) to federally funded research. Limiting the scope of the FWA allows for an appropriate level of flexibility for review and oversight of research projects without compromising protection of human participants. Research projects that present no more than minimal risk to human participants are eligible for flexible review and oversight. University applies commensurate protections for research projects that are eligible for this policy. This policy is limited to 1) unfunded studies involving no greater than minimal risk and 2) funded research that is not federally funded. 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 Food and Drug Administration (FDA) of Veterans Affairs (VA) regulated research be reviewed under this policy.

All human 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. Research projects eligible for flexible review and oversight are not subject to the same federal reporting requirements as federally sponsored projects. For projects conducted under this policy, the IRB follows internal reporting requirements for serious or continuing noncompliance, suspensions or terminations, or reporting of unanticipated problems involving risk to subjects or others.

University IRB Flexibility Policy

At the discretion of Research Integrity and the IRB, the IRB-Flex policy may be applied to human research under these two conditions:

  1. The research involves no more than minimal risk.
  2. 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 Research Integrity staff of changes to personnel (not Principal Investigator) and study sites for research approved by expedited procedures or at a convened IRB meeting;
  • expanded list of types of research that qualify for expedited review (in accordance with the policy for IRB review types);
  • flexibility related to requirements for informed consent, including consent for video recordings or photographs (in accordance with the policies for informed consent);
  • flexibility related to requirements for additional protections for select vulnerable populations (in accordance with the policies for research involving pregnant women and research involving children); and
  • flexibility related to requirements for obtaining parent permission and assent (in accordance with the policy for research involving children).