6. Flexibility Policy

Updated March 12, 2026

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. The 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) or 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 & Security and the IRB, the IRB-Flex policy may be applied to human research under the following conditions:

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

When reviewing studies that meet the above conditions, the reviewer may exercise certain flexibilities that deviate from the regulatory requirements of the Common Rule on a case-by-case basis based on the design of the proposed study. Examples of flexibilities that may be utilized for eligible studies include:

• The flexibility policy extends FERPA’s definition of “eligible student” to allow minors enrolled in postsecondary coursework to consent and participate in research studies without parental permission if those studies are recruiting the University student population. The IRB calls these individuals “mature minors”. Examples of such extension include research conducted under exempt categories 2 and 3 where minors would otherwise be excluded.
• In relation to 45 CFR 46.104(d)(2)(i) and (ii), exempt category 2, the reviewer may allow mature minors to participate in survey procedures and interview procedures if the research is specifically enrolling postsecondary students.
• In relation to 45 CFR 46.104(d)(3), exempt category 3, the reviewer may allow mature minors to participate in benign behavioral interventions under sub criteria A & B if the research is specifically enrolling postsecondary students.
• In relation to 45 CFR 46.104(d)(3), exempt category 3, the reviewer may exercise flexibility in the interpretation of ‘brief in duration’ as well as extend data collection to include some commercially approved physical sensors; so long as their use is harmless, painless, not physically invasive and does not support a clinical hypothesis (e.g. pedometers).
• In relation to 45 CFR 46.104(d)(2)(iii) and 45 CFR 46.104(d)(3)(C), allowing limited IRB reviews to be conducted by a qualified IRB staff member who may not be listed as an IRB member.
• In relation to 45 CFR 46.110(b)(2), allowing expedited reviews to be conducted by a qualified IRB staff member who may not be listed as an IRB member.
• In relation to 45 CFR 46.116(b), at the discretion of the reviewer, they may allow basic elements of informed consent to be omitted from the consent document without requiring the study team to request a waiver or alteration of informed consent.
• In relation to 45 CFR 46.116(c), at the discretion of the reviewer, they may allow additional elements of informed consent to be omitted from the consent document without requiring the study team to request a waiver or alteration of informed consent.
• In relation to 45 CFR 46.116(f)(3), when a study team requests a wavier or alteration of consent, at the discretion of the reviewer, they may allow the waiver without all study justifications being addressed in the protocol.
• In relation to 45 CFR 46.117(a), the reviewer may allow the study team to not provide a copy of the informed consent document to the subject based on lack of feasibility or subject preference.
• In relation to 45 CFR 46.117(c)(1), at the discretion of the reviewer, they may allow a waiver of consent documentation without all study justifications being addressed in the protocol.
• In relation to 45 CFR 46.204(d), at the discretion of the reviewer, they may allow pregnant participants to be consented with some basic elements and/or additional elements of consent omitted from the consent document without requiring the study team to request a waiver or alteration of consent.
• In relation to 45 CFR 46.408(a), at the discretion of the reviewer, they may allow assent to be waived without all study justifications being addressed in the protocol.

Additional flexibilities may be exercised at the discretion of senior Research Integrity & Security staff for eligible studies. Any flexibilities utilized within a study review will be noted in the reviewer worksheet(s).

Please note that the addition of federal funding to research approved under the University’s IRB Flexibility Policy must be immediately reported to Research Integrity & Security. Research Integrity & Security staff will consider the requirements and categories for review and inform the PI if a new application or additional information is needed.