340. Informed Consent for Exempt and Minimal Risk Research

Updated April 6, 2026

Exclusion of Federal Requirements for Informed Consent for Exempt and Minimal Risk Research

Research that is exempt under 45CFR46.104 is also exempt from Department of Health and Human Services (DHHS) requirements for informed consent as described under §46.116 and for documentation of consent under §46.117.

Similarly, under the University's IRB Flexibility Policy, DHHS requirements for informed consent may be excluded at the discretion of the expedited reviewer so long as the project is not conducted or supported by a federal agency, must pose no more than minimal risk, and may not involve prisoners.

NOTE: At its discretion, the IRB may require Expedited or Full Committee Review for non-federal, minimal-risk projects.

(See IRB policy for information about consent requirements for greater than minimal risk research and for waiver/alteration of informed consent and waiver of documentation of consent.)

Requirements for Informing Participants about Exempt and Qualifying Minimal Risk Research

University and affiliate investigators conducting exempt, and qualifying minimal risk research must either

• explain why consent cannot be obtained from participants (e.g., no interaction between researchers and participants; no personal identifiers will be collected), or
• include a consent process that embodies key elements in the Belmont Report.

Equivalent Protections

The IRB reviews both federally funded research and non-federally funded research. The University applies the concept of respect for persons in the Belmont Report to informed consent for exempt and qualifying minimal risk research. Unless informed consent is not a reasonable requirement given study design (e.g., records reviews), investigators, Research Integrity & Security staff, and the IRB are required to ensure

• prospective participants are told that research participation is voluntary;
• prospective participants have sufficient information to make an informed decision about participation; and
• recruitment and consent processes are free from undue influence and coercion.

Review of Informed Consent for Exempt and Qualifying Minimal Risk Research

Research Integrity & Security staff (for exempt research) and IRB members (for qualifying minimal risk research) will assess the descriptions of the consent process and consent materials to ensure the requirements inherent in the concept of respect for persons are met.

Research Integrity & Security staff and IRB review determinations are documented through completion of the relevant review worksheet. The worksheets are attached to the specific submissions in IRBNet.

Approved Consent Materials

Research Integrity & Security staff date-stamp approved consent materials, including information sheets. The approved, date-stamped versions are added to the relevant project/package in IRBNet as Board Documents. Researchers must use the approved, date-stamped versions when enrolling participants.