340. Informed Consent for Exempt and Minimal Risk Research

Updated July 1, 2019

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

Research that is exempt under 45CFR46.101 is also exempt from 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 (IRB-Flex) DHHS requirements for informed consent do not apply to projects are that eligible for IRB-Flex Exempt Review. IRB-Flex exempt projects cannot be conducted or supported by a federal agency, must pose no more than minimal risk, and may not involve prisoners or incomplete disclosure or deception. (For examples of projects that meet the criteria for flex-exempt review, see IRB-Flex for Exempt Research in the Review Types policy.) NOTE: At its discretion, the IRB may require Expedited or Full Committee Review for non-federal, minimal-risk projects.

Additionally under IRB-Flex, federal requirements for informed consent do not apply to minimal risk research that is neither supported/conducted by a federal agency, nor involves prisoners or incomplete disclosure/deception. Consequently, under IRB-Flex:

  • The IRB is not required to approve a waiver/alteration of informed consent when consent processes do not include some or all of the basic elements of informed consent.
  • The IRB is not required to approve a waiver of documentation of consent when investigators will not obtain participants' signatures on a written consent form.

(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 (both DHHS and Flex-Exempt categories), and qualifying minimal risk research (i.e., per IRB-Flex) 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 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, RI 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

RI 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 aforementioned requirements inherent in the concept of respect for persons are met.

Per IRB-Flex for qualifying minimal risk research, the IRB is not required to approve a waiver/alteration of informed consent when some or all of the basic elements for informed consent are omitted from the consent process.

Also per IRB-Flex for qualifying minimal risk research, the IRB is not required to approve a waiver of documentation of consent when investigators will not require participants to sign a written consent form.

RI 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

RI 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.