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340. Informed Consent for Exempt and Minimal Risk Research

Updated June 7, 2024

Exclusion of Federal Requirements for Informed Consent for Exempt and Certain Types of 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 (IRB-Flex), DHHS requirements for informed consent do not apply to projects that are 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 IRB policy concerning review types.) 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 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.)

Informed Consent Requirements for Federally Funded and Non-Exempt Minimal Risk Research

Minimal risk research that is supported/conducted by a federal agency or involves prisoners or incomplete disclosure/deception must follow the Department of Health and Human Services (DHHS) requirements for informed consent. The DHHS requirements specify the following basic and additional elements of informed consent.

DHHS Basic Elements of Informed Consent

DHHS regulations require that all research participants be provided with the following basic elements of informed consent (at §46.116(b)):

  1. a statement that the study involves research, an explanation of the purpose of the research, the expected duration of participation, a description of the procedures, and identification of the experimental procedures
  2. a description of any reasonably foreseeable risks or discomforts
  3. a description of any benefits to the participant or to others that might be reasonably expected from the research
  4. disclosure of appropriate alternative procedures or courses of treatment, if any, that may be advantageous to the participant
  5. a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained including as appropriate:
    • what records may be examined by the sponsor, the IRB, other University personnel, FDA, or other regulatory agencies:
    • whether or not the data collected will be retained, and, if so, for what purpose and for what period of time, or when the data will be de-identified and/or destroyed,
    • what procedures will be put in place to ensure that unauthorized individuals will not have access to this information, and
    • the limitations (if any) to these confidentiality procedures such as legal reporting requirements for specific diseases and in the case of suspected child or elder abuse;
  6. for research involving more than minimal risk, an explanation as to whether any compensation and medical treatment are available if injury occurs to the participant and if so, what they consist of or where further information may be obtained
  7. identification of whom to contact for answers to questions about the research and the research participants' rights including whom to contact when the investigator may be unavailable or to discuss any other questions, complaints or concerns and whom to contact if the participant sustains a research-related injury
  8. a statement that research participation is voluntary, that the participant may discontinue participation at any time, and that the participant's refusal to take part or withdraw will not involve a penalty or loss of benefits to which the participant is otherwise entitled
  9. When the research involves the collection of identifiable private information or identifiable biospecimens one of the following statements must be included:
    • Identifiers might be removed and the de-identified information or biospecimens used for future research or distributed to another investigator without additional informed consent from the participant; or,
    • The participant's information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.

The IRB Consent Form and Consent Parent Permission Templates (available in IRBNet researcher libraries) include the required basic elements of informed consent.

DHHS Additional Elements of Informed Consent

DHHS regulations also require that when appropriate, research participants are provided with one or more of the following additional elements of informed consent (at §46.116(c)).

The need to inform participants of DHHS additional elements is determined by research design, participant populations, and level of risk. Investigators and the IRB must assess these factors for each project when considering if any of the additional elements are appropriate to ensure participants are fully informed.

When appropriate, as determined by the Principal Investigator (PI) or IRB, the following must be provided to participants:

  1. a statement that the treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant) which are unknown or currently unforeseeable
  2. anticipated circumstances under which the volunteer's participation may be terminated by the investigator without regard to the participant's consent or willingness to continue to participate;
  3. additional costs to the participant (or third-party payer) that may result from taking part in the research
  4. the consequences of the participant's decision to withdraw from the research and procedures for safe and orderly termination of participation
  5. a statement that significant new findings developed during the research which may relate to the participant's willingness to continue to participate will be provided to the participant
  6. the approximate number of participants involved in the study
  7. a statement that biospecimens (even if identifiers are removed) may be used for commercial profit and whether the participant will or will not share in this commercial profit.
  8. a statement about whether clinically relevant research results, including individual research results, will be disclosed to participants, and if so, under what conditions.
  9. a statement about whether the research project will or might include whole genome sequencing.

The Consent Form Instructions (available in IRBNet researcher libraries) address the additional elements, including circumstances in which the additional elements may apply.

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 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.

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 the basic elements for informed consent are omitted from the consent process.

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.

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.