335. Waiver/Alteration of Informed Consent and Waiver of Documentation of Consent

Updated August 31, 2026

In certain situations, the IRB may waive or alter the consent process in accordance with laws, regulations, codes, and guidance. When an IRB waives the requirement to obtain consent, it waives the entire requirement for consent, both the attributes of the consent process and the elements of disclosure. When an IRB alters the consent process, consent is still obtained, but the consent process or elements of disclosure differ from what is generally required. When the IRB approves a waiver or alteration of the consent process, records should document why the IRB judged that each criterion was met for the specific protocol being reviewed.

Except for exempt research and select minimal risk research where the IRB Flex policy may be invoked, University and Affiliate investigators must either (1) comply with DHHS requirements for informed consent at §46.116, items (a) - (b) and documentation of consent at §46.117 items (a) - (b) or (2) obtain prior IRB approval for a waiver or alteration of informed consent, and/or a waiver of documentation of consent as follows.

• Waiver/alteration of informed consent: Prior IRB approval is required when a consent process does not include or alters the DHHS-required elements of informed consent.
• Waiver of documentation of consent: Prior IRB approval is required when some or all participants will not be required to sign a written consent document approved by the IRB.

NOTE: The IRB must approve both a waiver/alteration of informed consent and a waiver of documentation of consent when a consent process does not include or alters the DHHS required basic/additional elements for informed consent and does not require participants to sign an IRB approved written consent document.

Investigators submit a Consent Waiver Request Form (available from the researcher library in IRBNet) to request prior IRB approval for a waiver/alteration of informed consent, waiver of documentation of consent, or both. In completing the form, investigators specify the type of request and provide study specific justifications to enable the IRB to determine that DHHS requirements for the specific waiver request are met.

FDA regulated studies only allow for waivers or alterations of consent and waivers of consent documentation in limited circumstances. Please see policy 101: FDA Regulations for the Protection of Human Subjects for additional guidance.

Requirements for a Waiver or Alteration of Consent

The IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that all the following conditions are met [45 CFR 46.116(f)(1)&(2)]:

• The research involves no more than minimal risk to the subjects
• The research could not practicably be carried out without the waiver or alteration
• If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format
• The waiver or alteration will not adversely affect the rights and welfare of the subjects
• Whenever appropriate, the subjects must be provided with additional pertinent information after participation

OR

• The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
• public benefit or service programs;
• procedures for obtaining benefits or services under those programs;
• possible changes in or alternatives to those programs or procedures; or
• possible changes in methods or levels of payment for benefits or services under
• those programs;
• The research could not practicably be carried out without the waiver or alteration

Waiver or Alternation of the Consent Process – Screening, Recruiting, Determining Eligibility

IRB may approve a research proposal in which an investigator will obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects without the informed consent of the prospective subject or the subject’s LAR, if either of the following conditions are met:

• The investigator will obtain information through oral or written communication with the prospective subject or LAR, or
• The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

The study recruitment/screening method should be outlined in the research protocol. There is no requirement to request a waiver of the informed consent process for these screening activities; however, a request for a waiver of HIPAA authorization is still required if accessing identifiable private information.

Waiver of Documentation of Informed Consent

The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds any of the following:

• Only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality, and the research is not FDA-regulated.
  Note: Subjects must be asked whether they want documentation linking them with the research, and their wishes must govern. Example: domestic violence research where the principal risk is discovery by the abuser that the subject is talking to researchers.
• Research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. Procedures such as non-sensitive surveys, questionnaires and interviews generally do not require written consent when conducted by non-researchers. This criterion applies to FDA regulated research. Or;
• If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects, the research is not regulated by the FDA, and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

Documentation of Consent for Online Research

It is challenging and often impractical to ask participants who participate in online research to provide the researchers with a signed consent form. Nonetheless, the DHHS requirement for documentation of signed consent or IRB approval for a waiver applies to:

• online research that poses greater than minimal risk; and
• minimal risk online research which does NOT qualify for the University's IRB-Flex policy (i.e., research that is conducted or supported by a federal agency or involves prisoners).

PIs conducting online research to which the DHHS requirement for documentation of informed consent applies, are advised to contact Research Integrity & Security to

• discuss reasonable mechanisms for obtaining participants' signatures on written consent documents, or
• determine if the research may meet one of the two DHHS categories (see above) for the IRB to approve a waiver of the requirement for documentation of consent.

Additional Considerations for Information Sheets/Scripts

Under DHHS regulations, when the IRB approves a waiver of the requirement for documentation of consent, the IRB may (and usually does) require PIs to provide participants with a written statement about the research (see consent information sheet template in the research library in IRBNet) but the IRB may approve use of a script to orally inform prospective participants about the research (in lieu of a written statement). In the latter case, the IRB may require PIs to provide written information for contacting the investigator and the University Research Integrity & Security.

NOTE: When the IRB approves a waiver of the requirement for documentation of consent but the information sheet/script does not contain all of the DHHS required elements for informed consent, the IRB must also approve an alteration of the DHHS requirements for informed consent.

1. The Consent Form Template (available in the IRBNet researcher library) contains all of the DHHS required elements for informed consent. If this template (in its entirety sans signature lines) is used to prepare an information sheet, the investigator need only request IRB approval for a waiver of documentation of consent.
2. The Consent Information Sheet or Script Template (available in the IRBNet researcher library) does not contain all of the DHHS required elements for informed consent. If this template is used to prepare an information script or sheet, the investigator must also request IRB approval for an alteration of informed consent.

Documentation of IRB Decisions Related to Informed Consent and Consent Waivers

The IRB documents its justification for waivers or alterations of consent and waivers of consent documentation within the reviewer worksheet for expedited review and within the full board meeting minutes for studies reviewed by the convened board.