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

Updated May 27, 2021

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, and the exceptions noted below for greater than minimal risk research, 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 information to enable the IRB to determine that DHHS requirements for the specific waiver request are met or an activity in greater than minimal risk research represents one of the exceptions noted below.

Informed Consent for Greater than Minimal Risk Research

Under DHHS regulations and University policy, greater than minimal risk research is always subject to the DHHS requirements for informed consent and documentation of consent unless the activity falls under one of the two exceptions noted below.

Exception 1: Under the University's IRB Flexibility Policy (IRB-Flex), the IRB may approve a waiver/alteration of informed consent, waiver of documentation of consent, or both for minimal risk components of a research study that otherwise poses greater than minimal risk (e.g., review of records to identify eligible participants or use of a benign questionnaire to screen for eligibility).

Exception 2: Under DHHS regulations at §45.117, item (c)(1), the IRB may approve a waiver of documentation of consent for greater than minimal risk research if the three following conditions are true:

The IRB finds and documents that the only record linking the participant and the research would be the consent document.
The principal risk would be potential harm resulting from a breach of confidentiality.
Each participant will be asked whether she/he wants documentation linking her/him to the research and the participant's wishes will govern.

Both exceptions require the investigator to submit the aforementioned consent waiver form to obtain prior IRB approval for the waiver/alteration of consent or waiver of documentation of consent.

Waiver or Alteration of the Consent Process – Obtaining Consent Not Practicable

DHHS regulations specify the conditions under which the IRB may approve a waiver/alteration of informed consent, a waiver of documentation of consent, or both for minimal risk research.

The IRB may approve a waiver/alteration of the requirements for informed consent for minimal risk research when all four of the following criteria are met:

The research involves no more than minimal risk to participants.
The waiver/alteration will not adversely affect the rights and welfare of participants (i.e., the research or specific components to which the waiver/alteration applies are designed to protect participant privacy, interests, and well-being).
The research could not practicably be carried out without the waiver/alteration (e.g., due to the number or the age of records, it may not be feasible for researchers to contact all persons whose records will be reviewed for a study or the research design requires information about the study be withheld or altered when disclosed to participants).
Whenever appropriate, participants will be provided with additional pertinent information after completing the relevant research activity.

NOTE: The appropriateness of the latter criterion is determined by the reasons for the waiver/alteration. For example, when the IRB approves an alteration of the requirements for informed consent for research involving incomplete disclosure/deception, it is appropriate to provide participants with information after participation to both

inform the participants that incomplete disclosure/deception was used and
clarify the purpose/intent of the research.

The investigator must provide sufficient information for the IRB to determine the four criteria are met.

NOTE: Before approving an alteration of informed consent, the IRB will generally require researchers to provide participants with the information necessary to make an informed decision about participation in the research (e.g., study purpose, participants' experiences, statement of privacy/confidentiality); and information for contacting the PI and Research Integrity. (Investigators are encouraged to use the information script/sheet template available in the researcher library in IRBNet.)

Under IRB-Flex, the University limits the DHHS requirements for prior IRB approval for a waiver/alteration of informed consent, a waiver of documentation of consent, or both to three types of minimal risk research:

minimal risk research that is conducted or supported by a federal agency;
minimal risk research that involves prisoners (see online Policy Manual Definitions); and
minimal risk research that involves incomplete disclosure or deception.

All other types of minimal risk research may use equivalent protections in lieu of prior IRB approval for waiver/alteration of informed consent, waiver of documentation of consent, or both

(see IRB policies for informed consent requirements, Application of Regulatory Flexibility for Informed Consent, item 4; and informed consent for exempt and minimal risk research.)

NOTE: On a case-by-case basis, the University IRB retains the right to require any non-exempt minimal risk research to comply with DHHS regulations for informed consent and of same.

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

The investigator will obtain information through oral or written communication with the prospective participant or legally authorized representative, or
The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
The research is not regulated by the US FDA.

Waiver or Alteration of the Consent Process – Public Demonstration Project

The IRB may approve a waiver/alteration of the requirements for informed consent for research or demonstration projects conducted by or subject to the approval of state or local government officials when

The research is conducted by or participant to the approval of state or local government officials.
The research or demonstration protocol 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.
Possible changes in methods or levels of payment for benefits or services under those programs.
The research cannot practicably be carried out without the waiver or alteration.
The research is not regulated by the US FDA.

DHHS Requirements for IRB Approval of a Waiver of the Requirement for Documentation of Consent

DHHS regulations at §46.117 item (c) describe two conditions under which the IRB may approve a waiver of the requirement for investigators to obtain a signed consent form from each participant or her/his legally authorized representative before the participant's involvement in the research.

NOTE: When the IRB approves a waiver of the requirement for documentation of consent, investigators must still inform prospective participants about the research and obtain their agreement to participate. The waiver simply relieves investigators of the requirement for each participant or her/his legally authorized representative to sign a written consent form (approved by the IRB). The IRB may (and usually does) require the investigator to provide participants with a written information sheet.

DHHS regulations allow the IRB to approve a waiver of documentation of informed consent under either of the following two conditions.

Condition (Category) 1: The only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant must be asked whether the participant wants documentation linking the participant to the research, and the participant's wishes must govern.
Condition (Category) 2: The research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context.

Waiver of Documentation of the Consent Process – Confidentiality

Investigators requesting a waiver of the requirement for signed consent under Category 1 must provide the IRB with sufficient information to conclude that except for the risk associated with breach of confidentiality the research risk is minimal, and the risk of a breach has been sufficiently mitigated. Researchers must also provide the IRB with information about how they will identify each participant's preference related to documentation linking her/him to the research.

The only record linking the participant and the research will be the consent document.
The principal risk will be potential harm resulting from a breach of confidentiality.
Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
The IRB or EC will determine whether the researcher should provide participants with a written statement regarding the research.
The research is not regulated by the US FDA.

Waiver of Documentation of the Consent Process – Consent Normally Not Required Outside the Research Context

Investigators requesting a waiver of the requirement for signed consent under Category 2 must provide the IRB with sufficient information to determine the research risk is minimal and the research is not subject to other regulations or laws that require signed permission for the disclosure of the information that will be obtained for the research (e.g., the research does not invoke HIPAA for disclosure of medical records; FERPA for disclosure of education records; or organizational policy for disclosure of personnel records).

The research presents no more than minimal risk of harm to participants.
The research involves no procedures for which written document of the consent process is normally required outside of the research context.
The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
The IRB or EC will determine whether the researcher should provide participants with a written statement regarding the research. (Also applies to research regulated by the US FDA).

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 of same applies to

online research that poses greater than minimal risk; and minimal risk online research which does NOT qualify for the University's more liberal IRB-Flex consent processes (i.e., research that is conducted or supported by a federal agency or involves prisoners or incomplete disclosure/deception).

PIs conducting online research to which the DHHS requirement for documentation of informed consent applies, are advised to contact Research Integrity 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 (see Researcher Contact Template available in the researcher library in IRBNet).

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.

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.
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

For minimal risk research that is conducted or supported by a federal agency or that involves incomplete disclosure/deception, IRB members use a review worksheet to document their assessment of:

The research presents no more than minimal risk of harm to participants.
the type of waiver requested for informed consent,
criteria for approving a waiver/alteration of informed consent (when requested),
IRB-Flex exceptions to requirements for IRB approval of an alteration of informed consent, and criteria for approving a waiver of documentation of consent (when requested). The completed review worksheet is added to the relevant submission in IRBNet.