Waivers & Alterations of Informed Consent

When a research study or component of a research study meets specific criteria, a researcher may request that the IRB waive the requirement for informed consent or approve a consent procedure that omits or alters elements of informed consent.

A waiver of informed consent allows a researcher to conduct human subjects research without obtaining informed consent from participants. The waiver may apply to an entire study or to particular study components; it may apply to all participants or only some participants. Situations in which a waiver of consent may be approved include:

• Collection and analysis of medical record information, with no participant interaction.
• Secondary analyses of existing datasets or specimens.
• FDA regulated investigation of in vitro diagnostic devices using anonymous tissue specimens

An alteration of informed consent allows a researcher to omit some or alter some or all elements of informed consent. Situations in which an alteration of consent may be approved include:

• Asking participants to do specific research activities, such as fasting or completing baseline questionnaires, before they provide consent to take part in the study as a whole.
• Requesting consent to retain identifiable information for research analysis from individuals who respond to eligibility screening questions but do not participate in the study. (See Eligibility Screening and Recruitment Elements and Scripts.)
• Omitting or altering certain consent information for scientific design reasons, such as omitting or altering the description of a study’s purpose to avoid expectation bias. (See Deception.)

Requesting a waiver or alteration of informed consent

To waive or alter informed consent, the IRB must find that all of the following criteria are met:

1. The research involves no more than minimal risk to the subjects;
2. The research could not practicably be carried out without the requested waiver or alteration;
3. 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;
4. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
5. Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

To request a waiver or alteration of consent, the ARROW application or study protocol should specify whether the waiver/alteration is requested for the study as a whole or for certain study activities or participants. The application or protocol should also describe how the research or research activities meet each of the criteria above. When requesting an alteration of consent, also submit the altered consent text for IRB review.

The IRB uses HRP-410 – CHECKLIST – Waiver or Alteration of Consent Process when reviewing such requests. Researchers can use this checklist for reference, to ensure that their application or protocol includes the information needed for IRB review.

Additional information

• Waiving the requirement for participant signatures to document informed consent (i.e., waiver of written documentation, waiver of signed consent) is separate from waiver/alteration of consent, with a different set of criteria. See Waivers of Signed Consent for more information.
• If HIPAA applies to a study that is requesting a waiver or alteration of informed consent, the ARROW application should also request a waiver, partial waiver, or alteration of HIPAA authorization. See Partial and Full Waivers of Authorization and Altered Authorization for more information.
• For FDA regulated studies, FDA guidance allows approval of waivers and alterations of informed consent when criteria (1), (2), (4), and (5) above are met, and for clinical investigations of in vitro diagnostic devices using anonymous tissue.
• Studies approved under the 2018 Common Rule may obtain information or biospecimens for the purpose of screening, recruiting, or determining eligibility without informed consent, if either of the following conditions are met:
  • The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or
  • The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.