Consent Waivers

Waiver or Alteration of Consent

Some research projects would not be possible if informed consent from research participants were required. The IRB may consider waiving the requirement for some or all of the elements of informed consent (45 CFR 46.116(d) and as allowed by the FDA).

The regulations state that informed consent may be waived in full or in part if the IRB determines that:

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

For federally funded studies approved by the IRB on or after January 21, 2019, the IRB must also determine that:

• If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably carried out without using such information or biospecimens in an identifiable format.

To request a waiver or alteration of informed consent for your research project, submit a Waiver of Consent Supplement with your study application to the IRB.

An example of a type of study that may qualify for a full waiver of consent is a retrospective chart review to look at a large number of patient records.

For FDA studies, activities limited to determining eligibility of potential participants may qualify for a partial waiver of consent.

Waiver of Documentation of Consent

In some situations, the IRB may waive the requirement for obtaining a signed Informed Consent Document (45 CFR 46.117(c) and 21 CFR 56.109(c)(1)). The regulations state that the requirement for a signed consent form may be waived if the IRB determines that:

• 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 or LAR will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern; or
• 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.

Effective January 21, 2019, the IRB may also permit a waiver of documentation of consent:

• If the participants or LARs 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 participants and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

For FDA-regulated studies, only the second criterion is permitted as a reason to waive documentation of consent.

To request a waiver of documentation of consent for your research project, indicate your consent plan in your study application to the IRB.

Examples of types of studies that fall into the first category are survey or interview studies that contain highly sensitive (e.g., criminal behavior, sexual behavior) questions.

Studies that fall into the second category are mailed-out surveys about topics that could not reasonably damage a research participant's reputation or employability or be otherwise stigmatizing.

Waiver of documentation of consent may mean that no written document is provided to the subject at all, for example, in a random-dial telephone survey study. In this type of study, the telephone interview would begin with a script that includes all of the required elements of consent, but the study subjects would receive no written information about the study, either before or after the interview. The telephone script containing the elements of consent must be included with the study application to the IRB.

On the other hand, the waiver of documentation of consent may mean only that the subject's signature does not have to be obtained. The regulations stipulate that the IRB may still require that the investigator provide the subject with a written statement about the research when granting a waiver of documentation. For example, in a mailed-out survey study, the IRB may determine that it is reasonable for the investigator to provide the subjects with a cover letter containing all of the basic elements of consent. The letter would simply conclude with a statement that returning the survey or questionnaire would be considered agreement to participate.

Eligibility Activities without Consent

Effective January 21, 2019, under the 2018 Requirements of the Common Rule [45 CFR 46.116(g)]:

An 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 participants without the informed consent of the prospective participant or the LAR, if either of the following conditions are met:

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

To request to determine eligibility of participants without obtaining informed consent, indicate your consent plan in your study application to the IRB.