Waiver or Alteration of Consent
Under certain circumstances, the IRB may consider waiving the requirement for some or all of the elements of informed consent.
The regulations state that informed consent may be waived in full or in part if the IRB determines that all of these criteria are met:
- The research involves no more than minimal risk to the subjects; and
- The research could not practicably be carried out without the waiver or alteration; and
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; 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, complete Section A or B of the Consent Supplement and submit it with your study application to the IRB.
Examples
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 (Waiver of the Signature)
In some situations, the IRB may waive the requirement for obtaining the participant's signature on an informed consent form. The regulations state that the requirement for a signed consent form may be waived if the IRB determines that:
- Option 1: 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. This is the only option allowed for FDA-regulated studies.
- Option 2: All of the following are true, and the study is not FDA-regulated:
- The consent form would be 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; and
- 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.
Effective January 21, 2019, the IRB may also permit a waiver of documentation of consent:
- Option 3: All of the following are true, and the study is not FDA-regulated:
- The participants (or LARs) are members of a distinct cultural group or community in which signing forms is not the norm; and
- The research presents no more than minimal risk of harm to participants; and
- There is an appropriate alternative mechanism for documenting that informed consent was obtained.
For FDA-regulated studies, only Option 1 above is permitted as a reason to waive documentation of consent.
To request a waiver of documentation of consent for your research project, complete Section C of the Consent Supplement and submit it with your study application to the IRB.
Examples
Studies that may fall into the first option above are mailed-out surveys about topics that could not reasonably damage a research participant's reputation or employability or be otherwise stigmatizing.
Examples of types of studies that may fall into the section option are survey or interview studies that contain highly sensitive (e.g., criminal behavior, sexual behavior) questions.
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.
For studies approved after January 21, 2019 (or that underwent de novo review after that date), there is no need to request a waiver to cover such eligibility activities. However, take careful note that this only applies to gathering of information, not to physical procedures such as a blood draw or ECG to determine eligibility.