This document describes options and circumstances for requesting a waiver of signed consent.
Waiver of Signed Consent
A request for waiver of signed consent, also known as a waiver of documentation of consent, means that the study team will obtain informed consent from participants but is not required to have them sign a consent form. IRBs may grant waivers of signed consent under the following circumstances:
Under the Common Rule, but not FDA regulations, the IRB also may grant a waiver of signed consent if it finds and documents that subjects or their 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 and there must be appropriate alternative mechanism for documenting that informed consent was obtained.
Please note that if the IRB waives the requirement for documentation of informed consent, it may still require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.
Two of the most common circumstances when study teams request a waiver of signed consent:
|4.1 Are you requesting a waiver of signed consent for all components of the study?||This should be answered "yes" or "no" depending on whether the waiver is being sought for all study activities. Note that as of January 21, 2019, study teams no longer need to request a waiver of signed consent for screening activities.|
|4.1.1 If no, list the component(s) of the study for which the waiver of signed consent is being requested.||If the waiver of signed consent is being sought for only part of the study, please list the study activity (or activities) to which it should apply.|
|4.2 If your study enrolls minors, are you requesting a waiver of signed assent and parental permission?||If the study activities for which the waiver of signed consent is requested apply to minor subjects, this question should be answered "yes." If the study does not enroll minors, "not applicable" should be selected.|
|4.3 Under which of the following criteria does this research qualify for waiver of signed consent?||The study team must select one of the option provided.|
|The 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. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern.||This criterion usually only applies to studies in which highly sensitive and/or stigmatizing information is being obtained. If the study team thinks that this is the correct option, they should consult the staff reviewer assigned to their application.|
|The 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.||This is the most common reason for a request for a waiver of signed consent. The IRB considers the rislevel of the research or activity for which the waiver of signed consent is requested. If the activity is minimal risk, a waiver can be approved even if the study as a whole presents more than minimal risk to subjects.|
|The research involves a distinct cultural group or community where signing forms in not the norm, and research presents no more than minimal risk of harm to subjects and there is an appropriate alternative mechanism for documenting that informed consent was obtained.||If this criterion is selected, it will be critical for the study team to provide information in 4.4 regarding which population(s) in the study represent a distinct cultural group or community and what mechanism they have in place to document that informed consent was obtained.|
|4.4 Provide a justification for the criterion selected above.|
For most studies, this justification should explain why the study activity for which the waiver of signed consent is requested presents minimal risk to subjects. This can address the fact that data security measures are sufficient to protect the data that are collected under the waiver from breach of confidentiality.
If the request is for a waiver for a distinct cultural group or community where signing forms in not the norm, provide support for this assertion, such as any data, published accounts or an expert opinions
Once this information is provided, an additional page displays in ARROW, Waiver of Signed Consent: Continued. This table is intended to assist study teams in completing the Waiver of Signed Consent: Continued page:
5.1 Describe the consent process (e.g., oral consent or use of an information sheet).
This response should provide a detailed description of the consent process, such as a discussion over the telephone or indicated by a button on an online form. The description should include information on how and when the consent information will be provided to the subjects.
If the request for a waiver of signed consent was for a distinct cultural group or community where signing forms in not the norm, also describe the mechanism for documenting that informed consent was obtained.
5.2 upload a copy of the oral consent script or the information sheet.
The consent information that will be provided to subjects must be uploaded in the ARROW application, whether this information is provided orally via a script, on paper as an information sheet, as an introduction to a survey, etc. Note that consent scripts for phone screening may be uploaded on the Phone Screening page, rather than on the Waiver of Signed Consent page.