Waiver of Signed Consent

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 investigator will obtain subject consent but will not have subjects sign a consent form.  This waiver can be requested either for the full study or for part of the study.  This option should be chosen in the following circumstances (these are the most common):

  1. The study team will conduct a survey, interview, or focus group and the study does not otherwise qualify for exemption.  Consent for this type of research can be indicated in a variety of ways, including verbally (usually over the phone or in person), clicking a consent button (usually used with online surveys),  or simply by submitting a completed survey.  The last example is termed "implied consent," and the consent information provided to subjects must state that return of completed surveys implies consent to participate in the study.
  2. The study team will conduct a preliminary screening process for basic eligibility. Eligibility screening requires a consent process, as it involves obtaining subject information for research purposes.  A waiver of signed consent is commonly requested when screening is done over the phone and consent for eligibility screening is given verbally.  Waiving signed consent may also be permissible for in-person screening, if the study team provides adequate justification for screening prior to obtaining written consent.

This table is intended to assist study teams in completing the Waiver of Signed Consent page:

 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 or not the waiver is being sought for all study 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, e.g. phone screening.
 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 typically the appropriate response for this question.  The IRB considers the risk level of the activity for which the waiver of signed consent is requested.  If the activity (e.g. screening) is minimal risk, a waiver can be approved even if the study as a whole presents more than minimal risk to subjects.
 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.

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 be a detailed description of the consent process, whether it will be verbal, implied, indicated by a button on a computer form, or whatever it is.  The description should include information on how and when the consent information will be provided to the subjects.
 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.

Keywords:waiver of signed consent, waiver, consent   Doc ID:49816
Owner:Monica E.Group:Health Sciences IRBs
Created:2015-03-31 14:24 CDTUpdated:2015-10-13 15:14 CDT
Sites:Health Sciences IRBs
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