Guidance on Waivers of Informed Consent, Waivers of Signed Consent, and Altered Consent Processes

This guidance illustrates the differences of Waivers of Informed Consent, Waivers of Signed Consent and Altered Consent Processes.

Waiver of Informed Consent

Waiver of Signed Consent

Altered Consent Processes [anchor]


Waiver of Informed Consent

A request for waiver of informed consent means that the investigator wishes to eliminate the consent process altogether, either for the full study or for part of the study.  This option should be chosen in the following circumstances:

  1. The study team intends to conduct a medical record review prior to recruitment in order to identify potentially eligible patient subjects for the study.  This is often referred to as "pre-screening."  Click here [link to pre-screening guidance] for guidance about requesting a waiver of informed consent for this purpose.
  2. The research involves retrospective review of data with no interaction with subjects.  Retrospective data can include medical records and/or images, or data obtained from outside UW-Madison.  "Retrospective" means that the data are in existence at the time the application is submitted to the IRB.  Note: if the data review involves a small number of subjects, the study team may be required to obtain informed consent.
  3. The research involves obtaining existing biological specimens for analysis with no interaction with subjects.  Existing specimens can include fluid or tissue samples originally collected fro clinical purposes, for a previous study, or from outside UW-Madison.  "Existing" means that the specimens are in existence at the time the application is submitted to the IRB.  Note: if the sample analysis involves a small number of subjects, the study team may be required to obtain informed consent.
  4. Please note that a waiver of informed consent is not typically approved for research on data or specimens obtained prospectively.  When it is, there tend to be specific circumstances and/or a strong justification for the waiver.  These cases are reviewed individually, taking into account the full context of the research.

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

 2.1 Are you requesting a waiver of informed consent for all components of the study?  As noted above, a waiver of informed consent can apply to all or part of a study.  Please answer "yes" or "no," depending on whether the full study falls into the listed categories above or not.
 2.1.1 If no, list the component(s) of the study for which the waiver is being requested, (e.g., retrospective chart review).  If you are requesting the waiver only for part(s) of the study, e.g. pre-screening, please state which part(s) of the study the waiver will apply to.
 2.2 If your study enrolls minors, are you requesting a waiver of assent and parental permission?
  •  If data or specimens from minors will be included in the aspect(s) of the study for which you are requesting a waiver of consent, select "yes."
  • If data or specimens from minors will not be included in the aspect(s) of the study for which you are requesting waiver of consent, select "not applicable."
  • By selecting "no" to this question you are indicating that you plan to obtain assent and parental permission for obtaining data or specimens from minors.
 2.3 Provide a justification for how the following criteria for a waiver of informed consent will be met: 1) The study involves no more than minimal risk to the subjects; 2) The waiver will not adversely affect the rights and welfare of the subjects; and 3) The study could not practicable be carried out without the waiver.

 In response to this question, each criterion for a waiver of informed consent must be addressed.  If the waiver of informed consent is being requested for pre-screening, use the template language provided in this document [link to Consent Waiver for Pre-Screening].  If the waiver is being requested for another aspect of the study, the study team may use the following suggestions to address the justification criteria:

  1. The study likely poses minimal risk to subjects because the research activities are limited to use of retrospective data and/or existing specimens, and there are sufficient measures in place to protect the data and/or specimens.
  2. The research likely does not affect the subjects' rights and welfare because a) only those who have valid access to their medical records will collect study data, b) the subjects have previously consented to the use of their data/specimens for future research, or c) the study team will use only leftover material from clinical specimens that is not required for clinical care.
  3. It may be impracticable to obtain informed consent from subjects because the study team will not be interacting with the subjects and the data and/or specimens may be for a) patients who may no longer be seen at UWHC or, b) subjects of another study with which the current study team has no involvement.  Given the large number of data records and/or specimens to be included in the study, it would likely be difficult for the study team to contact the subjects in order to obtain informed consent.





Keywords:waiver of informed consent, waiver of signed consent, altered consent processes   Doc ID:50344
Owner:Faye L.Group:Health Sciences IRBs
Created:2015-04-13 09:25 CSTUpdated:2016-10-12 10:59 CST
Sites:Health Sciences IRBs
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