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Waivers of consent

See information on informed consent

See information on consent of non-English speaking subjects

Waiver of Informed Consent versus Waiver of Documentation of Informed Consent

In some circumstances, if appropriate criteria are met, the IRB may waive informed consent requirements. This could be:
  • Waiver of consent - waiver of the requirement to obtain informed consent
  • Alteration - waiver of one or more of the required elements of informed consent
  • Waiver of documentation - waiver of the requirement to document informed consent (waiver of signature)
FDA regulated research (21 CFR 56.102(c); 21 CFR 312.3 (b)) is not eligible for waivers or alterations except in the case of emergency use or planned emergency research. In these cases there are many specific criteria that must be met (21 CFR 50.23; 21 CFR 50.24).

FDA Guidance: Exceptions from Informed Consent for Emergency Research

Waiver of Consent (45 CFR 46.116 (d))

If a waiver of consent is granted, the research can proceed without obtaining a subject's informed consent (none of the required elements of informed consent are presented) provided that the following criteria are met and documented by the IRB:
  1. The research involves no more than minimal risk to the subjects;
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  3. The research could not practicably be carried out without the waiver or alternation; AND
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation
Example: a retrospective chart review in which:
  • Researcher de-identifies the information (1, 2)
  • Consent is not easily obtained (3)
  • Not necessary to provide subject with any pertinent information (4)

Alteration of Consent (45 CFR 46.116 (d))


If an alternation of consent is granted, the IRB agrees that one or more of the required elements of informed consent can be eliminated or changed in some way provided the required criteria are met. The criteria are the same as for waiver of consent.
  1. The research involves no more than minimal risk to the subjects; 
  2. The waiver or alteration will not adversely affect the rights and welfare of the subjects; 
  3. The research could not practicably be carried out without the waiver or alteration; AND 
  4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Neither the regulations nor OHRP define what is meant by "practicable." However, the Secretary's Advisory Committee on Human Research Protections (SACHRP) has recommendations on what IRBs should consider when looking at the issue of whether the research could not practicably be carried out without the waiver or alteration (see number 4.)

Waiver of Documentation of Consent (45 CFR 46.117(c); 21 CFR 56.109)


If a waiver of documentation is granted some or all subjects, depending on the approval, do not have to sign a consent document. However, there is still the requirement to obtain their informed consent before beginning study related activities. The IRB may also require the investigator to provide the subject with a written statement of the research (instead of a copy of a signed consent).

The following criteria must be met:

  1. That the only record linking the subject and the research would be the consent document and the principle 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 criteria does not apply to FDA regulated research)
  2. That 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. 
  3. The FDA exceptions to the requirement for informed consent for emergency research are met (21 CFR 50.24). 
Example: phone/internet study (oral script) for a minimal risk survey
  • Research presents no more than minimal risk
  • Procedure does not normally require consent
  • IRB may require investigator to give subjects a written statement regarding the research

Requesting a waiver from the IRB


Ideally, all subjects participating in research should voluntarily agree and document this agreement by signing a document that contains all the required elements of informed consent. However, the nature of some research projects may make a request to waive all or some aspect of informed consent appropriate.

When requesting a waiver, it is important to know the differences between the waivers as well as the criteria for approval for each to determine which, if any, is appropriate for a particular project. When requesting, investigators should clearly specify to the IRB which waiver is being requested. For example, if a waiver of consent is requested, it is not necessary to also ask for a waiver of documentation. If the IRB agrees it is not necessary to obtain consent, then inherently documenting consent is also not required. However, if a waiver of documentation is requested and granted, there is still the requirement to obtain informed consent.

Waiver of consent or waiver of documentation of consent request form
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