Waivers of consent

In some circumstances, if appropriate criteria are met, the Institutional Review Board (IRB) may waive informed consent requirements. This could include:

  1. Waiver of consent - waiver of the requirement to obtain informed consent; or,
  2. Alteration - waiver of one or more of the required elements of informed consent; or,
  3. Waiver of documentation - waiver of the requirement to document informed consent (waiver of signature)

FDA regulated research 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.

Waiver of informed consent vs. waiver of documentation for informed consent

Waiver of Consent

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 information (1, 2)
  • Consent is not easily obtained (3)
  • Not necessary to provide subject with any pertinent information (4)

Alteration of Consent

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 "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 for Informed Consent

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).