Waivers in the Informed Consent Process

For most human subjects research there is a requirement to ask if potential subjects want to participate and to document their voluntary agreement to enroll in the study. Researchers provide an Informed Consent Document that contains specific information about the study. Researchers discuss the study, allow time for subjects to read the document and ask questions, and then obtain the subject’s signature on the form. However, there are exceptions to these regulatory requirements. For additional information related to the criteria for obtaining waivers of aspects of the informed consent process, see the UI IRB Standard Operating Procedures and Researcher Guide, Section II, Part 5.C.

Federal regulations allow an IRB to fully waiver informed consent or waive one or more required elements of informed consent.  Requirements for these types of waivers are provided below.

See also information about partial waivers of HIPAA authorization.


Under a full waiver of consent there is no informed consent document provided and agreement by the subject is not sought. With proper justification, the IRB may waive informed consent for minimal risk research when the waiver would not adversely affect the rights and welfare of subjects and the research could not practicably be carried out without the waiver (45 CFR 46.116(f)).

A full waiver of consent is commonly granted when there will be no contact with subjects, and data or specimens that researchers wish to use already exist and include identifiers (such as with medical record number). Secondary analysis of data where researchers do not have access to identifiable private information or identifiable biospecimens, or where data exist in aggregate form, are not considered human subjects research and so are not subject to regulations for obtaining informed consent. 

In the HawkIRB application, researchers requesting a waiver of informed consent should explain how they have access to the data and the inclusive dates of the data that will be used for analyses. The HawkIRB form should also include a list of all variables that will be included in analyses. 

Sometimes, researchers do not want to provide one or more of the pieces of information that is required to be presented to subject in the Informed Consent Document because it might affect subject behavior in the study. Under certain circumstances, researchers may request a waiver of one or more elements of informed consent. Under this type of waiver, there is a consent document and a consent process, but one or more required pieces of information is withheld from subjects. The IRB may require that pertinent information be given to subjects after participation, referred to as a debriefing.

Several situations where a waiver of elements of consent may be requested: 

  • If providing the purpose of the project might affect how subjects participate in the study.
  • When minor subjects will age-up to the legal age of majority (18 years of age) while data collection from the medical record is ongoing but there are no further contacts with subjects.
  • Waiver of parental permission for teen mothers who are able to give informed consent for their child to participate in the study.

Under a waiver of documentation of consent, an Informed Consent Document is provided but subject signature is not required. They may verbally indicate agreement to participate (such as in an in-person interview) or click a button to continue (such as in an online survey).

Under DHHS regulations (45 CFR 46.117(c)), a waiver of documentation of informed consent may be granted if the IRB determines that:

  1. The consent document would be the only record linking the subject to the study, and the principal risk of harm to the subject would result from a breach of confidentiality, and
  2. The research presents no more than minimal risk and involves no procedures for which written consent is normally required outside the research context, or
  3. Subjects or their legally authorized representatives belong to a cultural group or community in which signing consent forms is not the norm, provided that the research presents no more than minimal risk of harm and there is no other appropriate alternative mechanism for documenting informed consent was obtained.

Under FDA regulations (21 CFR 56.109(c)), a waiver of documentation of consent may be granted if the IRB determines that:

  1. 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, or
  2. Requirements in 21 CFR 50.24 for an exception from informed consent for emergency research are met.