Obtaining informed consent from subjects prior to their participation in research is a basic, ethical obligation for the conduct of human subjects research. But some situations can make the possibility of getting consent from subjects unlikely. There are three types of waivers of consent that the UI IRB may grant with the required and appropriate justification.

Full Waiver of Informed Consent

With a full waiver of informed consent, there is no consent document or consent process. Subjects are not given information about the study or a choice about whether their data or specimens can be used for research purposes. This type of waiver is commonly granted for retrospective record reviews, use of archived specimens or secondary data analysis. This type of waiver cannot be granted if data or specimens will be collected prospectively or if the study involves a drug, device, biologic, or other product regulated by the Food and Drug Administration (FDA).

In order to grant this waiver, the principal investigator (PI) needs to demonstrate that ALL the following apply:

  • The research involves no more than minimal risk to the subjects.

  • It would be impracticable (not possible) to conduct the research without the waiver.

  • If the research involves the use of identifiable private information or biospecimens, and it would be impracticable (not possible) to conduct the research without the use of the identifiable information or biospecimens.

  • The waiver will not adversely affect the rights and welfare of the subjects.

  • Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

To request a full waiver of informed consent, select the ‘Yes, for all subjects’ option in Section IV.3 of the HawkIRB application. Additional questions will open for the PI to provide justification for the full waiver of consent.

In some instances, the PI may want to request a waiver of informed consent for some subjects but obtain informed consent from others. An example would be if a study involves a secondary data analysis of existing records along with the prospective collection of new data. In Section IV.3, select the ‘Yes, but only for some of the subjects’ and provide justification for the waiver of consent.

Waiver of Elements of Informed Consent

A researcher can request a waiver of one or more elements of informed consent when they need to withhold certain information about the study that might affect how subjects participate in the study. Examples might be if the researcher wanted to withhold the true purpose of the study or tell the subjects that they will be working with another study participant when actually, they will be working with a trained, study confederate.  This is called a “deception” study when there is incomplete disclosure of information prior to or during the conduct of the study. There is still a consent document and consent process, but subjects do not receive complete information about the purpose or study procedures prior to giving consent. Researchers may also wish to request a waiver of elements for parental consent. For example, a study may request to waive parental permission for teen mothers who are enrolling their children and will also be subjects in the study.

There are a few things to be aware of when requesting a waiver of one or more elements of consent. The PI will need to complete Section IV in the following manner to request this waiver:

  • IV.3—select ‘Yes, but only for some of the subjects’ so that the sections of the application about recruitment, consent and study procedures remain open.
  • IV.5—select “Other” and put “waiver of elements of consent” in the open text field and describe what information will be withheld from subjects.

The remainder of the questions in Section IV are the same as the questions for a full waiver of informed consent. The PI must provide an adequate justification for the waiver of elements of informed consent.

Waiver of Documentation of Consent (45 CFR 46.117)

With a waiver of documentation of consent, there is still a consent document and consent process, but subjects do not sign the document. Instead, subjects verbally agree to participate, or click a button in a web-based survey or complete the research activities.

There are three circumstances in which the IRB may waive the requirement for the investigator to obtain a signed informed consent form from some or all subjects if any of the following conditions apply:

  • The only record linking the subject and the research would be the informed consent document and the principal risk would be the potential harm resulting from a breach of confidentiality.
  • 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.
  • If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

The study must meet all parts of the at least one option above to be considered by the IRB.

The PI requests a waiver of documentation of consent in Section VII.D.16-18 of the HawkIRB application. Select the appropriate category in Section VII.D.17 and provide justification for the request in Section VII.D.18.

In studies with more than one subject population, a waiver of documentation of consent may not be appropriate for all subjects (e.g. a minimal risk study that involves both adult subjects and minor subjects). The response to VII.D.18 should indicate for which subject population the waiver is requested. Research that involves the use of any protected health information (PHI) is not eligible for a waiver of documentation of consent.