Informed Consent

Federal regulations require that researchers obtain legally effective, documented, voluntary informed consent from prospective subjects (or subjects' legally authorized representatives) before subjects may be included in research.

The primary purpose of informed consent is to protect the prospective human subjects. Informed consent provides the individual with the pertinent information regarding the research in which s/he is being asked to participate, and the opportunity to make an informed decision regarding whether or not to participate in the research. 

Keep in mind that obtaining informed consent is a continuous process throughout the research, not simply a one-time event when a subject signs a form.

To ensure informed consent, researchers should:

  • Work to communicate clearly and effectively with their participants and to build trust and cooperation.

  • Openly and willingly explain their research, answer questions, and be sensitive to the needs and concerns of their prospective research participants.

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The informed consent form

Obtaining informed consent is most often accomplished through an informed consent form that each investigator creates for his/her particular research project.

The informed consent form documents the information regarding the research which the subject has been given, and his/her agreement to participate in the research. For guidelines on how to create an informed consent form, see Elements of Informed Consent and Sample Informed Consent Form

Waiver of documented informed consent

When the use of an informed consent form would be impractical or detrimental to the study, a waiver may be requested. Federal regulations allow an IRB to waive the requirement to obtain written documentation of informed consent for some or all subjects under either of the following circumstances:

  1. When the consent document would provide the only link to the subject and the principal risk of the research would be a breach of confidentiality.

  2. When the risk to the subjects is minimal and consent would not be required outside the research context.

If you would like to request a waiver of informed consent, explain in your protocol how one or both of the above circumstances apply to your research. Be sure to clearly explain why you believe your research qualifies for the waiver.

Where the IRB waives the requirement for documented informed consent, investigators must understand that they are still required to communicate all the required elements of informed consent to their subjects and that the subject's active consent must be obtained before proceeding with the research.

Examples of projects that might qualify for a waiver of informed consent include online anonymous surveys, telephone surveys and some group research.

Information sheets in lieu of documented informed consent

In cases where documentation of consent is waived, the IRB may require investigators to provide subjects with a written statement regarding the research called an Information Sheet.

The information sheet generally includes all the elements of informed consent without requiring the subject's signature.

Research involving deception

The use of deception limits the subject's ability to make a fully informed decision of whether to participate in the research -- one of the essential ethical concerns in human subjects research -- and a waiver or alteration of informed consent must be requested by the IRB whenever deception is planned.

For more information regarding the use of deception in human subjects research, see the IRB's Deception webpage.

Research involving children

Research involving minors (non-emancipated subjects < 18 of age) involves special considerations and federal regulations require certain additional protections for children involved as subjects in research.

For guidance, see:

HHS Code of Federal Regulations 45 CFR 46 Subpart D

HHS IRB Guidebook

HHS Research with Children FAQ

Further guidance regarding the informed consent process