Informed Consent

Overview

Informed consent is one of the most important documents involved in the research process. This document tells your participants what they can expect by taking part in your research study. The IRB provides instructions and templates to ensure that you include all of the federally-mandated information.

More information is available below:


Consent Waivers

There are two waivers that may apply to your research study, depending on what you are proposing:

Waiver of Informed Consent Elements

Research Involving Deception

If you plan to conduct research involving deception, it may be reasonable for you to withhold certain information or modify the consent form. More information can be found on the deception research page:

Archival (Secondary) Data

  • If an investigator receives secondary data about human subjects or biological samples from human subjects where no possible personal identifiers are transferred to the researcher, you may not need to provide a consent document. The source of the data, however, must be disclosed in the application.

Waiver of Signatures on the Informed Consent Document

Anonymous Questionnaires and Surveys

  • If the only link to the subject would be the signed consent document, the requirement to collect signatures can be waived because the participant is better protected without the existence of a signed document.

Obtaining Consent from Minors (Assent)

Studies involving minors (those under 18 years old) typically require parental consent as well as the child’s assent. The IRB provides templates for parent/guardian consent and assent to ensure that you provide all of the federally-mandated information.

The assent information must be explained to the child(ren) in a manner that is understandable for their age and developmental level.

  • In most cases, if the minors are high school age, assent and parental consent can be combined using the parental consent template.
  • For cases in which the minors are younger than high school age, they should be given an assent form and parents should receive a separate consent form specific to their child's participation.

For more information, review the IRB's minors in research policy:


Stamped Consent Documents

Once your study has been approved, your consent document will be stamped, saved as a PDF, and returned to you by email along with your approval letter.

Using a stamped consent document assures potential participants that your study has been reviewed and approved by the IRB.