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700-17-Informed Consent

Title: Informed Consent
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: Investigators are required to obtain and document legally valid informed consent from each participant before involving them in research.

The IRB reviews the research application and any written consent documents to ensure that the required elements of informed consent are included in the informed consent process. Additional information or language to be included in informed consent may be required based on the study.

The IRB Handbooks provide investigators with a checklist that outlines required elements.

The general requirements for informed consent are:

  • Before involving a human subject in research, the investigator must obtain informed consent from the prospective participant.
  • Consent is sought under circumstances that provide the prospective participant with sufficient opportunity to ask questions and consider whether to participate. Further, the possibility of coercion or undue influence must be minimized.
  • The information that is given to the prospective participant shall be in language understandable to the participant. See the IRB Handbook for details related to translated documents.
  • Any information that a reasonable person would want to have in order to make an informed decision about participation should be provided to the prospective participant.
  • Consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective participant in understanding the reasons why an individual may or may not want to participate in the research.
  • The information must be presented in sufficient detail and organized in a way that does not merely provide lists with isolated facts but rather facilitates the understanding of why one may or may not want to participate. 
  • No informed consent may include any exculpatory language through which the prospective participant is made to waive or appear to waive legal rights or releases or appears to release the investigator, a collaborating institution or sponsor, or USU from liability for negligence.
  • In seeking informed consent, the required elements of informed consent must be provided to the prospective participant.

Documenting informed consent occurs after the investigator or designated study personnel has conducted a consent process (i.e., explains the research, answers questions, etc.). Consent to participate may be gathered via a signature (including electronic) of the participant or via other electronic means approved by the IRB (for example, clicking a button on an online survey consenting to participate).

If documentation occurs in person, the signature of the person obtaining consent indicates that they conducted a consent process, and the research has been explained to the prospective participant.

It is the responsibility of the IRB to determine whether the proposed method of documentation of consent is appropriate in protocols that it reviews. Therefore, investigators must describe the method of documentation of consent in the IRB submission.

Purpose: This policy outlines the requirements for informed consent, the process, and its documentation.

Procedures:

  1. General Requirements for Informed Consent
    1. Based on the investigator’s proposal for obtaining informed consent, the IRB determines whether the plans for obtaining consent meet the general requirements for informed consent (see above). Documentation is made using the IRB Reviewer Checklist.
  2. Elements of Informed Consent
    1. The IRB determines whether the information provided to the potential participant includes the required elements of informed consent. Documentation is made using the IRB Reviewer Checklist.
    2. If the IRB determines any additional elements of informed consent should be included, it will be documented using the IRB Reviewer Checklist.
  3. Requirements for Informed Consent Process
    1. The IRB determines that requirements are included in the informed consent process. Documentation is made using the IRB Reviewer Checklist.
    2. In addition to information specifically required by applicable regulations, the IRB may require that information be given to the participants when, in the IRB’s judgment, the information would meaningfully add to the protection of the rights and welfare of participants.
  4. Documentation of Informed Consent with a Written Consent Document
    1. A written consent document presented in person should be signed and dated by the prospective participant prior to enrollment or any participation in the study. The investigator should allow the prospective participant adequate opportunity to read the consent document and ask questions before it is signed and dated. A copy of the document must be given to the prospective participant.
    2. The IRB may approve a process that allows the written informed consent document to be delivered by mail or email to the prospective participant and to conduct the consent interview by telephone or video call when the prospective participant can read the consent document as it is discussed. All other applicable conditions for documentation of informed consent must also be met when using this procedure.
    3. If presented in person, the written consent document must be signed and dated by:
      • The prospective participant
      • The person obtaining the informed consent

    4. Consent may be obtained electronically. For example, the presentation of an informed consent form in an online survey where the participant must click “agree” before proceeding.

Scope: This policy applies to investigators obtaining consent for participation in research.

Documents and Forms:

IRB Handbook - Doctoral Student Edition

IRB Handbook - Faculty & Staff Edition

IRB Reviewer Checklist (available on IRB Google Drive)