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Informed Consent Forms and Process

Summary

Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP. The process begins with recruitment all the way to the end of their participation in the study.

Full Description

General Details of the Informed Consents

• All protocols must detail the informed consent process personnel will use if participants will be involved in the research study. Protocols must use the W&M-approved Informed Consent Form (ICF) linked below.
  • Exempt studies do not require signatures of partcipants, but a consent or study information sheet should be provided to participants prior to enrolling in the study. 
• Consent documents should be maintained by the PI for at least 5 years beyond the end of the study.
• Information about obtaining consent can be found on the HHS website.

Elements of an Informed Consent

HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements.

Key elements:

1. Disclosing to potential research subjects information needed to make an informed decision;
2. Facilitating the understanding of what has been disclosed;
3. Promoting the voluntariness of the decision about whether or not to participate in the research;
4. Document using a written document that provides key information regarding the research, i.e. ICF
5. The ICF should be updated when necessary (e.g. new risks, potential benefits, etc.)
6. Collection of identifiable information (e.g. audio/video recordings, PHI, etc.) should be made clear to the participant. If it is optional, the participant should be made aware that they can opt out of the collection of such information.
7. If using a wearable device or other technology to collected, please make sure to follow the guidance outlined in "Management and Retention of Data" informational page. 
   NIH Guidance and Sample Language

Once consent forms are approved, they will be "stamped." The stamped versions must be used when consenting participants.

Templates & Types of Informed Consent

Click on each header below to learn more about the various types of consents. Each type of consent has a template that can be used in each scenario. Note: The linked "templates" provide a skeleton of what should be included in your consent forms. Please adjust as you see fit.

Types of consent

Adult Informed Consent - Signed Consent/Informed Consent Form (ICF) Informed Consent for 18+ Participants Generally required for research with human participants Document is signed by participant and/or LAR and researcher/personnel administering the consent. If any collection of identifiable information is optional (i.e. audio recordings), provide a separate section in the form that allows the participant to agree or not agree to the collection of this information. Can be obtained electronically via AdobeSign or DocuSign. Collection of electronic consent must be stated clearly in your protocol submission. Anonymity for the participants cannot be guaranteed if you are collecting a signature from a consent!

Implied Consent (e.g. Online Studies) IMPLIED CONSENT TEMPlATE Common in most Internet-based research Online studies: Only for use with participants 18 years or older. A question verifying age must be included before the participant begins with the study. Online surveys and consents must be administered through an approved W&M platform (such as Qualtrics) Participants are still given all the information that would've been presented in a "signed consent" If expedited or a full board study: A waiver of documentation of informed consent is required, and the study must meet the requirements stipulated by the HHS to waive consent

Oral/Verbal Consent IMPLIED CONSENT TEMPlATE Researcher reads IRB-approved script and pt. gives verbal agreement Participants should be given an IRB-approved information sheet about the study The process should meticulously documented including who was present and date/time the consent was collected Witness should be present when oral consent is obtained and a signature of the witness should be collected If expedited or a full board study: A waiver of documentation of informed consent must be obtained; the study must meet the requirements stipulated by the HHS to waive consent See guidance on how to administer informed consent verbally

Consent of Minors and Parents/Guardian Permission Child Assent Template Parent/Guardian Permission Template Consent from minors (called "Child Assent") requires permission from a parent/guardian or legally authorized representative (LAR). Child Assent forms should be written to match the reading and comprehension level of your participant population. Assent is required for children between the ages of 7-17. Children younger than 7 should still be informed about the study and asked their permission. Signatures are not required for young children; however, the protocol submission should clearly document how consent will be obtained and how proof of consent will be recorded if no signatures are collected. Parent/guardian permission should be obtained for all studies involving minors. The parent/guardian should sign the permission form prior to the child assention.

Waiver of Documentation of Consent

"This means that the study team must provide a subject with the required consent information, but the study team is not required to obtain the subject’s signature on the informed consent document. A waiver of documentation is permissible when:

• The signature on the informed consent document would be the only record linking the subject to the research and the principal risk of harm to the subject would be a breach of confidentiality.  For example, for research on sensitive topics, such as domestic violence or illegal activities;
• The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.  For example, minimal risk research that involves surveys/interviews conducted via telephone or online.
• Where the participants are members of a cultural group in which signing forms is not a normal/acceptable practice." (from University of Michigan)

Informed Consent Exceptions

Per HHS regulations 45 CFR part 46, the investigator must obtain informed consent from the participant or their legally-authorized representative (LAR). Unless the research is....

1. Exempt under 45 CFR 46.101(b)
2. Informed consent can be waived (45 CFR 46.116(c) or (d), or
3. Meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) in emergency settings

OHRP Resources