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• Consenting Participants

Consent Process for Participants

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.

• 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.
• Consent documents should be maintained by the PI for at least 3 years beyond the end of the study.
• Information about obtaining consent can be found on the HHS website.

WILLIAM & MARY ICF TEMPLATe

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.

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

Types of Informed Consent Processes/Forms

Types of consent

Signed Consent/Informed Consent Form (ICF) 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 Common in most Internet-based research Participants are still given all the information that would've been presented in a "signed consent" Requires a waiver of documentation of informed consent and must meet the requirements stipulated by the HHS to waive consent

Oral/Verbal Consent 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 Requires a waiver of documentation of informed consent and must meet the requirements stipulated by the HHS to waive consent See guidance on how to administer informed consent verbally

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