OPRS SOP 702: General Requirements Of Documentation Of Consent
This SOP outlines the requirements and acceptable methods for documentation of informed consent. The University of Illinois Urbana-Champaign Institutional Review Board (IRB) may also approve a waiver of documentation of consent under limited circumstances as outlined in this policy.
This policy applies to non-exempt human subject research conducted at the University of Illinois Urbana-Champaign. This policy applies to investigators obtaining adult consent and parental permission for participation in research.
A. A legally authorized representative (LAR) is an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. The University of Illinois Urbana-Champaign IRB will accept consent from an LAR given that the researcher has established that the consenting individual has legal authority to do so (provided the IRB determined there is adequate justification for the inclusion of an LAR in the consent process).
B. In this procedure witness means an individual who can attest to the identity of the person so entitled. The witness cannot be the person who obtained informed consent from the participant but may be another member of the study team or may be a family member.
Documenting informed consent occurs after the investigator or designated study personnel has conducted a consent process (i.e., explains the research, answers questions, etc.). The signature of the participant or the participant’s legally authorized representative indicates consent to participate. The signature of the person obtaining consent indicates that they conducted a consent process, and the research has been explained to the participant.
The University of Illinois Urbana-Champaign IRB may approve procedures for documentation of informed consent which involves (a) a written consent document signed and dated by the participant or the participant’s legally authorized representative; (b) a short form written consent stating that the required elements of informed consent have been presented orally; or (c) in limited circumstances, waiver of documentation of consent. It is the responsibility of the University of Illinois Urbana-Champaign IRB to determine whether the proposed method of documentation of consent or waiver of documentation of consent is appropriate in protocols that it reviews. Investigators must describe the method of documentation of consent or request a waiver of documentation of consent in the IRB application submitted.
1. Documentation of Informed Consent with a Written Consent Document
1.1. In most circumstances, the University of Illinois Urbana-Champaign IRB requires that informed consent is documented using a written consent document approved by the IRB. The written consent document should be signed and dated by the participant or the participant’s legally authorized representative prior to enrollment or any participation in the study. The investigator should allow the participant or the participant’s legally authorized representative 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 person signing.
1.1.1.The IRB may approve a process that allows the written informed consent document to be delivered by mail, electronic mail or facsimile to the potential participant or the potential participant’s legally authorized representative and to conduct the consent interview by telephone or video call when the participant or the participant’s legally authorized representative 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.
1.2. For all studies, including those involving veterans, IRB approval of the written informed consent is documented by an electronic stamp that indicates the date of the most recent IRB approval of the document. If the consent is amended, the date stamp must be that of the most recent approved consent.
1.3. For all studies, including those involving veterans, the written consent document must be signed and dated by:
- The participant or the participant’s legally authorized representative.
- The person obtaining the informed consent. The IRB may waive this requirement if no physical contact with the participant will occur.
1.4. For participants who cannot read, write, talk, or are blind [or whenever it is required by the IRB or sponsor], a witness should be present during an oral presentation of the consent process for the research and documentation of the process.
1.5. If a witness was part of the consent process:
1.5.1.Have the witness print their name on the consent document.
1.5.2.Have the witness personally print, sign, and date the consent document to attest that the information in the consent document and any other information provided was accurately explained to, and apparently understood by, the participant, and that consent and assent, if applicable was freely given.
2. Waiver of the Requirement to Obtain Written Documentation of the Consent Process
The convened IRB or a designated IRB reviewer using the expedited procedure determines and documents whether the waiver of written documentation can be granted by using the appropriate section of the Reviewer Checklist.
2.1. The IRB may waive the requirement for the investigator to obtain a signed consent document for some or all participants if it is not subject to FDA regulation and it finds either:
2.1.1.That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context; or
2.1.2.That the only record linking the participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each participant will be asked whether he/she wants documentation linking the participant with the research, and the participant's wishes will govern. In such cases, investigators must submit a description of the information that would be disclosed or a consent document for participants who wish to have their consent documented.
2.1.3.If the participants or the participant’s legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate mechanism documenting that informed consent was obtained.