IRB and Signatures for the Documentation of Consent
Requirements for Signatures on Documentation of Consent
Exempt IRBs
Exempt IRBs do not require documentation of consent. The subjects still need to have a consent document presented to them, with all the required information, but no signature is needed.This is one reason we work to keep online surveys at the Exempt review level - since no signature is needed, the problematic logistics of meeting to obtain it can be avoided.
Digital signatures are not accepted at this time by the Texas A&M University System for Documentation of Consent regarding IRB subjects unless we can meet the validation requirements.
We can accept digital or scanned signatures for internal forms, for IRB (and other protocol) submissions, but for a participant in research, we cannot accept their signature on an Informed Consent document.
Expedited and Convened IRBs
Expedited and Convened reviews usually DO require documentation of consent:In these instances, the PI can request a waiver for documentation of consent if the reviewers both agree it meets the criteria in 45 CFR 46.102(g)(j)(l).
(1) An IRB (45 CFR 46.102(g)) may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following:
(i) That the only record linking the subject, and the research (45 CFR 46.102(j)) would be the informed consent form, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
(ii) That the research presents no more than minimal risk (45 CFR 46.102(l)) of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
(iii) If the subjects or 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 alternative mechanism for documenting that informed consent was obtained.
(2) In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research.