326. Short Form Written Consent Documentation
Updated Oct. 4, 2019
Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented in language understandable to the participant, that informed consent embody specific basic elements and required additional elements as applicable (45 CFR 46.116); and in most situations, that informed consent be documented in writing (§46.117).
However, the regulations at 45 CFR 46.117, item (b)(2) permit oral presentation of informed consent information in conjunction with a short form written consent document. The written document should state that the elements of consent have been presented orally, and that the key information required by §46.116(a)(5)(i) was presented first to the participant, before any other information was provided.
The short form written consent process does not apply when
- research is exempt, including IRB-Flex exempt;
- the IRB approves a consent procedure that waives or alters the DHHS requirements for informed consent as codified at §46.116, items (e) or (f);
- the IRB waives the DHHS requirement for documentation of informed consent as codified at §46.117, item (c); or
- the investigators expect the sample population to include participants who do not speak/read English.
NOTE: Whenever possible, participants who do not speak English must be provided with a consent document that is written in a language understandable to them. The approved English versions of consent documents must be translated and submitted for IRB review and approval, either as certified translations or “back-translations”).
Requirements for Short Form Written Consent Documentation
Short form written consent documentation requires the person obtaining consent to provide the participant or her/his legally authorized representative (LAR) with both
- an oral presentation of the research based on an IRB-approved written summary of the research that begins with the key information and includes the basic and required additional elements of informed consent (e.g., the English-language informed consent document); and
- an IRB-approved short form written consent document that states the key information, along with the basic and required additional elements of informed consent (at §46.116) have been presented orally to the participant or her/his LAR.
NOTE: Templates for the short form consent document and the English-language consent document (to be used for the “summary”) are available in the researcher library in IRBNet. )
Short Form Informed Consent Process
- An IRB-approved summary of the research and short form written consent document are presented orally to the participant/LAR.
- The oral presentation is witnessed by a person who is conversant in both English and the language of the participant.
- The participant/LAR signs the short form written consent document.
- The witness signs both the short form and a copy of the summary.
- The person obtaining consent signs a copy of the summary.
- The participant/LAR is given a copy of the signed short form.
- The participant/LAR is given a signed copy of the short form and the summary.