Informed Consent Process - The Short Form

The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46 and FDA regulations at 21 CFR part 50.

This requirement is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report.

45 CFR 46.117(b)(2) permits oral presentation of informed consent information in conjunction with a Short Form written consent document (stating that the elements of consent have been presented orally) and a written summary (Long Form) of what is presented orally.

Overview

Department of Health and Human Services and Food and Drug Administration regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing.

Where informed consent is documented in accordance with §46.117(b)(1), the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent. Subjects who do not speak English should be presented with a consent document written in a language understandable to them.

Alternatively, §46.117(b)(2) permits oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.

When this procedure is used with subjects who do not speak English, (i) the oral presentation and the short form written document should be in a language understandable to the subject; (ii) the IRB-approved English language informed consent document may serve as the summary; and (iii) the witness should be fluent in both English and the language of the subject.

At the time of consent, (i) the short form document should be signed by the subject (or the subject's legally authorized representative); (ii) the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and (iii) the short form document and the summary should be signed by the witness. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.

IRB Review

The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of §46.117(b)(2). Requests may be made at initial approval or via a modification, as submitted by the Principal Investigator (PI) or their proxy, in ZOT IRB. When Short Forms are not requested at initial review a modification must be submitted in ZOT IRB for IRB review and approval of their use.

Greater than minimal risk research: Expedited review of the use of Short Forms is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.
For minimal risk research, modifications may be reviewed at subcommittee.

Required Translation

Per UC Irvine policy (HRP-090), once confirmed eligible to participate, a translation of the Long Form must be made within 1 month’s-time. The translated Long Form must be submitted in ZOT IRB for IRB review and approval, prior to providing to the subject.

Greater than minimal risk: A professional or certified translation is required. A certificate or evidence of education, native language fluency is required.
Minimal risk: Professional or certified translation not required; the IRB will accept documents translated by an individual fluent in the language. A letter or statement from the translator describing their qualifications must be provided.

When to Request Short Forms

When specific language translations are not anticipated
When the process may be the best way to facilitate informed consent

Examples:

- Low literacy, low numeracy
- Physical or sensory disabilities (unable to talk, write, hearing, visual loss and unable to use other reasonable accommodations)

Definitions for this Webpage

Witness The role of the witness may be served by a member of the IRB or may be an impartial third party. A witness must be an adult who is not a member of the study team and who is not a family member of the subject. The witness and the interpreter may be the same person. The witness may not be a person involved in the design, conduct, or reporting of the research study.
In cases where the interpreter or translator is an impartial third party to an oral / IRB approved short form consent process but is not physically present (e.g., a virtual consent process), the family member of the participant may be allowed to serve as a witness. The family member serving as a witness must be fluent in both English and the language of the participant.