For use of the short form, the requirements are as follows: (Updated 1-26-21)
- Short forms may be used in SIREN trials when the participant or LAR being asked about consent is not fluent in English or a language into which the long consent version has already been translated and approved.
- The study staff obtaining consent must use an interpreter (or must speak the language of the person providing consent) for this process. Interpreters are no longer required to sign the consent forms.
- There must be one or more witnesses to short form consent process. Witnesses may be almost anyone (such as clinical staff, family members, the interpreter, or other study staff). A witness cannot be the study staff obtaining consent or the person providing consent. A witness may speak English or the language of the participant or LAR.
- With the help of the interpreter, the study staff obtaining consent must verbally review the content of both the short consent form and the English long form (which is used as a supplemental information sheet in this process). Any questions from the person providing consent should be answered.
- To document consent in the short form process, the person providing consent (the participant or LAR) signs and dates the short form written in the language that they understand. A witness also signs this form.
- In addition, the study staff obtaining consent must sign and date the English language long form used as supplemental information. A witness also signs this form. The witness may sign anywhere on the form. A witness signature line is not needed. The person providing consent (participant or LAR) does not sign the long form.
- The person providing consent should be provided copies of both the short and long forms. Trial specific information, such as the study team contact, can be handwritten on the short form as well if desired.
- If a supplemental HIPAA authorization document is needed at your site, then this must be obtained separately from the short form, following your institutions rules for translation.
- As with any paper consent form, a photo or scanned PDF of both the signed short form and the signed long form must be uploaded for monitoring as instructed by the Clinical Coordinating Center.
Studies conducted under the Revised Common Rule: The short form must state that the elements of informed consent required by the regulations (21 CFR 50.25 and 45 CFR 46.116) have been presented orally to the subject or the subject’s legally authorized representative, and that the key information required by 45 CFR 46.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided.
Available Short Forms: