For use of the short form, the requirements are as follows:
- Add your site PI’s full name in the footer of the form.
- There must be a witness to the oral presentation.
- The witness will be fluent in English and the language of the subject.
- The subject or the subject’s LAR must sign and date the short form.
- The witness must sign and date both the short form and a copy of the standard cIRB approved consent form.
- The person obtaining consent must sign and date a copy of the standard cIRB approved consent form.
- A copy of the short form and standard cIRB approved consent form must be given to the subject or the subject’s legally authorized representative.
- For research involving children where the IRB requires that both parents/legal guardian provide parental consent, both parents/legal guardians should sign on the signature line.
- HIPAA authorization: Use of a short form consent does not satisfy the requirements for authorization of PHI under HIPAA. The investigator may consult with his or her institution to obtain a translated HIPAA authorization.
- Trial-specific information can be handwritten on top of the form.
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: