Short Form Consent
The consent process, whether written or oral, must cover all basic elements unless a waiver is formally requested.
The short form is most useful when a study is complex and the investigator can't be sure that a signed written consent is understood well enough to indicate a valid consent process. The short form allows the individual obtaining the consent to engage in a continuous dialogue with the subject to ensure fully informed consent.
For IRB approval, two documents must be submitted for short form consent.
- One is a summary of the oral presentation of the elements of consent required by 45 CFR 46.116. After the consent process that includes an oral description of the research to the subject, a written copy of the summary should be signed by a witness to the oral presentation certifying that all the points in the summary were covered during the consent process. The subject does not sign the summary but must receive a copy of it.
- The second document is the short form itself that states that the elements of informed consent have been presented orally to the subject or a legally authorized representative (e.g., Dr. Smith told me the purpose of the study; Dr. Smith told me what the risks of this study are). The short form must be signed by the subject or a legally authorized representative and by a witness to the oral presentation.
- Observe the Oral Presentation of Informed Consent Information to the Subject
- Sign and date the Short-form Written Consent
- Sign a copy of the Summary of the Oral Presentation
- Sign Short-form Consent
Investigator Conducting Consent Process:
- Sign and date the Summary of the Oral Presentation