Short Form Consent Instructions & Examples
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
- 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
Investigator Conducting Consent Process:
- Sign the Summary of the Oral Presentation
Consent Form Short Form Example
Short Form Consent Oral Presentation/Script Example