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.

  1. 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.
  2. 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.

Witness:

  • 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

Subject:

  • Sign Short-form Consent

Investigator Conducting Consent Process:

  • Sign the Summary of the Oral Presentation

Examples

Consent Form Short Form Example

Short Form Consent Oral Presentation/Script Example