Short Form Consent

The consent process, whether written or oral, must cover all basic elements unless a waiver is formally requested.

A short form consent is used when the participant or legally authorized representative is verbally presented the elements of informed consent.  This is most useful when a study is complex.  The short form allows the individual obtaining the consent to engage in a continuous dialogue with the participant. 

Download the following template and adapt according to your research. Appropriate documents need to be submitted with the IRB.

Short Form Consent Template

For IRB approval, two documents are required for short form consent.

1. The oral summary of the elements of consent required by 45 CFR 46.116.
   1. Provide the document to the IRB in English and in the participant's preferred language.
2. The short form consent that states the elements of informed consent have been orally presented to the participant or a legally authorized representative
   1. Provide the document to the IRB in English and in the participant's preferred language.

Participant or Legally Authorized Representative

• Sign and date short form consent
• Provided with the signed copy of the short form consent and oral summary

Witness

• Observe the oral presentation of informed consent 
• Must understand both English and the participant's preferred language
• Must not be a part of the research team or involved in the research
• Sign and date the short form consent and oral summary

Individual Obtaining Consent

• Verbally presents the elements of informed consent
  • Research team may use a translator to obtain consent
  • A second individual is still required to serve as the witness
• Sign and date the oral summary