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Are there adequate provisions for documenting consent?

Robert Hood

03/30/2008 10:08 am

Help for IRB Committee Members: Are there adequate provisions for documenting consent?

Belmont principle Respect for Persons
Where to start: initial application Consent section
Where to start: continuing review application Continuing review question O
Required IRB determinations Consent processes are documented in accordance
with regulatory requirements.
General Considerations IRB committee members, or reviewers using the expedited procedure, should evaluate whether consent will be documented in accordance with regulations.

To use the long form of consent documentation, reviewers must determine that:

  • The consent document embodies the basic and required additional elements of disclosure.
  • The participant or the participant's legally authorized representative will sign the consent document.
  • If the research is FDA-regulated, the participant or the participant's legally authorized representative will date the consent document.
  • A copy of the consent document will be given to the person signing the consent document.
  • The investigator will give either the participant or the representative adequate opportunity to read the consent document before it is signed.

To use the short form of consent documentation, reviewers must determine that

  • The consent document states that the elements of disclosure required by regulations have been presented orally to the participant or the participant's legally authorized representative.
  • A written summary that embodies the basic and required additional elements of disclosure.
  • There will be a witness to the oral presentation.
  • For participants who do not speak English, the witness is conversant in both English and the language of the participant.
  • The participant or the participant's legally authorized representative will sign the consent document.
  • If the research is FDA-regulated, the participant or the participant's legally authorized representative will date the consent document.
  • The witness will sign both the short form and a copy of the summary. The person actually obtaining consent will sign a copy of the summary.
  • A copy of the short form will be given to the participant or the legally authorized representative.
  • A copy of the summary will be given to the participant or the legally authorized representative.
Accreditation Element Element II.7.D: The Research Review Unit has and follows written policies and procedures requiring that the investigator has and follows a procedure for properly documenting informed consent.
Regulations 45 CFR §46.117, 21 CFR §50.25(a), 21 CFR §50.25(b), 21 CFR §50.27(a), 21 CFR §50.27(b), 21 CFR §56.111(a)(5)
Guidance OHRP Guidance on Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English; FDA Information Sheets: Frequently Asked Questions: Informed Consent Process
OHRP Guidebook OHRP Guidebook, Chapter 3: Basic IRB Review: Informed Consent

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