Lesson 13 · IRB and HRPP Administration: From Coordinator to CIP

13. Documenting Consent: Short Form, Waivers, LARs, Assent, and eConsent

55 min

After this lesson you can

  • State the documentation requirements of 45 CFR 46.117 and 21 CFR 50.27
  • Apply the short form procedure, including who signs what
  • Apply the three waiver-of-documentation criteria in 46.117(c) and the two in 21 CFR 56.109(c)
  • Explain legally authorized representatives, assent, and parental permission mechanics
  • Describe electronic consent, the posting requirement in 46.116(h), and consent with non-English speakers

Video coming soon

Scheduled for release on September 29, 2026.

Documenting Consent: Short Form, LARs, Assent, and eConsent explains how consent is signed, witnessed, and recorded under 45 CFR 46.117 and 21 CFR 50.27. The consent conversation itself leaves no record, so this lesson focuses on the documentation that auditors and inspectors actually check.

5 Key Facts from This Lesson

  1. In the short form procedure, the subject signs the short form, the witness signs both the short form and the written summary, and the person obtaining consent signs the summary.
  2. A waiver of documentation is not a waiver of consent; consent is still obtained, but no signature is collected.
  3. HHS has three waiver-of-documentation criteria since the 2018 Requirements, while FDA has two.
  4. Consent forms for federally funded clinical trials must be posted after recruitment closes and no later than 60 days after the last study visit by any subject.
  5. A child's assent means affirmative agreement, and failure to object is not assent.

Exam traps

The distinctions exam questions on this topic are most often built to test. Know them cold.

  • Short form: the subject signs the short form only; the witness signs both the short form and the summary; the person obtaining consent signs the summary

  • Waiver of documentation is not a waiver of consent; consent is still obtained

  • Three waiver-of-documentation criteria under HHS since 2018; two under FDA

  • Under 46.117(c)(1)(i) the subject's wishes govern whether documentation is created

  • Posting deadline: no later than 60 days after the last study visit, after recruitment closes

  • Failure to object is not assent

Practice quiz

  1. Question 1
    Under the short form procedure in 46.117(b)(2), who signs the IRB-approved written summary?
  2. Question 2
    An IRB may waive documentation of consent under 46.117(c)(1) when:
  3. Question 3
    Which waiver-of-documentation criterion exists under 45 CFR 46 but NOT under 21 CFR 56.109(c)?
  4. Question 4
    Under 45 CFR 46.402(b), a child's assent means:
  5. Question 5
    Under 46.116(h), a consent form for a federally funded clinical trial must be posted publicly no later than:

Recap

  • Documentation: an IRB-approved written form, signed including electronically, with a copy to the signer; FDA adds signed and dated
  • Short form: subject signs the short form; witness signs both; person obtaining consent signs the summary
  • Waiver of documentation: three HHS criteria, two FDA criteria; consent still obtained
  • LARs under applicable law or institutional policy; assent is affirmative agreement; one parent for 404 and 405, both for 406 and 407 with four exceptions
  • eConsent under 46.102(m), 46.117(a), and Part 11; posting within 60 days of the last visit; translated forms or the short form for non-English speakers; a witness for subjects who cannot read

Coming next

Lesson 14, privacy, confidentiality, HIPAA, and Certificates of Confidentiality.

Saved in your browser only: no account, no server.

This course is for educational purposes only and is not legal, regulatory, or compliance advice. Regulations and guidance change, so confirm every requirement against the current eCFR text, OHRP and FDA guidance, and your institution's IRB policies before relying on it. CIP® is a registered certification mark of Public Responsibility in Medicine and Research (PRIM&R). This course is produced independently by Subthesis and is not affiliated with, endorsed by, or reviewed by PRIM&R or the CIP Council. The instructor is not a Certified IRB Professional. Completing this course does not confer CIP certification, satisfy CIP eligibility requirements, or count as CIP recertification continuing education.