Lesson 12 · IRB and HRPP Administration: From Coordinator to CIP

12. Informed Consent Elements, Key Information, Broad Consent, and Waivers

60 min

After this lesson you can

  • State the general requirements for informed consent in 45 CFR 46.116(a)
  • Recite the basic elements in 46.116(b) and the additional elements in 46.116(c)
  • Explain broad consent under 46.116(d) and its relationship to exemption categories 7 and 8
  • Apply the waiver and alteration criteria in 46.116(e) and (f), and the screening provision in 46.116(g)
  • Contrast FDA consent requirements in 21 CFR 50.20 and 50.25, including the 50.22 minimal risk waiver

Video coming soon

Scheduled for release on September 28, 2026.

Informed Consent Elements, Key Information, and IRB Waivers covers everything a consent form must contain under 45 CFR 46.116, from the key information section to broad consent and the waiver criteria. It also shows where FDA's 21 CFR 50.25 differs from the Common Rule.

5 Key Facts from This Lesson

  1. Since the 2018 Requirements there are nine basic elements of consent, and the ninth is the statement about future use of identifiable information and biospecimens.
  2. Consent must begin with a concise and focused presentation of the key information most likely to help a prospective subject decide.
  3. Compensation for research-related injury is a basic element only for research involving more than minimal risk.
  4. A waiver or alteration of consent under 46.116(f) requires all five criteria, and the identifiability criterion was added in 2018.
  5. Broad consent exists only under the HHS regulations at 46.116(d); FDA does not recognize it.

Exam traps

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

  • Nine basic elements since 2018; the ninth is the future-use statement; before 2018 there were eight

  • Compensation for injury is a basic element only for more than minimal risk research

  • Waiver criteria: five, all required; the identifiability criterion (iii) was added in 2018

  • Broad consent is HHS-only; FDA does not recognize it

  • FDA's 50.25(c) ClinicalTrials.gov statement is a required verbatim sentence for applicable clinical trials

  • Screening under 46.116(g) is not a waiver; it is a separate provision

Practice quiz

  1. Question 1
    Which of the following is a basic element of informed consent required for all research under 46.116(b)?
  2. Question 2
    A statement about compensation and medical treatment for research-related injury is required when:
  3. Question 3
    Which is NOT a criterion for waiver of informed consent under 46.116(f)?
  4. Question 4
    Broad consent under 46.116(d) applies to:
  5. Question 5
    Since the 2018 Requirements, the informed consent document must begin with:

Recap

  • General requirements: legally effective consent, circumstances minimizing coercion, understandable language, the reasonable person standard, key information first, no exculpatory language
  • Nine basic elements and nine additional elements, with the 2018 additions on future use, commercial profit, results, and whole genome sequencing
  • Broad consent as an alternative for storage and secondary use, with its own content and the no-waiver-after-refusal rule
  • Waivers: (e) for public benefit programs, (f) with five criteria, (g) for screening without consent, (h) posting
  • FDA: 50.20, 50.25 with the ClinicalTrials.gov statement, 50.22 minimal risk waiver since 2024, no broad consent

Coming next

Lesson 13, documentation of consent.

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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.