Lesson 2 · IRB and HRPP Administration: From Coordinator to CIP

2. The Belmont Report Explained: Three Principles, Three Applications

58 min

After this lesson you can

  • State the three principles and the application paired with each
  • Explain the boundary between practice and research
  • Apply the three components of consent: information, comprehension, voluntariness
  • Explain systematic assessment of risks and benefits
  • Explain individual and social justice in subject selection

The Belmont Report Explained: Respect, Beneficence, Justice reads the 1979 report section by section and shows how each principle became a criterion IRBs still apply today. Ten pages written by the National Commission still decide whether a protocol gets approved, and this lesson shows you why.

5 Key Facts from This Lesson

  1. The Belmont Report was published in the Federal Register on April 18, 1979, by the National Commission created under the National Research Act of 1974.
  2. It names three principles, not four: respect for persons, beneficence, and justice. Nonmaleficence is not a separate Belmont principle.
  3. Each principle maps to one application: respect for persons to informed consent, beneficence to the assessment of risks and benefits, and justice to the selection of subjects.
  4. Belmont describes informed consent through three elements: information, comprehension, and voluntariness.
  5. Coercion is an overt threat of harm, while undue influence is an excessive, unwarranted, or improper reward offered to obtain compliance.

Exam traps

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

  • Pairings: respect for persons with consent, beneficence with risk-benefit, justice with selection

  • Coercion is a threat; undue influence is an improper reward

  • Three principles, not four; nonmaleficence and autonomy are not separate Belmont principles

  • Brutal or inhumane treatment is never justified regardless of benefit

Practice quiz

  1. Question 1
    Which Belmont principle is applied through the selection of subjects?
  2. Question 2
    According to Belmont, an offer of an excessive, unwarranted, or inappropriate reward to obtain compliance is:
  3. Question 3
    Belmont describes informed consent as containing which three elements?
  4. Question 4
    Under Belmont, an innovative clinical procedure that departs from standard practice:
  5. Question 5
    The Belmont Report was produced by:

Recap

  • Three principles, three applications, three pairs
  • Practice versus research; innovative practice should become research early
  • Consent has three elements: information, comprehension, voluntariness
  • Risk-benefit assessment is systematic; brutal treatment is never justified; payment is not a benefit
  • Justice is individual and social; classes of subjects ranked by ability to bear burdens

Coming next

Lesson 3, Nuremberg, Helsinki, CIOMS, and ICH GCP.

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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.