Lesson 3 · IRB and HRPP Administration: From Coordinator to CIP

3. Nuremberg, Helsinki, CIOMS, and ICH GCP: The International Codes

66 min

After this lesson you can

  • State the ten principles of the Nuremberg Code and their origin
  • Explain Helsinki's authorship, audience, and positions on placebo, post-trial access, vulnerable groups, and registration
  • Describe the CIOMS guidelines and their focus on low-resource settings
  • Describe ICH E6 GCP: principles, the IRB/IEC section, and its legal status in the United States
  • Compare how each code treats consent, risk, and oversight

Nuremberg, Helsinki, CIOMS, and ICH GCP: International Codes compares the four documents that shape every multinational trial and every protocol compliance statement an IRB reads. The CIP exam tests who wrote each one, when, and what it requires, so this lesson puts them side by side.

5 Key Facts from This Lesson

  1. The Nuremberg Code was written by judges in 1947, while the Declaration of Helsinki was written by the World Medical Association in 1964 and most recently revised in 2024.
  2. Helsinki, not Nuremberg, introduced independent committee review, in its 1975 Tokyo revision.
  3. The CIOMS International Ethical Guidelines are prepared in collaboration with the World Health Organization, and the 2016 edition contains 25 guidelines.
  4. ICH E6 Good Clinical Practice is FDA guidance in the United States, not regulation; the binding rules remain 21 CFR 50, 56, 312, and 812.
  5. Since 2008, FDA has required foreign clinical studies not conducted under an IND to follow Good Clinical Practice under 21 CFR 312.120, not the Declaration of Helsinki.

Exam traps

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

  • Nuremberg by judges; Helsinki by physicians; CIOMS with WHO; ICH by regulators and industry

  • ICH GCP is guidance in the United States, not regulation

  • Helsinki, not Nuremberg, introduced independent committee review, in 1975

  • Helsinki's placebo rule: no proven intervention, or compelling methodological reasons without serious or irreversible harm

  • FDA's standard for foreign studies not under an IND is GCP since 2008, not Helsinki

Practice quiz

  1. Question 1
    The Nuremberg Code was authored by:
  2. Question 2
    Which document is a statement of the World Medical Association?
  3. Question 3
    In the United States, ICH E6 Good Clinical Practice has the legal status of:
  4. Question 4
    Which section of ICH E6 addresses composition, functions, and records of the ethics committee?
  5. Question 5
    The CIOMS guidelines were developed in collaboration with:

Recap

  • Nuremberg: ten principles, judges, 1947, consent first, no committee
  • Helsinki: physicians, 1964, committee review since 1975, placebo and post-trial and registration positions
  • CIOMS: with WHO, 2016 edition, low-resource settings, benefit sharing
  • ICH E6: regulators and industry, guidance in the United States, section 3 on the IRB/IEC
  • All four in one table by author, year, status, consent, oversight

Coming next

Lesson 4, The Common Rule.

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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.