The Nuremberg Code and Helsinki: Where the Rules Started

Part of Human Subjects Protection for Clinical Research Staff: Why Human Subjects Protection Exists.

About 5 minutes. Free, in your language, no account needed.

Why this matters

Every consent form you hand to a participant, and every protocol that goes to an ethics committee before the first visit, traces back to a short list of ideas written down in the twentieth century. Knowing where they came from makes the daily rules feel less like paperwork.

ICH E6(R3) is the international baseline in this course. The US federal regulations (HHS 45 CFR 46, FDA 21 CFR 50 and 56, HIPAA 45 CFR 164) are taught as the detailed worked example, and passages that name them are US law. Outside the United States, follow your national law and ethics committee requirements. State or local rules may add requirements. The two documents here are ethics statements, not regulations.

The Nuremberg Code

The Nuremberg Code was published in 1947 in the judgment of the Doctors' Trial, which was heard by an American military tribunal at Nuremberg. It lists ten points about when experiments on people are acceptable.

Point 1 is the one to remember: the voluntary consent of the human subject is absolutely essential. The Code spells out what that means. The person must have legal capacity to consent. The person must be free of force, fraud or coercion. And the person must understand enough about the experiment to make an informed decision.

Three other points matter:

• Point 5: no experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur. (The Code notes an exception where the experimenters also serve as subjects.)
• Point 9: the subject is at liberty to bring the experiment to an end.
• Point 10: the scientist in charge must be prepared to end the experiment at any stage if continuing is likely to result in injury.

Points 9 and 10 cut both ways: the participant can stop, and so must the person running the study if harm becomes likely.

One caveat: the Nuremberg Code was not itself binding law. Later statements of ethics drew on it.

The Declaration of Helsinki

The World Medical Association (WMA) adopted the Declaration of Helsinki in June 1964, at its 18th General Assembly in Helsinki. It has been amended many times since, from 1975 (Tokyo) through 2013. The current text is the 2024 revision, titled "Ethical Principles for Medical Research Involving Human Participants," adopted by the 75th WMA General Assembly in October 2024.

Several paragraphs of the 2024 text show up in site routines:

• Paragraph 23: the protocol must be sent to an independent research ethics committee for consideration, comment, guidance and approval before the research begins. In the US this committee is usually called an IRB (in many countries, an IEC or ethics committee).
• Paragraphs 25 to 32: informed consent. Paragraph 27 specifically addresses participants who are in a dependent relationship with the person asking, such as a patient with their own physician.
• Paragraph 35: research involving human participants must be registered in a publicly accessible database before the first participant is recruited.
• Paragraph 34: post-trial provisions must be arranged by sponsors and researchers before a trial begins.
• Paragraphs 19 and 20: vulnerable groups should receive specifically considered support and protections, and research with them is justified only if it responds to their health needs and priorities.

You do not need to memorize paragraph numbers. The pattern is what matters: independent review before the start, voluntary consent, extra care for vulnerable people, and openness about what research is being done.

In practice

A coordinator is preparing a new study. The PI mentions that one of her own patients is interested. The coordinator remembers paragraph 27 from this lesson: a person asked by their own doctor may feel they cannot say no. She suggests that someone other than the treating physician explain the study, and she tells the patient that declining will not affect their care. The study has not even started, and she is already applying an idea that goes back to Helsinki.

(That suggestion is a good habit, not a rule from this lesson's sources.)

What this looks like when it goes wrong

A site starts screening on a Friday because the sponsor is pushing hard for early enrollment. The ethics committee has not yet issued its approval, and a staff member says it is "basically a formality." The first participant signs a consent form on Monday, and the approval letter arrives on Thursday.

Nobody intended harm. But the independent committee had not yet looked at the protocol, and the participant was asked to trust a process that had not been checked. The lesson of Helsinki paragraph 23 is that independent review comes first, whatever the schedule says.

Key takeaways

• The Nuremberg Code (1947) opens with voluntary consent as absolutely essential: capacity, freedom from force, fraud or coercion, and enough understanding to decide.
• Participants may end an experiment, and the person in charge must be prepared to end it if continuing is likely to cause injury.
• The Nuremberg Code was not itself binding law, but later ethics statements drew on it.
• The Declaration of Helsinki was adopted in 1964 and its current text is the 2024 revision. It calls for independent committee approval before research begins, consent, extra support for vulnerable groups, and public registration before the first participant is recruited.
• US regulations and ICH E6(R3) build on these ideas, and local rules may add requirements.