Belmont report (1979) and Nuremberg code (1947)

The Belmont Report (1979):

Purpose

The Belmont Report was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to establish ethical principles and guidelines for research involving human subjects.

Key Focus Areas

1. Distinction Between Research and Practice:
• Practice aims to improve the well-being of individual patients.
• Research seeks to generate generalizable knowledge.
• Any activity involving research must undergo ethical review.

Three Basic Ethical Principles

The Belmont Report outlines three core ethical principles for conducting clinical research:

1.     Respect for Persons:
Participants must be treated as autonomous individuals who can choose whether to participate. Extra protection must be given to those with limited autonomy. This principle is applied through informed consent, privacy protection, and safeguarding vulnerable groups.

2.     Beneficence:
Researchers must maximize benefits and minimize harm to participants. This includes using sound research designs, ensuring competent investigators, and maintaining a favourable risk-benefit ratio through ethical review.

3.     Justice:
Research benefits and burdens must be fairly distributed. Participant selection should be equitable, avoiding exploitation of vulnerable populations.

Applications of the Principles

1.     Informed Consent:

• Requires information, comprehension, and voluntariness.
• Subjects must understand the study’s purpose, risks, and benefits.

2.     Risk–Benefit Assessment:

• Research must present a favorable balance between risks and potential benefits.
• Unnecessary or inhumane risk is never justified.

3.     Selection of Subjects:

• Must ensure equity and fairness in participant recruitment.
• Avoid targeting vulnerable groups unless research directly concerns them.

Essence

The Belmont Report established the ethical foundation for modern human research regulations, emphasizing Respect for Persons, Beneficence, and Justice—the three core principles that guide Institutional Review Boards (IRBs) and all human research ethics today.

The Nuremberg Code (1947)
(BMJ, Vol. 313, No. 7070, 7 Dec 1996)

The Nuremberg Code was established after World War II by the war crimes tribunal to set ethical standards for medical research involving humans. It introduced voluntary informed consent as an essential requirement, recognizing individuals’ right to control their own bodies. The Code emphasized that risks must be balanced against expected benefits, unnecessary suffering must be avoided, and physicians must prevent harm to participants.

Key Principles:

1. Voluntary informed consent is mandatory.
2. Research must provide benefit to society and not be random.
3. Animal studies and prior knowledge should justify human trials.
4. Avoid unnecessary harm and suffering.
5. No studies with a risk of death or disability, unless researchers also participate.
6. Risk must not exceed potential benefit.
7. Ensure adequate safety measures and facilities.
8. Conducted by qualified professionals with utmost care.
9. Participants may withdraw at any time.
10. Investigators must terminate the study if harm is likely.

These ten principles became the foundation for modern medical ethics and human rights in research.