The question (12 marks)
Discuss the ethical regulation of experimentation on human beings with reference to the Nuremberg Code and the Declaration of Helsinki. What additional protection does each give to participants who cannot freely consent? (12 marks)
MU Module IV, clinical trials of drugs on human beings; pack ch. 04.
Plan your answer on paper before you look at the authorities — issue first, then the rule, then apply it to these facts.
It tests Unit 4 · Medico-Legal Issues of Law and Medicine.
Authorities you will need
- The Nuremberg Code, ten principles
- The Declaration of Helsinki, adopted by the 18th World Medical Association General Assembly, Helsinki, June 1964, as revised by the 75th General Assembly, Helsinki, October 2024
- Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002, prohibition on experimenting without consent
- National Medical Commission Act 2019, s. 10(1)(b), policies for regulating medical research
- Bharatiya Nyaya Sanhita 2023, ss. 26, 27 and 28
- Transplantation of Human Organs and Tissues Act 1994, ss. 2(o) and 11, therapeutic purposes only
How an answer is marked
A full-marks answer names the issue in one line, states the rule with its section, cites the authority, applies it to these facts and concludes — in that order. The app's model answer for this question is written in exactly that shape, with a checklist to mark your own attempt against.