Concern over ethical principles in medical research grew after World War II, following the crimes of Nazi doctors revealed by the Nuremberg war crimes tribunal. A number of scientists called for stricter adherence to ethical principles including Beecher (1966) and Pappworth (1967).
In 1964 the World Medical Association held their General Assembly in Helsinki, Finland. There they set out ethical principles for medical research involving human subjects in the Declaration of Helsinki. Some of the main points of special relevance to experimental design are given here:
- It is the duty of the physician in medical research to protect the life, health, privacy and dignity of the human subject.
- The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. The protocol should be submitted for consideration , comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence.
- Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others. This does not preclude the participation of healthy volunteers in medical research. The design of all studies should be publicly available.
- Medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research.
- The subjects must be volunteers and informed participants in the research project.
- Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication.
- The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic method exists.
- At the conclusion of he study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic or therapeutic methods identified by the study.