Declaration of Helsinki
The Declaration of Helsinki is a central guideline for research ethics adopted by the World Medical Association (WMA) in 1964. The Declaration contains ethical principles for doctors and other participants in medical research.
The Declaration of Helsinki is not legally binding, but has had major impact on national legislation. Since 2000, it refers explicitly to research using identifiable samples and data. One of the fundamental principles of the Declaration is that concern for the individual must always take precedence over the interests of science and society.
Another principle states that informed consent must be obtained for research that uses identifiable samples and data – for collection, analysis, storage and use for new purposes. Situations may exist where it is impossible or unsuitable to obtain consent. In such cases, the Declaration states that research may only be carried out if an Ethical Review Agency has approved the research project.
It is further stated that all conceivable safety measures must be undertaken to respect the private lives of participants, and to treat patient information confidentially, and to minimise the impact the study may have on the participants’ physical and mental integrity and personality.