The Declaration of Helsinki is a landmark document of the World Medical Association (WMA) that establishes ethical principles for medical research involving human subjects. First adopted in 1964 and revised several times since, it is considered the most important ethical standard for clinical research worldwide and forms the basis for many national laws and international guidelines, including Good Clinical Practice (GCP).
Core principles include the protection of life, health, dignity, integrity, the right to self-determination, privacy, and the confidentiality of research participants’ personal information. The Declaration emphasizes that the well-being of the individual participant must always take precedence over the interests of science and society. For CROs and all those involved in research, strict adherence to the principles enshrined in the Declaration of Helsinki is an indispensable ethical and regulatory obligation.