Historical Overview

The World Medical Association (WMA) published its first version of the Declaration of Helsinki in 1964, which has been revised several times since (last revision 2013). The first revision of the declaration in 1975 stated that protocols for clinical research should be sent to a ‘specially appointed committee for consideration, comment and guidance’.

This was the first international statement on the concept of review of research where the review is independent from the researcher, the sponsor or any other influence. However, under the Declaration of Helsinki, the ultimate duty to ensure the protection of human participants remains with doctors.