Declaration of Helsinki
lHealth of patient is primary consideration
lReview of research by independent committees
lBoundaries between therapeutic and non-therapeutic
lUse of accepted scientific methods
lVoluntary informed consent
lConsent of legal guardian is permissible for those incapable of informed consent
•Declaration of Helsinki – Adopted in 1964 by the World Medical Association. Contains the guiding principles for human subject research – internationally
•Important because this was a group of physicians and researchers deciding that “we” do need rules and guidance.
•Represented a reinterpretation of Nuremberg
•Provoked a reaction in the medical community
•Journal editors began requiring that research papers be accompanied by statement of compliance with Helsinki
•Established boundaries between therapeutic and non-therapeutic research
•Introduced concept of review of research by independent committees
•Use of accepted scientific methods