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Lawrrnco Borkdry Lobwrlory Archivr8 and Rocofdr Otfico Code of Ethics of the World Medical Association A draft code of ethics on human expm’mentation drawn up by the World 6fedical Association was publirhrd in rkr British Medical Journal of 27 October 1962. The origittal draft of fliis was in Englirk. A rmired rnrrcti :a accepted as the final draft at the meeting of the World Medical Association in Hrlsinki in June 1961 Thr m’ginal of this droit was in French, of which the W.MA.’s English version is printed below. I f is fo be h n w n JI i h r Decimation of Helrinki. DECLARATION OF HELSINKI It is the mission of the doctor to safeguard the health of the pmple. His knowledge and conscience are dedicated to the fulfilment of this mission. The Declaration of Geneva of the World Medical Association binds the doctor with the words: “ T h e health of my patient will be my first consideration ” ; and the Intemationnl Code of Medical Ethics which declares that ‘‘ Any act or advice which could weaken physical or mental resistance of a human k i n g may be used only in his interest.” Bearuse it is essential that the results of laboratory olperimenu k applied to human kings tu further scientific howled@ and to help sdering humanity, the World Medical 4uociation has prepared the following recommendations aa a ide to each doctor in clinical research. It must be stressed at the standards as drafted are only a guide to physicians all dw the world. Docton are not relieved from criminal, civil, and ethical responsibilities under the laws of their o m In the field of clinical research a fundamental distinction must be recognized benveen clinical mcarch in which the aim is essentially therapeutic for a patient, and clinical research the asential object of which is purely scientific and without therapeutic value to the person subiected to the research.. 1. Clinical research must conform to the moral and scientific principles that jus:ify medical research, and should be based on laboratory and animal experiments or other scientifically estab2. Clinical research should be conducted only by scientifically qualified persons and under the supervision of a qualified 3. Clinical research cannot legitimately be carried out unlar the importance of the obiective is in proportion tu the inhervlt risk to the subjecr. 4. Every clinical research projm should k preceded by careful assessment of inherent risks in comparison tu foraceable benefit$ to the subject or to orhen. I. Special caution should be exercised by the doctor in prrming clinical research in which the personality of the subim liable to be altered by drugs or experimental procedure II. C h i 4 Research Combined with Prolasional cut 1. In the treatment of the sick pmon the docra r n x r Sr fm to u x a new therapeutic measure if m his w2p?c?r u patient has been given a full explanation. In =IC of i c p l incapacity consent should also be procured Imr, *.e k p l guardian ; in case of physical incapacity the pn n ; rimn of the legal guardian replaces that of the patient. 2. The doctor can combine clinical research with polesrional care, the objective King the acquisition of n t w &id howledge, only to the ment that clinical rMr:h 1% n ~ r ! .Sd by i n therapcutic value for the patient. IIX. Non-tberaptntic Clinical Research 1. In the pdy scientific application of clmid rw113b carried out on a human king it h the duty of rhc dmw to remain the protector of the life and health of rhrr p M n M whom clinical research is being carried out. 2. The nature, the purpose, and the risk of c lipid rocIIch must be explained to the subject by the doctor. 3u. Clinical rocarch on 0 human being cannot be tmdcrrakn without his fm consent, after he has k n fully domed. if he is legally incompetent the consent of the Icp I rard lan should be procured. 3b. The subjm of clinical research should be rn such mental, physical, and legal state as to be able 10 exercise f . d v his power of choice. ever, the responsibility for clinical research alu-ays rcmmn) uxh the research worker ; it never falls on the sub~ect.even e f t s 41. The investigator must respect the right of a c h mdividual to safeguard his personal integrity, ap cully if rhe rubiect is in a dependent relationship to the ini,oripror. 4b. At mythe during the course of clinical rrxaxh the subject or his guardian should be free to withdraw perm~srion for rc urch to k continued. The investigator or rhe mvatigating team should discontinue the racarch if in hu or chcu judgment it may, if continued, be harmful to the individ*ual. 3c. Consent should as a rule be obtained in unrmg