Human Experimentation

Page 1

Code of Ethics of the World Medical Association A draft code of ethics on human rrperimentution dram up byflu World Medical Association war published in the British Medical Toumal of 27 October 1962. The original draft of this was in English. A r a i s e d version was acccpted as the f i n d draft at the meeting of the W o r l d Medical Association in Helsinki in Tune 1964. The original of this draft cas in French, of which the W N . A . ’ s English cersion is printed below. It is to be known as the Declaration of Helsinki. DECLARATION OF HELSINKI It is the mission of the doctor to safeguard the health of the pople. His knowledge and conscience are dedicated to the fulfilment of this mission. The Declaration of Geneva of the World Medical Associadon 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 o hich declares that “ Any act or idvice which could waken physical or mental resistance of a human k i n g may be used only in his interest.” Because it is essential that the results of laboratory erpaimenu k applied to human k i n p to further scientific knowledge and IO help su5ering humanity, the World Medical Association has prepared the following recommendations as a :de to each doctor in clinical research. It must k sueued .Ithe standards as drafted are only a guide to physicians all over the world. Doctors are not relieved from criminal, civil, and ethical responsibilities under the laws of their own In the field of clinical research a fundamental distinction must be recognized between clinical research in which the aim is essentially therapeutic for a patient, and clinical research the essential obiect of which is purely scientific and without therapeutic value to the person subjected to the research. 1. Clinical research must conform to the moral and scientific principles that iustify 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 8 qualified 3. Clinical rcrearch cannot legitimately k carried out unlas the imp rt an a of the obiective is in proportion m the inherent risk to the subject. 4. Every clinical research project should be p d e d by careful assessment of inherent risks in comparison to fortsceable benefits to the subicct or to others. 5 . Special caution should be exercised by the doctor in puming clinical rerearch in which the personality of the subject liable to be altered by drugs or experimcntal procedure. XI. Clinical Research Combined with Professional Care 1. In the treatrnment of the sick penon the doctor must be free to UY 8 new therapeutic measure if in his judgment it offers h o p of saving life, re-estahlishing health, or alleviating If at d1 possible, consistent with patient psychology, the dmor should obtain the patient’s freely given consent after the patient has been given a full explanation. In case of legal incapacity consent should also be procured from the legal guardian ; in ax of physical incapacity the permission of the legal guardian replorn that of the patient. 2. The doctor can combine clinical research with profariod care, the objecdvc king the acquisition of n w medical knowledge, only to the ment that clinical march is justified by its therapeutic value for the patient. IIL Non-therapeutic Clinical Ruearch 1. In the purely scientific application of clinical research carried out on a human being it b the duty of the doctor to remain the protector of the life and health of that person on whom clinical march is being carried out. 2. The mature, the purpose, and the risk of clinical mearch must k explained to the subject by the doctor. 3& Clinical research on Ihuman king cannot k undercalm without his free consent, after he has been fully informed ; if he is legally incompetent the consent of the legal guardian should be procured. 3b. The subject of clinical meprch, should be in such a mental, physical, and legal state as to be able to exercise fully his power of choice. ever, the responsibility for dipicrl research always remains with the m a r c h worker ; it never falls on the subist, even after 4a. The investigator must respm the right of each in&- vidual to safeguard his p n o ~ lintegrity, especially if the subitxt is in a dependent relationship IO the investigator. 4b. At any time during the course of clinical research the subiect or his guardian should k free to withdraw permission for rerearch to k continued. The investigator or the inwtigating t a m should discontinue the research if in his or their iud-mcnt it may, if continued, bc harmful IO the individual. 3c. Consent should as a rule be obtained in writing. ‘ HIS TOR IC ALI972 - 1 975

Page 2

Code of Ethics of the World Medical Association A draft code of ethics 011 human experimenfation drawn up by the World Medical Association was published in the British Medical 7 o u ~ a lo f 27 October 1962. The original draft of tltir mar in English. A rrvised version (car accepted as rhe final draft at the meeting of the W o r l d Medical Association in Helsinki in yune 1964. The m’ginal of this draft was in Freitclt, of which the W.M.A.’s English version i s printed below. It is to be known as the Declmation of Helsinki. DECLARATION OF HELSINKI It is the mission of the doctor to safeguard the health of the people. His knowledge and conscience are dedicated to the fulfilment of h i s mssion. The Declaration of Geneva of the SGorld Medical Association binds the doctor with the words: “The health of my patient will be my h i t consideration ” ; and the International Code of Medical Ethics which declares that “ Any act or advice which could weaken physical or mental rcsistanct of a human being may be used only in his interest.” Because it is essential that the results of laboratory amim a t s k applied 10 human kings to further rcientiIic howlcdp and to help suffering humanity, the World Medical Association has prepared the following recommendations as a It must be svased d t the standards as drafted are only a guide to physicians all over the world. Docton are not reli~-cdfrom criminal, avil, m d ethical responsibilities under the laws of their own In the field of clinical research a fundamental distincrion must k mognizcd h e e n clinical research in which the aim is essentially therapeutic for a patient, and clinical research the asenrial object of which IS purely scientific and without therapeutic value to the person subjected to the raearch. iide to each doctor in clinical mearch. 1. Clinical research must conform to the moral and scientific principles that justify medical research, and should be based on laboratory and animal experiments or other scientifically atab2. Clinical research should bc conducted only by scientifically qdjfied persons and under the supervision of a qualified 3. Clinical research cannot legitimately be carried out unless the importan= of the objective is in proportion to the inherent rirk to the subject. 4. Every clinial research project should be p d e d by careful assessment of inherent risks in comparison to forruea5le benefits to the subject or to others. 5. Special caution should be exercised by the doctor in perrming clinical research in which the persondiry of the subiect IS liable to bc alicrcd by drugs or experimental procedure. II. Clinical Research Combined with Professional Care 1. In the veatment of the sick pmon the doctor must be fm to we new therapeutic measure if in his judgment k offen hope of saving life, reutablishing health, or alleviating If at 111 possible, consistent with paticnt psychology, the doctor should obtain the patient’s freely given consent after the patient has been given a full explanation. In case of legal incapacity consent should also be procured from the legal guardian ; in case of physical incapaciry the permission of the leg111guardian replacu that of the patient. 2. The doccor can combine clinical research with profnrional care, the objective being the acquisition of MW medical knowledge, only (0 the merit that clinical research is justified by its therapeutic valve for the patient. EL Non-therapeutic Clinical Research 1. In the purely scientific application of clinical r e s a d carried out on a human being it k the duty of the doctor to rctnain the protenor of the life Md health of that p n c n OQ whom clinical march k being camcd out. 2. The M~LUC, the purpose, and the risk of clinical -ch must k cxplried m the subia by the doctor. 3a. Clinical research on ;I human k i n g cannot be undertaken without his free consent, after he has k n fully informed; Ihe ia lepllly incompetent the consent of the legal guardian should be procured. 3b. The subject of clinical research. should be in such a mental, physical, and legal state as to be able to exercise fully his power of choice. ever, the responsibility for clinical research always remains with the Rsprdl worker; it never falls on the subject, even after 4a. The invetigator must respect the right of each individual to safeguard his personal integrity, especially if the subject is in a dependent relationship to the investigator. 4b. At m y time during the course of clinical ruearch the s u b w or his guardian should k free to withdraw permission for re arch to be mntinued. The investigator or the invatigaring t a m should discontinue the research if in his or their judgment it may, if continued, k harmful to the individual. 3c. Consent should as I rule be obtained in writing.