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ETHICAL GUIDELINES FOR

CLINICAL INVESTIGATION

American Medical Association

1966 

At the 1966 Annual Convention of its House of Delegates, the American Medical Association endorsed the ethi­cal principles set forth in the 1964 Declaration of Helsinki of the World Medical Association. The 1966 Ethical Guidelines for Clinical Investigation, which are printed below, were intended to enlarge on the Nuremberg Code and the Declaration of Helsinki, as well as on the fundamental concept.s found in the AMA Principles of Medical Ethics. In 1974, when asked to establish mechanisms and procedures to protect the rights of the institutionalized in clinical investigations, the AMA House of Delegates reaffirmed the 1966 guidelines; emphasized the ethical responsibility of each investigator; endorsed the principle that precautions must be taken to protect the rights of subjects whose abil­ity to consent knowingly and voluntarily is impaired; and affirmed the goal of establishing uniformity of standards and procedures for medical experimentation throughout the world.

 

1. A physician may participate in clinical investigation only to the extent that his activities are a part of a sys­tematic program competently designed, under accepted standards of scientific research, to produce data which is scien­tifically valid and significant.

2. In conducting clinical investigation, the investigator should demonstrate the same concern and caution for the welfare, safety and comfort of the person involved as is required of a physician who is furnishing medical care to a patient independent of any clinical investigation.

3. In clinical investigation primarily for treatment—

A.     The physician must recognize that the physician-patient relationship exists and that he is expected to exercise his professional judgment and skill in the best interest of the patient.

B.     Voluntary consent must be obtained from the patient, or from his legally authorized representative if the patient lacks the capacity to consent, following: (a) disclosure that the physician intends to use an investigational drug or experimental procedure, (b) a reasonable explanation of the nature of the drug or procedure to be used, risks to be expected, and possible therapeutic benefits, (c) an offer to answer any inquiries concerning the drug or proce­dure, and (d) a disclosure of alternative drugs or procedures that may be available.

i.     In exceptional circumstances and to the extent that disclosure of information concerning the nature of the drug or experimental procedure or risks would be expected to materially affect the health of the patient and would be detrimental to his best interests, such information may be withheld from the patient. In such cir­cumstances such information shall be disclosed to a responsible relative or friend of the patient where pos­sible .

ii.    Ordinarily, consent should be in writing, except where the physician deems it necessary to rely upon con­sent in other than written form because of the physical or emotional state of the patient.

iii.    Where emergency treatment is necessary and the patient is incapable of giving consent and no one is avail­able who has authority to act on his behalf, consent is assumed.

 4. In clinical investigation primarily for the accumulation of scientific

knowledge—

A.     Adequate safeguards must be provided for the welfare, safety and comfort of the subject.

B.     Consent, in writing, should be obtained from the subject, or from his legally authorized representative if the subject lacks the capacity to consent, fol lowing: (a) a disclosure of the fact that an investigational drug or pro­cedure is to be used, (b) a reasonable explanation of the nature of the procedure to be used and risks to be ex­pected, and (c) an offer to answer any inquiries concerning the drug or procedure.

C.    Minors or mentally incompetent persons may be used as subjects only if:

i.     The nature of the investigation is such that mentally competent adults would not be suitable subjects.

ii.    Consent, in writing, is given by a legally authorized representative of the subject under circumstances in which an informed and prudent adult would reasonably be expected to volunteer himself or his child as a subject.

D.    No person may be used as a subject against his will.

 

[Reprinted with the permission of the American Medical Association from American Medical Association Proceedings of the House of Delegates, C-66; 189-190 and A-74: 127—131.]