Code of Ethics on Human Experimentation (1968)

Organization: 

American Orthopsychiatric Association

Source: 

CSEP Library

Date Approved: 

March, 1968

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CODE OF ETHICS ON HUMAN EXPERIMENTATION
Adapted from the Helsinki Declaration of the World Medical Association

0ne of the important and necessary functions of the American Orthopsychiatric Association is to convey the results of clinical research in the mental health field to professional personnel qualified to supplement them and to apply them. One important obligation of the members of AOA is to safeguard the health welfare, and privacy of their patients and clients.

AOA's functions do not include supervision of the research whose results are presented at its meetings to ensure that proper. safeguards are provided. It is understood, however, that acceptance of a place on an AOA program to report any clinical research or experience presumes adherence to the following principles, adapted from the code of ethics on human experimentation of the World Medical Association.

I. BASIC PRINCIPLES

1. Clinical research should be conducted only by scientifically qualified persons under appropriate supervision.

2. Clinical research cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.

3. Every clinical research project should be preceded by careful assessment of inherent risks in comparison to foreseeable benefits to the subject or to others.

4. Special caution should be exercised by the investigator in performing clinical research in which the personality of the subject is liable to be altered by drugs or experimental procedure.

II. CLINICAL RESEARCH COMBINED WITH PROFESSIONAL CARE

1. In the treatment of the sick person the professionally qualified therapist must be free to use a new therapeutic measure if in his judgment it offers hope of saving life, reestablishing health, or alleviating suffering. If at all possible, consistent with patient psychology, the patient's freely given consent should be obtained 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 incapacity, the permission of the legal guardian replaces that of the patient.

2. The professional person can combine clinical research with professional care, the objective being the acquisition of new knowledge, only to the extent that clinical research is justified by its therapeutic value for the patient.

III. NONTHERAPEUTIC CLINICAL RESEARCH

1. In the purely scientific application of clinical research carried out on a human being, it is the duty of the investigator to remain the protector of the life, health, and privacy of that person on whom clinical research is being carried out.

2. The nature, the purpose, and the risk of clinical research must be explained to the subject by the investigator.

3a. Clinical research on a human being cannot be undertaken 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. Consent should as a rule be obtained in writing. However, the responsibility for clinical research always remains with the research workers; it never falls on the subject, even after the consent is obtained.

4a. The investigator must respect the right of each individual to safeguard his personal integrity and privacy, especially if the subject is in a dependent relationship to the investigator.

4b. At any time during the course of clinical research, the subject or his guardian should be free to withdraw permission for research to be continued. The investigator or the investigation team should discontinue the research if in his or their judgment it may, if continued, be harmful to the individual.

 

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