Guiding Principles for Research Involving Animals and Human Beings
Recommendations from the Declaration of Helsinki
I. Basic Principles
- 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 established facts.
- Clinical research should be conducted only by scientifically qualified persons and under the supervision of a qualified medical person.
- Clinical research cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.
- Every clinical research project should be preceded by careful assessment of inherent risks in comparison to foreseeable benefits to the subject or to others.
- Special caution should be exercised by the doctor 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
- In the treatment of the sick person, the doctor 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 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 incapacity the permission of the legal guardian replaces that of the patient.
- The doctor can combine clinical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that clinical research is justified by its therapeutic value for the patient.
III. Non-Therapeutic Clinical Research
- In the purely scientific application of clinical research carried out on a human being, it is the duty of the doctor to remain the protector of the life and health of that person on whom clinical research is being carried out.
- The nature, the purpose and the risk of clinical research must be explained to the subject by the doctor.
- Clinical research on a human being cannot be undertaken without his free consent after he has been informed; if he is legally incompetent, the consent of the legal guardian should be procured.
- 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.
- Consent should, as a rule, be obtained in writing. However, the responsibility for clinical research always remains with the research worker; it never falls on the subject even after consent is obtained.
- The investigator must respect the right of each individual to safeguard his personal integrity, especially if the subject is in a dependent relationship to the investigator.
- 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 investigating team should discontinue the research if in his or their judgment, it may, if continued, be harmful to the individual.
Guiding Principles in the Care and Use of Animals
Approved by the Council of The American Physiological Society
Animal experiments are to be undertaken only with the purpose of advancing knowledge. Consideration should be given to the appropriateness of experimental procedures, species of animals used, and number of animals required.
Only animals that are lawfully acquired shall be used in the laboratory, and their retention and use shall be in every case in compliance with federal, state and local laws and regulations, and in accordance with the National Research Council (NRC) Guide.
Animals used in research and education must receive every consideration for their comfort; they must be properly housed, fed, and their surroundings kept in a sanitary condition.
All experimental procedures must be carried out in accordance with the NRC Guide. Appropriate anesthetics must be used to eliminate sensibility to pain during all surgical procedures. Muscle relaxants or paralytics are not anesthetics and they must not be used alone for surgical restraint, but may be used in conjunction with drugs known to produce adequate analgesia. The postoperative care of animals shall be such as to minimize discomfort and pain, and in any case shall be equivalent to accepted practices in veterinary medicine. All measures to minimize pain and distress that would not compromise experimental results must be employed. If the study requires the death of an animal, the most humane euthanasia method consistent with the study must be used.
When animals are used by students for their education or the advancement of science, such work shall be under the direct supervision of an experienced teacher or investigator.
The American Physiological Society endorses the Recommendations from the Declaration of Helsinki and the Guiding Principles in the Care and Use of Animals and insists that all investigations involving humans and all animal experimentation reported in its publications be conducted in conformity with these principles. Editors/Associate Editors are expected to refuse papers in which evidence of the adherence to these principles is not apparent. They reserve the right to judge the appropriateness of the use of animals and humans in experiments published in the journals. Differences of opinion will be adjudicated by the Publications Committee.
- Revised 1996.
- Guide for the Care and Use of Laboratory Animals (7th ed.). Washington, DC: Natl. Acad. Press, 1996."!> Guide for the Care and Use of Laboratory Animals (7th ed.). Washington, DC: Natl. Acad. Press, 1996.