The American Pain Society strongly endorses the view that the professional activities of its members must be conducted in accordance with the highest ethical standards. Given the diversity of the membership, the standards advanced by the Society must specifically address animal research, clinical research, and clinical practice. To accomplish this, the Society recognizes the valuable contributions of other professional organizations whose published guidelines for ethical practice may apply to a large segment of the membership.
Reference is made to several documents below, and they may be reviewed for a fuller exposition of the ethical principles accepted by the American Pain Society.
The American Pain Society endorses the ethical guidelines for investigations of experimental pain in conscious animals published by the International Association for the Study of Pain and the guidelines for the use of animals published by the Society for Neuroscience. The fundamental principle guiding both these documents is that ethical animal research requires that the investigator attempt to minimize pain and avoid unnecessary distress or discomfort at all times. The acquisition and care of experimental animals should be performed in accordance with the guidelines published by the National Institutes of Health.
The American Pain Society is a national chapter of the International Association for the Study of Pain. The following guidelines, adopted by the International Association for the Study of Pain, are most relevant to the Society:
1. It is essential that the intended experiments on pain in conscious animals be reviewed beforehand by scientists and lay persons. The potential benefit of such experiments to our understanding of pain mechanisms and pain therapy needs to be shown. The investigator should be aware of the ethical need for a continuing justification of his investigations.
2. If possible, the investigator should try the pain stimulus on himself; this principle applies for most noninvasive stimuli causing acute pain.
3. To make possible the evaluation of the levels of pain, the investigator should give a careful assessment of the animal's deviation from normal behavior. To this end, physiological and behavioral parameters should be measured. The outcome of this assessment should be included in the manuscript.
4. In studies of acute or chronic pain in animals, measures should be taken to provide a reasonable assurance that the animal is exposed to the minimal pain necessary for the purposes of the experiment.
5. An animal presumably experiencing chronic pain should be treated for relief of pain, or should be allowed to self-administer analgesic agents or procedures, as long as this will not interfere with the aim of the investigation.
6. Studies of pain in animals paralyzed with a neuromuscular blocking agent should not be performed without a general anesthetic or an appropriate surgical procedure that eliminates sensory awareness.
7. The duration of the experiment must be as short as possible and the number of animals involved kept to a minimum.
The ethics of research involving normal human volunteers or patients have been clarified by several international and national organizations. The American Pain Society endorses the principles enunciated by the World Medical Association, the World Health Organization and the Council for International Organizations of Medical Sciences, the American College of Physicians, and the American Psychological Association.
Several of the principles included in these documents are germane to pain-related research. Each pain practitioner involved in pain-related clinical research should observe the following principles:
1. All planned clinical studies should be reviewed by an independent committee on human research prior to implementation. The committee, which should include scientists, healthcare practitioners, and lay persons, should evaluate the risks inherent in the research and the extent to which the significance of the potential results justifies the risks involved, even if minimal. The committee also should ensure that potential subjects have the opportunity to provide informed consent prior to participation.
2. Informed consent implies that potential subjects are fully apprised of the goals, procedures, and risks of the study. Potential subjects must be able to decline, and those who consent must be able to withdraw prior to completion, without any risk of penalty.
3. Those who may be incapable of giving fully informed consent, including children and adults who are not fully competent, should not be used in pain research unless it is essential to the goals of the experiment. In the latter circumstance, consent must also be obtained from an individual with legal responsibility for the welfare of the subject.
4. In pain studies, the minimal intensity of noxious stimulation necessary to the goals of the experiment should be established beforehand and not exceeded during the study. Subjects should be able to stop the painful stimulus at will. In research on clinical pain, the use of placebos or sham treatments require that alternative methods of pain relief be available to those patients who require it.
The American Pain Society believes that the principles of medical ethics published by the American Medical Association should apply to all clinical disciplines engaged in pain therapy with patients. The following principles have each been altered so that the word “physician” has been replaced by the phrase “healthcare provider”:
1. A healthcare provider shall be dedicated to providing competent medical service with compassion and respect for human dignity.
2. A healthcare provider shall deal honestly with patients and colleagues, and strive to expose those healthcare providers deficient in character and competence or who engage in fraud or deception.
3. A healthcare provider shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient.
4. A healthcare provider shall respect the rights of patients, of colleagues, and of other health professionals, and shall safeguard patient confidences within the constraints of the law.
5. A healthcare provider shall continue to study; apply and advance scientific knowledge; make relevant information available to patients, colleagues and the public; obtain consultations; and use the talents of other health professionals when indicated.
6. A healthcare provider, in the provision of appropriate patient care, except in emergencies, shall be free to choose whom to serve, with whom to associate, and the environment in which to provide healthcare services.
7. A healthcare provider shall recognize a responsibility to participate in activities contributing to an improved community.