Ethical Guidelines for Pain Research in Humans
The following Ethical Guidelines are the product of a lengthy period of deliberation by the Committee on Ethical Issues of the International Association for the Study of Pain (IASP®). The guidelines published here have been approved, after modification, by the Council of IASP.
These guidelines may not be perfect and are intended to stimulate debate among members. Council of IASP encourages suggestions for improvement which can be made through the correspondence columns of this journal or directly to the current chairman of the Committee on Ethical Issues: Dr. George Mendelson, Suite 18, 33 Queens Road, Melbourne, VIC 3004, Australia.
Membership of the Committee on Ethical Issues has undergone much change during the preparation of these guidelines and names of members who contributed are printed at the end of this article.
Ethical Guidelines for Pain Research in Humans
The International Association for the Study of Pain (IASP) endorses the ethical principles for research involving human subjects given in the following documents: the World Medical Association's Declaration of Helsinki, Recommendations Guiding Doctors in Clinical Research (1964, revised 1975), the Ethic Principles of the American Psychological Association (1973), the Declaration of Lisbon, the Rights of the Patient (1981), the proposed International Guidelines for Biomedical Research Involving Human Subjects, and Council for International Organizations of Medical Sciences (1982).
IASP believes further guidelines are necessary to supplement the ethical principles contained in these documents.
The goal of pain research is to acquire new knowledge on the mechanisms, pathogenesis, diagnosis, and treatment of pain. This requires research on humans and animals. Human research may be undertaken on both healthy persons and patients. This research may involve painful stimuli or delaying pain relief in patients. The primary intention is to advance knowledge so that patients in general may benefit; the individual patient may or may not benefit directly.
The health, safety and dignity of human subjects have the highest priority in pain research. The investigator is personally responsible for the conduct of research and its effects on the experimental subject at all times, even though the patients have given their consent to participate.
- Before starting any study of human subjects, the proposed experimental protocol must be reviewed and approved by an independent committee on human research. The functions of the committee are as follows:
- a) to ensure that participants are not coerced or harmed,
b) to evaluate the potential for undesirable physical or psychological effects occurring during the research,
c) to decide whether the proposed research should be the subject of regular review.
The committee should be appropriately constituted and normally should include scientists, health care practitioners and lay members.
The scientific merit of the proposal and the research methods proposed normally should be the subject of independent evaluation by an appropriately constituted peer review committee. The scientific review process normally should take place before the consideration of ethical matters.
- Potential participants should be informed fully about the goals, procedures and risks of the study before giving their consent.
- Healthy subjects and patients must be able to decline, or to terminate, participation at any stage without risk or penalty whatsoever.
- Written consent must be obtained to indicate that the subject understands the nature and purpose of the proposed study, has had the opportunity to ask questions and agrees to participate on a voluntary basis. Where possible, informed consent should be endorsed by an independent signatory.
- There is a duty to protect those who may be incapable of giving fully informed and voluntary consent. These include children, the elderly, the mentally handicapped, prisoners and those very ill with other disease. Such persons should not be used for medical research unless they are essential for the goals of the proposed research. In such cases, consent must be obtained also from those who have legal responsibility for their welfare.
- In any pain research, stimuli should never exceed a subject's tolerance limit and subjects should be able to escape or terminate a painful stimulus at will. The minimal intensity of noxious stimulus necessary to achieve goals of the study should be established and not exceeded.
- In all circumstances, including studies that employ placebo and sham treatment methods, an effective, accepted method of pain relief must be provided on request of the patient or subject. The availability of alternative pain relief should be made clear in the consent form and the instruction before the study begins.
American Psychological Association, Ethical Principles in the Conduct of Research with Human Participants, 1973, pp. 58-69.
Council for International Organizations of Medical Sciences, Proposed International Guidelines for Biomedical Research Involving Human Subjects, 1982.
World Medical Association, Declaration of Helsinki: Recommendations Guiding Doctors in Clinical Research, 1964, revised edition, Tokyo, 1975.
World Medical Association, Declaration of Lisbon: The Rights of a Patient, 1981.
McNeill, P.M., The Ethics and Politics of Human Experimentation, Cambridge University Press, Cambridge, 1993.
Membership of the Committee on Ethical Issues
C. Benedetti, Columbus, Ohio (USA)
M.R. Bond, Glasgow, Scotland (UK) - Chairman 1990-1993
K.L. Casey, Ann Arbor, Michigan (USA)
J.E. Charlton, Newcastle upon Tyne (UK) - Chairman 1993
M.L. Cousins, St. Leonards, NSW (Australia)
R. Dubner, Baltimore, Maryland (USA)
G.F. Gebhart, Iowa City, Iowa (USA)
U. Lindblom, Stockholm (Sweden)
L. Vyklicky, Prague (Czechoslovakia)
T. Yokota, Seta Otsu (Japan)
M. Zimmermann, Heidelberg (Germany) - Chairman 1978-1990
IASP Executive Committee ex officio