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The Declaration of Helsinki - the Cornerstone of Research Ethics

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The Declaration of Helsinki - the Cornerstone of Research Ethics Review article UDC: 615.277:323.233(480.1 Helsinki) Archive of Oncology 2001;9(3):179-84. The Declaration of Helsinki - The cornerstone of research ethics Sne¾ana BO©NJAK The modern era of oncology is dominated by data arising from cancer clinical trials. Research ethics guidelines are needed to help investigators to protect the rights and welfare of human participants involved in research, to promote the adherence to the ethical and scientific principles underlying research and to allay public concerns about the responsible conduct of medical research. Three fundamental ethical principles underlying research that involves humans are respect for persons, beneficence and justice. The Declaration of Helsinki (DoH), developed by the World Medical Association (1964), is the most widely accepted code of research ethics. The DoH has been revised five times, the last time by the 52nd WMA General Assembly in Edinburg, Scotland (October, 2000). The distinction between therapeutic ("clinical") and non-therapeutic research, the standards of care ethically required when research is combined with medical care and the ethics of placebo-controlled trials were three major points of dis- cussion. In the revised version of the DoH, the WMA holds its main position to serve and protect human participants from potentially harmful research projects, while at the same time encouraging their involvement in ethical and scientifically valid research aiming to challenge and improve the understanding and treatment of disease. KEY WORDS: Clinical trials; Research; Helsinki Declaration; Ethics, Medical INSTITUTE FOR ONCOLOGY AND RADIOLOGY OF SERBIA, Archive of Oncology 2001,9(3):179-184©2001,Institute of Oncology Sremska Kamenica, Yugoslavia BELGRADE, YUGOSLAVIA INTRODUCTION The principle of respect for persons ("respect a person' s wish- linical trials are the most widely accepted tools in the search es") incorporates two ethical convictions: a) respect for autono- C for more effective prophylactic, diagnostic or therapeutic my: potential participants should be treated as autonomous procedures in oncology. A clinical trial is defined as an experiment beings, capable of making an informed decision whether to par- on humans, being carried out in order to answer a precisely ticipate in a research and b) persons with diminished autonomy defined scientific question (s) and to find better ways to prevent, are entitled to additional protection. The implementation of this diagnose, or treat cancer (1,2). The research involving human general principle is the requirement for informed consent of each participants must be conducted in accordance with the standards potential participant. of research ethics that promote and protect their rights and wel- The principle of beneficence ("do the most positive good") oblig- fare. ates the investigator to maximize benefits and minimize harm that Fundamental ethical principles might occur from the research. The principle finds expression in the requirement for risk/benefit assessment and balance before Three fundamental ethical principles underlying research involving and during the research. human participants are respect for persons, beneficence and jus- The principle of beneficence relies on Hippocratic principle of tice (3). non-maleficence ("do no harm") which, applied to the field of medical research, means that one should not injure one person Address correspondence to: regardless of the benefits that might come to others. Dr. Sne¾ana Bo¹njak, Institute for Oncology and Radiology of Serbia, Pasterova The physician's fundamental duty is to do his best to protect rights 14, 11000 Belgrade, Yugoslavia and welfare of people in their research projects. In other words, The manuscript was received: 04. 10. 2001. the goals of research should always be secondary to the welfare Provisionally accepted: 18. 10. 2001. of research participants. In the Declaration of Geneva of the World Accepted for publication: 19. 10. 2001. Medical Association (WMA) it is written: "The health of my patient © 2001, Institute of Oncology Sremska Kamenica,Yugoslavia 179 Bo¹njak S. will be my first consideration" (4). The International Code of rest in part on experimentation involving human subjects. In med- Medical Ethics states that "a physician shall act only in the ical research on human subjects, considerations related to the patient's interest when providing medical care which might have well-being of the human subject should take precedence over the the effect of weakening the physical and mental condition of the interests of science and society" (paragraph 5) patient" (4). Since it was drawn up in 1964, the DoH has been revised five The principle of justice ("be fair") requires that we select partici- times, the last time by the 52nd WMA General Assembly in pants fairly and without bias. Individual participants or communi- Edinburg, Scotland (October, 2000). Last revision of the DoH ties should be selected in such a way that the risks of the caused one of the most thorny debate and polarization in the research are equally distributed and benefits will be equally medical community (7-11). The need for the distinction between enjoyed. The principle finds its application in fairness in the selec- therapeutic ("clinical") and non-therapeutic research, the stan- tion of individual research participants and in the protection of vul- dards of care ethically required when research is combined with nerable communities / groups. medical care and the ethics of placebo-controlled trials were three major points of discussion (9). The Declaration of Helsinki The revised DoH (5) consists of 32 paragraphs arranged in intro- The Declaration of Helsinki (DoH) is the cornerstone statement of duction (part A), basic principles for all medical research (part B) ethical principles in biomedical research (5). The full title of the and additional principles for medical research combined with DoH is "Ethical Principles for Medical Research Involving Human medical care (part C). Previous distinction between therapeutic Subjects". It was adopted by the 18th WMA General Assembly in (ÒclinicalÓ) and non-therapeutic research is rejected (see argu- Helsinki (1964) as a set of principles to guide physicians and oth- ments for in ref. 8). ers engaged in medical research to protect human participants The goal of this paper is not to retell the paragraphs of the DoH; and conduct their research in an ethical manner. the reader must refer to the original document. Important ethical Historically, the DoH stems from the Nuremberg code (6), which principles and procedures will, however be highlighted and inter- was written as a reaction to the horror of the Nazi experiments preted. To achieve this objective other international research during the Second World War. In 1946, 23 Nazi physicians and ethics guidelines (2,3,12,13), as well as two recently published administrators were indicted before the Nuremberg war crimes reports (9,14) on the revision, interpretation and implementation Tribunal for their willing participation in the systematic torture, of the revised DoH were used as a reference. mutilation, and killing of the concentration camp prisoners in bio- medical experiments. During the Trial, the Nuremberg code was BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH (paragraphs drafted as a set of standards for judging physicians and scientists 10-27) about ethics of their experiments. Despite the arguments that "It is the duty of the physician in medical research to protect the life, experiments were medically justified, the Nuremberg Tribunal health, privacy, and dignity of the human subject" (paragraph 10). condemned them as "crimes against humanity"; the physicians were found guilty and imprisoned or were sentenced to death. In The importance of good research design formulated in an the 1947 verdict, the judges included a section called experimental protocol (paragraphs 11-14). Medical research "Permissible Medical Experiments", with a set of ten conditions to involving human participants should be scientifically sound and be met before research could be deemed ethically possible. This properly designed to permit valid conclusions (1,2). Scientifically section became known as the Nuremberg code of 1947 (6). The unsound research exposes participants to risk to no purpose. The Nuremberg code was the first international standard of human research question should be formulated after detailed review of all experimentation ethics. existing scientific data, other relevant literature and results of pre- The DoH (5) was developed by medical community in response liminary testing. All aspects of a research (the rationale, the to the Nuremberg code to refocus the physicians on their funda- objective and procedures designed to reach the objective) should mental duty to safeguard the welfare of people in their research be prospectively described in an experimental protocol. The projects: research protocol should always contain a statement of the ethi- "It is the duty of the physician to promote and safeguard the cal considerations involved and should indicate that it is compli- health of the people. The physician's knowledge and conscience ant with the principles of the DoH (5). are dedicated to the fulfillment of this duty" (paragraph 2), and to Qualifications/competence of the research investigator (para- affirm the WMA position that responsible conduct of ethical graph 15). The investigator should be medically qualified and human research is the basis for medical progress: trained in
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