"...the physician's role in the physician patient relationship is different from the researcher's role in the researcher-research subject relationship"
All physicians make use of the results of medical research in their clinical practice. To maintain their competence, physicians must keep up with the current research in their area of practice through Continuing Medical Education/ Continuing Professional Development programs, medical journals and interaction with knowledgeable colleagues. Even if they do not engage in research themselves, physicians must know how to interpret the results of research and apply them to their patients. Thus, a basic familiarity with research methods is essential for competent medical practice.
The best way to gain this familiarity is to take part in a research project, either as a medical student or following qualification. The most common method of research for practicing physicians is the clinical trial. Before a new drug can be approved by government mandated regulatory authorities, it must undergo extensive testing for safety and efficacy. The process begins with laboratory studies followed by testing on animals. If this proves promising, the four steps, or phases, of clinical research, are next.
The rapid increase in recent years in the number of ongoing trials has required finding and enrolling ever-larger numbers of patients to meet the statistical requirements of the trials. Those in charge of the trials, whether independent physicians or pharmaceutical companies, now rely on many other physicians, often in different countries, to enroll patients as research subjects. Although such participation in research is valuable experience for physicians, there are potential problems that must be recognized and avoided. In the first place, the physician's role in the physician patient relationship is different from the researcher's role in the researcher research subject relationship, even if the physician and the researcher are the same person. The physician's primary responsibility is the health and well-being of the patient, whereas the researcher's primary responsibility is the generation of knowledge, which may or may not contribute to the research subject's health and well being. Thus, there is a potential for conflict between the two roles.
When this occurs, the physician role must take precedence over the researcher. Another potential problem in combining these two roles is conflict of interest. Medical research is a well-funded enterprise, and physicians are sometimes offered considerable rewards for participating. These can include cash payments for enrolling research subjects, equipment such as computers to transmit the research data, invitations to conferences to discuss the research findings, and co-authorship of publications on the results of the research. The physician's interest in obtaining these benefits can sometimes conflict with the duty to provide the patient with the best available treatment. It can also conflict with the right of the patient to receive all the necessary information to make a fully informed decision whether or not to participate in a research study.
These potential problems can be overcome. The ethical values of the physician – compassion, competence, autonomy – apply to the medical researcher as well. So there is no inherent conflict between the two roles. As long as physicians understand and follow the basic rules of research ethics, they should have no difficulty participating in research as an integral component of their clinical practice.
The basic principles of research ethics are well established. It was not always so, however. Many prominent medical researchers in the 19th and 20th centuries conducted experiments on patients without their consent and with little if any concern for the patients well-being. Although there were some statements of research ethics dating from the early 20th century, they did not prevent physicians in Nazi Germany and elsewhere from performing research on subjects that clearly violated fundamental human rights.
Following World War Two, some of these physicians were tried and convicted by a special tribunal at Nuremberg, Germany. The basis of the judgment is known as the Nuremberg Code, which has served as one of the foundational documents of modern research ethics. Among the ten principles of this Code is the requirement of voluntary consent if a patient is to serve as a research subject.
The World Medical Association was established in 1947, the same year that the Nuremberg Code was set forth. Conscious of the violations of medical ethics before and during World War Two, the founders of the WMA immediately took steps to ensure that physicians would at least be aware of their ethical obligations. In 1954, after several years of study, the WMA adopted a set of Principles for Those in Research and Experimentation. This document was revised over the next ten years and eventually was adopted as the Declaration of Helsinki (DoH) in 1964. It was further revised in 1975, 1983, 1989, 1996, 2000 and 2008. The DoH is a concise summary of research ethics. Other, much more detailed, documents have been produced in recent years on research ethics in general (e.g., Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993, revised in 2002) and on specific topics in research ethics (e.g., Nuffield Council on Bioethics [UK], The Ethics of Research Related to Healthcare in Developing Countries, 2002). Despite the different scope, length and authorship of these documents, they agree to a very large extent on the basic principles of research ethics. These principles have been incorporated in the laws and/or regulations of many countries and international organizations, including those that deal with the approval of drugs and medical devices.
All physicians make use of the results of medical research in their clinical practice. To maintain their competence, physicians must keep up with the current research in their area of practice through Continuing Medical Education/ Continuing Professional Development programs, medical journals and interaction with knowledgeable colleagues. Even if they do not engage in research themselves, physicians must know how to interpret the results of research and apply them to their patients. Thus, a basic familiarity with research methods is essential for competent medical practice.
The best way to gain this familiarity is to take part in a research project, either as a medical student or following qualification. The most common method of research for practicing physicians is the clinical trial. Before a new drug can be approved by government mandated regulatory authorities, it must undergo extensive testing for safety and efficacy. The process begins with laboratory studies followed by testing on animals. If this proves promising, the four steps, or phases, of clinical research, are next.
The rapid increase in recent years in the number of ongoing trials has required finding and enrolling ever-larger numbers of patients to meet the statistical requirements of the trials. Those in charge of the trials, whether independent physicians or pharmaceutical companies, now rely on many other physicians, often in different countries, to enroll patients as research subjects. Although such participation in research is valuable experience for physicians, there are potential problems that must be recognized and avoided. In the first place, the physician's role in the physician patient relationship is different from the researcher's role in the researcher research subject relationship, even if the physician and the researcher are the same person. The physician's primary responsibility is the health and well-being of the patient, whereas the researcher's primary responsibility is the generation of knowledge, which may or may not contribute to the research subject's health and well being. Thus, there is a potential for conflict between the two roles.
When this occurs, the physician role must take precedence over the researcher. Another potential problem in combining these two roles is conflict of interest. Medical research is a well-funded enterprise, and physicians are sometimes offered considerable rewards for participating. These can include cash payments for enrolling research subjects, equipment such as computers to transmit the research data, invitations to conferences to discuss the research findings, and co-authorship of publications on the results of the research. The physician's interest in obtaining these benefits can sometimes conflict with the duty to provide the patient with the best available treatment. It can also conflict with the right of the patient to receive all the necessary information to make a fully informed decision whether or not to participate in a research study.
These potential problems can be overcome. The ethical values of the physician – compassion, competence, autonomy – apply to the medical researcher as well. So there is no inherent conflict between the two roles. As long as physicians understand and follow the basic rules of research ethics, they should have no difficulty participating in research as an integral component of their clinical practice.
The basic principles of research ethics are well established. It was not always so, however. Many prominent medical researchers in the 19th and 20th centuries conducted experiments on patients without their consent and with little if any concern for the patients well-being. Although there were some statements of research ethics dating from the early 20th century, they did not prevent physicians in Nazi Germany and elsewhere from performing research on subjects that clearly violated fundamental human rights.
Following World War Two, some of these physicians were tried and convicted by a special tribunal at Nuremberg, Germany. The basis of the judgment is known as the Nuremberg Code, which has served as one of the foundational documents of modern research ethics. Among the ten principles of this Code is the requirement of voluntary consent if a patient is to serve as a research subject.
The World Medical Association was established in 1947, the same year that the Nuremberg Code was set forth. Conscious of the violations of medical ethics before and during World War Two, the founders of the WMA immediately took steps to ensure that physicians would at least be aware of their ethical obligations. In 1954, after several years of study, the WMA adopted a set of Principles for Those in Research and Experimentation. This document was revised over the next ten years and eventually was adopted as the Declaration of Helsinki (DoH) in 1964. It was further revised in 1975, 1983, 1989, 1996, 2000 and 2008. The DoH is a concise summary of research ethics. Other, much more detailed, documents have been produced in recent years on research ethics in general (e.g., Council for International Organizations of Medical Sciences, International Ethical Guidelines for Biomedical Research Involving Human Subjects, 1993, revised in 2002) and on specific topics in research ethics (e.g., Nuffield Council on Bioethics [UK], The Ethics of Research Related to Healthcare in Developing Countries, 2002). Despite the different scope, length and authorship of these documents, they agree to a very large extent on the basic principles of research ethics. These principles have been incorporated in the laws and/or regulations of many countries and international organizations, including those that deal with the approval of drugs and medical devices.
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