The ethics activities of the World Medical Association

Since its formation in 1947, the World Medical Association (WMA) has been a leading voice in international medical ethics. The WMA’s principal ethics activity over the years has been policy development on a wide variety of issues in medical research, medical practice and health care delivery. With the establishment of a dedicated Ethics Unit in 2003, the WMA’s ethics activities have intensified in the areas of liaison, outreach and product development. Initial priorities for the Ethics Unit have been the review of paragraph 30 of the Declaration of Helsinki, the expansion of the Ethics Unit section of the WMA website and the development of an ethics manual for medical students everywhere. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.     

Placebo: Its action and place in health research today

The place for the placebo in human clinical research is addressed in this paper. The World Medical Association which is comprised of some 80 National Medical Associations uses much of its resources to address medical ethics and human rights issues. It adopted the Declaration of Helsinki in June 1964 which addressed the protection of individuals in clinical trials. The use of placebos assumes an important role in this document. Five Revisions of the Declaration of Helsinki have occurred and the most recent was adopted in October 2000. The provisions on placebo are now in Paragraph 29 which reads as follows: “The benefit, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic methods exists.” The reactions to the newly revised version of the Declaration of Helsinki were numerous and rapid, not the least of which was the paragraph I quoted above. At the direction of the WMA Council, a small group of experts together with the WMA workgroup studied the Paragraph 29 to ensure that no ethically sound research was being restricted by the revision. The outcome was approved by the Council and later the WMA General Assembly in October 2000. This gives a note of clarification as to the appropriate use of placebos. Numerous papers and statements over the last several years have described positions very much in line with the Note of Clarification cited above. This paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Partnerships with Psychiatry and Other Clinical Disciplines: A Key to Psychology's Success in U.S. Medical Schools

This paper describes the growth of psychology in medical schools and the distribution of psychologists across medical school departments. The Association of American Medical Colleges (AAMC) and American Psychological Association (APA) use different data collection approaches that reflect their different missions. AAMC focuses solely on medical school faculty, whereas APA tries to reach all psychologists working in academic health centers (AHCs). The number of psychologists in medical school settings has increased, largely due to their research expertise; but psychologists also contribute through teaching and clinical service. Psychologists hold appointments in wide variety of medical school departments, which has been a key factor in their success. Through partnership and interdisciplinary collaboration with a wide range of academic physicians, psychologists have gained increased support, become valued members of the AHC and medical school communities, and can rise to leadership positions in medical schools.     

Conflict of interest in Croatia: doctors with dual obligations

There is an emerging awareness of the possibility of conflicts of interest in the practice of medicine in Croatia. The paper examines areas within the medical profession where conflicts of interest can and have occurred, probably not only in Croatia. Particularly addressed are situations when a doctor may have dual obligations and how independent ethics committees can help in decreasing the influence of a conflict of interest. The paper also presents extracts from the Croatian Code of Ethics for the medical profession that address problems of conflict of interest. An earlier version of this paper entitled was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Medical journals' conflicts of interest in the publication of book reviews

The purpose of the study was to assess medical journals’ conflicts of interest in the publication of book reviews. We examined book reviews published in 1999, 2000, and 2001 (N=1,876) in five leading medical journals: Annals of Internal Medicine, British Medical Journal (BMJ), Journal of the American Medical Association (JAMA), Lancet, and New England Journal of Medicine. The main outcome measure was journal publication of reviews of books that had been published by the journal’s own publisher, that had been edited or authored by a lead editor of the journal, or that posed another conflict of interest. We also surveyed the editors-in-chief of the five journals about their policies on these conflicts of interests. During the study period, four of the five journals published 30 book reviews presenting a conflict of interest: nineteen by the BMJ, five by the Annals, four by JAMA, and two by the Lancet. These reviews represent 5.8%, 2.7%, 0.7%, and 0.7%, respectively, of all book reviews published by the journals. These four journals, respectively, published reviews of 11.9%, 25.0%, 0.9%, and 1.0% of all medical books published by the journals’ publishers. Only one of the 30 book reviews included a disclosure statement addressing the conflict of interest. None of the journals had a written policy pertaining to the conflicts of interest assessed in this study, although four reported having unwritten policies. We recommend that scientific journals and associations representing journal editors develop policies on conflicts of interest pertaining to book reviews. Disclosure: R.M. Davis was North American editor of the BMJ from 1998 to 2001, and is a member of the Board of Trustees of the American Medical Association, which publishes JAMA. The opinions expressed in this paper are those of the authors and do not reflect the official policy of any organization with which the authors have been affiliated.     

Conflict of interest: the importance of potential

The UK Medical Research Council (MRC) takes the issue of conflict of interest very seriously. The overall aim is to preserve a climate in which personal and organisational innovation can flourish while ensuring that potential conflicts are disclosed and identified and conflicts are either avoided or managed with integrity. The approach needs to encompass the MRC’s various responsibilities and the levels at which conflicts might arise: MRC staff (scientists and administrators); the governing Council; research Boards and committees; external peer-reviewers; and applicants for funding. To achieve its goals, the MRC has issued practical guidance on various aspects of conflict of interest. For the future, the MRC has identified the continuing commercialisation of science and the increasing involvement of lay people in scientific decision-making as special challenges in this area. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Conflict or harmony? Clinical research and the medical press in Russia

The author relates conditions for conducting clinical trials in Russia, current experiences of ethics committees, areas where conflicts of interest can occur regarding publishing the results of clinical trials in medical journals and the state of medical journalism in Russia today. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002. The author is a science editor of Meditsynskaya Gazeta.     

Individual and institutional conflict of interest: policy review by research universities in the United States

This paper is a discussion of efforts to manage real and potential conflicts of interest in university research in the United States. The focus is on the report by an Association of American Universities (AAU) task force that addresses both individual and institutional conflict of interest issues. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

"Enhanced" interrogation of detainees: do psychologists and psychiatrists participate?

After revelations of participation by psychiatrists and psychologists in interrogation of prisoners at Guantánamo Bay and Central Intelligence Agency secret detention centers, the American Psychiatric Association and the American Psychological Association adopted Position Statements absolutely prohibiting their members from participating in torture under any and all circumstances, and, to a limited degree, forbidding involvement in interrogations. Some interrogations utilize very aggressive techniques determined to be torture by many nations and organizations throughout the world. This paper explains why psychiatrists and psychologists involved in coercive interrogations violate the Geneva Conventions and the laws of the United States. Whether done with ignorance of professional ethical obligations or not, these psychiatrists and psychologists have crossed an ethical barrier that may best be averted from re-occurring by teaching medical students and residents in all medical specialties about the ethics principles stemming from the 1946–1947 Nuremberg trials and the Geneva Conventions, together with the Ethics Codes of the World Medical Association and the American Medical Association; and, with regard to psychiatric residents and psychological trainees, by the teaching about The Principles of Medical Ethics With Annotations Especially Applicable to Psychiatry and the Ethical Principles of Psychologists and Code of Conduct, respectively. In this way, all physicians and psychologists will clearly understand that they have an absolute moral obligation to "First, do no harm" to the human beings they professionally encounter.     

Welfare Rights and Conflicts of Rights

The fact that welfare rights – rights to food, shelter and medical care – will conflict with one another is often taken to be good reason to exclude welfare rights from the catalogue of genuine rights. Rather than respond to this objection by pointing out that all rights conflict, welfare rights proponents need to take the conflicts objection seriously. The existence of potentially conflicting and more weighty normative considerations counts against a claim’s status as a genuine right. To think otherwise would be to threaten the peremptory force – and hence the analytical integrity – of rights. The conflicts objection is made more pressing once we have conceded that welfare rights give people entitlements to what are potentially scarce goods. I argue that welfare rights can survive the conflicts objection if, and only if, we take scarcity into account in the framing of a given welfare right. Earlier versions of this paper were presented at the Nuffield Political Theory Workshop in Oxford and the Canadian Philosophical Association Congress 2006 at York University. I am grateful to Adam Swift, David Miller, Idil Boran, Sarah McCallum and two anonymous referees for their comments, and to the Economic and Social Research Council for research funding.     

Psychology’s Adaptation to Medical Schools,Teaching Hospitals,and Academic Medical Centers: The Role of Academic Medicine Organizations

Psychologists in medical schools, teaching hospitals, and academic medical centers are comparatively small in number, and are often undervalued and denied full practice privileges. As a profession, psychologists must therefore adapt to the realities of a physician-driven, physician-controlled environment. Psychologists’ adaptation to academic medical settings has been considered from several vantage points. An overlooked aspect of adaptation is psychologists’ knowledge of and participation in academic medicine organizations that regulate medical education and specialization. These organizations significantly influence teaching hospital and medical school environments and the psychologists and academic physicians who work in those environments. This paper focuses primarily on three academic medicine organizations, the Liaison Committee on Medical Education (LCME), the Accreditation Council for Graduate Medical Education (ACGME), and the American Board of Medical Specialties (ABMS), which together shape and regulate medical education across all levels and specialties. Knowledge of the evolution and workings of these organizations is useful information for psychologists, but beyond that, such information is a framework that provides benchmarks for understanding psychology’s evolving system of education and specialization.     

The use of the placebo effect in clinical medicine — ethical blunder or ethical imperative?

The current debate in medical ethics on placebos focuses mainly on their use in health research. Whereas this is certainly an important topic the discussion tends to overlook another longstanding but nevertheless highly relevant question, namely if and how the placebo effect should be employed in clinical practice. This paper describes the way the placebo effect is perceived in modern medicine and offers some historical reflections on how these perceptions have developed; discusses elements of a definition of the placebo effect; and suggests some conditions under which making use of the therapeutic potential of the placebo effect can be ethically acceptable, if not warranted. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003. Nikola Biller-Andorno, MD, PhD, is Assistant Professor in the Dept. of Medical Ethics and History of Medicine, University of Goettingen, Germany. Dr. Biller-Andorno also serves as an ethicist for the World Health Organization (WHO). This paper does not necessarily reflect the views of the World Health Organization.     

Managing financial conflicts of interest in clinical research

Upholding public trust in clinical research necessitates that human subjects be protected from avoidable harm and that the design, interpretation and reporting of research results be shielded from avoidable bias. On both counts, managing financial conflicts of interest is critically important, especially in the modern era when the opportunities for investigators to benefit personally from the commercialization of their intellectual property are overtly encouraged and rapidly expanding. Efforts are underway in the United States to provide more useful guidance to universities and medical schools for purposes of strengthening the oversight and management of financial conflicts of interest in clinical research. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Conflict of interest from a Romanian geneticist’s perspective

This paper examines Romanian bioethics regulations for biomedical sciences, looking in particular at the genetics area as a source for conflict of interest. The analysis is focused on the organizational level, national regulations, the sources for generating conflicts of interest, and management of conflicts. Modern biotechnology and gene technology are among the key technologies of the twenty-first century. The application of gene technology for medical and pharmaceutical purposes is widely accepted by society, but the same cannot be said of the development and application of gene technology in agriculture and food processing. Because the use of a technology in the production and processing of food is regarded more sceptically than in the production of biomedical products, there can be areas of conflict in many cases when communication is undertaken about gene technology in the agro-food sector. Ethical concerns play an important factor in this, but a society’s attitude to a developing technology is an amalgam of many effects which are beyond ethics as such. This paper contains a study carried out by the author for the Romanian Association for Consumer Protection about the attitudes of consumers towards genetically modified (GM) foods. This study revealed that in Romania more than 98% of consumers did not know anything about GM foods and frequently were confused about the definitions of these terms. In conclusion, it is necessary to say that there is a low level of knowledge regarding biotechnology in Romania and this is an important reason why there is neither public acceptance of gene technology products nor is there a rejection. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002. Ioana Ispas, MD in Molecular Biology, is a scientific researcher and Member of the Romanian Association for Consumer Protection, NCP for FP5-Quality of life and management of living resources.     

Ethical and legal aspects in teaching students of medicine

Due to the rapid advances in medical technology, medical students are now being faced with increasingly complex and unparalleled ethical and practical dilemmas during their training. The new and future challenges of high-tech medicine demand improvements in current medical education, not only by meeting the needs of students through humanized training programs, but also by involving them in finding solutions to the ethical and legal quandaries they encounter. Today’s students of medical universities must acquire knowledge and understanding of the ethical and legal issues relevant to the practice of medicine, and we have to do everything possible to introduce these students to the current discussions on more or less controversial ethical and legal topics. Although final answers may not be found, the very discussion, argumentation, and awakening of students’ interest should become an essential part of the core curriculum of every doctor. An earlier version of this paper was presented at an international conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004. The author is a student and member of the Senate Committee on Teaching.     

Academic-industrial relationships: Opportunities and pitfalls

Over the past 50 years, academic-industrial collaborations and technology transfer have played an increasingly prominent role in the biomedical sciences. These relationships can speed the delivery of innovative drugs and medical technologies to clinical practice, creating important public health benefits as well as income for universities and their faculty. At the same time, they raise ethical concerns, particularly when research involves human subjects in clinical trials. Lapses in oversight of industry sponsored clinical trials at universities, and especially patient deaths in a number of trials, have brought these issues into the public spotlight and have led the federal government to intensify its oversight of clinical research. The leadership of Harvard Medical School convened a group of leaders in academic medicine to formulate guidelines on individual financial conflicts of interest. They and other groups are working to formulate a national consensus on this issue. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Polish Research Ethics Committees in the European Union System of Assessing Medical Experiments

The Polish equivalents of Research Ethics Committees are Bioethics Committees (BCs). A questionnaire study has been undertaken to determine their situation. The BC is usually comprised of 13 members. Nine of these are doctors and four are non-doctors. In 2006 BCs assessed an average of 27.3 ± 31.7 (range: 0–131) projects of clinical trials and 71.1 ± 139.8 (range: 0–638) projects of other types of medical research. During one BC meeting an average of 10.3 ± 14.7 (range: 0–71) projects of medical research were assessed (2006). The amendment of Polish laws according with Directive 2001/20/EC caused a percentage increase in BCs which assessed less than 20 projects per year (16% vs. 33% or 42% in 2003 vs. 2005 or 2006 respectively, p < 0,05). The results confirm the usefulness of the current practice of creating BCs by medical universities, medical institutes and regional chambers of physicians and dentists but rationalization of the workload for individual BCs is necessary.

The Association of American Medical Colleges and the Association of Medical School Psychologists: Finding Psychology’s Place in Academic Medicine

This paper highlights the role of the Association of Medical School Psychologists (AMSP) as a bridge between academic medicine and psychology. AMSP’s affiliation with Division 12 of the American Psychological Association is discussed, but the primary focus is AMSP’s affiliation with the Association of American Medical Colleges (AAMC) and the AAMC’s Council of Academic Societies (CAS). The history, structure, activities, and goals of AAMC and CAS are examined. AMSP’s affiliation with AAMC is important for psychologists in medical schools and academic medical centers, and for psychology in general, because AAMC is the major voice of academic medicine in the US. AAMC activities affect medical education at all levels, as well as research and health services at academic medical centers, and health care policy at the national level. AMSP’s dual affiliation with AAMC’s CAS and APA’s Society of Clinical Psychology will increase psychology’s visibility and influence in academic medical centers and enhance the two-way flow of ideas and information between academic medicine and psychology.     

Conflict of interest in medical research in Estonia

An area where conflicts of interest can take place in Estonia is in the conduct of clinical trials. The paper lists the main areas where such conflicts of interest can occur. The author also briefly discusses Estonia’s current position with regard to regulating genetic information and the commencement of the Estonian Genome Project. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.