Ethics in clinical drug trial research in private practice

INTRODUCTION: Private clinics and clinicians have been involved in clinical drug trials for approximately two decades. This paper reviews the ethical consideration inherent in this process. METHODS: Involvement of a single community based, private, Australian neurological clinic in the conduct of trials was audited. Changes in ethical considerations were analysed. RESULTS: The clinic previously audited its clinical trial involvement, starting with pharmaceutical company orchestrated trials. These were vetted by hospital based ethics committees (ECs) which then refused to review private research. A private EC accommodating NH & MRC standards was formed to assess private research. Indemnity concerns forced return to institutional ECs with government guaranteed indemnification. Trials evolved to investigator initiated, company sponsored studies thence a company asking the clinic to devise, sponsor and manage a trial. The latter relegated trial co-ordination to the clinic which would control publication thereby creating new ethical standards. DISCUSSION: Private practice trial involvement evolved from reluctant inclusion to a pivotal role in privately sponsored studies. Access to ECs is government endorsed and publication is independent for investigator-sponsored trials. There has been modification of standard operating procedures and enhanced ethical standards.     

Research ethics committees and community values: Devlin, Dworkin, Hart and beyond

Two fundamental requirements ought to be met in any selection to research ethics committees: (i) professional scientific competence, and (ii) the understanding of moral values which prevail in any community. The question is: Should the verdicts of research ethics committees be based on community values? This article critically examines theories of community as were propounded by Devlin, Dworkin and Hart in answer to this question. It is argued that community values are complementary rather than conflicting, and that Dworkin's theory of community provides an analytical framework for research ethics on the new genetic technologies. Finally, it is submitted that the verdicts of research ethics committees should be based on community values.     

Medical ethics surveillance in the Armed Forces

Modern defense services depend on a policy of the vigorous promotion of research to ensure that they retain an advantage in any future operational context. Research involving personnel within the armed forces, however, has certain constraints with respect to contemporary, best-practice medical ethics. Service members are one example of a class of "captive subjects" who require special protection in the context of medical research. (Prisoners, students, children, and the intellectually disabled are other such examples.) The majority of national defense forces now have ethical watchdog groups--institutional ethics committees--that oversee research involving service members. Such groups monitor the special considerations and constraints under which subjects in uniform can volunteer for biological research. These committees audit particularly the ethical themes of confidentiality, equality, and justice. Themes inherent in medical research in the military include the standard Beauchamp-Childress paradigm of autonomy, beneficence, nonmaleficence, and justice, to which are added the traditional military values of loyalty, respect, courtesy, and chivalry. Contemporary thinking is that the general principle of affording service members the opportunity to volunteer for research should be maintained within the constraints of compromised training time, national security, and operational necessity. Most biological research (and its outcome) does not in practice compromise confidentiality or military security. This paper presents an audit of the functioning of one national military medical ethics committee, the Australian Defence Medical Ethics Committee, and presents a discussion of its philosophies and influence within the broader military context. The Australian Defence Medical Ethics Committee believes that most research should, as an a priori condition of approval, be intended for open publication in peer-reviewed journals.     

Ethical issues in health care institutions. Lesson three: Hospital ethics committees

The hospital ethics committee serves as the topic for this third lesson of a five-part WMU/AHRA magazine course on ethics. Proliferating during the last ten years and fostered by the Karen Ann Quinlan case, hospital ethics committees today function in three areas: education, development of guidelines and policies, and individual case consultation. Using specific examples in the discussion of each function, the authors give a detailed picture of the valuable contribution these committees make to the institutions they serve.     

A survey of Army clinicians on hospital ethics committees

The use of hospital ethics committees (HECs) has increased over the previous 5 to 8 years. A recent survey of physician-administrators in Army Medical Centers and community hospitals revealed that most favored the existence and utilization of these committees within their own hospitals. A follow-up survey was conducted to ascertain the perceptions that clinicians in Army Medical Centers have of these committees and their current or potential utilization in Army hospitals. The results indicate that clinicians as well as physician-administrators in the Army view these committees as beneficial.     

Ethics review of health research on human participants in South Africa

In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.     

The experience of the research ethics committees in Turkey

In this article the experience of the research ethics committees in Turkey, which are nearly ten years old, is introduced. Although the legislation related to Research on Human Beings by using Drugs and Chemical Substances, issued on 29th January 1993 by the Ministry of Health, there are a lot of problems about RECs, for example the central ethics committee has no medical ethicist as a member, and there is no ethical concept other than "consent" in their operational procedures. Membership characteristics of the ECs, and their specialty areas described functions of the ECs, the forms used, and the major items used for the evaluation of the proposals are explained. Finally the ethics committee of the Turkish Medical Association is also introduced as another model of ECs in Turkey.     

Ethical assessment of clinical research publications

The ethical quality of research could be improved in four ways: increasing the expertise of research committees, encouraging the popularization of research in ethics, delivering medical training in ethics, and improving the a posteriori control of editorial committees. With regard to the last point, we propose ethical guidelines that may be used as a screening device for publication. Scientific publications have a duty to contribute to the diffusion and application of ethical principles. But too often pieces of research published in these journals do not adequately demonstrate their ethical reflections and chosen ethical procedures. Only scientific procedures are extensively discussed. We think it is essential to develop an assessment of the ethical value of research that is featured in journals, in the same way that the methodological value is assessed. This paper reports what motivated our group to create an ethical scheme, how we developed this scheme and what was our process of validation. In the same way that today a study can be refused publication for methodological inadequacies, in the future publication could more likely be refused for ethical shortcomings.     

Genetic research & human biological samples: some legal and ethical considerations

This paper examines the medico-legal and medico-ethical issues that ethics committees and researchers will have to consider when examining proposals pertaining to non-therapeutic genetic research. This paper is limited to the examination of issues that relate to those individuals who donate bodily/DNA samples for the purposes of non-therapeutic genetic research. The issues that arise are those of (i) informed consent and those with diminished capacity (ii) the drafting of consent forms as they relate to genetic research (iii) confidentiality, genetic research with non-EU countries and the implications of the EC Directive on the Protection of Data: 95/46/EC and (iv) an examination of international ethical guidelines. The paper concludes with (i) a summary of the main points of concern that ethics committees must consider before the approval of genetic research (ii) the manner in which consent forms must be drafted and (iii) a brief look at medico-legal issues that will become important and will have to be considered in Ireland in the near future in relation to genetic research.     

The ethics of post-marketing surveillance of therapeutic agents

Trials of new therapies have strict codes of conduct which expect the highest of ethical practice. Local ethics committees review protocols, patient information, consent. National research councils delineate guidelines for minimum standards regarding subjects in such trials. Once medications enter the market place, there is less definition of minimal codes of conduct. Clinical trials are designed to meet regulatory demands to access commercial markets. Prior to marketing, there is a usual drug trial exposure of less than 5,000 individuals which diminishes identification of rare adverse events. Australian case law has found negligence for not warning of a 1:14,000 risk of sympathetic ophthalmia and more recently, in Chappel v Hart, even a speculative risk was grounds for negligence. Recent reports of serious adverse events for conditions such as epilepsy or depression resulted in companies appearing to expend considerable effort to suppress concern rather than to seriously investigate these complications in the post marketing period. This paper will explore such cases and discuss approaches to improve post marketing surveillance and patient protection.     

The ethical commitment of Australian radiographers: Does medical dominance create an influence?

There is a lack of awareness and openness surrounding ethical debate in Diagnostic Radiography literature and culture, perpetuated in part by the historical growth of the technical realm of radiography, radiology and medicine. Hence, the impact of Australian radiographers' current level of professional autonomy, combined with the influence of medical dominance and radiographers' ethical commitment was undocumented. This study investigated the role, importance and attitudes of Australian radiographers towards ethics through a qualitative study following a grounded theory approach. Semi-structured interviews were conducted with 25 Australian. A conceptual framework mapping the causal conditions affecting the ethical commitment was developed.This study argues that a number of internal and external variables weave an intricate fabric of poor identity, subservience and negative workplace culture. Australian radiographers, whist attempting to set a standard of ethical commitment, are hindered by difficulties of medical dominance, relatively poor professional autonomy and difficulty in accepting responsibility. The presence of private radiology enterprise and the association between patient referral and money has eroded the radiographer-patient relationship and introduced the potential for unethical practice in the radiographer-radiologist-referring practitioner relationship.     

Institutional ethics committees and health care decision making

Institutional ethics committees and health care decision making. Edited by Cranford, R.E., and Doudera, A.E. (Health Administration Press, Ann Arbor, Michigan, 1984), 425 pages, $28.00.     

Healthy human volunteers and informed consent

The use of healthy human volunteers poses major ethical and medical dilemmas. The ethical dilemma is "without some form of payment most volunteers will not volunteer." Furthermore, no clear distinction exists between legal consent and valid consent. The former involves signing a document of informed consent. Valid consent poses unique problems, since the animal experiments performed prior to clinical trial are not predictive with any degree of confidence for human beings. Participants in clinical trials (particularly early phase) must always receive written assurances that they, or their next-of-kin, will receive significant guaranteed (i.e., no fault) financial compensation (at least on a par with a reputable life insurance company), in the event of participant damage or death. In addition, ethical committees whose task it is to approve or oversee clinical trials should be comprised of at least 50% non-scientists (as in the Danish system of medical ethics).     

Ethics education in medical schools: the role of jurists

Ethical thinking has always existed in the area of medicine. The oldest law case has known human experiment difficulties, but this comes from the doctor. The power of the practitioner relies on the lack of medical knowledge of the patient and often in practice, on the lack of information for the patient. The doctor has ethical difficulties when he considers the patient and the solution, in fact is dependent on his conscience. With the various medical discoveries, the doctor can create life (assisted procreation), manipulate life (gene therapy) and suppress life (abortion, suppression of frozen embroyos). These discoveries have increased the necessity for ethical reflection. Ethics committees have been created at local level (as part of special establishments or departments) rather than at national and international levels. The scope of the stakes (the development of the human race) give to this ethical reflection a multidisciplinary approach. There is a general tendency for the influence of law in these fields. Therefore, the jurist has a more and more important place on these ethics committees. Actually, the interaction from ethics to law is frequent. Also during legal proceedings, a jurist has and will have more and more need of a medical assessor. So, cooperation is necessary between doctors and jurists. The teaching of ethics in medical schools by the jurist can be important because it will recall the humanist mission of the doctor. The jurist must be able to increase the medical professions' awareness of essential notions such as respect for the fundamental rights of the human being.     

Ethical issues in health care institutions. Lesson 2: Ethical considerations in group decision making and groupthink

In this second lesson of a five-part WMU/AHRA magazine course on ethics, Dr. Alie tackles an interesting concept--group-think. According to the author, this tendency occurs when cohesive groups lose their ability to critically evaluate alternatives in problem solving. Since groups such as committees or task forces frequently resolve issues and make policy in health care organizations, warning signs of this phenomenon are detailed as well as suggestions to help avoid the problem.     

A comparison of morbidity in the Australian Defence Force with Australian general practice

This study was designed to examine morbidity patterns among Australian Defence Forces members and to compare them with civilian general practice. The study was conducted in the outpatient departments of the Royal Australian Air Force (RAAF) No. 6 Hospital, Melbourne, Australia. The patients studied were male and female members of the RAAF (66%), Army (25%), and Navy (9%). The problems managed at all primary care consultations during 1993 and 1994 were coded using the Ninth Revision of the International Classification of Diseases (Clinical Modification). The codes were grouped and compared against a major study of Australian general practice. In the 6 Hospital study, 21,910 problems were managed at 19,909 consultations. The main differences found between the two studies were that service personnel had more medical examinations, more musculoskeletal and respiratory problems, and fewer psychological and cardiovascular problems. Most of the differences observed may reflect the Defence Force's recruitment selection criteria and the emphasis on physical fitness and diet.     

Euthanasia in the Netherlands: experiences in a review committee

Since 1999 reported cases of euthanasia in The Netherlands are examined in five regional review committees. In these committees a lawyer, an ethicist and a medical doctor investigate whether the cases reported are in correspondence with the so-called criteria for careful practice. Issues to be investigated include the patient's suffering, the nature of the patient's request, the consultation by another doctor and the way in which the termination of life has been performed. Since April 2002 the judgment of the committees is final. This paper describes the working of the review committees. It also discusses the relevance of experiences in the committee for issues of social and public debate, such as the role of the consulting doctor, the relation between euthanasia and palliative care, and the place of patient autonomy.     

The law and ethics of the use of experimental medication in patients incapable of expressing consent: between a rock and a hard place

In Australia, human research ethics committees approve clinical trials of drugs in accordance with federal regulations. Federal guidelines allow for the possible conduct of clinical trials in all populations. Within the State of New South Wales, persons unable to consent because of disability are subject to State legislation which, until 1998, regarded drug trials as Special Medical Treatment requiring consent of the Guardianship Tribunal. That consent could only be given if an anticipated individual benefit could be proved. As no such guarantee could be given prior to conduct of a clinical trial, it being unethical to trial an active substance against a placebo if potential individual benefit is already proven for the active substance, a conundrum resulted whereby the Tribunal could not give the required approval. Many argued that the New South Wales law resulted in some experimental medications, such as those being available to minimise tissue damage following stroke, or those being specifically developed for those with late stage dementia, not being made available to their target populations. Amendments were made to remove reference to clinical drug trials as Special Medical Treatment, and a new system established whereby such trials could proceed, including the use of a placebo, with the approval of an ethics committee and the Tribunal.     

Bioethics committees and examining consent within the patient-physician relationship in Turkey

Clinical exercises include questions about a physician's behaviour, decision making process, values, rights and responsibilities, as much as the scientific-technical questions concerning the disease. Some of these questions may be easily answered, for there are well-constructed activity options that have found widespread acceptance regarding what has to be done. However, it is quite difficult to answer the questions with problematic options, or the ones on which a compromised attitude is not present. Patient participation in treatment-related decision-making has been promoted as being ethically and clinically desirable in Western countries. Several studies have indicated that patient participation in decision-making has a positive influence on their health outcomes, thereby increasing patient satisfaction regarding medical care and promoting patient autonomy. Over the last decade, patient involvement in treatment-related decision-making has been widely advocated in Turkey, where patient-physician encounters are still under the influence of the long-standing tradition of paternalism. Despite this profound change in clinical practice, studies investigating the actual preferences of Turkish people regarding involvement in treatment-related decision-making are limited. In Turkey, to protect the rights of patients, current Govermental requirements mandate that all human biomedical research and medical intervention be accompanied by a consent form that contains the information necessary for an informed decision. In addition, they require that the information provided to the subject or the representative shall be explained in appropriate language. Especially after the new regulations in the Turkish Penal Code, physicians and nurses have started to be more sensitive towards informed consent and have become more conscious about their responsibilities. It has started to be questioned more, and as a result, the problems experienced about patient consent in medical applications created new ethical dilemmas. Informed consent is acknowledged to be the most essential constituent of patient rights today. In this paper, after introducing a general overview of the significance and requirements of informed consent, we will consecutively discuss the decision making and informed consent process, legal arrangements concerning this issue in Turkey, the approaches of physicians and patients towards the topic, and regarding informed consent, we will discuss the responsibilities of hospital ethics committees.     

The clinical nurse researcher in a military setting: bringing practice into research

The clinical nurse researcher (CNR) is emerging as an integral part of every major medical center. The CNR has six basic roles: facilitate the conduct of research projects; stimulate staff to conduct research: upgrade the research skills of the staff; participate on committees related to research; conduct and disseminate research; and obtain funding for research studies. Readiness issues for military missions, health promotion, and disease management and prevention are consistently of interest. The CNR should be an active participant on the institutional review board and should conduct primary studies that further the reputation of the facility. The viability of any military research program today is contingent on procurement of funding; therefore, the CNR must refine skills in grantsmanship. The demands of the medical facility and the needs of the staff must be a prime consideration in the development of the role of the CNR.