Towards local participation in the creation of ethical research guidelines

Research ethics committees are entrusted with implementing guidelines to protect both scientists and human subjects of research from harm. These guidelines are often based on western contexts and may not resonate with the local moral traditions of the communities that they seek to protect. In this essay, we discuss how using principles of deliberative democracy with a "local derivation" approach may help in the drafting and implementation of ethical guidelines for research that better serve society.     

Ethics in a scientific approach: the importance of the biostatistician in research ethics committees

In medical practice and research it is necessary to consider the rights of the researcher or physician and of the subject or patient, to conform to scientific standards and to examine the appropriateness with respect to laws and moral values. Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research on human subjects. Research of no scientific value is also against ethical principles. To obtain valid and reliable results from biomedical research, it is a scientific and ethical obligation to make use of the science of statistics. Therefore, for research to be evaluated using biostatistics intensively from ethical and scientific points of view, a biostatistics expert is necessary on research ethics committees. Developments in Turkey are used as examples.     

The case for a new system for oversight of research on human subjects

The increasing emphasis on evidence-based clinical practice has thrown into sharp focus multiple deficiencies in current systems of ethical review. This paper argues that a complete overhaul of systems for ethical oversight of studies involving human subjects is now required as developments in medical, epidemiological and genetic research have outstripped existing structures for ethical supervision. It shows that many problems are now evident and concludes that sequential and piecemeal amendments to present arrangements are inadequate to address these. At their core present systems of ethical review still rely on the integrity and judgment of individual investigators. One possible alternative is to train and license research investigators, make explicit their responsibilities and have ethics committees devote much more of their time to monitoring research activity in order to detect those infringing the rules.     

Balancing the scales of public interest: medical research and privacy

Guidelines for the protection of privacy in the conduct of medical research have been issued by the National Health and Medical Research Council, approved by the Commonwealth Privacy Commissioner, and gazetted on 1 July 1991 (Commonwealth of Australia Gazette No. P19) to remain in force until 30 June 1994. This paper examines the guidelines and seeks to inform researchers, institutional ethics committees and the institutions those committees represent of their content. Responsibilities are placed upon those engaged in the conduct of research and those involved in undertaking ethical review who now have to decide that the public interest in conducting the research substantially outweighs the public interest in privacy. There is also an emphasis on the requirement for surveillance of research projects by institutional ethics committees which has not previously been apparent. Questions are posed to assist in deciding whether a particular research protocol is subject to the guidelines.     

如何处理临床研究中研究者的经济利益冲突?--主体、原则与方法

临床研究中研究者的经济利益冲突可能会影响到受试者的安康和研究的客观性、可靠性.我们是否应该处理这种利益冲突?应该由谁处理?根据哪些伦理原则处理?具体采取哪些措施处理?围绕这些问题,本文批判地分析了反对处理利益冲突的观点,主张研究者、研究机构、行业组织、政府部门和学术期刊多方共同努力,根据公正、有利/不伤害、尊重三个伦理原则,采取公开、管理和禁止等措施,处理研究者的经济利益冲突,以保护受试者的安康和研究的客观性.     

Issues in bioethics. Teaching research ethics

All research should meet the highest ethical and scientific standards, and so persons who may be involved in conducting research should be fully conversant with the relevant ethical principles of biomedical research and its requirements. Further, scientists, academicians, physician-researchers, student-researchers, and members of research ethics committees should be able to distinguish between therapy and research, evaluate risk and benefit, be sensitive to various forms of conflicts of interest, and be fully aware of the special provisions necessary for vulnerable populations. This article recommends a number of subject areas that should be addressed as a part of this academic process.     

Experimentation with human subjects: a critique of the views of Hans Jonas.

The ethics of experimentation on human subjects has become the subject of much debate among medical scientists and philosophers. Ethical problems and conflicts of interest become especially serious when research subjects are recruited from the class of patients. Are patients who are ill and suffering in a position to give voluntary and informed consent? Are there inevitable conflicts of interest and moral obligation when a personal physician recruits his own patients for an experiment designed partly to advance scientific knowledge and only partly as therapy for those patients? The views of the eminent American ethicist Hans Jonas on these issues are briefly summarised and criticised, and some moral guidelines are then proposed to regulate experimentation on human subjects.     

What is the role of the research ethics committee? Paternalism,inducements, and harm in research ethics

In a recent paper Edwards, Kirchin, and Huxtable have argued that research ethics committees (RECs) are often wrongfully paternalistic in their approach to medical research. They argue that it should be left to competent potential research subjects to make judgments about the acceptability of harms and benefits relating to research, and that this is not a legitimate role for any REC. They allow an exception to their overall antipaternalism, however, in that they think RECs should have the power to prohibit the use of financial inducements to recruit research subjects into trials. In this paper it is argued that these claims are unjustified and implausible. A sketch is provided of an alternative model of the role of the REC as an expert body making judgments about the acceptability of research proposals through a consensual weighing of different moral considerations.     

医院伦理委员会建设若干问题的探讨

通过介绍上海几家有代表性医院的伦理委员会建设成就,阐明了我国的医院伦理委员会建设应具有自己的特点。对人才培养成为医院伦理委员会建设的瓶颈、缺乏针对伦理委员会委员的系统化培训、缺乏可操作性强的操作指南、伦理委员会的建设发展不平衡、伦理委员会的工作缺乏较高的独立性和透明度、缺乏利益冲突的管理机制等医院伦理委员会建设中存在的问题进行了探讨,提出了加快医学伦理学的人才培养、探索实行伦理委员会注册和伦理委员资格认定、尝试建立联合伦理委员会、广泛开展保护受试者和患者安全和权益的社会宣传、明确利益冲突的防范和管理原则等对策。     

Ethics committees, principles and consequences.

When ethics committees evaluate the research proposals submitted to them by biomedical scientists, they can seek guidance from laws and regulations, their own beliefs, values and experiences, and from the theories of philosophers. The starting point of this paper is that philosophers can only be helpful to the members of ethics committees if they take into account in their models both the basic moral intuitions that most of us share and the consequences of people's choices. A moral view which can be labelled as a consequentialist interpretation of mid-level principlism is developed, defended and applied to some real-life and hypothetical research proposals.     

关于医疗机构伦理委员会审查中值得注意的几个问题

为了维护受试者／患者的权益,创建和谐的医患环境和宽松的科研环境,保护国家的生物医学资源,促进临床研究和临床试验的正常进行,我们对伦理审查中经常遇到的问题（如临床试验样本的使用及管理问题、损害赔偿等）进行分析,从而提出了一些用于提高医疗机构伦理委员会审查质量的有效措施,包括加强管理、提高认识,建议国家行政管理部门出台和完善相应的管理办法,加强各级伦理委员会的监督和相关人员的生命伦理学及法规教育,提倡开展临床试验及研究项目伦理盲审法,保证伦理委员会专家的审阅时间、施行有记名投票等方法。     

Research on human subjects: Australian ethics committees take tentative steps.

Australian medical researchers are attempting to formulate a response to some of the ethical issues in medical research. The debate over the in vitro fertilisation programme has highlighted some community concern about research ethics and the role of the ethics committee. While very little is known about Australian ethics committees, it appears that a two-tiered approach comprising both ethical review and scientific review is acceptable to the research community. However, this approach plus some problems with the nature of informed consent, begs the question of the role of these committees in the broader context of medical research in the community. Important aspects of a seminar for members of hospital ethics committees are reported.     

Should physicians be gatekeepers of medical resources?

Physicians have an ethical responsibility to their patients to offer the best available medical care. This responsibility conflicts with their role as gatekeepers of the limited health care resources available for all patients collectively. It is ethically untenable to expect doctors to face this trade-off during each patient encounter; the physician cannot be expected to compromise the wellbeing of the patient in the office in favour of anonymous patients elsewhere. Hence, as in other domains of public policy where individual and collective interests conflict, some form of collective solution is required. Collective solutions may take the form of placing explicit resource constraints on resources available to physicians, or clinical practice guidelines that recognise cost-effective care as acceptable. Such solutions will be politically and ethically sustainable only if patients as citizens of the larger population accept the need for rationing of limited resources in health care.     

浅析人类生殖细胞基因治疗的伦理学问题及对策

人类生殖细胞基因治疗是一个全新的医学领域,它可以从根本上治疗许多疾病,但是由于技术不完善以及存在众多伦理问题,所以该技术未能广泛应用于临床治疗和研究.人类生殖细胞基因治疗引发的伦理问题有：科学不可预知性的问题;生殖细胞基因治疗的社会风险问题;生殖细胞基因治疗改变人类多样性的问题;生殖细胞基因治疗的人权问题;如何判断基因“好”与“坏”的问题;生殖细胞基因治疗的经济价值问题.避免这些问题的对策有：政府应建立有效的管理和法律制度;生殖细胞治疗基因应符合国际技术规范和伦理规范;科学家和医学工作者应该加强道德修养,掌握应有的伦理学知识;加强教育宣传工作,使公众了解并接受该治疗方法.     

Trust based obligations of the state and physician-researchers to patient-subjects

When may a physician enroll a patient in clinical research? An adequate answer to this question requires clarification of trust‐based obligations of the state and the physician‐researcher respectively to the patient‐subject. The state relies on the voluntarism of patient‐subjects to advance the public interest in science. Accordingly, it is obligated to protect the agent‐neutral interests of patient‐subjects through promulgating standards that secure these interests. Component analysis is the only comprehensive and systematic specification of regulatory standards for benefit‐harm evaluation by research ethics committees (RECs). Clinical equipoise, a standard in component analysis, ensures the treatment arms of a randomised control trial are consistent with competent medical care. It thus serves to protect agent‐neutral welfare interests of the patient‐subject. But REC review occurs prior to enrolment, highlighting the independent responsibility of the physician‐researcher to protect the agent‐relative welfare interests of the patient‐subject. In a novel interpretation of the duty of care, we argue for a “clinical judgment principle” which requires the physician‐researcher to exercise judgment in the interests of the patient‐subject taking into account evidence on treatments and the patient‐subject‘s circumstances.With increasing demand for contemporary medicine to be placed on a firmer scientific foundation, clinical research is enjoying unprecedented expansion. Accordingly, doctors in increasing numbers are participating in clinical trials, as are greater numbers of patients. Hence, it is surprising that the central moral dilemma of the randomised controlled trial (RCT) remains so vexing: when may physicians, consistent with their duty of care to patients, offer the them enrolment in an RCT?¹ If reasonable public trust in the ethical integrity of clinical research is to be maintained, a convincing answer to this question must be given. Presently, we explore the dilemma, examine solutions that have failed to galvanise support, and offer a new one.The dilemma arises because offering patients enrolment in RCTs imperils the doctors'' duty to act in their interests. This is because, in seeming contrast to clinical practice, an activity structured to protect and advance the medical interests of the patient, clinical research necessarily calls for the pursuit of other interests, including the public interest in the production of generalisable knowledge, and the variable private interests of industry, institutions and researchers. The pursuit of these interests inevitably influences the conduct of clinical research materially. To ensure scientifically valid results, treatment in a clinical trial is restricted by design features of the study protocol (eg, randomisation to treatment, blinding of treatment allocation and fixed schedules for treatment provision). Further, patient‐subjects typically undergo non‐therapeutic procedures to answer the scientific question. In these ways, the demands of science place the conduct of clinical trials in tension with the doctor‐researcher''s positive duty of care (hereinafter referred to as duty of care) to the patient‐subject.Hellman and Hellman² have argued that an unmanageable conflict exists between the interests of the patient‐subject and those of others in clinical research. Conducting RCTs, in their view, necessarily violates the rights of patient‐subjects to have their interests protected. They view the rights violation as being of such magnitude that RCTs on patients must be abandoned and replaced by non‐randomised forms of clinical research. We believe that their position is untenable. RCTs have a pivotal role in the generation and scrutiny of the evidentiary foundation of clinical practice. The results of clinical research are not merely of private and academic interest; they further the public good of high quality medical care. Without clinical research, much of the practice of medicine would remain untested, and medical progress would be stymied. Furthermore, we question whether the tension between the demands of science and the rights of patients results in an insoluble conflict of interest, requiring an either/or solution.A recent proposal from the US purports to solve the dilemma by denying its existence. Miller and colleagues deny that doctor‐researchers operate under a duty of care to patient‐subjects. They argue as follows. Clinical practice and clinical research have differing goals. The goal of clinical practice is to provide the patient with optimal care. The goal of research is to produce generalisable knowledge that may benefit future patients and society. They assert that because the goals of clinical practice and clinical research differ, the norms governing each must not overlap.³ Implicit is the suggestion that the physician‐researcher ceases to be a physician when conducting research by virtue of the nature of research as an activity. They explicitly deny that the physician‐researcher has a positive obligation to act in the interests of the patient‐subject when conducting research.^4,5 The only duties of the physician‐researcher to the patient‐subject are to obtain informed consent and avoid exploitation.The solution given by Miller and colleagues is unsatisfactory. It has already been noted that an implausible form of moral dissociation is required, whereby doctors engaging in research must wilfully ignore the professional obligations they have as doctors.⁶ Further, the assertion that activities themselves generate norms is counterintuitive and requires argument. Finally, the additional assertion that the norms governing activities with differing ends are non‐overlapping is obviously false. Norms prohibiting fraud and murder are universal and thus apply across diverse activities. Worse still, Miller et al''s view is internally inconsistent on this very point. They recognise a duty to obtain informed consent applicable to clinical practice and clinical research. Thus, at least one norm in their schema is overlapping, refuting a central premise of their argument.Given this, we think physician‐researchers will rightly continue to wonder about the implications of their duty of care to patient‐subjects when conducting clinical research. When, consistent with this obligation, can a doctor offer a patient enrolment in an RCT? Is approval by the research ethics committee (REC) sufficient? Is there a role for clinical judgement when doctors act as physician‐researchers? To consider these questions and the broader dilemma satisfactorily, in our view, requires recognition and elucidation of the independent obligations of the state and the doctor‐researcher to protect the interests of patient‐subjects. These obligations are understood to be derived from the trust‐based relationship between the patient‐subject and the state and the doctor‐researcher, respectively.     

Ethical decision-making about older adults and moral intensity: an international study of physicians

Through discourse with international groups of physicians, we conducted a cross-cultural analysis of the types of ethical dilemmas physicians face. Qualitative analysis was used to categorise the dilemmas into seven themes, which we compared among the physicians by country of practice. These themes were a-theoretically-driven and grounded heavily within the text. We then subjected the dilemmas to an analysis of moral intensity, which represents an important (albeit novel within healthcare research) theoretical perspective of ethical decision making. These constructs (ie, culture and moral intensity) represent salient determinants of ethical behaviour and our cross-cultural sample afforded us the opportunity to consider both the pragmatic aspects of culture, as they are perceived by physicians, as well as the theory-driven concept of moral intensity. By examining both culture and moral intensity, we hope to better elucidate the complexities of ethical decision-making determinants among physicians in their daily practice. Doing so may potentially have practical implications for ethics training of medical students and foreign physicians.     

Rethinking paternalism: an exploration of responses to the Israel Patient's Rights Act 1996

Questions of patient autonomy have formed an important part of ethical debate in medicine from at least the post-war period onwards. Although initially important as a counterweight to widespread medical paternalism, recent years have seen a reaction against a widely perceived 'triumph of autonomy'. In particular, competent patients' refusal of life-saving or clearly beneficial treatment presents complex dilemmas for both healthcare professionals and ethicists. Discussion of the mechanism provided by the Israel Patient's Rights Act of 1996 for ethics committees to override refusal of treatment by such patients has provided several examples in which it seems an obligation to benefit the patient can outweigh concerns regarding respect for their autonomy. However, such analyses as have been undertaken so far may be seen to omit important elements of the moral decision-making process that takes place even when the latter appears to 'win out'. In addition to helping better prepare clinicians to meet such challenges in the future, a fuller appreciation of those elements that are present in justified cases of coercive treatment may enable them to arrive at a better understanding of what autonomy itself can mean in a medical context.     

Is it possible to assess the "ethics" of medical school applicants?

Questions surrounding the assessment of medical school applicants' morality are difficult but they are nevertheless important for medical schools to consider. It is probably inappropriate to attempt to assess medical school applicants' ethical knowledge, moral reasoning, or beliefs about ethical issues as these all may be developed during the process of education. Attitudes towards ethical issues and ethical sensitivity, however, might be tested in the context of testing for personality attributes. Before any "ethics" testing is introduced as part of screening for admission to medical school it would require validation. We suggest a number of ways in which this might be achieved.     

Voluntarism and realism in medieval ethics.

In contrast to other articles in this series on the history of moral philosophy the present essay is not devoted to expounding the views of a single author, or to examining a particular moral theory. Instead it discusses an important dispute between two medieval accounts of the relation between theological and moral propositions. In addition to its historical interest this debate is important both because it connects earlier and later ethical thought--being influenced by Greek moral theories and influencing subsequent European philosophy--and because it concerns issues that remain important to philosophers and to those who claim that their ethical beliefs are dictated by religious convictions.     

The current state of clinical ethics and healthcare ethics committees in Belgium

Ethics committees are the most important practical instrument of clinical ethics in Belgium and fulfil three tasks: the ethical review of experimental protocols, advising on the ethical aspects of healthcare practice, and ethics consultation. In this article the authors examine the current situation of ethics committees in Belgium from the perspective of clinical ethics. Firstly, the most important steps which thus far have been taken in Belgium are examined. Secondly, recent opinion by the Belgian Advisory Committee on Bioethics with regard to ethics committees is presented and the activities of Belgian ethics committees are discussed. Finally, the option to bring research ethics and clinical ethics under the roof of just one committee is criticised using a pragmatic and a methodological argument. Concomitantly, the authors build an argument in favour of the further development of ethics consultation.