Not Fit for Purpose: The Ethical Guidelines of the Indian Council of Medical Research

In 2006, the Indian Council of Medical Research (ICMR) published its ‘Ethical guidelines for Biomedical Research on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India.     

Research Ethics: Beyond the Guidelines

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold the guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, vary in different settings.     

Ethics committees. Research ethics: beyond the guidelines

There is international recognition of the need for sustainable research ethics committees to provide ethical review of human subjects research in developing countries, but many developing countries do not have such committees (often called 'IRBs'). Theoretical and practical uncertainties encountered by an IRB on the Caribbean island of Grenada offer insight into ethical review of research in developing countries. Theoretical uncertainties include questions about whether means of ensuring confidentiality and obtaining informed consent will be effective in local settings, and whether deviations from Western norms are justifiable. International guidelines are helpful in addressing these concerns, but are subject to interpretation. Guidelines are less helpful in practical areas like selecting members or chairs. They do not address what sort of procedures and paperwork will work in a developing country, or IRBs' relationships to governments that have no mandate for them. Experiences presented here show that IRBs in developing countries can sustainably adhere to international standards. Sustainability requires knowledge, personal commitment, and an official mandate to uphold international standards. Capacity building must therefore focus on educational programs to make developing country leaders knowledgeable about the value of international guidelines to their nations. Such knowledge is needed before people will become motivated to promote, implement, and uphold their guidelines. People in developing countries must help design bridges to help their nations put international standards into practice. The structure of such bridges may, of necessity, very in different settings.     

The reporting of IRB review in journal articles presenting HIV research conducted in the developing world

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved. Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics. Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = 0.001), more sponsor‐country authors (P = 0.003), sponsor‐country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host‐country involved (P = 0.002), journals having sponsor‐country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor‐country editors and research being biomedical. Conclusions: One‐third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards.     

Ethics and biomedical research

Ethics in biomedical research took off from the 1947 Nuremberg Code to its own right in the wake of the Declaration of Helsinki in 1964. Since then, (inter)national regulations and guidelines providing a framework for clinical studies and protection for study participants have been drafted and implemented, while ethics committees and drug evaluation agencies have sprung up throughout the world. These two developments were crucial in bringing about the protection of rights and safety of the participants and harmonization of the conduct of biomedical research. Ethics committees and drug evaluation agencies deliver ethical and scientific assessments on the quality and safety of the projects submitted to them and issue respectively approvals and authorizations to carry out clinical trials, while ensuring that they comply with regulatory requirements, ethical principles, and scientific guidelines. The advent of biomedical ethics, together with the responsible commitment of clinical investigators and of the pharmaceutical industry, has guaranteed respect for the patient, for whom and with whom research is conducted. Just as importantly, it has also ensured that patients reap the benefit of what is the primary objective of biomedical research: greater life expectancy, well-being, and quality of life.     

医学研究伦理学的发展现状与前景

创新技术的开展和转化医学的注重给医学的发展注入了新的活力,但同时,也带来了一系列社会伦理问题和法律问题。生命医学伦理学的兴起和发展催生了医学研究伦理学分支学科形成,目的在于推进解决涉及人体的医学研究的伦理问题。当前,面临的最突出的伦理问题在于,对医学研究合法性、先进性及伦理性的把握,对医学研究伦理审查必要性的认知,对医学研究方案设计与伦理道德的匹配,对医学研究知情同意的告知,对医学研究风险与受益的平衡。逐步与国际接轨,加强伦理委员会制度建设;提高伦理审查能力建设,形成高水平的伦理审查队伍;学术组织和团体共同努力,推进医学研究伦理学的发展,这将助推医学研究伦理学的发展。     

The rise of research ethics committees in Western Europe: some concomitant problems

The rise of research ethics committees in Western Europe has accelerated since 1975 when the World Medical Association recommended that protocols for experiments involving human subjects be submitted to independent committees for consideration, comment, and guidance. This article describes the numbers, types, composition, function, authority, and problems of institutional, regional, and national research ethics committees in the Netherlands, Great Britain, West Germany, France, Switzerland, and Sweden. Among the problems are lack of authority to require ethical review, underrepresentation of nonmedical members, inconsistencies in definitions of and standards for human experimentation, and nonconsideration of the rights of investigators as well as subjects. The author urges legislation to strengthen the self regulating mechanism of research ethics committees.     

The ethics of HIV research in developing nations

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo-control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta-ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations.     

Animal Abolitionism Meets Moral Abolitionism

The use of other animals for human purposes is as contentious an issue as one is likely to find in ethics. And this is so not only because there are both passionate defenders and opponents of such use, but also because even among the latter there are adamant and diametric differences about the bases of their opposition. In both disputes, the approach taken tends to be that of applied ethics, by which a position on the issue is derived from a fundamental moral commitment. This commitment in turn depends on normative ethics, which investigates the various moral theories for the best fit to our moral intuitions. Thus it is that the use of animals in biomedical research is typically defended by appeal to a utilitarian theory, which legitimates harm to some for the greater good of others; while the opposition condemns that use either by appeal to the same theory, but disagreeing about the actual efficacy of animal experimentation, or by appeal to an alternative theory, such as the right of all sentient beings not to be exploited. Unfortunately, the normative issue seems likely never to be resolved, hence leaving the applied issue in limbo. The present essay seeks to circumvent this impasse by dispensing altogether with any moral claim or argument, thereby cutting the Gordian knot of animal ethics with a meta-ethical sword. The alternative schema defended is simply to advance relevant considerations, whereupon “there is nothing left but to feel.” In a word, motivation replaces justification.     

Systemic Negligence: Why It Is Morally Important for Developing World Bioethics

In the context of clinical and non‐clinical biomedical practices, negligence is usually understood as a lapse of a specific professional duty by a healthcare worker or by a medical facility. This paper tries to delineate systemic negligence as another kind of negligence in the context of health systems, particularly in developing countries, that needs to be recognized and addressed. Systemic negligence is not just a mere collection of stray incidences of medical errors and system failures in a health system, but is proposed in this paper as a more pervasive kind of neglect. Several non‐medical factors, such as lack of social and political will, also contribute to it and hence is more difficult to address in a health system. This paper argues that recognizing systemic negligence and including it research agenda have special moral importance for researchers in developing world bioethics, public health ethics and for health activists in the developing world. For, it can be a potent health system barrier, and can seriously impair efforts to ensure patient safety, particularly in the weaker health systems. As it erodes accountability in a health system, addressing it is also important for the twin goals of ensuring patient safety and improving health system performance. Above all, it needs to be addressed because the tolerance of its persistence in a health system seems to undervalue health as a social good.     

Biomedical Scientists' Perceptions of Ethical and Social Implications: Is There a Role for Research Ethics Consultation?

Background

Research ethics consultation programs are being established with a goal of addressing the ethical, societal, and policy considerations associated with biomedical research. A number of these programs are modelled after clinical ethics consultation services that began to be institutionalized in the 1980s. Our objective was to determine biomedical science researchers'' perceived need for and utility of research ethics consultation, through examination of their perceptions of whether they and their institutions faced ethical, social or policy issues (outside those mandated by regulation) and examination of willingness to seek advice in addressing these issues. We conducted telephone interviews and focus groups in 2006 with researchers from Stanford University and a mailed survey in December 2006 to 7 research universities in the U.S.

Findings

A total of 16 researchers were interviewed (75% response rate), 29 participated in focus groups, and 856 responded to the survey (50% response rate). Approximately half of researchers surveyed (51%) reported that they would find a research ethics consultation service at their institution moderately, very or extremely useful, while over a third (36%) reported that such a service would be useful to them personally. Respondents conducting human subjects research were more likely to find such a service very to extremely useful to them personally than respondents not conducting human subjects research (20% vs 10%; chi² p<0.001).

Conclusion

Our findings indicate that biomedical researchers do encounter and anticipate encountering ethical and societal questions and concerns and a substantial proportion, especially clinical researchers, would likely use a consultation service if they were aware of it. These findings provide data to inform the development of such consultation programs in general.     

We need to talk about disruption in bioethics: a commentary on Rueda,Pugh and Savulescu

Rueda, Pugh, and Savulescu intervene in the debate of reprogenetic enhancement technologies that can lead to ethical disruption. In response, we think such innovations may not so much disrupt biomedical ethics but instead may reanimate older debates in this field.     

Perspectives on environmental adaptability and physiological polymorphism in thermoregulation

The environmental adaptability of human beings has progressed according to various environments experienced in the course of evolution. Therefore, various phenotypes for environmental adaptability exist and are considered to be physiological polymorphism. Physiological polymorphism in thermoregulation is influenced by genotype, individual characteristics, environmental factors, cultural factors, etc. Moreover, it is thought that physiological polymorphism is evidenced more clearly in physiological responses to extreme situations and/or changing conditions than in environments where homeostasis is easily maintained. In the field of physiological anthropology, I think that it is important not only to discover the physiological responses that demonstrate polymorphism, but also to hypothesize about the mechanisms and the processes by which such polymorphisms were formed, and their meaning for human beings. Such discussions may be supposed to lead to an evaluation of the environmental adaptability of humans from the viewpoint of physiological anthropology.     

LIFE-CENTERED ETHICS, AND THE HUMAN FUTURE IN SPACE

In the future, human destiny may depend on our ethics. In particular, biotechnology and expansion in space can transform life, raising profound questions. Guidance may be found in Life‐centered ethics, as biotic ethics that value the basic patterns of organic gene/protein life, and as panbiotic ethics that always seek to expand life. These life‐centered principles can be based on scientific insights into the unique place of life in nature, and the biological unity of all life. Belonging to life then implies a human purpose: to safeguard and propagate life. Expansion in space will advance this purpose but will also raise basic questions. Should we expand all life or only intelligent life? Should we aim to create populations of trillions? Should we seed other solar systems? How far can we change but still preserve the human species, and life itself? The future of all life may be in our hands, and it can depend on our guiding ethics whether life will fulfil its full potentials. Given such profound powers, life‐centered ethics can best secure future generations. Our descendants may then understand nature more deeply, and seek to extend life indefinitely. In that future, our human existence can find a cosmic purpose.     

空化微流体在生物医学方面的应用

空化效应是发生在液体内部的一种极其复杂的流体物理现象,能产生极高的中心能量密度,并伴随发光、发热、冲击波、高速射流等极端物理现象,它的存在能使一些极端的反应得以实现。空化效应发生时形成的空化微流体在破坏细胞形貌、微操控、微混合等方面有广泛地应用。本文综述了空化微流体及其产生的强烈冲击波在生物医学方面的应用,包含空化微流体在破坏细胞形貌、微小元件的操控以及加快液体混合等三个方面。     

The dangers of euthanasia and dementia: how Kantian thinking might be used to support non-voluntary euthanasia in cases of extreme dementia

Some writers have argued that a Kantian approach to ethics can be used to justify suicide in cases of extreme dementia, where a patient lacks the rationality required of Kantian moral agents. I worry that this line of thinking may lead to the more extreme claim that euthanasia is a proper Kantian response to severe dementia (and similar afflictions). Such morally treacherous thinking seems to be directly implied by the arguments that lead Dennis Cooley and similar writers to claim that Kant might support suicide. If rationality is the only factor in valuing a human life, then the loss of that rationality (however such loss might be defined) would allow us to use essentially utilitarian thinking in order to support non-voluntary euthanasia, since the patients themselves would no longer be moral agents that demand respect.     

The Ethics of Research on Less Expensive,Less Effective Interventions: A Case for Analysis

The Kennedy Krieger lead paint study is a landmark case in human experimentation and a classic case in research ethics. In this paper I use the lead paint study to assist in the analysis of the ethics of research on less expensive, less effective interventions. I critically evaluate an argument by Buchanan and Miller who defend both the Kennedy Krieger lead paint study and public health research on less expensive, less effective interventions. I conclude that Buchanan and Miller’s argument is flawed but that does not mean that research designed to find less effective interventions cannot be justified in some situations. Based on my analysis, I suggest questions to ask when considering such research and I offer some principles to guide us. In the process, light is shed on the various debates and issues raised by the lead paint study; e.g. standards of care, researchers’ responsibilities to research subjects, the distinction between treatment and research and the question of what it is that legitimizes public health research. Merle Spriggs is supported by a grant from the Alfred Felton Bequest which is managed by ANZ Trustees.     

Emergence of norms for biomedical research. At the origin of the Huriet law (1975-1988)

The French law for the Protection of persons involved in biomedical research, known as "Loi Huriet", defines the frame in which biomedical experimentations on human subjects can take place. Insisting on the emergent character of the norms (laws, scientific standards...) for clinical research in France, this paper presents the general context in which such a law was promulgated. It gives an historical focus on its principal dispositions and underlines the conceptual issues raised by the public acknowledgment of the existence of scientific investigations on humans. This paper contributes to the debate on the meaning of the main notions of the French normative system applying to biomedical researches (protection of the person, individual direct benefice...)