In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind the (...) Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

How far should we go in protecting and promoting public health? Can we force people to give up unhealthy habits and make healthier choices, or does everyone have the right to decide their own lifestyle? Should we stop treating smokers who refuse to give up smoking? Should we put a tax on fatty foods and ban vending machines in schools to address the obesity epidemic? Should parents be required to have their children vaccinated? Are some of our screening programmes unethical (...) Downs syndrome screening, for example or should we be screening people for more conditions, such as Huntington disease? Such questions are at the heart of public health ethics. Holland shows that to understand and debate these issues requires philosophy: moral philosophies, such as utilitarianism and deontology, as well as political philosophies such as liberalism and communitarianism. And philosophy informs other aspects of public health, such as epidemiology and health promotion. The aim of this book is to provide a lively, accessible and philosophically informed introduction to such issues. It is an ideal textbook for students taking courses in public health ethics. And since this book develops systematic discussions of issues in public health ethics, there is also much here to engage and challenge the more advanced reader. (shrink)

Moore and Donnelly argue in the paper ‘The job of “ethics committees”’ that research ethics committees should be renamed and that their job should be specified as “review of proposals for consistency with the duly established and applicable code” only.1 They raise a large number of issues, but in this comment I briefly want to suggest that two of their arguments are fundamentally flawed. The first flawed argument is the argument related to the separation of powers. Moore and Donnelly proceed (...) from the premise that it is pro tanto better to have an institutional arrangement that separates code-making powers and decisional powers, and then proceed to argue that this separation is not feasible for what they call ‘ethics consistency review’ because “no matter who established any prespecified review standards, the review decision maker must be empowered at review to revise those standards when this would make for an ethical improvement. This is because any understanding of ethics-consistency standards themselves and of their implications for any case is fallible and improvable in …. (shrink)

BackgroundCommunity engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation.MethodsIn this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.Results and conclusionsDrawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research. (shrink)

Biomedical research involving human subjects is an arena of conflicts of interests. One of the most important conflicts is between interests of participants and interests of future patients. Legal regulations and ethical guidelines are instruments designed to help find a fair balance between risks and burdens taken by research subjects and development of knowledge and new treatment. There is an universally accepted ethical principle, which states that it is not ethically allowed to sacrifice individual interests for the sake of society (...) and science. This is the principle of precedence of individual. But there is a problem with how to interpret the principle of precedence of individual in the context of research without prospect of future benefit involving children. There are proposals trying to reconcile non-beneficial research involving children with the concept of the best interests. We assert that this reconciliation is flawed and propose an interpretation of the principle of precedence of individual as follows: not all, but only the most important interests of participants, must be guaranteed; this principle should be interpreted as the secure participant standard. In consequence, the issue of permissible risk ceiling becomes ethically crucial in research with incompetent subjects. (shrink)

Alice considered [the idea of un-birthday presents] a little. “I llke birthday presents best,” she said at last.“You don’t know what you’re talking about!” cried Humpty Dumpty. … “[There are three hundred and sixty-four days when you might get un-birthday presents… And only one for birthday presents, you know. There’s a ‘glory’ for you!”“I don’t know what you mean by ‘glory,’” Alice said.Humpty Dumpty smiled contemptuously. “Of course you don’t—till I tell you. I meant ‘there’s a nice knock-down argument for (...) you!’”“But ‘glory’ doesn’t mean ‘a nice knock-down argument,’” Alice objected.“When I use a word,” Humpty Dumpty said in a rather scornful tone, “it means just what I choose it to mean—neither more nor less.”. (shrink)

Community engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation. (shrink)

It has been suggested that community advisory boards can play a role in minimising exploitation in international research. To get a better idea of what this requires and whether it might be achievable, the paper first describes core elements that we suggest must be in place for a CAB to reduce the potential for exploitation. The paper then examines a CAB established by the Shoklo Malaria Research Unit under conditions common in resource-poor settings – namely, where individuals join with a (...) very limited understanding of disease and medical research and where an existing organisational structure is not relied upon to serve as the CAB. Using the Tak Province Border Community Ethics Advisory Board as a case study, we assess the extent to which it might be able to take on a role minimising exploitation were it to decide to do so. We investigate whether, after two years in operation, T-CAB is capable of assessing clinical trials for exploitative features and addressing those found to have them. The findings show that, although T-CAB members have gained knowledge and developed capacities that are foundational for one-day taking on a role to reduce exploitation, their ability to critically evaluate studies for the presence of exploitative elements has not yet been strongly demonstrated. In light of this example, we argue that CABs may not be able to perform such a role for a number of years after initial formation, making it an unsuitable responsibility for many short-term CABs. (shrink)

Alice considered [the idea of un-birthday presents] a little. “I llke birthday presents best,” she said at last.“You don’t know what you’re talking about!” cried Humpty Dumpty. … “[There are three hundred and sixty-four days when you might get un-birthday presents… And only one for birthday presents, you know. There’s a ‘glory’ for you!”“I don’t know what you mean by ‘glory,’” Alice said.Humpty Dumpty smiled contemptuously. “Of course you don’t—till I tell you. I meant ‘there’s a nice knock-down argument for (...) you!’”“But ‘glory’ doesn’t mean ‘a nice knock-down argument,’” Alice objected.“When I use a word,” Humpty Dumpty said in a rather scornful tone, “it means just what I choose it to mean—neither more nor less.”. (shrink)

Epidemiological studies usually do not pose high risk to participants. At the same time they provide valuable knowledge and improve public and individual health. In many countries, studies involving human subjects are subject to ethics review. Research shows that the process of obtaining ethical approval from institutional research boards or research ethics committees is sometimes costly, time-consuming and seriously delays important research projects. In this article we consider arguments against and in favor of ethics review of epidemiological studies. On the (...) one hand, it seems that minimal risk epidemiological studies should not be a subject to ethics review, since any delay of an important study has its death toll and health costs. In this perspective, the calculus of costs and benefits supports rejecting the whole existing approach. Nevertheless, we argue that institutional research boards or ethics research committees protect research participants from wrongs and up till now are the best tools of social and political control over the research enterprise. (shrink)

What should authorities establish as the job of ethics committees and review boards? Two answers are: review of proposals for consistency with the duly established and applicable code and review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad code and (...) independence arguments for the opposite view. It then argues that authorities at present variously specify both code-consistency and ethics-consistency jobs, but most are also unclear on this issue. The paper then argues that they should reform the job of review boards and ethics committees, by clearly establishing code-consistency review and disestablishing ethics-consistency review, and through related reform of the basic orientation, focus, name, and expertise profile of these bodies and their actions. (shrink)

I want to sound a warning note and suggest some changes that are needed in the practice of ethical review. It is easy to assume that with a policy as high-minded as the policy of reviewing research on human beings, the only difficulties will be the obstacles put in its way by recalcitrant and unreformed paries: by the special-interest groups affected. But this is not always true of high-minded policies and it is not true, in particular, of the policy of (...) reviewing research. Ethical review is endangering valuable research on human beings and, moreover, it is endangering the very ethic that is needed to govern that research. And this is not anyone's fault, least of all the fault of any special-interest groups. The problem is that the process of ethical review has been driven by an institutional dynamic that is not in anyone's control and this dynamic is now driving us, willy nilly, on to some very stony ground. My argument is developed in four sections. In the next section, section two, I look at a model of policy-making which identifies a reactive, institutional dynamic that lies at the origin of certain policy intitiatives. In the third section I argue that this model fits the appearance and development of the ethical review of human research, showing how the process of review has been motored by a dynamic of step-by-step reaction to chilling tales of abuse. In the fourth section I look at the predictions of the future development of ethical review that the extrapolation of that model yields. And then in the fifth and.. (shrink)

In this article we attempt to answer the question of how the ethical and conceptual framework (ECF) for a learning health‐care system (LHS) affects some of the main controversies in research ethics by addressing five key problems of research ethics: (a) What is the difference between practice and research? (b) What is the relationship between research ethics and clinical ethics? (c) What is the ethical relevance of the principle of clinical equipoise? (d) Does participation in research require a higher standard (...) of informed consent than the practice of medicine? and (e) What ethical principle should take precedence in medicine? These questions allow us to construct two opposite idealized positions on the distinction between research and practice: the integration model and the segregation model of research and practice. We then compare the ECF for an LHS with these two idealized positions. We argue that the ECF for a LHS does not, in fact, solve these problems, but that it is a third, separate position in the relationship between research ethics and clinical ethics. Moreover, we suggest that the ECF for a LHS raises new ethical problems that require additional ethical analysis and justification. Our article contributes to the discussion on the relationship between research ethics and clinical ethics, revealing that although a learning health‐care system may significantly change the landscape of health care, some ethical dilemmas still require resolving on both theoretical and policy‐making levels. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population‐level research and big data because it results in a primary focus on consent (meta‐, broad, dynamic and/or specific consent). Two recent guidelines – the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health‐related research involving humans – both focus on the growing reliance on health data (...) for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision‐making capacity? I propose that a public health ethics framework – based on public benefit, proportionality, equity, trust and accountability – provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest. (shrink)

Since January 2016, the Mahidol Oxford Tropical Medicine Research Unit has trialled a data-sharing policy where requests to access research datasets are processed through a Data Access Committee. In this paper, we share our experiences establishing data management systems and data-sharing infrastructure including a data-sharing policy, data access committee and related procedures. We identified a number of practical and ethical challenges including requests for datasets collected without specific or broad consent to data sharing and requests from pharmaceutical companies for data (...) to support drug registration applications. We also encountered significant resource constraints which required the development of appropriate human resources and infrastructure. We suggest a research agenda to promote responsible and equitable data sharing while safeguarding the rights and interests of research participants and researchers. (shrink)

Research funders, regulatory agencies, and journals are increasingly expecting that individual-level data from health research will be shared. Broad consent to such sharing is considered appropriate, feasible and acceptable in low- and middle-income settings, but to date limited empirical research has been conducted to inform the design of such processes. We examined stakeholder perspectives about how best to seek broad consent to sharing data from the Mahidol Oxford Tropical Medicine Research Unit, which implemented a data sharing policy and broad consent (...) to data sharing in January 2016. Between February and August 2017 qualitative data were collected at two sites, Bangkok and the Thai-Myanmar border town of Mae Sot. We conducted eighteen semi-structured interviews. We also conducted four focus group discussions with a total of nineteen people. Descriptive and thematic coding informed analysis of aspects of data sharing that are considered most important to inform participants about, and the best ways to explain complex and abstract topics relating to data sharing. The findings demonstrated that clinical trial participants prioritise information about the potential benefits and harms of data sharing. Stakeholders made multiple suggestions for clarifying information provided about data sharing on such topics. There was significant variation amongst stakeholders’ perspectives about how much information should be provided about data sharing, and it was clear that effective information provision should be responsive to the study, the study population, the individual research participant and the research context. Effectively communicating about data sharing with research participants is challenging in practice, highlighting the importance of robust and effective data sharing governance in this context. Broad consent should incorporate effective and efficient explanations of data sharing to promote informed decision-making, without impeding research participants’ understandings of key aspects of the research from which data will be shared. Further work is required to refine both the development of core information about data sharing to be provided to all research participants, and appropriate solutions for context specific-challenges arising when explaining data sharing. (shrink)