Ethics Committees in Asia
In: Politeia. Notizie di Politeia, Band 18, Heft 67, S. 120-122
ISSN: 1128-2401
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In: Politeia. Notizie di Politeia, Band 18, Heft 67, S. 120-122
ISSN: 1128-2401
In: Politeia. Notizie di Politeia, Band 18, Heft 67, S. 54-59
ISSN: 1128-2401
The sixth edition of the Manual for Research Ethics Committees was first published in 2003, and is a unique compilation of legal and ethical guidance which will prove useful for members of research ethics committees, researchers involved in research with humans, members of the pharmaceutical industry and students of law, medicine, ethics and philosophy. Presented in a clear and authoritative form, it incorporates the key legal and ethical guidelines and specially written chapters on major topics in bioethics by leading academic authors and practitioners, pharmaceutical industry associations and professional bodies
In: The Journal of Clinical Ethics, Band 22, Heft 1, S. 74-93
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In: Biomedical and health research v. 51
Every accredited American hospital is required to have a mechanism for handling ethical concerns; most hospitals satisfy this requirement by constituting an institutional healthcare ethics committee (HEC), a pattern which is repeated in most western countries. This text provides definitive, comprehensive guidance for members of healthcare ethics committees who find themselves confronted with ethically challenging situations. Each chapter includes learning objectives, clinical case studies and questions to stimulate discussion among committee members. Particular emphasis is given to consultation, as this often presents the greatest challenges to committee members. Each chapter stands alone as a teaching module, as well as forming part of a comprehensive volume. Written and edited by nationally and internationally recognized experts in bioethics, this is essential reading for every member of a healthcare ethics committee
For the first 25 years of their existence in the United Kingdom research ethics committees were left more or less in peace by the Department of Health. Since the publication of the "red book" in 1991, 1 however, they have undergone a continual process of radical change, from the introduction of multicentre research ethics committees in 1997, through research governance, to various legislative reforms of research practice including the clinical trials regulations of 2004. 2–4 Ethical review has been extended to more and more kinds and locations of research. At the same time, ethics committees have been subject to continuous criticism from researchers and public and private sector sponsors of research. Criticism from patients and the public has been less audible. Some of the criticism of research ethics committees has focused on issues for which they can bear no responsibility, such as the interpretation of the Data Protection Act 1998 or the operation of trusts' research governance procedures. Ethics committees have been the lightning rod for the frustration researchers have felt about the bureaucratisation of research. Yet much of this frustration is reasonably directed at ethics committees. They can be slow, idiosyncratic, and poorly informed about research methods or guidelines on the ethics of research. And researchers can reasonably feel that many of the reforms since 1991, while intended to simplify ethics review of research, have actually made matters worse. This criticism appears to be common across Europe, with wide variations in approval times and required amendments being reported by many researchers. 56 Late last year Lord Warner, then a junior health minister, commissioned an ad hoc advisory group to review the operation of NHS research ethics committees in the health and social care sector. The group's findings were published in June. 7 The group's principal conclusions are that independent ethical review of research is important but that it needs to be efficient and timely and to concentrate on ...
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In this paper the authors argue that research ethics committees (RECs) should not be paternalistic by rejecting research that poses risk to people competent to decide for themselves. However it is important they help to ensure valid consent is sought from potential recruits and protect vulnerable people who cannot look after their own best interests. The authors first describe the tragic deaths of Jesse Gelsinger and Ellen Roche. They then discuss the following claims to support their case: (1) competent individuals are epistemologically and ethically in the best position to say which risks are reasonable for them, so RECs should be no more restrictive than the "normal" constraints on people taking risks with themselves; (2) RECs do not judge individual competence (that is for researchers and psychiatrists); (3) individual liberty is mostly limited by what serves the public interest, and RECs do not determine public interest; (4) RECs may have a paternalistic role in preventing exploitation of competent people vulnerable to the use of incentives, and in protecting the interests of incompetent people; however, (5) the moral and political authority of RECs has not been established in this respect.
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Intro -- Contents -- Preface -- Acknowledgments -- I. Curriculum for Ethics Committees -- 1. Ethical Foundations of Clinical Practice -- The Role of Ethics in Clinical Medicine -- Ethics Committees in the Health Care Setting -- Fundamental Ethical Principles -- Principlism and Alternative Approaches -- The Role of Culture, Race, and Ethnicity in Health Care -- Conflicting Obligations and Ethical Dilemmas -- 2. Decision Making and Decisional Capacity in Adults -- Health Care Decisions and Decision Making -- Decision-Making Capacity -- Assessment and Determination of Capacity -- Deciding for Patients without Capacity -- 3. Informed Consent and Refusal -- Evolution of the Doctrine of Informed Consent -- Elements of Informed Consent and Refusal -- The Nature of Informed Consent -- Exceptions to the Consent Requirement -- 4. Truth Telling: Disclosure, Privacy, and Confidentiality -- Justifications -- Disclosure -- Disclosure of Adverse Outcomes and Medical Error -- Privacy and Confidentiality -- Genomic Testing and Control of Information -- 5. Special Decision-Making Concerns of Minors -- Decisional Capacity and Minors -- Consent for and by Minors -- Confidentiality and Disclosure -- Special Problems of Functionally Alone Adolescents -- 6. Ethical Issues in Reproduction -- The Ethics and Politics of Reproductive Choice -- Assisted Reproductive Technologies -- Surrogacy and Gestational Carriers -- Termination of Pregnancy -- Maternal-Fetal Issues -- Prenatal/Newborn Genetic Testing and Genomic Newborn Screening -- 7. Special Decision-Making Concerns of the Elderly -- The Other Side of the Mountain -- Diminishing Autonomy and Decisional Capacity -- "Promise that you won't ever put me in a nursing home" -- Independence, Dependence, and Role Reversals -- Prior Wishes and Current Needs -- Intimacy and Security.
In: Agenda: a journal of policy analysis & reform, Band 10, Heft 2
ISSN: 1447-4735
In: Politeia. Notizie di Politeia, Band 18, Heft 67, S. 123-138
ISSN: 1128-2401
In: Journal of empirical research on human research ethics: JERHRE ; an international journal, Band 9, Heft 3, S. 67-73
ISSN: 1556-2654
Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee.
In: Journal of empirical research on human research ethics: JERHRE ; an international journal, Band 9, Heft 3, S. 93-94
ISSN: 1556-2654
In: Politeia. Notizie di Politeia, Band 18, Heft 67, S. 87-94
ISSN: 1128-2401
The Law of 3 January 2018 established in Italy the "National Centre for the Coordination of Regional Ethics Committees for Clinical Trials of Medicines and Medical Devices for Human Use" and reduced the number of ethics committees in the country to 40. This Act should, amongst other things, facilitate Italy's compliance with the provisions set forth in European Regulation (EU) 536/2014. Hopefully, in addition to the provisions set forth in the Law, the National Centre will strive to foster the harmonisation of ethics committee procedures, in order to reform Italian legislation on the evaluation of clinical trials and, more generally, biomedical studies. Unfortunately, certain organizational and structural conditions do not bode well for the success of the National Centre.
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