Suchergebnisse

Cover -- Half Title -- Title -- Copyright -- Contents -- List of Contributors -- Preface -- Acknowledgements -- PART I: BACKGROUND INFORMATION ON THE EURICON STUDY -- 1 Ethical Issues and Practical Problems in Obtaining Informed Consent for Neonatal Research -- 2 The Practical Problems in Obtaining Informed Consent for a Neonatal Randomised Controlled Trial -- PART II: RESEARCH ETHICS COMMITTEES IN EUROPE: THEIR ROLE IN ETHICAL REVIEW -- 3 The Structure, Composition, and Operation of European RECs -- 4 The Attitudes of RECs in 11 European Countries to Informed Consent in Neonatal Research -- 5 The Views of RECs in Eight European Countries on the Process of Obtaining Informed Consent in Neonatal Research, and on the Structure and Organisation of RECs -- 6 The Role of RECs in Europe in the Ethical Review of Paediatric Research: a Critical Discussion -- 7 The Role of Research Ethics Committees and of the Law in the Ethical Review of Medical Research -- a Critical Discussion -- PART III: COMPARATIVE ANALYSIS OF THE LAW ON INFORMED CONSENT IN NEONATAL RESEARCH WITHIN EUROPE -- 8 Overview of European Legislation on Informed Consent in Neonatal Research -- 9 The Regulation of Neonatal Research in Finland -- 10 The Regulation of Neonatal Research in Greece -- 11 The Regulation of Neonatal Research in Ireland -- 12 The Regulation of Neonatal Research in Norway -- 13 The Regulation of Neonatal Research in Spain -- 14 The Regulation of Neonatal Research in Sweden -- 15 The Regulation of Neonatal Research in the UK -- 16 Principles Underlying the Regulation of Research with Children in Europe: International Bioethics or Moral Bankruptcy? -- PART IV: INFORMED CONSENT IN NEONATAL RESEARCH -- 17 Is Obtaining Informed Consent to Neonatal Randomised Controlled Trials an Elaborate Ritual? Interviews with Parents and Clinicians.

Background Rationing and allocation decisions at the clinical level – bedside rationing – entail complex dilemmas that clinicians and managers often find difficult to handle. There is a lack of mechanisms and aids for promoting fair decisions, especially in hard cases. Reports indicate that clinical ethics committees (CECs) sometimes handle cases that involve bedside rationing dilemmas. Can CECs have a legitimate role to play in bedside rationing? Main text Aided by two frameworks for legitimate priority setting, we discuss how CECs can contribute to enhanced epistemic, procedural and political legitimacy in bedside rationing decisions. Drawing on previous work we present brief case vignettes and outline several potential roles that CECs may play, and then discuss whether these might contribute to rationing decisions becoming legitimate. In the process, key prerequisites for such legitimacy are identified. Legitimacy places demands on aspects such as the CEC's deliberation process, the involvement of stakeholders, transparency of process, the opportunity to appeal decisions, and the competence of CEC members. On these conditions, CECs can help strengthen the legitimacy of some of the rationing decisions clinicians and managers have to make. Conclusions On specified conditions, CECs can have a well-justified advisory role to play in order to enhance the legitimacy of bedside rationing decisions. ; publishedVersion

Background. Good quality, ethically sound research is needed in order to better understand, appropriately respond to, and reduce the incidence of suicide. There is, however, a lack of clarity around the nature of ethical problems associated with suicide research and how to resolve them. This is a formidable challenge for ethics committee members in approving and monitoring research. Aims. To describe the views that members of health research ethics committee hold regarding ethical problems and ethical practice in research involving people who are, or who have, been suicidal. Methods. Ethics committee members were invited to complete an online survey addressing the risks, benefits, and ethical problems associated with suicide research. Findings were aggregated into themes using an inductive form of content analysis. Results. Concerns of ethics committees centered on accessing the population, potential harm to participants or the researcher, researcher competency, maintaining confidentiality, providing support to participants, and responding sensitively to the needs of family. Conclusions. Ethical research involving suicidal people requires both procedures to protect participants, and consideration of ethics as an ongoing negotiated process. The findings of this research provide a snapshot of views held by a number of ethics committee members.

Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being over-protective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.