Ethics and Governance of Biomedical Research

In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflectionsand aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research.

Discusses concrete, empirically salient, and timely ethical issues in research governance Provides case studies that vividly demonstrate the wide dimensions of preclinical, clinical and public health research ethics Contains contributions by authors from different nations guaranteeing international perspectives Includes supplementary material: sn.pub/extras

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Introducing new domains of research governance; Govind C. Persad, JD, BS, BA.- Should Research Ethics Encourage the Production of Cost-Effect Interventions?; Rebecca Johnson, MA.- From altruists to Workers: What Claims Should Healthy Participants in Phase I Trials Have Against Trial Employers?; Luana Colloca, PhD.- Nocebo effect: The dilemma of disclosing adverse events; Jan-Ole Reichardt, MA.- Encouraging conscientiousness in risk associated areas of medical research Challenges in common domains of research governance; Sara Anna Suzan Dekking, MAE et al.- Discriminating between Research and Care in Paediatric Oncology. Ethical Appraisal of the ALL- 10 and 11 protocols of the Dutch Childhood Oncology Group (DCOG); Imme Petersen, PhD et al.- What Does the Child's Assent to Research Participation Mean to Parents? Empirical Findings in Paediatric Oncology in Germany; Marcin Waligóra, PhD.- Assent in paediatric research and its consequences; Rosemarie Bernabe, PhD.- Ethical Issues in Postauthorization Drug Trials; Anette Blümle, PhD et al.- Fate of Clinical Research Studies after Ethical Approval Follow-Up of Study Protocols until Publication; Daniel Strech, MD, PhD.- et al. Do editorial policies support ethical research? A thematic text analysis of author instructions in psychiatry journals Improving common domains of research governance; Jonathan Kimmelman, PhD.- Risk/Benefit Assessment in Launching Early Human Trials; Annette Rid, MD.- Guidelines for Biomedical Research Involving Human Subjects Setting Thresholds of Acceptable Research Risk: Lessons from the Debate about Minimal Risk; Sapfo Lignou, MSc, MA et al.- Towards an Alternative Account for Defining Acceptable Risk in Non-beneficial Pediatric Research; Roger Brownsword, PhD.- Big biobanks: Three Major Governance Challenges and Some Mini-Constitutional Responses; Bettina Schmietow, MA.- Dynamic Consent to Biobank Research Paradigm Shift or Red Herring?.