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Full Description
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.
Contents
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?.
