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In this book,scholars with different disciplinary and national backgrounds argue forpossible answers and analyse case studies on current issues of governance inbiomedical research. These issues comprise among others the research-caredistinction, risk evaluation in early human trials, handling of incidentalfindings, nocebo effects, cluster randomized trials, publication bias, orconsent in biobank research. This book demonstrates how new technologies andresearch possibilities multiply or intensify already known governancechallenges, leaving room for ethical analysis and complex moral choices.Clinical researchers, research ethics committee members and research ethicistshave all to deal with such challenges on a daily basis. While generalreflection on core concepts of research ethics is seldom pointless, thoseconfronted with hard moral choices do need more practical and contextualizedreflection on the said issues. This book particularly provides suchcontextualized reflectionsand aims to inform all those who study, conduct,regulate, fund, or participate in biomedical research.
List of 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: WhatClaims Should Healthy Participants in Phase I Trials Have Against TrialEmployers?; Luana Colloca, PhD.- Nocebo effect: The dilemma of disclosingadverse events; Jan-Ole Reichardt, MA.- Encouraging conscientiousness in risk associated areas of medicalresearch Challenges in common domains of research governance; Sara Anna SuzanDekking, MAE et al.- Discriminating between Research and Care in PaediatricOncology. Ethical Appraisal of the ALL- 10 and 11 protocols of the DutchChildhood Oncology Group (DCOG); Imme Petersen, PhD et al.- What Does theChild's Assent to Research Participation Mean to Parents? Empirical Findings inPaediatric Oncology in Germany; Marcin Waligóra, PhD.- Assent in paediatricresearch and its consequences; Rosemarie Bernabe, PhD.- Ethical Issues inPostauthorization Drug Trials; Anette Blümle, PhD et al.- Fate of ClinicalResearch Studies after Ethical Approval - Follow-Up of Study Protocols untilPublication; Daniel Strech, MD, PhD.- et al. Do editorial policies supportethical research? A thematic text analysis of author instructions in psychiatryjournals Improving common domains of research governance; JonathanKimmelman, PhD.- Risk/Benefit Assessment in Launching Early HumanTrials; Annette Rid, MD.- Guidelines for Biomedical Research Involving Human SubjectsSetting Thresholds of Acceptable Research Risk: Lessons from the Debate aboutMinimal Risk; Sapfo Lignou, MSc, MA et al.- Towards an Alternative Account forDefining Acceptable Risk in Non-beneficial Pediatric Research; RogerBrownsword, PhD.- Big biobanks: Three Major Governance Challenges and SomeMini-Constitutional Responses; Bettina Schmietow, MA.- Dynamic Consent toBiobank Research - Paradigm Shift or Red Herring?.
About the author
Summary
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.
