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…mehr
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 aimsto inform all those who study, conduct,regulate, fund, or participate in biomedical research.
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?.
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?.
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?.
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?.
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