LEADER 05230nam 22006015 450 001 9910255338803321 005 20200707023203.0 010 $a3-319-28731-1 024 7 $a10.1007/978-3-319-28731-7 035 $a(CKB)3710000000657953 035 $a(EBL)4526240 035 $a(DE-He213)978-3-319-28731-7 035 $a(MiAaPQ)EBC4526240 035 $a(EXLCZ)993710000000657953 100 $a20160509d2016 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aEthics and Governance of Biomedical Research $eTheory and Practice /$fedited by Daniel Strech, Marcel Mertz 205 $a1st ed. 2016. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2016. 215 $a1 online resource (223 p.) 225 1 $aResearch Ethics Forum,$x2212-9529 ;$v4 300 $aDescription based upon print version of record. 311 $a3-319-28729-X 320 $aIncludes bibliographical references at the end of each chapters. 327 $aIntroducing 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?. 330 $aIn this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research. 410 0$aResearch Ethics Forum,$x2212-9529 ;$v4 606 $aEthics 606 $aMedical ethics 606 $aMedical laws and legislation 606 $aEthics$3https://scigraph.springernature.com/ontologies/product-market-codes/E14000 606 $aTheory of Medicine/Bioethics$3https://scigraph.springernature.com/ontologies/product-market-codes/H66000 606 $aMedical Law$3https://scigraph.springernature.com/ontologies/product-market-codes/R16005 615 0$aEthics. 615 0$aMedical ethics. 615 0$aMedical laws and legislation. 615 14$aEthics. 615 24$aTheory of Medicine/Bioethics. 615 24$aMedical Law. 676 $a174.2 702 $aStrech$b Daniel$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aMertz$b Marcel$4edt$4http://id.loc.gov/vocabulary/relators/edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910255338803321 996 $aEthics and Governance of Biomedical Research$92509794 997 $aUNINA