Ethics and Governance of Biomedical Research: Theory and Practice

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?.