Titlebook: Ethics and Governance of Biomedical Research; Theory and Practice Daniel Strech,Marcel Mertz Book 2016 Springer International Publishing Sw

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https://doi.org/10.1007/978-3-663-16168-4 to our translational efforts, they are also highly expensive. To save costs, they are often relocated into developing countries where the protection of study participants is minimal. Such relocation is not necessarily amoral, as those in charge might nevertheless adhere to high ethical standards. H

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Introduction,cal research over the past 100 years. “Biomedical research” here is used as a broad term, covering basic, translational, clinical, and post-authorization research towards increasing an understanding of causes, development, and effects of diseases and developing and improving preventive, diagnostic,

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From Altruists to Workers: What Claims Should Healthy Participants in Phase I Trials Have Against Trlthy participants and recent data suggest that some of the healthy participants treat phase I research participation as a form of work. This chapter examines three facets of the shift from research participation as a form of altruism to research participation as a form of work. First, I set out thre

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Nocebo Effects: The Dilemma of Disclosing Adverse Eventsrug, but a substantial proportion is due to patients being alerted to potential adverse events as part of the informed consent process. Presenting patients with side effects of treatments and interventions can induce so-called “nocebo effects”, which refers to adverse events related to negative expe

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Discriminating Between Research and Care in Paediatric Oncology—Ethical Appraisal of the ALL-10 and ironments such as paediatric oncology we should no longer draw sharp distinctions between research and care. Recently, two Dutch protocols for the treatment of children with Acute Lymphoblastic Leukaemia (ALL) have been categorised in two different ways, one as research (ALL-11) and the other as tre

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Assent in Paediatric Research and Its Consequencesssent has been about the necessary conditions for making a morally significant decision. Some argue that to make a morally significant decision a child has to understand the abstract concept of altruism. Therefore it is crucial to determine at what stage of development this ability arises. Others ar

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Ethical Principles in Phase IV Studiesof phase IV studies has led to a greater need to examine the applicable ethics at this stage. Building on our previous work on ethics in phase IV studies, we propose that the following ethical principles are indispensable to implementing ethics in phase IV: (A) When discussing the possibility of wai

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Fate of Clinical Research Studies After Ethical Approval—Follow-Up of Study Protocols Until Publicate Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publi