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  1.  22
    Challenges and proposed solutions in making clinical research on COVID-19 ethical: a status quo analysis across German research ethics committees.Alice Faust, Anna Sierawska, Joerg Hasford, Anne Wisgalla, Katharina Krüger & Daniel Strech - 2021 - BMC Medical Ethics 22 (1):1-11.
    Background In the course of the COVID-19 pandemic, the biomedical research community’s attempt to focus the attention on fighting COVID-19, led to several challenges within the field of research ethics. However, we know little about the practical relevance of these challenges for Research Ethics Committees. Methods We conducted a qualitative survey across all 52 German RECs on the challenges and potential solutions with reviewing proposals for COVID-19 studies. We de-identified the answers and applied thematic text analysis for the extraction and (...)
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  2.  39
    Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards.Vilma Lukaseviciene, Joerg Hasford, Dirk Lanzerath & Eugenijus Gefenas - 2021 - Journal of Medical Ethics 47 (12):e82-e82.
    The upcoming Regulation No 536/2014 on clinical trials on medicinal products for human use, which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will (...)
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    Redundant trials can be prevented, if the EU clinical trial regulation is applied duly.Daria Kim & Joerg Hasford - 2020 - BMC Medical Ethics 21 (1):1-19.
    The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end (...)
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