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Consent for Biobanking: The Legal Frameworks of Countries in the BioSHaRE-EU Project

Kaye, Jane; Briceño Moraia, Linda; Curren, Liam; Bell, Jessica; Mitchell, Colin; Soini, Sirpa; Hoppe, Nils; Øien, Morten; Rial-Sebbag, Emmanuelle (New Rochelle, NY : Liebert, 2016)

Currently, there is no single, Europe-wide regulation of biomedical research using human samples and data. Instead, the law that applies spans a number of areas of law, such as data protection, clinical trials, and tissue ...
Do Editorial policies support ethical research? A thematic text analysis of author instructions in psychiatry journals

Strech, Daniel; Metz, Courtney; Knüppel, Hannes (San Francisco : Public Library of Science, 2014)

Introduction: According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical ...
Public involvement in the governance of population-level biomedical research: Unresolved questions and future directions

Erikainen, Sonja; Friesen, Phoebe; Rand, Leah; Jongsma, Karin; Dunn, Michael; Sorbie, Annie; McCoy, Matthew; Bell, Jessica; Burgess, Michael; Chen, Haidan; Chico, Vicky; Cunningham-Burley, Sarah; Darbyshire, Julie; Dawson, Rebecca; Evans, Andrew; Fahy, Nick; Finlay, Teresa; Frith, Lucy; Goldenberg, Aaron; Hinton, Lisa; Hoppe, Nils; Hughes, Nigel; Koenig, Barbara; Lignou, Sapfo; McGowan, Michelle; Parker, Michael; Prainsack, Barbara; Shabani, Mahsa; Staunton, Ciara; Thompson, Rachel; Varnai, Kinga; Vayena, Effy; Williams, Oli; Williamson, Max; Chan, Sarah; Sheehan, Mark (London : BMJ Publ., 2020)

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these ...
Research governance in placebo-controlled trials: Is the EMA/ICH position consistent in itself and in accordance with the declaration of helsinki?

Lenk, Christian; Hoppe, Nils (London : SAGE Publications Ltd., 2014)

The European Medicines Agency and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use are powerful international institutions for the regulation of ...

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