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Current Medical Research and Opinion Volume 27, 2011 - Issue 3
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Editorial

Informed consent and phase IV non-interventional drug research

Rosemarie D.C. Bernabe Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Utrecht, The NetherlandsCorrespondence[email protected]
,
Ghislaine J.M.W. van Thiel Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Utrecht, The Netherlands
,
Johannes J.M. van Delden Julius Center for Health Sciences and Primary Care, Utrecht University Medical Center, Utrecht, The Netherlands
&
Jan A.M. Raaijmakers GlaxoSmithKline, The Netherlands
Pages 513-518 | Accepted 03 Dec 2010, Published online: 06 Jan 2011

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NoorA. A. Giesbertz, AnnelienL. Bredenoord & JohannesJ. M. van Delden. (2013) A Thick Opt-Out Is Often Sufficient. The American Journal of Bioethics 13:4, pages 44-46.
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Articles from other publishers (5)

Hisashi Urushihara, Louise Parmenter, Shimon Tashiro, Kenji Matsui & Nancy Dreyer. (2017) Bridge the gap: The need for harmonized regulatory and ethical standards for postmarketing observational studies. Pharmacoepidemiology and Drug Safety 26:11, pages 1299-1306.
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Rosemarie D. L. C. Bernabe. 2016. Ethics and Governance of Biomedical Research. Ethics and Governance of Biomedical Research 97 107 .
Markus Hartmann & Patricia Schaffner. (2013) Legal Requirements, Definitions, and Standards for Non-interventional Drug Studies: A Global Picture of Variability—Results and Conclusions From a Single-Institution Survey. Therapeutic Innovation & Regulatory Science 47:6, pages 684-691.
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Frederieke H. van der Baan, Rose D. C. Bernabe, Annelien L. Bredenoord, Jochem G. Gregoor, Gerben Meynen, Mirjam J. Knol & Ghislaine J. M. W. van Thiel. (2013) Consent in psychiatric biobanks for pharmacogenetic research. International Journal of Neuropsychopharmacology 16:3, pages 677-682.
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Rosemarie D.C. Bernabe, Ghislaine J.M.W. van Thiel, Jan A.M. Raaijmakers & Johannes J.M. van Delden. (2011) Is informed consent necessary for randomized Phase IV ‘observational’ drug studies?. Drug Discovery Today.
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