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Rosemarie Bernabe
Rosemarie Bernabe
Verified email at medisin.uio.no - Homepage
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Cited by
Year
The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods
RDLC Bernabe, GJMW van Thiel, JAM Raaijmakers, JJM van Delden
BMC medical ethics 13 (1), 1-9, 2012
322012
Back to WHAT? The role of research ethics in pandemic times
JH Solbakk, HB Bentzen, S Holm, AKT Heggestad, B Hofmann, ...
Medicine, Health Care and Philosophy 24 (1), 3-20, 2021
252021
The fiduciary obligation of the physician-researcher in phase IV trials
RDLC Bernabe, GJMW Van Thiel, JAM Raaijmakers, JJM Van Delden
BMC Medical Ethics 15 (1), 1-8, 2014
182014
What do international ethics guidelines say in terms of the scope of medical research ethics?
RDLC Bernabe, GJMW Van Thiel, JJM van Delden
BMC medical ethics 17 (1), 1-18, 2016
162016
Decision theory and the evaluation of risks and benefits of clinical trials
RDC Bernabe, GJMW van Thiel, JAM Raaijmakers, JJM van Delden
Drug discovery today 17 (23-24), 1263-1269, 2012
122012
Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports
R Bernabe, G van Thiel, NS Breekveldt, CC Gispen-de Wied, ...
Current medical research and opinion 35 (4), 637-645, 2019
112019
Phase IV non-inferiority trials and additional claims of benefit
RDLC Bernabe, G Wangge, MJ Knol, OH Klungel, JJM Van Delden, ...
BMC medical research methodology 13 (1), 1-5, 2013
92013
Informed consent and phase IV non-interventional drug research
RDC Bernabe, GJMW van Thiel, JJM van Delden, JAM Raaijmakers
Current medical research and opinion 27 (3), 513-518, 2011
92011
Patient representatives' contributions to the benefit–risk assessment tasks of the European Medicines Agency scientific committees
RDLC Bernabe, GJMW van Thiel, J van Delden
British journal of clinical pharmacology 78 (6), 1248-1256, 2014
82014
Consent in psychiatric biobanks for pharmacogenetic research
FH van der Baan, RDC Bernabe, AL Bredenoord, JG Gregoor, G Meynen, ...
International Journal of Neuropsychopharmacology 16 (3), 677-682, 2013
82013
Consent in psychiatric biobanks for pharmacogenetic research
FH van der Baan, RDC Bernabe, AL Bredenoord, JG Gregoor, G Meynen, ...
International Journal of Neuropsychopharmacology 16 (3), 677-682, 2013
82013
Exportation of unethical practices to low and middle income countries in biomedical research
G Novoa-Heckel, R Bernabe, J Linares
Rev. Bioetica & Derecho 40, 167, 2017
72017
Drug regulators and ethics: which GCP issues are also ethical issues?
RDLC Bernabe, GJMW van Thiel, NS Breekveldt, JJM van Delden
Drug discovery today 21 (2), 217-224, 2016
72016
The need to explicate the ethical evaluation tools to avoid ethical inflation
RDC Bernabe, GJMW van Thiel, JAM Raaijmakers, JJM van Delden
The American Journal of Bioethics 9 (11), 56-58, 2009
72009
A survey in Mexico about ethics dumping in clinical research
NH Germán, B Rosemarie
BMC medical ethics 20 (1), 1-11, 2019
62019
Regulatory sanctions for ethically relevant GCP violations
R Bernabe, G van Thiel, N Breekveldt, C Gispen, J van Delden
Drug Discovery Today, 2019
3*2019
Is informed consent necessary for randomized Phase IV ‘observational’drug studies?
RDC Bernabe, GJMW van Thiel, JAM Raaijmakers, JJM van Delden
Drug discovery today 16 (17-18), 751-754, 2011
32011
The role of research ethics committees after the approval of clinical trial protocols in the EU and the USA: a descriptive content analysis of international and regional …
S Cox, JH Solbakk, RDLC Bernabe
Current Medical Research and Opinion 37 (6), 1061-1069, 2021
22021
The ambivalent place of ethics in European regulatory documents
R Bernabe, G van Thiel, CC Gispen-de Wied, NS Breekveldt, ...
Drug discovery today 23 (2), 205-207, 2018
22018
Exportación de prácticas éticas deficientes de investigación biomédica hacia países con menor grado de desarrollo
G Novoa-Heckel, R Bernabe, J Linares
Revista de Bioética y Derecho, 167-177, 2017
22017
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Articles 1–20