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Rosemarie Bernabe
Rosemarie Bernabe
Verified email at medisin.uio.no - Homepage
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Year
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, 3-20, 2021
352021
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, 1-9, 2012
342012
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, 1-8, 2014
192014
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, 1-18, 2016
172016
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
142012
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, 1-5, 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
A survey in Mexico about ethics dumping in clinical research
NH Germán, B Rosemarie
BMC Medical Ethics 20, 1-11, 2019
82019
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
82016
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
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
Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study
YZ Seralegne, CK Wangamati, RDLC Bernabe, B Farsides, A Aseffa, ...
Developing world bioethics 23 (1), 50-58, 2023
42023
Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives
S Cox, JH Solbakk, RDLC Bernabe
Current Medical Research and Opinion 38 (11), 1897-1907, 2022
42022
Regulatory sanctions for ethically relevant GCP violations
R Bernabe, G van Thiel, N Breekveldt, C Gispen, J van Delden
Drug Discovery Today, 2019
4*2019
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
32021
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
32017
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