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Showing results 1-15 of 15

2019
1 Novoa-Heckel, Germán; Bernabe, Rosemarie de la Cruz.
A survey in Mexico about ethics dumping in clinical research. BMC Medical Ethics 2019 ;Volume 20:38. p. 1-11
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2018
2 Bernabe, Rosemarie de la Cruz; van Thiel, GJMW; Breekveldt, NS; Gispen-de Wied, CC; Van Delden, Johannes JM.
Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports. Current Medical Research and Opinion 2018 p. 1-9
UiO Untitled
 
2017
3 Bernabe, Rosemarie de la Cruz.
Exportation of unethical practices to low and middle income countries in biomedical research. Revista de Bioética y Derecho: Perspectivas Bioéticas 2017
UiO Untitled
 
4 Bernabe, Rosemarie de la Cruz.
The ambivalent place of ethics in European regulatory documents. Drug Discovery Today 2017
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2016
5 Bernabe, Rosemarie de la Cruz.
Drug regulators and ethics: which GCP issues are also ethical issues?. Drug Discovery Today 2016
UiO Untitled
 
6 Bernabe, Rosemarie de la Cruz.
What do international ethics guidelines say in terms of the scope of medical research ethics?. BMC Medical Ethics 2016
UiO Untitled
 
2014
7 Bernabe, Rosemarie de la Cruz.
Fiduciary obligation of physician-researchers in phase IV clinical trials. BMC Medical Ethics 2014
UiO Untitled
 
8 Bernabe, Rosemarie de la Cruz.
Patient representatives’ contributions to the benefit-risk assessment task of EMA scientific committees. British Journal of Clinical Pharmacology 2014
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2013
9 Bernabe, Rosemarie de la Cruz.
Phase IV non-inferiority trials and additional claims of benefit. BMC Medical Research Methodology 2013
UiO Untitled
 
2012
10 Bernabe, Rosemarie de la Cruz.
Consent in psychiatric biobanks for pharmacogenetic research. International Journal of Neuropsychopharmacology 2012
UiO Untitled
 
11 Bernabe, Rosemarie de la Cruz.
Decision theory and the evaluation of risks and benefits of clinical trials. Drug Discovery Today 2012
UiO Untitled
 
12 Bernabe, Rosemarie de la Cruz.
The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate decision studies methods. BMC Medical Ethics 2012
UiO Untitled
 
2011
13 Bernabe, Rosemarie de la Cruz.
Informed consent and phase IV noninterventional drug research. Current Medical Research and Opinion 2011
UiO Untitled
 
14 Bernabe, Rosemarie de la Cruz.
Is informed consent necessary for randomized phase IV “observational” drug studies?. Drug Discovery Today 2011
UiO Untitled
 
2009
15 Bernabe, Rosemarie de la Cruz.
The need to explicate the ethical evaluation tools to avoid ethical inflation. American Journal of Bioethics 2009
UiO Untitled