Rosemarie de la Cruz Bernabe

Image of Rosemarie de la Cruz Bernabe
Norwegian version of this page
Phone +47 22850624
Visiting address Kirkeveien 166 Fredrik Holsts hus 0450 OSLO
Postal address Postboks 1130 Blindern 0318 OSLO

Academic interests

  • Medical research ethics: ethics and the regulation of clinical trials, ethical risk benefit assessment, ethics of late phase clinical trials
  • The capabilities approach and the human rights framework

Courses taught

  • Research ethics
  • Ethics and public health
  • International research ethics


Prior to coming to Oslo University, I worked as assistant professor of medical research ethics in the University Medical Center of Utrecht from 2013 to 2017. My research was mainly on the ethical issues encountered by drug regulators during the assessment of marketing authorization applications. I also looked at the contribution of patient representatives in benefit-risk assessment tasks of EMA scientific committees.

In 2013, in the University of Utrecht, I defended my PhD dissertation entitled, “Ethical issues in postauthorization drug trials.” From 2008 to 2013, as a PhD fellow, apart from working on my dissertation, I also taught medical ethics and medical research ethics subjects.

In 2005, I earned my MA in Applied Ethics, cum laude, from both in the University of Utrecht and Linköping University. My MA thesis entitled, “An Investigation on the Aristotelian Foundations of Martha Nussbaum's Capabilities Approach and the Disability Issue Utilizing Nussbaum's Earlier Works on Aristotle” won the MA Thesis Award in 2007.

From 1998 to 2008, I have been teaching philosophy and ethics courses in Philippine universities and colleges.

In 1998, I earned my BA Humanities with specialization in Philosophy, magna cum laude, from the University of Asia and the Pacific.


  • Marie Curie Scientia Postdoctoral Fellowship, Oslo University, March 2017 -- February 2019
  • Postdoctoral Research Grant by the Dutch Medicines Evaluation Board, Sept 2015 – September 2016
  • Postdoctoral Research Grant by Dutch Medicines Evaluation Board, March 2013 – February 2015
  • Postdoctoral Research Grant by the Dutch Top Institute Pharma, September 2012 – February 2013
  • PhD research fellowship by the Dutch Top Institute Pharma September 2008 – August 2012

Positions held

  • Scientia postdoctoral fellow (current)
  • Assistant professor (2013 to 2017)
  • PhD fellow (2008-2013)
  • Philosophy and ethics instructor (1998-2008)


  • the Dutch Top Institute Pharma
  • the Dutch Medicines Evaluation Board
  • the Dutch Health Inspectorate



  • Bernabe, Rosemarie de la Cruz; van Thiel, Ghislaine JMW; Breekveldt, Nancy S; Gispen, Christine C & Van Delden, Johannes JM (2019). Regulatory sanctions for ethically relevant GCP violations. Drug Discovery Today.  ISSN 1359-6446.  24(11), s 2116- 2119 . doi:
  • Jimenez, Edlyn B; Virtudazo, Jessa Mae P; Torres, Cristina E & Bernabe, Rosemarie de la Cruz (2019). Availability of post-trial access in clinical trials: a review of clinical trial protocols submitted to the research ethics board of the University of the Philippines Manila. Current Medical Research and Opinion.  ISSN 0300-7995.  35(11), s 1849- 1855 . doi: 10.1080/03007995.2019.1644851
  • Novoa-Heckel, Germán & Bernabe, Rosemarie de la Cruz (2019). A survey in Mexico about ethics dumping in clinical research. BMC Medical Ethics.  ISSN 1472-6939.  20:38, s 1- 11 . doi: 10.1186/s12910-019-0378-6
  • Bernabe, Rosemarie de la Cruz; van Thiel, GJMW; Breekveldt, NS; Gispen-de Wied, CC & Van Delden, Johannes JM (2018). Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports. Current Medical Research and Opinion.  ISSN 0300-7995.  s 1- 9 . doi: 10.1080/03007995.2018.1528214 Full text in Research Archive.
  • Bernabe, Rosemarie de la Cruz (2016). What do international ethics guidelines say in terms of the scope of medical research ethics?. BMC Medical Ethics.  ISSN 1472-6939.
  • Bernabe, Rosemarie de la Cruz (2014). Fiduciary obligation of physician-researchers in phase IV clinical trials. BMC Medical Ethics.  ISSN 1472-6939.
  • Bernabe, Rosemarie de la Cruz (2014). Patient representatives’ contributions to the benefit-risk assessment task of EMA scientific committees. British Journal of Clinical Pharmacology.  ISSN 0306-5251.
  • Bernabe, Rosemarie de la Cruz (2013). Phase IV non-inferiority trials and additional claims of benefit. BMC Medical Research Methodology.  ISSN 1471-2288.
  • Bernabe, Rosemarie de la Cruz (2012). Decision theory and the evaluation of risks and benefits of clinical trials. Drug Discovery Today.  ISSN 1359-6446.
  • Bernabe, Rosemarie de la Cruz (2012). The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate decision studies methods. BMC Medical Ethics.  ISSN 1472-6939.

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  • Bernabe, Rosemarie de la Cruz (2017). Exportation of unethical practices to low and middle income countries in biomedical research. Revista de Bioética y Derecho: Perspectivas Bioéticas.  ISSN 1886-5887.
  • Bernabe, Rosemarie de la Cruz (2017). The ambivalent place of ethics in European regulatory documents. Drug Discovery Today.  ISSN 1359-6446.
  • Bernabe, Rosemarie de la Cruz (2016). Drug regulators and ethics: which GCP issues are also ethical issues?. Drug Discovery Today.  ISSN 1359-6446.
  • Bernabe, Rosemarie de la Cruz (2012). Consent in psychiatric biobanks for pharmacogenetic research. International Journal of Neuropsychopharmacology.  ISSN 1461-1457.
  • Bernabe, Rosemarie de la Cruz (2011). Informed consent and phase IV noninterventional drug research. Current Medical Research and Opinion.  ISSN 0300-7995.
  • Bernabe, Rosemarie de la Cruz (2011). Is informed consent necessary for randomized phase IV “observational” drug studies?. Drug Discovery Today.  ISSN 1359-6446.
  • Bernabe, Rosemarie de la Cruz (2009). The need to explicate the ethical evaluation tools to avoid ethical inflation. American Journal of Bioethics.  ISSN 1526-5161.

View all works in Cristin

Published Apr. 6, 2017 3:15 PM - Last modified Apr. 14, 2020 12:13 PM