Rosemarie de la Cruz Bernabe

Førsteamanuensis

Fakultet for helse- og sosialvitenskap
Institutt for optometri, radiografi og lysdesign
Campus Kongsberg (5305)
Rose is Associate Professor of Medical Research Ethics at the University of South-Eastern Norway. She is also an adjuct researcher of medical research ethics at the Centre for Medical Ethics, University of Oslo.

Ansvarsområder


Rose is the administrative coordinator of the I-merse Group. I-merse is an interdisciplinary research group with an aim to advance equitable and effective utilization of immersive environments in education, the public and commercial sectors, and society as a whole.

She is also the assistant coordinator and one of the main drafters of the Horizon 2020 project, Responsible Open Science in Europe (ROSiE). ROSiE will provide an analysis of the ethics and research integrity issues raised by open science and develop practical tools aimed at ensuring research ethics / research integrity in open science and citizen science. The consortium consists of the University of Oslo, University of South-Eastern Norway, Austrian Agency for Research Integrity, European Citizen Science Association (Germany), European Network of Research Ethics Committees (Germany), Federation of Finnish Learned Societies, High Council for the Evaluation of Research and Higher Education (France), National Research Institute for Agriculture, Food and Environment (France), National Technical University of Athens (Greece),

Her research interests include ethical issues in immersive technologies, stakeholder involvement in medical research processes, post-trial access, intersection of regulatory science and research ethics, and global research ethics. 

Kompetanse

Medical research ethics, Research integrity, Social justice and human rights, Stakeholder involvement, Global ethics

CV

Education:

2008-2013: PhD in Medical Research Ethics, Utrecht University (NL)

2005-2006: MA Applied Ethics,  cum laude , Utrecht University and Linköping University (SE)

1994-1998: BA in Humanities with specialization in Philosophy,   magna cum laude , University of Asia and the Pacific (PH) 

 

Work Experience:

2020-: Associate Professor, I-Merse project, USN 

2019-: Researcher, Center for Medical Ethics, University of Oslo

2017-2019: Marie Curie postdoctoral fellow, Center for Medical Ethics, University of Oslo

2013-2017: Assistant Professor, Medical Ethics Unit, University Medical Center Utrecht, NL

2012-2013: Postdoctoral Fellow, Medical Ethics Unit, University Medical Center Utrecht, NL

2008-2012: PhD Fellow, Medical Ethics Unit, University Medical Center Utrecht, NL

1998-2008: Lecturer in philosophy and ethics, Philippines

Publikasjoner

Jimenez EB, Virtudazo JM, Torres CE,  Bernabe RD.  (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 . https://doi.org/10.1080/03007995.2019.1644851(Impact factor: 2.665)

Heckel GN,  Bernabe RD.  (2019). A survey in Mexico about ethics dumping in clinical research. BMC Medical Ethics . 20:38. (Impact factor: 1,969)

Bernabe RD,  van Thiel GJ, Breekveldt NS, Gispen CC, van Delden JJ. (2019). Regulatory sanctions for ethically relevant GCP violations. Drug Discov. Todayhttps://doi.org/10.1016/j.drudis.2019.07.001  (Impact factor: 6.848)

Bernabe RD,  van Thiel GJ, Breekveldt NS, Gispen CC, van Delden JJ. (2018). Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports, 2008-2012. Current Medical Resarch and Opinion . 35: 4, 637-645. (Impact factor: 2,665)

Bernabe RD . van Thiel GJ, Gispen CC, Breekveldt NS, van Delden JJ. (2018). The ambivalent place of ethics in European regulatory documents. Drug Discov Today . Feb; 23 (2): 205-207. (Impact factor: 6,848)

Heckel GN, Bernabe RD, Linares, J. (2017). Exportation of unethical practices to low and middle income countries in biomedical research. Revista de Bioética y Derecho: Perspectivas Bioéticas, 40: 167-177. 

Bernabe RD, van Thiel GJ, Breekveldt NS, van Delden JJ.(2016). Drug regulators and ethics: which GCP issues are also ethical issues? Drug Discov Today, Feb;21(2):217-24. (Impact factor: 6.848)

Bernabe RD, van Thiel GJ, van Delden JJ. (2016). What do international ethics guidelines say in terms of the scope of medical research ethics? BMC Medical Ethics. April 26, https://doi.org/10.1186/s12910-016-0106-4. (Impact factor: 1.969)

Bernabe RD. (2016). Ethical principles in phase IV studies. In Ethics and Governance of Biomedical Research: Theory and Practice, eds. Strech D. Mertz M. Springer.

Bernabe RD, van Thiel GJ, van Delden JJ (2014). Patient representatives’ contributions to the benefit-risk assessment task of EMA scientific committees. British Journal of Clinical Pharmacology. Dec;78(6):1248-56. (Impact factor: 2.524)

Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ. (2014). Fiduciary obligation of physician-researchers in phase IV clinical trials. BMC Medical Ethics 2014, 15:11. (Impact factor: 1.969)

Bernabe RD, Wangge G, Knol MJ, Klungel OH, van Delden JJ, de Boer A, Hoes AW, Raaijmakers JA, van Thiel GJ (2013). Phase IV non-inferiority trials and additional claims of benefit. BMC Med Res Methodol. May 30; 13:70. (Impact factor: 2.524)

Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ. (2012). Decision theory and the evaluation of risks and benefits of clinical trials. Drug Discovery Today, Jul 20. (Impact factor: 6.848)

Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ. (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, Apr 20; 13(1): 6. (Impact factor: 1.969)

Bernabe RB, van der Baan FH, Bredenoord AL Gregoor JG, Meynen G, Knol MJ, van Thiel GJ. (2012). Consent in psychiatric biobanks for pharmacogenetic research. International Journal of Neuropsychopharmacology, May 21: 1-6. (Impact factor: 3.981)

Bernabe RD, van Thiel GJ, Raaijmakers JA, van Delden JJ. (2011). Is informed consent necessary for randomized phase IV “observational” drug studies? Drug Discovery Today, Sept; 16 (17-18): 751-4. (Impact factor: 6.848)

Bernabe, RD, van Thiel, GJ, Raaijmakers, JA, van Delden, JJ. (2011). Informed consent and phase IV non-interventional drug research. Current Medical Research and Opinion, Mar; 27(3): 513-8. (Impact factor: 2.665)

Bernabe RD , or Thiel GJ, Raaijmakers JA, or Delden JJ. (2009). The need to explain the ethical evaluation tools to avoid ethical inflation. American Journal of Bioethics,  Nov; 9 (11): 56-8. (Impact factor: 4,847)

Bernabe, RD . (2013). Ethical Issues in Postauthorization Drug Trials. PhD Thesis. Utrecht University. ISBN: 978-90-393-5940-2. Digital Version: http://igitur-archive.library.uu.nl/dissertations/2013-0405-200542/UUindex.html

Bernabe. RD.  (2006). An Investigation on the Aristotelian Foundations of Martha Nussbaum's Capabilities Approach and the Disability Issue Utilizing Nussbaum's Earlier Works on Aristotle. Master's thesis. Linkoping University and Utrecht University. Digital version:  http://www.essays.se/essay/a248b11728