Rosemarie de La Cruz Bernabe

Image of Rosemarie de La Cruz Bernabe
Norwegian version of this page
Phone +47 22850624
Mobile phone 96756419
Username
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, intersection of ethics and and regulatory science, research ethics in low and middle income countries
  • Research ethics and emerging technologies
  • Research integrity
  • The capabilities approach and the human rights framework

Courses taught

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

Projects

Project coordinator, The Equitable, Inclusive, and Human-Centered XR Project (XR4Human)

Co-coordinator, Responsible Open Science in Europe (ROSiE)

Project coordinator, Improving Post-Trial Access In Africa (AccessAfrica)

Project coordinator, Ethics in Research and Clinical Practice (ETHIMED)

 

 

Publications

  • Cox Née Dawkins, Shereen; Solbakk, Jan Helge & Bernabe, Rosemarie de La Cruz (2022). Research ethics committees and post-approval activities: a qualitative study on the perspectives of European research ethics committee representatives. Current Medical Research and Opinion. ISSN 0300-7995. p. 1–10. doi: 10.1080/03007995.2022.2115773.
  • Seralegne, Yemisrach Zewdie; Wangamati, Cynthia Khamala; Bernabe, Rosemarie de la Cruz; Farsides, Bobbie; Aseffa, Abraham & Zewdie, Martha (2022). Composition and capacity of Institutional Review Boards, andchallenges experienced by members in ethics reviewprocesses in Addis Ababa, Ethiopia: An exploratory qualitative study. Developing World Bioethics. ISSN 1471-8731. p. 1–9. doi: 10.1111/dewb.12348.
  • Bernabe, Rosemarie de la Cruz; Torres, Cristina E; Wangge, Grace; Jimenez, Edlyn B & Karbwang, Juntra (2021). Regulatory oversight on the use of experimental therapies during a pandemic: The case of early access to convalescent plasma therapy in three LMICs. Drug Discovery Today. ISSN 1359-6446. doi: 10.1016/j.drudis.2021.12.002. Full text in Research Archive
  • Cox Née Dawkins, Shereen; Solbakk, Jan Helge & Bernabe, Rosemarie de la Cruz (2021). 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 normative documents. Current Medical Research and Opinion. ISSN 0300-7995. 37(6), p. 1061–1069. doi: 10.1080/03007995.2021.1905621.
  • Bernabe, Rosemarie de la Cruz; van Thiel, Ghislaine J.M.W.; Breekveldt, Nancy S.; Gispen, Christine C. & van Delden, Johannes J.M. (2020). Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization? BMC Medical Ethics. ISSN 1472-6939. 21:103, p. 1–8. doi: 10.1186/s12910-020-00543-w. Full text in Research Archive
  • Solbakk, Jan Helge; Bentzen, Heidi Beate; Holm, Søren; Heggestad, Anne Kari Tolo; Hofmann, Bjørn Morten & Robertsen, Annette [Show all 10 contributors for this article] (2020). Back to WHAT? The role of research ethics in pandemic times. Medicine, Health care and Philosophy. ISSN 1386-7423. p. 1–16. doi: 10.1007/s11019-020-09984-x. Full text in Research Archive
  • 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), p. 2116–2119. doi: 10.1016/j.drudis.2019.07.001. Full text in Research Archive
  • 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), p. 1849–1855. doi: 10.1080/03007995.2019.1644851. Full text in Research Archive
  • 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, p. 1–11. doi: 10.1186/s12910-019-0378-6. Full text in Research Archive
  • 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. p. 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. doi: 10.1186/s12910-016-0106-4.
  • Bernabe, Rosemarie de la Cruz (2014). Fiduciary obligation of physician-researchers in phase IV clinical trials. BMC Medical Ethics. ISSN 1472-6939. doi: 10.1186/1472-6939-15-11.
  • 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. doi: 10.1111/bcp.12456.
  • Bernabe, Rosemarie de la Cruz (2013). Phase IV non-inferiority trials and additional claims of benefit. BMC Medical Research Methodology. ISSN 1471-2288. doi: 10.1186/1471-2288-13-70.
  • 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. doi: 10.1186/1472-6939-13-6.
  • Bernabe, Rosemarie de la Cruz (2012). Decision theory and the evaluation of risks and benefits of clinical trials. Drug Discovery Today. ISSN 1359-6446. doi: 10.1016/j.drudis.2012.07.005.

View all works in Cristin

  • Solbakk, Jan Helge; Cox, Shereen; Bernabe, Rosemarie de la Cruz & Vidal Suarez, Susana Maria (2021). Covid 19, Comedy and Crimes against Humanity. Uniforum. ISSN 1891-5825.
  • Mathew, Ryan K; Mushtaq, Faisal; Baraas, Rigmor C. & Bernabe, Rosemarie de la Cruz (2021). Three principles for the progress of immersive technologies in healthcare training and education. BMJ Simulation & Tecnnology Enhanced Learning (BMJ STEL). ISSN 2056-6697. p. 1–2. doi: 10.1136/bmjstel-2021-000881.
  • Solbakk, Jan Helge; Bernabe, Rosemarie de la Cruz & Cox, Shereen (2020). Kynisk svar om TRIPS. Klassekampen. ISSN 0805-3839.
  • Solbakk, Jan Helge; Bernabe, Rosemarie de la Cruz & Cox, Shereen (2020). Mer enn symbolpolitikk. Klassekampen. ISSN 0805-3839.
  • Solbakk, Jan Helge; Bentzen, Heidi Beate; Holm, Søren; Heggestad, Anne Kari Tolo; Hofmann, Bjørn Morten & Robertsen, Annette [Show all 10 contributors for this article] (2020). Høyrisikostudier på alle mennesker i Covid-19-sammenheng er etisk uforsvarlig. Uniforum. ISSN 1891-5825.
  • 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.
  • Baraas, Rigmor C. & Bernabe, Rosemarie de la Cruz (2021). The Role of Immersive Technology in Healthcare Training & Education: The Immersive Healthcare Collaboration. University of Leeds.

View all works in Cristin

Published Apr. 6, 2017 3:15 PM - Last modified Aug. 3, 2022 9:15 AM

Projects