Rosemarie de La Cruz Bernabe

• Stendal, Karen & Bernabe, Rosemarie de La Cruz (2024). Extended Reality-New Opportunity for People With Disability? Practical and Ethical Considerations. Journal of Medical Internet Research. ISSN 1438-8871. 26. doi: 10.2196/41670. Show summary

  Since the introduction of virtual environments in the 70s, technologies have moved through virtual reality, mixed reality, and augmented reality into extended reality (XR). This development is promising for various groups. Previous research has shown people with disability benefiting from using technology in social and professional settings. Technology has offered people with disability the opportunity to communicate, interact, participate, and build new relationships. However, we do not know what impact XR has or will have and whether it will offer new opportunities for people with disability. This paper aims to indicate potential opportunities and challenges afforded by XR to people with disability. We offer reflections on the opportunities as well as the ethical considerations needed when introducing immersive technologies to a marginalized group.

• Cox Née Dawkins, Shereen; Solbakk, Jan Helge; Luthardt, Frederick & Bernabe, Rosemarie de La Cruz (2023). Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA. Current Medical Research and Opinion. ISSN 0300-7995. 39(3), p. 341–350. doi: 10.1080/03007995.2023.2175999. Full text in Research Archive Show summary

  Objective: To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities. Method: This was a qualitative study. Thematic analysis was the method to review the webpage content of selected academic health centers (AHC) within the USA. Results: Some US academic health “centers” IRB administrative or research compliance offices conduct post- approval monitoring (PAM) of human subjects’ research including clinical trials. The goals of this PAM programmes are to (a) ensure compliance to approved protocols, (b) preserve research integrity, (c) manage institutional risks, d) provide advisory/educational support to researchers, (e) recommend corrective actions for identified issues, and most importantly, (f) to protect the safety, rights, and well-being of research participants. Although not a requirement by law, the PAM program has legislative support in the US Code of Federal Regulations as part of the US Office for Human Research Protection’s (OHRP) Federal Wide Assurance (FWA). This is especially for institutions that conduct studies funded by the Federal government. PAM on-site checks reveal various incidents of protocol deviations and violations. This includes issues with recruitment processes, informed consent discrepancies, and incidents of non-compliance. When a study protocol is identified as non-compliant, the principal investigator works with the PAM monitor to develop a corrective action plan that would allow the study to become compliant and avoid sanctions from the IRB or the regulatory authority. Conclusions: REC/IRB post-approval monitoring of clinical trials is a valuable mechanism of protection for research participants while giving educational and quality assurance support to researchers. The program enables early detection and resolution of non-compliance to approved protocols. The impact of the program in the USA requires further exploration.

• 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. Show summary

  Objective: To explore the views of Research Ethics Committee (REC) representatives in the European Union (EU) on what the status quo is in terms of RECs’ activities after the approval of trial protocols for clinical studies. Method: This is a qualitative study. The participants in this study are members or representatives of a research ethics committee from the member countries of the European Network of Research Ethics Committees (EUREC) and the United Kingdom. Thematic analysis was the method to assess interview transcripts. Results: Interviews of REC representatives from 19 countries across Europe reveals that REC postapproval activities are predominantly limited to review and approval of protocol amendments. The majority of the RECs do not have mandatory continuing reviews or receipt of notifications of adverse events or protocol violations. In fact, most post-approval activities are the remit of the regulatory authorities. The interviewed members were also of the opinion that RECs in the EU do not have the legislative support, the organizational structure, the expert staff nor time to do active post approval follow-up. Conclusions: Post-approval follow-up activities for clinical studies by RECs is a valuable resource and means for early detection and resolution of protocol deviations and violations. However, a majority of RECs within Europe do not have active post-approval follow-up of approved protocols. The interviews revealed that resource challenges such as time, personnel, and organizational structure contribute to the lack of follow-up by RECs. Some RECs in the represented countries do not identify post-approval follow-up as part of their mandate but instead place emphasis on the culture of trust between the RECs and researchers. Current EU Regulations do not directly address the role of the REC after the approval of clinical trials.

• 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. Show summary

  Few studies in sub‐Saharan Africa evaluate Institutional Review Boards (IRBs) ca-pacity. The study aims to explore the composition of IRBs, training, and challengesexperienced in the ethics review processes by members of research institutions anduniversities in Addis Ababa, Ethiopia. Our findings indicate that most IRBs memberswere trained on research ethics and good clinical practice. However, majorityperceived the trainings as basic. IRB members faced several challenges including:investigators wanting rapid review; time pressure; investigators not followingchecklists; limited expertise in reviewing clinical trials, studies on genetics, and tra-ditional medicine; lack of IRB offices for administrative work; competing tasks;limited staffing and the lack of a standardized review system. There is need foradvanced training on research ethics to meet the evolving research needs. In addi-tion, investments in IRBs are needed in terms of funding, and physical and humanresources in Addis Ababa and Ethiopia in general

• 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. Show summary

  Aim: To conduct a descriptive content analysis of normative documents on the role of research ethics committees (RECs) after the approval of clinical trial protocols. The question to be addressed is whether and to what extent normative documents support a monitoring role for RECs in the United States and the European Union. Design: A qualitative content analysis of 19 normative documents on clinical research as outlined by the International Compilation of Human Research Standards 2020 edition and other related documents for the EU and USA. Results: After the approval of research protocols, RECs’ general role is to receive reports from researchers on the trials’ progress. Additionally, RECs receive notifications of protocol amendments, deviations and, to a lesser extent, violations, which is the remit of the regulatory/competent authorities. RECs are expected to issue opinions on clinical trials’ progress and give supplemental opinions/approval or withdraw/suspend/terminate previous favorable opinions on adverse events or safety concerns that may arise. RECs are to receive an end of the trial report. Conclusion: The role of RECs post approval of protocols is to protect human participants through activities such as continuing review of: (a) progress reports, (b) notifications of significant protocol amendments, (c) adverse events, (d) protocol deviations, and (e) protocol violations. Although some international guidelines such as the Declaration of Helsinki emphasize the right to monitor, RECs’ predominant activity is document review. In the USA, RECs are authorized to issue approvals and terminate/suspend previously issued approvals. However, in the EU, the approach is to relegate to member states to decide the extent of legislative power they wish to give to the RECs. The REC’s opinion on the end of trial report is identified as an area for further exploration.

• 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 Show summary

  Background: In the EU, clinical assessors, rapporteurs and the Committee for Medicinal Products for Human Use are obliged to assess the ethical aspects of a clinical development program and include major ethical flaws in the marketing authorization deliberation processes. To this date, we know very little about the manner that these regulators put this obligation into action. In this paper, we intend to look into the manner and the extent that ethical issues discovered during inspection have reached the deliberation processes. Methods: To gather data, we used the Dutch Medicines Evaluation Board database and first searched for the inspections, and their accompanying site inspection reports and integrated inspection reports, related to central marketing authorization applications (henceforth, application/s) of drugs submitted to the European Medicines Agency (EMA) from 2011 to 2015. We then extracted inspection findings that were purely of ethical nature, i.e., those that did not affect the benefit/risk balance of the study (issues related to informed consent, research ethics committees, and respect for persons). Only findings graded at least major by the inspectorate were included. Lastly, to identify how many of the ethically relevant findings (ERFs) reach the application deliberation processes, we extracted the relevant joint response assessment reports and reviewed the sections that discussed inspection findings. Results: From 2011 to 2015, there were 390 processed applications, of which 65 had inspection reports and integrated inspection reports accessible via the database of the Dutch Medicines Evaluation Board. Of the 65, we found ERFs in 37 (56.9%). The majority of the ERFs were graded as major and half of the time it was informed-consent related. A third of these findings were related to research ethics committee processes and requirements. Of the 37 inspections with ERFs, 30 were endorsed in the integrated inspection reports as generally GCP compliant. Day 150 joint response assessment reports and Day 180 list of outstanding issues were reviewed for all 37 inspections, and none of the ERFs were carried over in any of the assessment reports or list of outstanding issues. Conclusion: None of the ethically relevant findings, all of which were graded as major or critical in integrated inspection reports, were explicitly carried over to the joint assessment reports. This calls for more transparency in EMA application deliberations on how ERFs are considered, if at all, in the decision-making processes.

• 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 Show summary

  The Covid-19 pandemic creates an unprecedented threatening situation worldwide with an urgent need for critical reflection and new knowledge production, but also a need for imminent action despite prevailing knowledge gaps and multilevel uncertainty. With regard to the role of research ethics in these pandemic times some argue in favor of exceptionalism, others, including the authors of this paper, emphasize the urgent need to remain committed to core ethical principles and fundamental human rights obligations all reflected in research regulations and guidelines carefully crafted over time. In this paper we disentangle some of the arguments put forward in the ongoing debate about Covid-19 human challenge studies (CHIs) and the concomitant role of health-related research ethics in pandemic times. We suggest it might be helpful to think through a lens differentiating between risk, strict uncertainty and ignorance. We provide some examples of lessons learned by harm done in the name of research in the past and discuss the relevance of this legacy in the current situation.

• 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.

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• 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. Show summary

  The COVID-19 crisis has fundamentally transformed the healthcare training and education landscape, resulting in a desperate need for a system-wide exploration of scalable, flexible, user-friendly and resilient solutions that mitigate the long-term impact on the development of a skilled healthcare workforce that can deliver high-quality patient care.nA new generation of “immersive technologies” – a collection of tools, sometimes grouped under the term eXtended Reality (XR), including enclosed 3D Virtual Reality (VR) environments through to digital projections that overlay the real-world to create “Augmented/Mixed Reality” (AR/MR) – have potential to address many of the challenges faced in healthcare training and education.nDespite their potential, challenges exist in the design, development, implementation, and understanding of immersive training environments and must be overcome if these technologies are to realise their potential.nSystem development and implementation must focus on learning outcomes (e.g. academic, social and emotional learning, reduction in drop-out rates, demonstration of non-inferiority and subsequently, superiority over traditional non-immersive training methodologies) and patient-care related processes (e.g. safer delivery, reduced morbidity and readmission rates).nBold policies based on sound scientific evidence need to be developed, both in the short – and long-term – that are practically applicable and acceptable to the variety of stakeholders – to ensure that the power of immersive tools is harnessed for efficient and effective health education and training delivery.

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