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 regulatory science, responsiveness and post-trial responsibilities, research ethics in low and middle income countries
- Research ethics and emerging technologies
- Research integrity
- Open science
- Global health ethics
- The capabilities approach and the human development framework
Courses taught
- Research ethics and research integrity
- Global research ethics
- Ethics and public health
Selected projects
Project coordinator, Building Bridges for Equitable Opportunities for Underrepresented and Marginalized Researchers in the European Research Area (BEYOND BARRIERS)
Project coordinator, The Equitable, Inclusive, and Human-Centered XR Project (XR4Human)
Project 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)
Project coordinator, Strengthening Clinical Trial Regulatory and Ethical Review Oversight in East Africa (AccessAfrica2)
Project coordinator, Beyond Bad Apples: Towards a Behavioural and Evidence-Based Approach to Promote Research Ethics and Research Integrity in Europe (BEYOND)
Project coordinator, Developing national and global agendas for the ethics of post-trial arrangements in LMICs during pandemics/epidemics (Pandemic Ethics)
Ethics WP leader, Eastern Africa Consortium for Clinical Research 4 (EACCR4)
Publications
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Ddamulira, Christopher; Opolot, Hellen; Mutumba, Beth; Lamunu, Dorcas; Ssebale, Steven & Semakula, Irene
[Show all 11 contributors for this article]
(2026).
A Qualitative Exploration of Stakeholder Experiences and Perceptions of Uganda’s Clinical Research Policies and Guidelines During the COVID-19 Pandemic.
Open Research Europe.
6,
p. 297–297.
doi:
10.12688/openreseurope.24264.1.
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Background The COVID-19 pandemic disrupted research globally, placing unprecedented pressure on regulatory systems. In Uganda, research ethics committees (RECs) and regulatory bodies faced challenges in maintaining oversight, ethical compliance, and continuity of research. Specifically, the study explored stakeholder experiences and perceptions of how Uganda’s clinical research policies and guidelines were implemented and how they influenced the conduct of ethical and safe research during the COVID-19 pandemic. Methods A qualitative descriptive study was conducted across seven districts, involving all UNCST-accredited RECs. Data were collected through in-depth interviews, focus group discussions, and key informant interviews with 56 participants, including REC Chairpersons, administrators, researchers, and representatives from research regulatory authorities in Uganda. Purposive sampling ensured recruitment of participants with relevant expertise. Virtual interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Ethical approval and informed consent were obtained. Results Uganda’s research policies and guidelines were reported by participants to support continuity of research through strengthened collaboration, including joint protocol reviews and coordinated regulatory processes. Standardization and adaptive measures, such as digital submissions, virtual meetings, remote monitoring, and hybrid consent models, were perceived to enhance efficiency and facilitate study adjustments. However, constraints including increased workload, limited oversight due to movement restrictions, and financial challenges persisted, highlighting the need for more adaptable and resilient regulatory systems. Conclusions Uganda’s research policies and guidelines were perceived to supported continuity of ethical research during the pandemic through strengthened collaboration and standardized yet adaptable regulatory processes. However, operational and resource constraints highlighted gaps in system resilience. Strengthening digital infrastructure, institutionalizing collaborative review mechanisms, embedding adaptable procedures, and securing emergency research funding will be critical to enhance the responsiveness and resilience of Uganda’s research regulatory system in future public health emergencies.
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Ddamulira, Christopher; Opolot, Hellen; Mutumba, Beth; Lamunu, Dorcas; Ssebale, Steven & Semakula, Irene
[Show all 11 contributors for this article]
(2026).
Navigating ethical research during crisis: Facilitators and barriers to research conduct in Uganda amid the public health emergencies (COVID-19).
Open Research Europe.
6,
p. 238–238.
doi:
10.12688/openreseurope.24163.1.
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Background Research regulation shapes how studies are conducted during public health emergencies, ensuring adherence to ethical, safety, and legal standards. However, gaps in the practical implementation of regulation remain evident during crises. Uganda is particularly vulnerable to public health emergencies due to its proximity to epidemic hotspots, location within multiple disease belts, rapid population growth, and refugee influx. This vulnerability underscores the need for robust systems to support ethical research conduct. This study explored how the COVID-19 pandemic affected research regulation and ethical oversight in Uganda. Methods A qualitative descriptive design was employed. Data were collected through in-depth interviews, key informant interviews, and focus group discussions involving 56 participants across seven districts (Gulu, Mbale, Mbarara, Bushenyi, Wakiso, Mukono, and Kampala). Participants included Research Ethics Committee (REC) chairpersons, REC administrators, researchers involved in COVID-19 studies, and representatives from national regulatory bodies. Purposive, criterion-based sampling was used. Data were analyzed using thematic analysis. Results The COVID-19 pandemic disrupted research conduct and regulation but also prompted key adaptations. Facilitators included the development of research guidelines, implementation of risk management strategies, prioritization of COVID-19 studies, and adoption of digital submission and review systems. Barriers included suspension of studies due to travel restrictions, delays in protocol approvals, increased financial costs, unclear communication, technological challenges, and poor internet connectivity. Regulatory processes were reshaped through expedited reviews, new policies, and increased reliance on online systems. Conclusion The pandemic revealed both challenges and opportunities within Uganda’s research ecosystem. While disruptions hindered ethical research conduct, adaptations demonstrated potential for more efficient and resilient systems. Strengthening communication, digital infrastructure, and sustainable funding mechanisms is critical to ensuring research continuity during future public health emergencies.
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Voinov, Cristiana-Anca; Hagen, Lene A.; Baraas, Rigmor C.; Bernabe, Rosemarie DLC & Dawkins, Shereen Cox Née
(2026).
Mapping risks and harms of eXtended reality (XR) technologies – A scoping review and novel typology.
Open Research Europe.
6,
p. 203–203.
doi:
10.12688/openreseurope.23621.1.
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This article uses a scoping review method to extensively map risks and harms related to the design, development and application of XR technologies (VR, MR, AR, virtual environments, and metaverses). Through the application of qualitative content analysis, thematic categories emerged which were developed into a novel typology of risks comprising of six main themes and 19 sub-themes: 1) health and wellbeing (cognitive, psycho-emotional, socio-relational and physical), 2) autonomy (privacy, self-sovereignty, surveillance, authenticity), 3) epistemic and scientific (epistemic uncertainty, scientific uncertainty, algorithmic imperfection, manipulation), 4) normative (norm violations, rights violations), 5) structural (socio-political, economic/financial, legal), and 6) technical safety and security (security, dual use). Further considerations identified were risks pertaining to special populations (vulnerable groups), unknown risks and long-term use effects. A subsidiary aim was to map risk mitigations. Other key findings, such as geographical distribution of sources, and use cases, among others, are featured, lending to a robust discussion on the state of XR risks, potential motivators for development of XR harm mitigation-strategies, and key knowledge gaps.
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Hamza, Naheeda; Bernabe, Rosemarie De La Cruz; Coman, Alina & Kulkarni, Uma
(2026).
A survey on Open Science perceptions and experiences among One Health researchers in South Asia.
Open Research Europe.
6,
p. 158–158.
doi:
10.12688/openreseurope.23190.1.
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Background Open Science aims at improving the quality of research, transparency, and data sharing through open-access platforms, data sharing, inclusion of citizen scientists, making research results accessible to both professionals and citizens. As science becomes increasingly data-driven, responsible open science practices enable collaboration, reduce barriers in multisectoral teams, and support integrative approaches such as One Health. In response to the rise of zoonotic diseases globally, many countries have adopted the One Health approach, fostering collaboration across the human–animal–environment interface. However, open practices such as data sharing within One Health is not always implemented. Objective To identify key barriers affecting the adoption of Open Science practices in the One Health community in South Asia. Methods An online survey was conducted among One Health stakeholders in South Asia, including academic researchers, healthcare professionals, veterinarians, and policymakers. A 22-item semi-structured questionnaire was distributed via the Nettskjema platform of the University of Oslo (UiO) using a snowball sampling technique. The study was preregistered in the Open Science Framework registry. Results We received 90 responses with the majority being from India (55.6%), followed by Pakistan (17.8%), Nepal and Sri Lanka (6.7% each), Afghanistan and Bangladesh (5.6% each), and Bhutan (1.1%). Levels of awareness and practices of Open Science were mixed: while 60% engaged in open-access publishing, 27.8% shared data, 23.3% supported citizen science, and 12.2% used preprints. Reported barriers included lack of awareness, inadequate government support, institutional restrictions, to name a few. Despite these, the participants highlighted major benefits in practicing Open Science. Conclusion The survey highlights key opportunities and challenges in adopting Open Science for One Health in South Asia. Greater government and institutional support, improved data-sharing and infrastructure, inclusion of veterinary and environmental sectors, capacity-building, and international collaboration are essential to overcome barriers and strengthen One Health globally.
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Bernabe, Rosemarie De La Cruz; Baraas, Rigmor C.; Cox, Shereen & Hagen, Lene A.
(2026).
From principles to practice: A code of conduct for the human-centered and ethical development of immersive technologies.
Open Research Europe.
6,
p. 35–35.
doi:
10.12688/openreseurope.22230.2.
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The XR4Human Code of Conduct was developed over a 12-month period using a participatory co-design approach that combined multi-disciplinary expert workshops with members of the consortium followed by stakeholder and public consultations. The process was intentionally iterative. Drafting, review, and revision were guided by reflective equilibrium to reconcile empirical inputs from the project deliverables, normative principles, and practical constraints. The final Code is organised into nine domains that consolidate core principles relevant to the responsible design, development, and deployment of XR systems. These principles are made more concrete through seven articles that specify actionable obligations. To support real-world adoption, the Code is operationalised via an Ethical Impact Assessment and a companion Compliance Checklist aligned to the core principles and articles.
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Hamza, Naheeda; Bernabe, Rosemarie de La Cruz; Kulkarni, Uma & Coman, Alina
(2025).
Ethical Challenges and Opportunities at the Intersection of One Health and Open Science in India: A Scoping Review.
Open Research Europe.
5,
p. 302–302.
doi:
10.12688/openreseurope.21085.1.
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Background Open Science (OS) aims at accelerating responsible scientific research, promoting transparency in data sharing, and ensuring that data is accessible to all citizens. On the other hand, One Health (OH), an interdisciplinary field addressing outbreaks of zoonotic infectious diseases, relies heavily on data sharing. Considering the current emphasis on OS practices, it is crucial to identify the challenges associated with practicing OS within the multi-sectoral framework of OH. This scoping review explores how OS principles intersect with issues of data ownership, privacy, and participation within India’s multi-sectoral OH research ecosystem. Objective This study aims to identify the potential challenges and opportunities at the interfaces of OH, OS, society, and policy. Methods We conducted a scoping review, adhering to the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews (PRISMA-ScR) guidelines. We searched PubMed, Web of Science, Embase (OVID), MEDLINE (OVID), and Global Health to identify the articles. We included original articles and policy briefs on OS, Citizen Science, and OH published between 2013 and 2023. The protocol was preregistered in the Open Science Framework (OSF). Results A total of 46 studies met the inclusion criteria. We reviewed 33 original articles, 4 perspectives, 2 commentaries, 2 case studies, 2 policy briefs, 2 protocols, and 1 case report. Key challenges include barriers to cross-sector collaboration, data sharing, weak inter-ministerial collaboration, and challenges in Citizen Science. The study also highlights significant opportunities for advancing OH through improved data sharing techniques, and enhanced collaborative efforts. Conclusion Addressing these challenges and opportunities may foster effective collaboration, ethical data sharing in OH. These strategies are crucial for advancing OH framework and improving health at the human-animal-environment interface in India and other low-and middle-income countries. This review underscores the importance of integrating OS for the sustainable development of OH initiatives in these settings.
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Tucho, Gudina Terefe; Wangamati, Cynthia Khamala; Kumsa, Diribe Makonene & Bernabe, Rosemarie de La Cruz
(2025).
Perspectives of stakeholders on post-trial access arrangements in Ethiopia: a qualitative study.
Global Bioethics.
ISSN 1128-7462.
doi:
10.1080/11287462.2025.2497599.
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Seralegne, Yemisrach Zewdie; Wangamati, Cynthia Khamala; Bernabe, Rosemarie de La Cruz; Mdala, Ibrahimu; Zewdie, Martha & Adane, Hawult Taye
(2025).
Post-trial access practices in conducted clinical trials for Malaria, Tuberculosis, and Neglected Tropical Diseases (NTDs) across Sub-Saharan African countries: A quantitative study.
Open Research Europe.
doi:
10.12688/openreseurope.18175.4.
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Hellmann, Fernando|; Marceau, Emmanuelle & Bernabe, Rosemarie de la Cruz
(2024).
60th anniversary of the Declaration of Helsinki: ethical challenges in the 10th amendment.
Journal of the Royal Society of Medicine.
ISSN 0141-0768.
doi:
10.1177/01410768241261758.
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Dawkins, Shereen Cox Née; Kadlubsky, Alina; Svarverud, Ellen; Adams, Jonathan; Baraas, Rigmor C. & Bernabe, Rosemarie de La Cruz
(2024).
A scoping review of the ethics frameworks describing issues related to the use of extended reality.
Open Research Europe.
4(74).
doi:
10.12688/openreseurope.17283.2.
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The use of extended reality (XR) / immersive technologies such as virtual, augmented, mixed reality and virtual worlds (Metaverse) raises issues of ethical concern. The various issues, if left unaddressed, may impact human wellbeing over time. Immersive technologies are used in entertainment, commerce, training, education, health, and the military among others. Subsequently, there is a broad spectrum of users with various degrees of competencies and vulnerabilities. Special attention regarding long-term effects of immersive technologies on children and the lack of consideration of inclusivity for all persons in society is essential. Several publications have highlighted ethical issues related to immersive technologies, and some have sought to address these issues by proposing solutions or approaches in the form of frameworks, codes of conduct or best practices. This review examined literature between 2000 and 2023 to identify proposed or adopted ethical frameworks, codes of conduct or best practices for immersive technologies. Qualitative research method was applied, using a scoping review approach. Twenty-eight papers were selected for analysis. Approximately 70% of the selected papers were published between 2020 and 2022. Using an inductive thematic analysis method, seven fundamental values and twenty-two corresponding principles were generated. The main values are respect for persons, well-being, safety, integrity and trust, justice, and responsiveness. The dominant principles identified are privacy, informed consent, responsibility, transparency, and freedom. The authors of the papers were predominantly academic researchers. The normative approaches to addressing ethical issues were organised into four domains: society and governance, industry, research/academic organisations, and individuals. Recommendations are: 1) development and/or application of laws or guidelines to ethical, legal, and social issues with immersive technologies; 2) adoption of inclusive approaches to design and development; 3) minimisation of risk for research participants; 4) empowerment of users of immersive technologies; and 5) promotion of responsibility and sincerity in the use of virtual space, especially in matters concerning identity and conduct.
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Dawkins, Shereen Cox Née; 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.
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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.
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Dawkins, Shereen Cox Née; 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.
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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.
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Hellmann, Fernando|; Bernabe, Rosemarie de La Cruz & Homedes, Nuria
(2022).
Post-trial provisions in the Declaration of Helsinki: a watered-down principle that needs to be strengthened.
Journal of the Royal Society of Medicine.
ISSN 0141-0768.
115(11).
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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.
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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
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Dawkins, Shereen Cox Née; 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.
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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.
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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).
p. 1–2.
doi:
10.1136/bmjstel-2021-000881.
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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.
27(3).
doi:
10.1016/j.drudis.2021.12.002.
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Clinicians, especially in low- and middle-income countries (LMICs), contend with limited economic and healthcare resources in deciding appropriate and feasible care for their patients. Some of the LMICs affected by COVID-19 implemented convalescent plasma therapy without sufficient regulatory guidance. Based on this experience, there are several requirements going forward, including: the need for an immediately accessible data gathering and processing system; the necessity of establishing regulatory pathways for early access to experimental treatment during emergency situations; and the accompanying reporting and monitoring requirements must be set. The different stakeholders must also be properly incorporated in the system that such a pathway will create, without neglecting to properly inform the public of the patient rights especially during an emergency situation.
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Bernabe, Rosemarie de la Cruz; Thiel, Ghislaine J.M.W. van; Breekveldt, Nancy S.; Gispen, Christine C. & Delden, Johannes J.M. van
(2020).
Ethics and the marketing authorization of pharmaceuticals: what happens to ethical issues discovered post-trial and pre-marketing authorization?
BMC Medical Ethics.
21:103,
p. 1–8.
doi:
10.1186/s12910-020-00543-w.
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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.
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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.
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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.
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Novoa-Heckel, Germán & Bernabe, Rosemarie de la Cruz
(2019).
A survey in Mexico about ethics dumping in clinical research.
BMC Medical Ethics.
20:38,
p. 1–11.
doi:
10.1186/s12910-019-0378-6.
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Background The exportation of unethical practices to low- and middle-income countries (“Ethics Dumping”) has been conceived as a prevalent practice which needs to be examined more closely. Such a practice might point towards the exploitation of vulnerable population groups. We conducted a survey among Mexican research ethics committee members to explore the issue of ethics dumping in Mexico by understanding how its existence and contributing factors and norms are perceived by these ethics committee members. Method We designed an exploratory survey based on a five-point Likert scale, following an established, validated and published methodology. The questionnaire included both open close-ended questions. The aspects covered in the questionnaire were introductory questions on the existence of ethical issues; general perception on ethics dumping in Mexico; lack of voluntariness, undue inducement, and therapeutic misconception as exploitation risks; existence of exploitative practices; norms facilitating ethics dumping; acceptable levels of benefit to Mexico; boundaries of ethics dumping. The survey was administered to a sample of research ethics committee members from public and private Mexican hospitals in 2016. Results Most of the ethics committee members believed clinical trials are generally ethically sound, though almost a majority think that ethics dumping is a common occurrence and that it is a serious issue. Most agree that ethics dumping needs to be addressed. They also identified other issues such as ethical issues related to patient participation and ethics committees. Further, most committee members agree that undue inducement and therapeutic misconception affect voluntariness, and that both individuals and communities receive appropriate benefits. Conclusion From the perspective of Mexican research ethics committee members, ethics dumping commonly exists in Mexican clinical trials, as well as several related issues such as ethical issues on patient participation and ethics committees, as well as voluntariness issues. Further, most members believed these issues need to be addressed. However, most were also of the opinion that clinical trials are generally ethically compliant. This points to the need for further studies on the reasons for these perspectives.
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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.
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Objectives: Ethics guidelines such as the Declaration of Helsinki and the CIOMS International Ethical Guidelines for Health-related Research Involving Humans require the sponsors, in cooperation with relevant stakeholders, to provide post-trial access (PTA) to intervention and knowledge, especially in clinical trials held in resource-poor regions. To date, we have very limited knowledge in terms of whether PTA is provided at all, and in what form. To partially address this current limitation, this study wished to explore whether, for which type of drugs and in what form PTA is provided in the Philippines. Methods: We looked at all the clinical trial protocols submitted to the University of the Philippines Manila from 2012 to 2017. A total of 193 clinical trial protocols were included in the study. To identify whether, for which drug type and in what form PTA is provided, we gathered the following information: start and end date of the trial, name of study drug, tested indication of the study drug, region the sponsor is from, type/category of the study drug, type of funding agency, provisions for PTA (yes or no) and the explanation for the provisions. PTA provisions were further described according to the form in which PTA was provided and the types of drugs that were given PTA. Results: Of the 193 protocols, 51.81% indicated PTA, though PTA in the form identified in guidelines can be partially accounted for in only 29.5% (57). The most common form of PTA is the provision or sharing of information (40). None of the protocols provided PTA in the form of access to intervention after the trials, with the possible exemption of 10 protocols that declared future evaluation of the sponsor for PTA depending on patient need, and another seven that might offer the option to transfer to an open-label extension study after the trial. Conclusion: More work is needed if PTA, as stipulated in ethics guidelines, is to be reflected in reality.
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Bernabe, Rosemarie de la Cruz; Thiel, Ghislaine JMW van; Breekveldt, Nancy S; Gispen, Christine C & Delden, Johannes JM Van
(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.
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Although EU inspectors and clinical assessors are mandated to identify and act upon ethical issues, regulators lack guidance on how this can be done. Hence, we propose a four-step regulatory approach on ethically relevant GCP violation findings. The first step is identification of the ethical issue. Next is analysis [i.e., identifying the gravity (intensity or severity) and the magnitude (amount and duration) of the ethics violation as well as the responsible person(s) or entity or entities]. The third step is evaluation, (i.e., the process of deliberating to determine the significance of the ethics violation, with the intention of identifying the most reasonable sanction and/or corrective or reparative action). Last is decision-making or the process of choosing and implementing a regulatory course of action.
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Bernabe, Rosemarie de la Cruz; Thiel, GJMW van; Breekveldt, NS; Wied, CC Gispen-de & Delden, Johannes JM Van
(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.
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Background: Within the EU, regulators are obliged to take ethical issues into consideration during marketing authorization deliberation. The goal of this manuscript is to identify what kinds of ethical issues regulators encounter during marketing authorization application deliberations, and the incidence of these ethical issues. Methods: This study used an EMA-provided Excel file that contains all the GCP non-compliance findings from all inspection reports from 2008–2012. There were 112 medicinal products and a total of 288 clinical trial sites. There were a total of 4014 GCP non-compliance findings. The findings that were ethically relevant were extracted using NVivo 10.0 and categories for the ethically relevant findings (ERFs) were created. Note was taken of the incidence of ERFs for each category and the inspectors’ gradings of these findings were extracted. This study also looked at the mean and the maximum number of ERFs per grading per medicinal product application, as well as the number of medicinal products with at least one ERF and those with at least major ERFs. Results: With multiple coding, there were 1685 ERFs. ERFs were present in almost all of the medicinal products (97.3%). The majority of ERFs were graded as major. At least major ERFs were present in almost all medicinal products with ERFs. The categories with the highest number of ERFs were protocol issues, patient safety, and professionalism issues. In terms of the density of combined critical and major findings, monitoring and oversight, protocol issues, and respect for persons top the list. This study also showed that, on average, there were 7.54 major and 2.95 critical ERFs per medicinal product application, although ERFs can increase to 30 major and 12 critical. Conclusion: Regulators regularly encounter ERFs that at least “might adversely affect the rights, safety or well-being of the subjects”. It remains to be explored how regulators respond to these ethical issues.
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Bernabe, Rosemarie de La Cruz
(2016).
Ethical Principles in Phase IV Studies.
In Strech, Daniel & Mertz, Marcel (Ed.),
Ethics and Governance of Biomedical Research: Theory and Practice.
Springer.
ISSN 9783319287294.
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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.
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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.
doi:
10.1186/1472-6939-13-6.
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Bernabe, Rosemarie de La Cruz; Thiel, Ghislaine J.M.W. van; Delden, Johannes J.M. van & Raaijmakers, Jan A.M.
(2011).
Informed consent and phase IV non-interventional drug research.
Current Medical Research and Opinion.
ISSN 0300-7995.
27(3),
p. 518–518.
doi:
10.1185/03007995.2010.546393.
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Baños, David & Bernabe, Rosemarie de La Cruz
(2025).
En akademisk og medisinsk skandale.
Forskersonen.no.
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DEBATT: At seniorforskere med betydelig makt og innflytelse ikke ivaretar pasienters og forskningsdeltakeres rettigheter, og ikke anerkjenner sakens alvor, er dypt urovekkende.
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Seralegne, Yemisrach; Wangamati, Cynthia Khamala; Bernabe, Rosemarie de La Cruz; Mdala, Ibrahim; Zewdie, Martha & Adane, Hawult
(2024).
Post-trial access practice in Malaria, Tuberculosis, and NTDs Clinical Trial studies in Sub-Saharan African countries, quantitative study.
doi:
https:/zenodo.org/records/13752053.
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Stendal, Karen & Bernabe, Rosemarie de La Cruz
(2024).
Extended Reality-New Opportunity for People With Disability? Practical and Ethical Considerations.
26.
doi:
10.2196/41670.
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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.
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Solbakk, Jan Helge; Cox, Shereen; Bernabe, Rosemarie de la Cruz & Suarez, Susana Maria Vidal
(2021).
Covid 19, Comedy and Crimes against Humanity.
Uniforum.
ISSN 1891-5825.
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Solbakk, Jan Helge; Bernabe, Rosemarie de la Cruz & Cox, Shereen
(2020).
Kynisk svar om TRIPS.
Klassekampen.
ISSN 0805-3839.
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Bernabe, Rosemarie de la Cruz
(2017).
Exportation of unethical practices to low and middle income
countries in biomedical research.
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Bernabe, Rosemarie de la Cruz
(2017).
The ambivalent place of ethics in European regulatory documents.
Drug Discovery Today.
ISSN 1359-6446.
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Bernabe, Rosemarie de la Cruz
(2011).
Is informed consent necessary for
randomized phase IV “observational” drug studies?
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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.
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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.
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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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Published
Apr. 6, 2017 3:15 PM
- Last modified
Aug. 28, 2026 4:13 PM
