Shereen Cox Née Dawkins

Cox, Shereen (2012). Biosimilars in the Caribbean: Key Considerations. West Indian Medical Journal. (61) 9 doi:10.7727/wimj.2012.331

Cox S. To dispense or not to dispense: Lessons to be learnt from ethical challenges faced by pharmacists in the COVID-19 pandemic. Developing World Bioeth. 2020;00:1–8. https://doi.org/10.1111/dewb.12284 69- 70

• 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, s. 203–203. doi: 10.12688/openreseurope.23621.1. Fulltekst i vitenarkiv Vis sammendrag

  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.

• Bernabe, Rosemarie de La Cruz; Dawkins, Shereen Cox Née & Wied, Christine C. Gispen-de (2025). Gaps in the ethical governance of pharmaceutical clinical trials in Europe. Frontiers in Medicine. 11, s. 1–11. doi: 10.3389/fmed.2024.1507021. Fulltekst i vitenarkiv
• 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. Fulltekst i vitenarkiv Vis sammendrag

  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.

• 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), s. 341–350. doi: 10.1080/03007995.2023.2175999. Fulltekst i vitenarkiv Vis sammendrag

  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.

• 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. s. 1–10. doi: 10.1080/03007995.2022.2115773. Fulltekst i vitenarkiv Vis sammendrag

  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.

• 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), s. 1061–1069. doi: 10.1080/03007995.2021.1905621. Fulltekst i vitenarkiv Vis sammendrag

  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.

• Cox, Shereen (2020). To dispense or not to dispense: Lessons to be learnt from ethical challenges faced by pharmacists in the COVID-19 pandemic. Developing World Bioethics. ISSN 1471-8731. 00, s. 1–8. doi: 10.1111/dewb.12284. Fulltekst i vitenarkiv Vis sammendrag

  The year 2020 is facing one of the worst public health situations in decades. The world is experiencing a pandemic that has triggered significant challenges to healthcare systems in both high and low‐middle income countries (LMICs). Government policymakers and healthcare personnel are experiencing real‐life ethical dilemmas and are pressed to respond to these situations. Many possible treatments are being investigated, one of which is the use of hydroxychloroquine or chloroquine. These drugs are approved for use by patients with systemic lupus erythematosus (SLE), rheumatoid arthritis, and malaria. The demand for these products has increased, and the stocks are depleting for the patient population for whom the drugs are intended initially. Although both innovator and generic pharmaceutical manufacturers are making plans for increased production, there are challenges with global supply chains disruption and the retention of supplies for local markets. This may cause countries that rely on the importation of pharmaceuticals to be out of stock of supplies for an extended period. There are allegations of off‐label prescribing and hoarding. Pharmacists are the custodians and dispensers of medications and are faced with the task of assessing prescriptions and making decisions about the allocation of these products. This paper seeks to 1) highlight some of the ethical challenges of dispensing hydroxychloroquine by pharmacists during the COVID‐19 pandemic, 2) identify some of the responses to these issues from various regulatory authorities in the USA, and 3) recommend approaches to assist pharmacists in their decision‐making process, especially in LMICs.

• Solbakk, Jan Helge; Bentzen, Heidi Beate; Holm, Søren; Heggestad, Anne Kari Tolo; Hofmann, Bjørn Morten & Robertsen, Annette [Vis alle 10 forfattere av denne artikkelen] (2020). Back to WHAT? The role of research ethics in pandemic times. Medicine, Health care and Philosophy. ISSN 1386-7423. s. 1–16. doi: 10.1007/s11019-020-09984-x. Fulltekst i vitenarkiv Vis sammendrag

  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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• Dawkins, Shereen Cox Née; Svarverud, Ellen; Adams, Jonathan; Kadlubsky, Alina & Bernabe, Rosemarie de La Cruz (2024). A scoping review of the ethics frameworks describing issues related to the use of extended reality. doi: https:/zenodo.org/records/10854489. Fulltekst i vitenarkiv
• Solbakk, Jan Helge; Bernabe, Rosemarie de la Cruz & Cox, Shereen (2020). Kynisk svar om TRIPS. Klassekampen. ISSN 0805-3839. Fulltekst i vitenarkiv
• Solbakk, Jan Helge; Bernabe, Rosemarie de la Cruz & Cox, Shereen (2020). Mer enn symbolpolitikk. Fulltekst i vitenarkiv
• Solbakk, Jan Helge; Bentzen, Heidi Beate; Holm, Søren; Heggestad, Anne Kari Tolo; Hofmann, Bjørn Morten & Robertsen, Annette [Vis alle 10 forfattere av denne artikkelen] (2020). Høyrisikostudier på alle mennesker i Covid-19-sammenheng er etisk uforsvarlig. Fulltekst i vitenarkiv
• Bernabe, Rosemarie de La Cruz; Baraas, Rigmor C.; Barngrover, Michael; Dawkins, Shereen Cox Née; Hagen, Lene Aarvelta & Kadlubsky, Alina [Vis alle 13 forfattere av denne artikkelen] (2025). XR4HUMAN Code of Conduct for the Human-Centered and Ethical Development of Immersive Technologies. Zenodo. doi: https:/zenodo.org/records/17035113. Fulltekst i vitenarkiv
• Voinov, Cristiana-Anca; Hagen, Lene Aarvelta; Baraas, Rigmor C.; Bernabe, Rosemarie de La Cruz & Dawkins, Shereen Cox Née (2024). Mapping of risks and harms of eXtended reality (XR) technologies. Zenodo. doi: https:/zenodo.org/records/14044988. Fulltekst i vitenarkiv
• Dawkins, Shereen Cox Née; Svarverud, Ellen; Adams, Jonathan; Kadlubsky, Alina; Bernabe, Rosemarie de La Cruz & Baraas, Rigmor C. (2023). Mapping of the ethical Issues in XR-overview of Ethical Frameworks: A Scoping Review. Zenodo. doi: https:/zenodo.org/records/10886403. Fulltekst i vitenarkiv

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