Shereen Cox Née Dawkins

Researcher - Centre for Medical Ethics

Norwegian version of this page

Email s.c.n.dawkins@medisin.uio.no

Mobile phone +47 45236399

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Visiting address Kirkeveien 166 Stjerneblokka Ullevål 0450 Oslo

Postal address Postboks 1130 Blindern 0318 Oslo

Other affiliations Faculty of Medicine (Student)

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Academic interests

Regulatory Ethics
Health Law
Bioethics
Research Ethics
Pharmacy Ethics
Technology Ethics
Assisted Reproduction

Courses taught

Pharmacy Law and Ethics, Science Ethics, Research Ethics, Clinical research, Pharmacology, Community Pharmacy

Background

Shereen successfully defended her Doctor of Philosophy thesis at the Faculty of Medicine, University of Oslo in 2023. She received a Master of Arts in Healthcare Ethics and Law from the University of Manchester, England and a first class honors Bachelor of Pharmacy degree from the University of Technology, Jamaica in 2004 and Honors Diploma in 1998. She has been teaching ethics to Bachelors and Doctor of Pharmacy students at the Universities of the West Indies and Technology (Jamaica) since 2008 and to Masters and Doctoral students at the University of Oslo since 2021.

She worked as a Pharmacy Inspector with the Pharmacy Council of Jamaica and eventually was appointed a member of the same Council where she chaired the Standards Committee. She worked as adjunct lecturer at Excelsior Community College School of Nursing where she taught Pharmacology. She is the immediate Past- President of the Bioethics Society of the English speaking Caribbean, where she also served as Vice-President and secretary during 2008-2015. She was an Executive member of the Pharmaceutical Society of Jamaica and the National Bioethics Committee. She also serves as a Justice of the Peace for the Parish of St. Andrew.

Awards

Pharmacist of the year (2019), Pharmaceutical Society of Jamaica
Outstanding Pharmacy Entrepreneur (2017), University of Technology alumni

Positions held

Chair of the Standards Committee, Pharmacy Council of Jamaica
President, Vice-President, Secretary -Bioethics Society of the English speaking Caribbean
Member, National Bioethics Committee of Jamaica
Asst Secretary, Pharmaceutical Society of Jamaica

Shereen Cox, Jan Helge Solbakk, Frederick Luthardt Jr & Rosemarie DLC Bernabe (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, DOI: 10.1080/03007995.2023.2175999

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

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.
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.
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, p. 1–8. doi: 10.1111/dewb.12284. 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 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.

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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.