After nearly two years of global consultations, the World Medical Association (WMA) published the latest version of the Declaration of Helsinki. The Declaration of Helsinki is one of the most influential ethics guidelines for clinical research. Shereen Cox, a Jamaican pharmacist/ethicist, along with her PhD supervisors, Professors Rosemarie Bernabe and Jan Helge Solbakk, contributed to the 2024 revision based on the findings of her PhD research at the University of Oslo, Norway. The contribution called for expanding the scope of research ethics committees’ post approval/monitoring activities in clinical trials. These, along with many other very important amendments from experts across the world were accepted at the WMA’s General Assembly in Finland in October 2024.

The below is an appeal from Dr Cox.

CLINICAL trials are essential for public health. They involve rigorous pretesting of drugs, devices, and procedures before they can be approved by regulators. Unethical research outputs can adversely affect public health and diminish trust in science. My three-year research examined the post-approval role of research ethics committees, also known as institutional review boards (IRB), during clinical trials.

My thesis emphasised the importance of ethics committees remaining engaged throughout the clinical trial process by having the right to “recommend changes, withdraw approval, and suspend ongoing research”. I argue for the concept of end-to-end-ethics oversight in lieu of the emphasis on prospective ethics review which is the current practice. My research compared the practice of ethics committees in Europe and the United States (US). The key findings of note is that while post-approval follow-up of research is a quality assurance practice for academic IRBs in the US, it is not widely practised in Europe and the rest of the world. Instead, the bulk of the follow-up on clinical trials are conducted by regulators who often overlook or neglect to act on ethically relevant violations such as using unqualified persons to conduct research, failure to follow correct informed consent procedures, or to report or follow-up on serious adverse effects. Another important consideration is post-trial access to interventions that has helped research participants.

While there is progress in addressing some of the gaps in both legal and ethical governance of clinical research globally, many Caribbean countries, including Jamaica, have yet to establish legislation to regulate research on human participants. Though not a prohibition for the actual conduct of research, a lack of legislation regulating research can contribute to an unappealing research environment for funders and investigators who prefer an environment where regulatory requirements that are made explicit. Although research ethics committees have been established across the region, and significant stride made in ethics capacity building through programmes such as Caribbean Research Ethics Education Initiative, regulating clinical research by way of legislation provides objective guidance to research ethics committees, holds researchers accountable and ensure transparency.

A 2022 Pan American Health Organisation study published in The Lancet on research ethics systems in Latin America and the Caribbean highlights that while Latin America in general were advanced with their research ethics systems, countries such as Jamaica, Haiti, Trinidad and Tobago are lagging behind due to either lack of established oversight systems or the absence of laws. Jamaica was listed as “in progress” with respect to laws for health-related research while other important activities necessary for quality research oversight are recorded as not initiated. The current situation for many Caribbean countries including Jamaica is one where research ethics committees are guided by operational policies that are not legally binding. The authors stressed that the “responsible conduct of research has received increased attention, yet it remains a challenge. Deliberate efforts are needed to include it in national agendas.” Another appeal was made in a follow-up article following the publication of the revised declaration.

This is therefore an appeal to the Ministry of Health to prioritise the regulation of clinical research on its legislative agenda. Significant work has already been done to create draft legislation by Dr Derrick Aarons, consultant bioethicist at the Caribbean Public Health Agency. Biomedical research is evolving quickly, and with the growing integration of artificial intelligence and other emerging technologies in medicine, it is more important than ever to ensure Jamaica is not left behind because of the lack of a regulatory framework. Research funders such as the European Commission and the US National Institute of Health have strict rules of engagement for sponsored research. There are brilliant researchers in Jamaica who would welcome the opportunity to have more sponsored clinical trials to facilitate understanding of how to treat/manage various medical conditions in our population.

Dr Cox successfully defended her thesis in 2023 at the University of Oslo, Norway, where she became the first black woman and Caribbean person to earn a PhD at the Centre for Medical Ethics. She is now conducting post-doctoral research on the ethics of immersive technologies in the EU-funded project XR4Human. In July 2024, she became an ethics expert for the European Commission. She is also an adjunct lecturer at both The University of the West Indies and the University of Technology, Jamaica. E-mail: coxshereen@gmail.com.