Clinical trials are fundamental to advancing medical knowledge, allowing for the evaluation of the efficacy and safety of new treatments before they are made available to the public. However, the involvement of healthy volunteers in these trials raises significant ethical concerns, particularly regarding the prevention of exploitation and harm. To address these issues, the VolREthics initiative, spearheaded by Inserm (the French National Institute of Health and Medical Research), was created. This article highlights the progress of this global project, which led to the publication of an international ethical charter in June 2024 – a comprehensive code of conduct designed to safeguard the rights, well-being, and safety of healthy volunteers in biomedical research.
VolREthics: An International Partnership
Launched in 2022, the VolREthics initiative seeks to foster collaboration and discussion on best practices for protecting healthy volunteers in clinical trials. Through a series of plenary and regional meetings, this initiative brought together experts from over 40 countries to identify the risks faced by these volunteers and propose various solutions.
The first plenary meeting, held in Paris in February 2022, attracted more than 150 experts who discussed the key ethical challenges surrounding healthy volunteer participation. These discussions underscored the vulnerability of certain groups, particularly in low-resource countries or among younger and vulnerable populations. Following this meeting, regional workshops were organised to explore how these issues varied based on local circumstances in Africa, Asia, North America, Latin America, and Europe.
A Global Ethical Charter: A Framework for the Protection of Healthy Volunteers
In June 2024, the VolREthics initiative culminated in the publication of a global ethical charter aimed at protecting healthy volunteers in clinical trials. This Charter specifically focuses on healthy volunteers involved in interventional research on health products where there is no direct benefit to the participants, as these studies may carry the greatest risk of harm or exploitation.
The Charter outlines 15 fundamental rights designed to ensure the safety and dignity of healthy volunteers, and it emphasises the need for legal frameworks and regulations to safeguard these participants.
The key rights stated in the Charter include:
- Ensuring that participation in research is conducted ethically and scientifically justified.
- Appropriate representation of volunteers throughout the research process.
- Effective protection against potential short and long-term bodily harms.
- Transparency about the clinical trials in which volunteers participate.
- Fair compensation for their participation.
- Procedures for confidentially reporting any issues encountered.
Protecting Healthy Volunteers and Addressing the Global Challenge of Over-Participation
One of the critical issues addressed in the Charter is the risk of “over-participation,” where volunteers might engage in multiple clinical trials simultaneously or consecutively, without adhering to the necessary exclusion (or “wash-out”) periods between studies. These periods are essential to protect the health of participants and the integrity of the research. To date, only a few countries, including France, the United Kingdom, and Malaysia, have established national registries to prevent this risk.
A Step Towards Safer and More Ethical Clinical Research
The creation of this global ethical Charter represents a major step forward in clinical research ethics. By acknowledging the vulnerability of healthy volunteers and providing clear guidelines for their protection, this initiative not only strengthens public trust in clinical trials but also helps ensure more reliable and ethically sound research outcomes.
Conclusion
Healthy volunteers play an essential role in clinical research, from the early stages of drug development to pharmacokinetic studies. Their contributions drive medical advancements, but it is crucial that they are adequately protected from risks and exploitation.
The global ethical Charter developed through the VolREthics initiative marks a significant milestone in recognising and protecting the rights of healthy volunteers. It aims to increase awareness among policymakers, research sponsors, ethics committees, and research institutions, ensuring that clinical research is both ethical and secure.
Arthur Makadi,
Strategic Projects Coordinator, Pharmalys Ltd