The VolREthics Initiative: Healthy Research Volunteers and Ethics
In early 2022, Inserm set up an international initiative on ethical issues related to the participation of healthy volunteers in biomedical research. Called VolREthics, which is short for Volunteers in Research and Ethics, this initiative is supported by numerous international partners. Its objective is to lead to the sharing and discussion of practices at international level, so that each country can decide on the best way to protect its healthy volunteers.
Second plenary meeting, Brussels (Belgium)
- Date: April 24–25 2023
Every year, tens of thousands of people with no known major medical problems participate in research studies aimed at testing the tolerability and behavior within the body of medicines, vaccines, and other biomedical interventions. These people do not derive any direct medical benefit from their participation. The fact that they are healthy helps to avoid any changes in the behavior of the drug related to various diseases. They are called « healthy volunteers » to differentiate them from patients who suffer from the diseases in question, and for whom participation in biomedical research may provide medical benefit.
The central ethical question raised by the involvement of healthy volunteers in biomedical research is that of respect for the person’s free will to decide to participate in the research, without any direct or indirect pressure. Another ethical imperative is to ensure the safety and well-being of the healthy volunteers both during and after the research. This is because all biomedical research involves a certain number of risks that, even if kept to a minimum by the researchers and authorities, can never be ruled out entirely. The two main risks to which healthy volunteers are exposed are:
- That of being exploited in a context of vulnerability, for example economic, educational, cultural or related to age...
- That of experiencing adverse events during or after the study in which they are taking part.
However, ensuring the free will, safety and well-being of volunteers represents a considerable challenge, not just in resource-limited countries but also among young and vulnerable populations in industrialized countries.
Healthy volunteers are most often young people, for whom financial compensation can be decisive in their decision whether or not to participate in a research study. Such compensation is permitted in exchange for participation in the research and depending on the constraints related to the study. But the prospect of financial gain, especially if added to other forms of vulnerability, such as a low level of education, can be a major obstacle to the person’s capacity to freely decide, after taking into account the potential risks and benefits, to participate in a study.
VolREthics, for sharing and discussing best practices at an international level
In this context and in the face of these ethical issues, some countries have implemented effective measures to ensure the respect, safety, and well-being of healthy volunteers. The objective of the VolREthics initiative is to share and discuss these « best practices » internationally.
During a first meeting held in February 2022 at the UNESCO headquarters in Paris, more than 150 experts from over 40 different countries presented their viewpoints and questions. These exchanges have made it possible to identify in which situations the rights, well-being and safety of healthy volunteers can be endangered. Various solutions have been discussed.
Following this meeting, the Inserm Ethics Committee set up, with the support of local experts, regional workshops in order to understand these issues in relation to local regional particularities. Following these workshops, Inserm is planning to hold an international meeting in 2023 in order to summarize the recommendations to ensure respect for the rights, well-being, and safety of healthy volunteers in biomedical research.
VolREthics is led internationally by a group of Inserm Ethics Committee members, coordinated by François Hirsch. The initiative is also supported by an international steering committee.
- François Bompart
- François Eisinger
- François Hirsch
- Christine Lemaitre
- Pierre Lombrail
- Flavie Mathieu
- Isabelle Rémy-Jouet
- Yamina Sadani
- Corinne Sebastiani
- Interns: Lou Lennad et Meriem Karkar
- Elisabeth Allen, University of Cape Town (South Africa)
- CK Chew, Institute for Clinical Research (Malaysia)
- Jill Fisher, University of North Carolina (USA)
- Carleigh Krubiner, Wellcome Trust (United Kingdom)
- François Hirsch, Inserm Ethics Committee (France)
- Lembit Rägo, CIOMS (Switzerland)
- Doris Schroeder, University of Central Lancashire (United Kingdom)
- Esperança Sevene, Eduardo Mondlane University (Mozambique)
- Observers: Council of Europe (Laurence Lwoff), ERCEA (Filipa Ferraz-de-Oliveira), EUREC (Dirk Lanzerath), European Commission (Lisa Diependaele), EDCTP (Pauline Beattie), UNESCO (Irakli Khodeli), and WHO (Katherine Littler)
- Secretary: François Bompart, Inserm Ethics Committee (France) & Drugs for Neglected Diseases initiative (Switzerland)
VolREthics is supported by the Drugs for Neglected Diseases initiative (DNDi), as well as for certain events by partners such as the Council for International Organisations of Medical Sciences (CIOMS), Council of Europe, European Network of Research Ethics Committees (EUREC), European Commission, World Health Organization, European and Developing Countries Clinical Trials Partnership (EDCTP), UNESCO, and Wellcome Trust.
Documentary and video resources
Towards common ethical rules to protect healthy volunteers in biomedical research
Meeting of February 15 and 16, 2022, UNESCO, Paris
VolREthics initiative: Africa Regional Meeting
Meeting of May 24, 2022
VolREthics initiative: Asia Regional Meeting
Meeting of September 23, 2022
VolREthics initiative: North America Regional Meeting
Meeting of October 19, 2022
VolREthics initiative: Latin America Regional Meeting
Meeting of December 12, 2022
- Program (in Spanish, pdf, 337 Ko)
- Meeting report (pdf, 173 Ko)
- Video recordings of the interventions
VolREthics initiative: Europe Regional Meeting
Meeting of January 27, 2023
Other documentary resources
- « Volontaires sains » dans la recherche clinique : un engagement entre altruisme et vulnérabilité – The Conversation, February 2021 (only available in French)