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. In June 2024, after an international consultation which has included a panel of healthy volunteers, a key deliverable of the VolRethics initiative was made public: the Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials.

The VolREthics initiative

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 first plenary meeting, a series of regional workshops were organised to understand these issues in relation with regional specificities, in Africa, Asia, North America, Latin America and Europe. A second plenary meeting, held in Brussels (Belgium) in April 2023 with the support of the European Commission allowed to take stock of all information gathered during these meeting and to discuss our next steps. A key decision was the creation of thematic Working Groups, with the aim of producing in 2024 a global Code of Conduct to ensure respect for the rights, well-being, and safety of healthy volunteers in biomedical research.

Who we are

VolREthics is coordinated by the Inserm Ethics Committee, with the support of the 6 co-chairs of the Thematic Working Groups and an international steering committee.

International steering committee

  • Elisabeth Allen, University of Cape Town (South Africa)
  • CK Chew, Institute for Clinical Research (Malaysia)
  • Yves Donazzolo, Eurofins (France)
  • Jill Fisher, University of North Carolina (USA)
  • Benjamin Johnson, Nature Medicine (UK)
  • Carleigh Krubiner, Wellcome (UK)
  • Sucheta B Kurundkar, Ministry of Science & Technology (India)
  • François Hirsch, Inserm (France)
  • Nandini Kumar, FERCI (India)
  • Shadreck Mwale, University of West London (UK)
  • Lorenzo Montrasio, Italian Antidiscrimination Office (Italy)
  • Lembit Rägo, CIOMS (Switzerland)
  • Doris Schroeder, University of Central Lancashire (UK)
  • 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 (Montserrat Blasquez), UNESCO (Dafna Feinholz), WHO (Katherine Littler)
  • Secretary : François Bompart, Inserm Ethics Committee (France) & Drugs for Neglected Disease initiative (Switzerland)

Thematic Working Groups

Following the April 2023 Brussels meeting, 3 thematic working groups (WG) were launched with the objective of preparing a global Code of Conduct on research with healthy volunteers:

  • WG 1. Protect from risk of exploitation. Co-chaired by Sucheta B Kurundkar (Ministry of Science & Technology, India) & Yves Donazzolo (EUROFINS, France)
  • WG 2. Protect from risk of harm. Co-chaired by Jill Fisher (University Of North Carolina, USA) & Shadreck Mwale (University Of West London, UK)
  • WG 3. Ensure validity of studies, promote 4Rs approach. Co-chaired by Lorenzo Montrasio (Council of Europe) & CK Chew (National Institute. of Health, Malaysia

Supporting organizations

The support of our various meetings sponsors is gratefully acknowledged:

France : ANRS Maladies infectieuses émergentes (ANRS-MIE), Comité consultatif national d’éthique (CCNE), Conférence nationale des comités de protection des personnes (CNCPP), EIT-Health, Espace éthique de la région Île-de-France (EERIdF), Institut pour la recherche en santé publique (IReSP).

International: Council for International Organizations of Medical Sciences (CIOMS), Drugs for Neglected Diseases initiative (DNDi), European Commission, European Network of Research Ethics Committee (EUREC), European and Developing Countries Clinical Trials Partnership (EDCTP), Wellcome.

The Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials

The « Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials » is a key deliverable of the VolREthics initiative that was set up to promote ethical guidelines to protect healthy volunteers in biomedical research.

Reports and publications

Past meeting reports

First plenary meeting

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

VolREthics initiative: Europe Regional Meeting

Meeting of January 27, 2023

Second plenary meeting

Brussels (Belgium), April 2023

Third plenary meeting

Paris (France), April 18–19, 2024

Scientific Publications

Newspapers articles 

To find out more about VolREthics