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.

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.

Organization

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.

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.

Past meeting reports

First plenary meeting : Towards common ethical rules to protect healthy volunteers in biomedical research

Meeting of February 15 and 16, 2022, UNESCO, Paris

• Program (pdf, 1036 Ko)
• Meeting report (pdf, 302 Ko)
• Video recordings of the interventions

VolREthics initiative: Africa Regional Meeting

Meeting of May 24, 2022

• Program (pdf, 711 Ko)
• Meeting report (pdf, 196 Ko)
• Video recordings of the interventions

VolREthics initiative: Asia Regional Meeting 

Meeting of September 23, 2022

• Program (pdf, 339 Ko)
• Meeting report (pdf, 509 Ko)
• Video recordings of the interventions

VolREthics initiative: North America Regional Meeting 

Meeting of October 19, 2022

• Program (pdf, 329 Ko)
• Meeting report (pdf, 354 Ko)
• Video recordings of the interventions

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

• Program (pdf, 288 Ko)
• Meeting report (pdf, 306 Ko)
• Video recordings of the interventions

Second plenary meeting, Brussels (Belgium), April 2023

• Meeting agenda (pdf, 418 Ko)
• Meeting participants’ booklet (pdf, 2 Mo)
• Meeting report (pdf, 338 Ko)

Scientific Publications

• The Hastings Center Report (July 2023). “Global Efforts to Protect Healthy Volunteers”, by Jill A Fisher. doi.org/10.1002/hast.1494
• Nature Medicine (August 2023). “The VolREthics initiative to protect the well-being of healthy volunteers in biomedical research”, by François Bompart, Jill A. Fisher, Elizabeth Allen, Esperança Sevene, Nandini Kumar, Chun Keat Chew, Valeria Fink, Dirk Lanzerath and François Hirsch. doi.org/10.1038/s41591-023–02490‑6

Newspapers articles 

• The Conversation (February 2021). Altruism but also vulnerability drive healthy volunteers to take part in clinical research
• Le Monde (August 2023). Essais cliniques : vers un code de bonne conduite pour le recours aux volontaires sains, by Jean-Baptiste Jacquin (Only available in French) 

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

To find out more about VolREthics