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The VolREthics initiative to protect the well-being of healthy volunteers in biomedical research

Nature Medicine volume 29, pages 2393–2394 (2023)Cite this article

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Each year, thousands of people around the world agree to take part in clinical studies as healthy volunteers participating in the testing of new treatments, such as vaccines, drugs and medical devices, or in human behavioral or observational social science studies1. Direct medical benefit and payment for their time differentiate healthy volunteers from patients who enroll in biomedical research studies2.

Healthy volunteers are, by definition, healthy people who do not have a known medical condition related to the purpose of the study. Unlike patients with relevant conditions who take part in trials, in the vast majority of the studies they participate in, healthy volunteers cannot expect direct medical benefits from the tested treatment. Despite all precautions, their participation in research may affect their well-being, physical health or mental health. Harm resulting from a tested intervention may even affect their present and future quality of life, which in turn may influence their professional and educational prospects, as well as those of their family and relatives. In some trials, healthy volunteers are exposed to clear risks, such as when participating in human infection challenge trials3, studies considered to accelerate new vaccine development4.

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References

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Author information

Authors and Affiliations

  1. INSERM, Paris, France

    François Bompart & François Hirsch

  2. Drugs for Neglected Diseases Initiative, Geneva, Switzerland

    François Bompart

  3. University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    Jill A. Fisher

  4. Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa

    Elizabeth Allen

  5. The Global Health Network, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK

    Elizabeth Allen

  6. Department of Physiologic Science, Clinical Pharmacology, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique

    Esperança Sevene

  7. Forum for Ethics Review Committees in India, Mumbai, India

    Nandini Kumar

  8. Institute for Clinical Research, Shah Alam, Malaysia

    Chun Keat Chew

  9. Fundación Huésped, Buenos Aires, Argentina

    Valeria Fink

  10. European Network of Research Ethics Committees Network, Bonn, Germany

    Dirk Lanzerath

Authors
  1. François Bompart
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  2. Jill A. Fisher
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  3. Elizabeth Allen
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  4. Esperança Sevene
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  5. Nandini Kumar
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  6. Chun Keat Chew
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  7. Valeria Fink
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  8. Dirk Lanzerath
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  9. François Hirsch
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Corresponding authors

Correspondence to Jill A. Fisher or François Hirsch.

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Competing interests

V.F. has participated in expert discussion groups for Merck, Sharp and Dohme. All other authors declare no competing interests.

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Bompart, F., Fisher, J.A., Allen, E. et al. The VolREthics initiative to protect the well-being of healthy volunteers in biomedical research. Nat Med 29, 2393–2394 (2023). https://doi.org/10.1038/s41591-023-02490-6

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