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

François Bompart^{1

2}, Jill A Fisher³, Elizabeth Allen^{4

5}, Esperança Sevene⁶, Nandini Kumar⁷, Chun Keat Chew⁸, Valeria Fink⁹, Dirk Lanzerath¹⁰, François Hirsch¹¹

Affiliations

¹ INSERM, Paris, France.
² Drugs for Neglected Diseases Initiative, Geneva, Switzerland.
³ University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. jill.fisher@unc.edu.
⁴ Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
⁵ The Global Health Network, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
⁶ Department of Physiologic Science, Clinical Pharmacology, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
⁷ Forum for Ethics Review Committees in India, Mumbai, India.
⁸ Institute for Clinical Research, Shah Alam, Malaysia.
⁹ Fundación Huésped, Buenos Aires, Argentina.
¹⁰ European Network of Research Ethics Committees Network, Bonn, Germany.
¹¹ INSERM, Paris, France. francois.hirsch@inserm.fr.

François Bompart et al. Nat Med. 2023 Oct.

. 2023 Oct;29(10):2393-2394.

doi: 10.1038/s41591-023-02490-6.

François Bompart^{1

2}, Jill A Fisher³, Elizabeth Allen^{4

5}, Esperança Sevene⁶, Nandini Kumar⁷, Chun Keat Chew⁸, Valeria Fink⁹, Dirk Lanzerath¹⁰, François Hirsch¹¹

¹ INSERM, Paris, France.
² Drugs for Neglected Diseases Initiative, Geneva, Switzerland.
³ University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. jill.fisher@unc.edu.
⁴ Division of Clinical Pharmacology, University of Cape Town, Cape Town, South Africa.
⁵ The Global Health Network, Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
⁶ Department of Physiologic Science, Clinical Pharmacology, Faculty of Medicine, Eduardo Mondlane University, Maputo, Mozambique.
⁷ Forum for Ethics Review Committees in India, Mumbai, India.
⁸ Institute for Clinical Research, Shah Alam, Malaysia.
⁹ Fundación Huésped, Buenos Aires, Argentina.
¹⁰ European Network of Research Ethics Committees Network, Bonn, Germany.
¹¹ INSERM, Paris, France. francois.hirsch@inserm.fr.

No abstract available

References

1. National Center for Biotechnology Information. ClinicalTrials.gov https://clinicaltrials.gov/search?term=Healthy%20Volunteers (accessed July 2023).
1. Manton, K. J., Gauld, C. S., White, K. M., Griffin, P. M. & Elliott, S. L. BMJ Open https://doi.org/10.1136/bmjopen-2018-024224 (2019).
1. Tambornino, L. & Lanzerath, D. Res. Ethics https://doi.org/10.1177/1747016120943635 (2020). - DOI
1. Eyal, N., Lipsitch, M. & Smith, P. G. J. Infect. Dis. 11, 1752–1756 (2020). - DOI
1. Fisher, J. A. Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals (New York Univ. Press, 2020).