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

By Bompart F, Fisher JA, Allen E, Sevene E, Kumar N, Chew CK, Fink V, Lanzerath D, Hirsch F. Nature Medicine 2023. doi: doi.org/10.1038/s41591-023-02490-6 

Summary: Current regulations and ethical guidance do not distinguish between healthy volunteers and patients who participate in clinical trials. Healthy volunteers, who put themselves at potential risk, may be vulnerable to financial pressure if their socioeconomic level makes research participation more lucrative than other economic activities available to them. Market pressure on organisations conducting studies in healthy volunteers may lead to more aggressive recruitment processes and could lead to compromised ethical standards. In February 2022, an international panel of stakeholders launched the VolREthics initiative (volunteers in research and ethics) to promote good practices to protect healthy volunteers in biomedical research globally, and to consider how a 4R approach — Respect, Reduce, Refine and Replace — can guide research protocols for healthy volunteers

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