Review of research ethics guidelines on payment of healthy volunteers

Payment of healthy volunteers in medical research is a prevalent practice but is the subject of ethical debate. Although regulations to protect healthy volunteers exist, these regulations differ between countries. Few data are available on the disparities between countries regarding guidance on payment of healthy volunteers in medical research.

This study aims to analyse guidance regarding payment of healthy volunteers in medical research in different countries, to identify common characteristics and differences, and to assess whether these are ethically significant. To this end, we analysed policies and guidance documents on payment of medical research subjects in the 11 countries with the most clinical trials registered as of 12 December 2022.

41 guidelines addressing the treatment of research participants were identified. Of these, only six mention healthy volunteers, none of which are legally binding. All guidance documents identified lack details, and none define key terms such as "undue inducement".

Local research ethics committees (RECs) have a huge role in determining what payment is acceptable, but there is little guidance provided for them. This gives RECs the freedom to make context-specific decisions, but also leads to variation in the protection of research subjects. Based on these findings, we make the following recommendations: (1) More countries need guidelines addressing payment of healthy volunteers in medical research. (2) These guidelines need more details than are currently included. (3) RECs also need guidelines to aid them in context-specific decisions on payment of research participants.