Healthy volunteers are the backbone of early phase research, yet their motivations and needs have long been oversimplified, with the assumption that financial compensation was the dominant driver. The EUFEMED 2026 survey challenges this view. Understanding these deeper motivations is essential, not just ethically, but operationally. It enables better recruitment, retention, and trial design. For the first time, we have robust data showing that volunteer-centricity is not a luxury, it’s a scientific necessity.
The EUFEMED survey of 4,349 healthy volunteers provides one of the clearest quantitative signals yet that early phase research can no longer be framed as a purely transactional exchange of risk for money. We report how “in 54% of cases contributing to new treatments was the primary motivation to participate, vs. monetary compensation in 41% of responders” and that “healthy volunteers in clinical trials have specific needs during their stay in the Clinical Research Unit” [1]. These findings align with a broader shift toward participant‑centred early development, where engagement, experience and trust are treated as scientific enablers rather than soft add‑ons [2][3].
Historically, concerns in Phase I have focused on exploitation, undue inducement and risk communication to economically vulnerable volunteers [3]. Qualitative work has shown that financial reward is often the gateway motivator, but is embedded in more complex narratives of identity, contribution and calculated risk‑taking [4][5]. Our EUFEMED data nuance this picture: 88% of volunteers regarded contribution to new treatments as an important motivator, and older participants (>45 years) were more likely to prioritise therapeutic advancement over payment [1]. This directly supports current ethics and regulatory initiatives that call for recognition of healthy volunteers as stakeholders with values and expectations, not merely as ‘test systems’ [3].
Operationally, the survey exposes a gap between high‑level ‘patient centricity’ rhetoric and the day‑to‑day realities of clinical research units (CRUs). Volunteers rated basic environmental and lifestyle factors as critical: well‑functioning showers (89%), the ability to spend time outside (78%), meal quality (76%), high‑speed internet (73%) and a place to read or work alone (69%) [1]. These are not luxuries; they are controllable determinants of recruitment, protocol adherence and retention in confinement studies. Parallel literature on healthy participant engagement similarly highlights comfort, autonomy and respectful interaction with staff as key to sustained participation [2][5]. Investing in CRU design, to facilitate sleep quality, dietary flexibility (including vegetarian/vegan options) and meaningful activities during long stays directly addresses these concerns and is consistent with emerging “research facility as healing environment” initiatives in academic centres [2].
Risk–benefit communication remains a central concern. In the EUFEMED survey, 88% of volunteers reported carefully reading the risk section of the informed consent form, and 74% stated that potential risks were important for their decision [1]. This challenges assumptions that healthy volunteers routinely discount risk in favour of payment and supports ongoing efforts to improve consent materials, use layered information and incorporate teach‑back methods in phase I units [3]. At the same time, relatively low acceptance of invasive procedures such as lumbar puncture and radiolabelled studies underscores the need for realistic feasibility assessments and transparent discussion of procedural burdens [1][3].
Finally, the strong altruistic signal, 90% of respondents wanted lay summaries of trial results [1], connects directly to current transparency and return‑of‑results initiatives in Europe and internationally. Providing accessible feedback, acknowledging contribution and closing the loop after study completion are now recognised as ethical obligations and as practical strategies to maintain engaged volunteer panels [2][4][5]. Taken together, our EUFEMED findings argue for a formal “healthy volunteer‑centricity” agenda in early phase research: integrating environmental design, social interaction, tailored risk communication and post‑trial information into standard operating procedures, and treating these not as extras but as core quality metrics for modern Phase I programmes [1][2][3][4][5].
References
- Van Iersel T, Klein J, Hardman TC, et al. Why do healthy volunteers participate in clinical trials? Br J Clin Pharmacol. 2026.
- Klein J, van Iersel T, de Vries D, Donazzolo Y and Klingmann I (2025) Healthy participant engagement in early clinical trials: results from the European EUFEMED survey. Front. Pharmacol. 16:1540948.
- Pasqualetti G, Gori G, Blandizzi C, Tacca M. Healthy volunteers and early phases of clinical experimentation. Eur J Clin Pharmacol. 2010;66(7):647‑653.
- Manton KJ, Gauld CS, White KM, et al. Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials. BMJ Open. 2019;9(1):e024224.
- Fisher JA, McManus L, Wood MM, et al. Healthy volunteers’ perceptions of the benefits of their participation in phase I clinical trials. J Empir Res Hum Res Ethics. 2018;13(5):494‑510.
