Centre de Pharmacologie Clinique, CHU Clermont-Ferrand, Clermont-Ferrand, France.
CIC1405 & U1107 "Neuro-Dol", Inserm, Clermont-Ferrand, France.
Eur J Clin Invest. 2016 Jul;46(7):619-26. doi: 10.1111/eci.12638. Epub 2016 May 25.
Whether and how participants in biomedical research should receive financial compensation is debated. We wished to explore how this issue was perceived by French professionals, focusing on different conditions of research.
We surveyed referent responders of Clinical Investigation Centres, Research Ethics Committees and hospital administrative departments for clinical research, via referent responders who completed an online questionnaire on behalf of their respective teams. Financial compensation was addressed in terms of general perception, justifications, interpretation of French law, concrete clinical situations and compensation of incurred expenses. Descriptive analyses and correlations were carried out based on scalar responses.
The questionnaire was answered by 54/116 (45·6%) centres. The ethical aspects of compensation were viewed differently by Clinical Investigation Centres and Research Ethics Committees, whereas the practical aspects were viewed similarly. Agreement to compensation for patients was lower than for healthy volunteers (74·1 vs. 98·2%). The most frequently cited justifications for compensation apart from the inconveniences of research were the potential risk and the absence of medical benefit. Most of the proposed expenses incurred were to be compensated, but agreement to reimbursement of petrol bills or childcare expense was lower.
Although some of the responses align with previous surveys in other countries, this information may help French professionals to harmonise their practices. We also addressed practical issues which could be studied in other European countries, for professionals and participants. Finally, the reluctance to compensate patients requires further study, taking into account welfare environment and consequences for recruitment.
生物医学研究参与者是否应获得经济补偿以及如何补偿这一问题存在争议。我们希望探讨法国专业人士对此问题的看法，重点关注不同的研究条件。
我们通过代表各自团队填写在线问卷的临床研究中心、研究伦理委员会和医院行政部门的参照应答者，对参照应答者进行了调查。从总体认知、理由、法国法律的解释、具体临床情况和费用补偿等方面探讨了经济补偿问题。基于标量应答进行了描述性分析和相关性分析。
共有 54/116（45.6%）个中心回答了问卷。临床研究中心和研究伦理委员会对补偿的伦理方面有不同的看法，而对补偿的实际方面的看法则相似。对患者进行补偿的共识低于对健康志愿者（74.1%比 98.2%）。除了研究的不便外，补偿的最常见理由是潜在风险和缺乏医疗效益。大部分提议的费用都将得到补偿，但对报销汽油费或儿童保育费的共识较低。
尽管一些答复与其他国家的先前调查一致，但这些信息可能有助于法国专业人士协调其做法。我们还解决了其他欧洲国家的专业人士和参与者可能会研究的实际问题。最后，不愿意补偿患者需要进一步研究，需要考虑福利环境和对招募的影响。
