Gallo Lucas, Gallo Matteo, Yuan Morgan, Voineskos Sophocles H, Avram Ronen, McRae Mark H, McRae Matthew C, Coroneos Christopher J, Schwartz Lisa, Thoma Achilles
Division of Plastic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
Plast Surg (Oakv). 2024 Nov;32(4):743-749. doi: 10.1177/22925503221151185. Epub 2023 Jan 18.
To recruit enough patients to achieve adequate statistical power in clinical research, investigators often rely on financial incentives. The use of these incentives, however, remains controversial as they may cause patients to overlook risks associated with research participation. This concern is amplified in the context of plastic surgery where aesthetic procedures are often more desirable and are not typically covered by public or private insurance plans. Despite this, the ethical debate regarding the use of incentives has largely been absent from plastic surgery journals; therefore, efforts to summarize the existing literature in the context of plastic surgery are necessary. A narrative review of the peer-reviewed published literature was performed to identify existing articles pertaining to financial incentives in plastic surgery-related health research. While incentives have the potential to improve sample sizes and promote the recruitment of under-represented patient populations, undue inducement and biased recruitment are possible. At present, there exists a paucity of empirical evidence to substantiate this. Efforts should be taken by investigators and research ethics boards (REBs) to limit the potential negative impacts of monetary compensation. Investigators should place reasonable limits on the value of incentives as well as select models associated with lower risks of undue influence and enrollment bias. When financial remuneration is offered, additional care should be taken by investigators to ensure participants are adequately informed of the risks associated with research participation. Current best practice recommendations suggest that proposals submitted to REBs justify the incentives used. Information regarding incentives should also be included within study consent forms and communicated as part of the informed consent process.
为了招募到足够数量的患者以在临床研究中获得足够的统计效力，研究人员常常依赖经济激励措施。然而，这些激励措施的使用仍然存在争议，因为它们可能会使患者忽视与参与研究相关的风险。在整形外科领域，这种担忧更为突出，因为美容手术通常更具吸引力，而且公共或私人保险计划通常不予覆盖。尽管如此，整形外科期刊在很大程度上并未涉及关于使用激励措施的伦理辩论；因此，有必要努力总结整形外科领域的现有文献。对同行评审的已发表文献进行了叙述性综述，以确定与整形外科相关健康研究中的经济激励措施有关的现有文章。虽然激励措施有可能增加样本量并促进招募代表性不足的患者群体，但不当诱导和有偏倚的招募也是可能的。目前，缺乏实证证据来证实这一点。研究人员和研究伦理委员会（REB）应努力限制金钱补偿的潜在负面影响。研究人员应对激励措施的价值设定合理限制，并选择与不当影响和入组偏倚风险较低相关的模式。当提供经济报酬时，研究人员应格外注意确保参与者充分了解与参与研究相关的风险。当前的最佳实践建议表明，提交给REB的提案应说明所使用激励措施的合理性。关于激励措施的信息也应包含在研究同意书中，并作为知情同意过程的一部分进行传达。
