Why healthy subjects volunteer for phase I studies and how they perceive their participation?
Why healthy subjects volunteer for phase I studies and how they perceive their participation?
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DOI：
10.1007/s00228-007-0368-3
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发表时间：
2007-11-01
影响因子：
2.9
通讯作者：
Soares-da-Silva, Patricio
中科院分区：
文献类型：
--
作者：
Almeida, Luis;Azevedo, Benedita;Soares-da-Silva, Patricio
目的了解参与第一阶段研究的健康受试者的学习动机和态度，以及他们对知情同意程序和参与研究的看法。方法受试者(n=136，48.5/51.5%的男性/女性，26.9+/-5.5岁；51.9%的学生，42.2%的在校生，5.9%的失业者)匿名回答有关学习参与和个性的问卷(修订的NEO人格问卷)。结果经济奖励是最重要的动机，月收入较低(p<；0.01)和教育程度(p<；0.05)。人格特质与不同的参与动机有不同的相关性。对于94.9%的参与者来说，第一阶段研究的信息来源是“口碑”(主要由前参与者提供)。大多数(88.2%)受试者在决定参加之前咨询了其他人(53.3%的参与者是家人/伴侣；40.0%的人是朋友；25.0%的人是医生)。在80%的病例中，咨询的人建议受试者不参与，75.7%的病例以严重并发症的风险为主要反对对象。所提供的信息总体上得到了良好的评价；34.6%的受试者认为参与造成的不适比最初在同意程序中报告的要少，58.8%的受试者认为它是相同的，6.6%的受试者认为它更高。大多数受试者(81.6%)表示，他们在参与研究期间从未感到有严重并发症的风险，16.2%的人偶尔感到自己有风险，2.2%的人在很长一段时间内感到有风险。人格特征与询问他人意见的决定、提供信息的方式以及参与过程中的风险感知相关。结论经济奖励是参与I期研究的主要动机，收入和教育程度较高的健康志愿者不太重视经济奖励。研究发现，受试者的参与动机和知觉受到个体特征的影响，其中包括一些人格特征。
Objective To characterize the motivations and attitudes of healthy subjects who volunteer for phase I studies as well as their perception of the informed consent procedure and participation in the study.Methods Subjects (n=136, 48.5/51.5% males/females, 26.9 +/- 5.5 years; 51.9% students, 42.2% employed, 5.9% unemployed) anonymously answered questionnaires regarding study participation and personality (Revised NEO Personality Inventory).Results Financial reward was the most important motivation and was most valued by subjects with a lower monthly income (p < 0.01) and lower education (p < 0.05). Personality traits correlated differently with the various motivators for participation. "Word-of-mouth" (mainly by ex-participants) was the source of information on the phase I study for 94.9% of the participants. Most (88.2%) subjects consulted other people (family member/partner, 53.3% of participants; friends, 40.0%; physician, 25.0%) before deciding to participate. In 80% of the cases, the people consulted recommended that the subject not participate, with the risk of serious complications being the main objection in 75.7% cases. The information provided was generally assessed favorably; 34.6% of subjects considered the discomfort caused by participation to be less than that originally reported during the consent procedure, 58.8% considered it to be identical and 6.6% considered it to be higher. Most of the subjects (81.6%) declared that they never felt at risk of a serious complication during their participation in the study, 16.2% occasionally felt that they were at risk and 2.2% felt that they were at risk for a significant period of time. Personality traits correlated with the decision to ask someone else's opinion, the manner in which information provided was rated and the perception of the risk taken during participation.Conclusions Financial reward as the main motivator for participation in phase I studies was less valued by healthy volunteers with a higher income and education. A subject's motivations and perceptions toward participation were found to be influenced by individual characteristics, including some personality traits.