Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda
Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda
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DOI：
10.1186/s12910-015-0073-1
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发表时间：
2015-12-03
影响因子：
2.7
通讯作者：
Seeley, Janet
中科院分区：
文献类型：
--
作者：
Ssali, Agnes;Poland, Fiona;Seeley, Janet
背景：监管人体研究指南中规定的知情同意要求志愿者充分了解他们在试验中会发生什么。然而，研究人员面临着一个挑战，即如何确保同意参加临床试验的志愿者真正知情。我们对参与乌干达两项HIV临床试验的志愿者进行了定性研究，以了解他们是如何定义知情同意的，以及他们对试验程序、研究信息以及与研究团队的互动的看法。方法：2012年1月至12月，23名参加两项试验超过6个月的志愿者同意在9个月的时间里接受3次采访，了解他们在试验中的经历。他们还参加了焦点小组讨论。研究问题和新发现的主题被用于内容分析。结果：志愿者根据他们的个人福利定义了知情同意过程。只有两名志愿者报告在试验期间参考了试验开始时提供的参与者信息表。志愿者们记得试验开始时给他们的关于抽取血液和尿样的程序的信息，但不记得研究设计和随机试验的信息。志愿者们表示，他们已经理解了试验的目的。他们说，签署同意书表明他们同意参加试验，但他们也表示，签署同意书是为了保护研究人员，以防志愿者后来出现副作用。结论：志愿者在同意过程中更关注需要进行生物测试的程序，而不是研究设计问题。志愿者和研究团队之间建立的信任可以通过非正式讨论来确定和审查志愿者的看法，从而加强临床试验的成功进行。这些结果表明，研究人员需要将知情同意视为一个过程，而不是一个事件。
Background: Informed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study information and interactions with the research team.Methods: Between January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.Results: Volunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.Conclusion: Volunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers' perceptions. These results point to the need for researchers to view informed consent as a process rather than an event.