BACKGROUND In clinical research, obtaining informed consent from participants is an ethical and legal requirement. Conveying the information concerning the study can be done using multiple methods yet this step commonly relies exclusively on the informed consent form alone. While this is legal, it does not ensure the participant's true comprehension. New effective methods of conveying consent information should be tested. In this study we compared the effect of different methods on the knowledge of caregivers of participants of a clinical trial on Pemba Island, Tanzania. METHODS A total of 254 caregivers were assigned to receive (i) a pamphlet (n = 63), (ii) an oral information session (n = 62) or (iii) a pamphlet and an oral information session (n = 64) about the clinical trial procedures, their rights, benefits and potential risks. Their post-intervention knowledge was assessed using a questionnaire. One group of caregivers had not received any information when they were interviewed (n = 65). RESULTS In contrast to the pamphlet, attending an information session significantly increased caregivers' knowledge for some of the questions. Most of these questions were either related to the parasite (hookworm) or to the trial design (study procedures). CONCLUSIONS In conclusion, within our trial on Pemba Island, a pamphlet was found to not be a good form of conveying clinical trial information while an oral information session improved knowledge. Not all caregivers attending an information session responded correctly to all questions; therefore, better forms of communicating information need to be found to achieve a truly informed consent.

中文翻译：

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坦桑尼亚奔巴岛的一项双盲随机驱虫试验的知情同意程序：小册子和信息发布会增加看护者的知识吗？

背景技术在临床研究中，获得参与者的知情同意是一项道德和法律要求。可以使用多种方法来传达与研究有关的信息，但此步骤通常仅依赖于知情同意书。尽管这是合法的，但不能确保参与者的真正理解。应该测试传达同意信息的新有效方法。在这项研究中，我们比较了不同方法对坦桑尼亚奔巴岛的一项临床试验参与者的护理人员知识的影响。方法总共254位护理人员被分配来接受（i）小册子（n = 63），（ii）口头咨询（n = 62）或（iii）小册子和口头咨询（n = 64）。临床试验程序，其权利，收益和潜在风险。他们的干预后知识使用问卷进行了评估。一组护理人员在接受采访时没有收到任何信息（n = 65）。结果与手册相反，参加信息发布会大大提高了护理人员对某些问题的了解。这些问题大多数与寄生虫（钩虫）或试验设计（研究程序）有关。结论总之，在我们在奔巴岛进行的试验中，发现小册子不是传达临床试验信息的好方法，而通过口头信息交流会提高知识水平。并非所有参加信息发布会的看护人都能正确回答所有问题。因此，需要找到更好的信息交流形式，以获得真正的知情同意。