Das Debashish, Cheah Phaik Yeong, Akter Fateha, Paul Dulal, Islam Akhterul, Sayeed Abdullah A, Samad Rasheda, Rahman Ridwanur, Hossain Amir, Dondorp Arjen, Day Nicholas P, White Nicholas J, Hasan Mahtabuddin, Ghose Aniruddha, Ashley Elizabeth A, Faiz Abul
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd,, Bangkok 10400, Thailand.
Malar J. 2014 Jun 4;13:217. doi: 10.1186/1475-2875-13-217.
Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial.
In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh.
Of 16 participants, the vast majority (81%) were illiterate. All subjects had a 'therapeutic misconception' i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients' perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants' satisfaction with treatment and nursing care.
There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings.
现有证据表明，临床试验的参与者对知情同意过程的理解往往有限，导致他们在未真正理解研究目的、具体程序及其权利的情况下就提供了同意。本研究的目的是确定受试者对研究的理解、对自愿性的看法以及参与疟疾临床试验的动机。
在孟加拉国拉穆乌帕齐拉卫生中心，对患有单纯性恶性疟原虫疟疾的成年临床试验参与者进行了半结构化访谈。
16名参与者中，绝大多数（81%）为文盲。所有受试者都存在“治疗性误解”，即认为试验主要是为了个体患者的利益而进行，而实际上主要目的是提供信息以指导公共卫生政策。从患者的角度来看，康复是他们最主要的担忧。尽管参与者对治疗和护理感到满意，但报告显示他们对试验具体程序的实际理解较差。
在疟疾研究中，研究与临床护理的提供之间常常存在一定程度的重叠。尽管有冗长的同意过程，但患者可能在未充分理解研究主要目标的情况下就被激励参与研究。研究结果表明，遵循当前国际人用药品注册技术协调会 - 药物临床试验质量管理规范（ICH - GCP）指南使用标准同意书并不能实现完全知情同意，该过程应进行修订、简化并根据个别试验情况进行调整。
