Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, P.O. Box 9086, Addis Ababa, Ethiopia.
Malawi-Liverpool-Wellcome Research Programme, P.O. Box 30096, Blantyre, Malawi.
BMC Med Ethics. 2024 Sep 27;25(1):101. doi: 10.1186/s12910-024-01100-5.
Informed consent is the cornerstone of research ethics. One of its goals is that participants enter research with an understanding of what their participation entails. This paper is a study on how researchers understand the informed consent process. Previous studies have looked at this topic from a research participant perspective. However, few studies focus on the perspectives of the researchers. Therefore, this is an important paper that highlights an important issue (informed consent) from the perspective of those who administer it during research.
In-depth interviews were conducted with 18 researchers from 3 different research centers in Malawi working in clinical trials. The data was analyzed using open code utilizing the thematic approach to qualitative data.
This study identified that researchers have good awareness of the role of informed consent, how important it is for participants to understand the given information and ways to adjust their practice accordingly when obtaining it in order to enhance participant understanding. According to the research staff, most participants do not really understand all the concepts of the study at the initial visit, they gain more understanding during subsequent visits. It was emphasized that the best method of facilitating informed consent is reading the informed consent to the participant, thus a face-to-face conversation. Long and complex informed consent was identified as one of the barriers to participant understanding of the informed consent. Shortening the informed consent form and having additional conversation with the participants was suggested as one way of improving participant comprehension.
Most of the participants understand much of the information during subsequent visits as you keep reminding them since informed consent is an ongoing process. Existing relationship or trust between a participant and a researcher, may influence participants' decision and misguide their understanding on the purpose of the study. Adequate time should be allocated to informed consent discussions. Shortening the informed consent forms and having additional conversations with potential participants may help improve their understanding.
知情同意是研究伦理的基石。其目标之一是让参与者在了解参与研究的情况后参与研究。本文是一项关于研究人员如何理解知情同意过程的研究。以前的研究从研究参与者的角度来看待这个主题。然而，很少有研究关注研究人员的观点。因此，这是一篇重要的论文，它从进行研究的人员的角度强调了一个重要问题（知情同意）。
对来自马拉维 3 个不同研究中心的 18 名从事临床试验的研究人员进行了深入访谈。使用开放式编码，利用主题方法对定性数据进行了分析。
本研究发现，研究人员对知情同意的作用有很好的认识，参与者理解所提供信息的重要性，以及在获取知情同意时如何相应地调整实践以增强参与者的理解。根据研究人员的说法，大多数参与者在初次就诊时并没有真正理解研究的所有概念，他们在随后的就诊中获得了更多的理解。强调促进知情同意的最佳方法是向参与者宣读知情同意书，因此是面对面的交谈。冗长而复杂的知情同意书被认为是参与者理解知情同意书的障碍之一。建议缩短知情同意书并与参与者进行额外的对话，以提高参与者的理解能力。
由于知情同意是一个持续的过程，大多数参与者在随后的就诊中会理解大部分信息，因为你会不断提醒他们。参与者与研究人员之间现有的关系或信任可能会影响参与者的决定，并误导他们对研究目的的理解。应分配足够的时间进行知情同意讨论。缩短知情同意书并与潜在参与者进行额外的对话可能有助于提高他们的理解。
