Researchers experience and views on participants' comprehension of informed consent in clinical trials in Malawi: a descriptive qualitative study.

IF 3 1区 哲学 Q1 ETHICS BMC Medical Ethics Pub Date : 2024-09-27 DOI:10.1186/s12910-024-01100-5
Dorothy Maxwell Kazembe, Yimtubezinash Woldeamanuel, Solomon Mequanente Abay
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Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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研究人员对马拉维临床试验参与者理解知情同意书的经验和看法:一项描述性定性研究。
背景:知情同意是研究伦理的基石。其目标之一是让参与者在参与研究时了解其参与的意义。本文研究的是研究人员如何理解知情同意程序。以往的研究都是从研究参与者的角度来探讨这个问题。然而,很少有研究关注研究人员的视角。因此,这是一篇重要的论文,从研究过程中执行者的角度强调了一个重要问题(知情同意):对马拉维 3 个不同研究中心的 18 名临床试验研究人员进行了深入访谈。采用定性数据的主题方法,使用开放代码对数据进行分析:本研究发现,研究人员对知情同意书的作用、参与者理解所提供信息的重要性以及在获取信息时相应调整做法以增强参与者理解的方法有很好的认识。据研究人员称,大多数参与者在初次访问时并不能真正理解研究的所有概念,他们在随后的访问中会加深理解。研究人员强调,促进知情同意的最佳方法是向参与者宣读知情同意书,从而进行面对面的交谈。冗长复杂的知情同意书被认为是阻碍受试者理解知情同意书的障碍之一。建议缩短知情同意书的篇幅,并与参与者进行更多的交谈,以提高参与者的理解能力:结论:由于知情同意是一个持续的过程,大多数参与者在随后的访问中都能理解许多信息,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。应为知情同意讨论分配充足的时间。缩短知情同意书的篇幅并与潜在参与者进行更多的交谈可能有助于提高他们的理解。
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来源期刊
BMC Medical Ethics
BMC Medical Ethics MEDICAL ETHICS-
CiteScore
5.20
自引率
7.40%
发文量
108
审稿时长
>12 weeks
期刊介绍: BMC Medical Ethics is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies.
期刊最新文献
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