Nkosi Thandeka, Mulopo Chanelle, Schmidt Bey-Marrié
School of Public Health, University of the Western Cape, Bellville, Cape Town, South Africa.
Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Res Integr Peer Rev. 2024 Jul 29;9(1):8. doi: 10.1186/s41073-024-00148-6.
The informed consent process is an important step in conducting ethical clinical trials, as it ensures that research participants are aware of their rights and responsibilities in clinical trials. This study explored participants' perceptions, experiences and the factors motivating their participation in a COVID-19 vaccine trial in South Africa.
This descriptive qualitative study was conducted among twenty-five adult participants (18 to 64 years old) who participated in a COVID-19 vaccine trial in South Africa. Three focus group discussions and fifteen semi-structured interviews were carried out. Data were collected at a Clinical Research Site located in Prince Mshiyeni Memorial Hospital, in Umlazi Township, Durban, South Africa, where the COVID-19 vaccine trial participants were initially enrolled. Data were analysed iteratively using a thematic analysis approach.
Four key findings emerged: 1) Participants who experienced an event (such as tested positive for COVID-19) during the clinical trial were more likely to talk about the informed consent more thoroughly compared to the other participants. 2) Participants understood the purpose of informed consent process better when it was repeated multiple times throughout the course of the trial. 3) Where participants did not recall or understand various elements of the informed consent, participants were likely to create their own interpretations. 4) Factors influencing participations in trials were reimbursement for participation, access to health care, protection of family members, and ability to socialize without fear of COVID-19.
Overall, the findings show that the informed consent process should be regarded as an ongoing process rather than a once-off event that only happens at the start of a clinical trial. An understanding of participants' perspectives, experiences, and motivations for participating in clinical trials, can help trial staff strengthen the consent documents and processes.
知情同意程序是开展符合伦理的临床试验的重要一步，因为它确保研究参与者了解自己在临床试验中的权利和责任。本研究探讨了南非参与新冠疫苗试验的参与者的认知、经历以及促使他们参与试验的因素。
本描述性定性研究在25名成年参与者（18至64岁）中进行，他们参与了南非的一项新冠疫苗试验。开展了三次焦点小组讨论和15次半结构化访谈。数据在位于南非德班乌姆拉齐镇王子姆希耶尼纪念医院的一个临床研究点收集，新冠疫苗试验参与者最初在此登记入组。采用主题分析法对数据进行迭代分析。
出现了四项关键发现：1）与其他参与者相比，在临床试验期间经历过某一事件（如新冠病毒检测呈阳性）的参与者更有可能更全面地谈论知情同意。2）当在试验过程中多次重复知情同意程序时，参与者能更好地理解其目的。3）当参与者不记得或不理解知情同意的各项内容时，他们可能会自行作出解释。4）影响参与试验的因素包括参与试验的报酬、获得医疗保健、家庭成员的保护以及能够在无惧新冠病毒的情况下社交。
总体而言，研究结果表明，知情同意程序应被视为一个持续的过程，而非仅在临床试验开始时发生的一次性事件。了解参与者参与临床试验的观点、经历和动机，有助于试验工作人员强化同意书和程序。
