{"title":"描述中低收入国家艾滋病毒疫苗试验的风险和益处:一项综合审查。","authors":"Judith Shayo, Deodatus Sabas, Adamu Addissie, Eligius Lyamuya, Connie Ulrich","doi":"10.1186/s12910-025-01235-z","DOIUrl":null,"url":null,"abstract":"<p><p>Human immunodeficiency virus (HIV) vaccine trials are needed in efforts to prevent infection and acquired immunodeficiency syndrome (AIDS). Like other types of research, HIV vaccine trials present benefits and risks that may or may not be anticipated by participants. Perceptions of risks and benefits often vary with contextual factors, such as sociocultural and economic variables, which are important in low- and middle-income countries (LMICs).</p><p><strong>Aims: </strong>This integrative review aimed to determine the risks and benefits of HIV vaccine trial participation reported in the LMICs from 1995 to 2024. The risks and benefits were reported by participants and potential participants during trial preparations, recruitment, actual trial participation or after trial participation. In this review we assessed on how the risks and benefits were described by the authors of the reviewed studies. We also sought to categorize these risks and benefits, consider ethical implications, identify gaps for further research, and recommend actions for policy improvement.</p><p><strong>Methods: </strong>The integrative review screened studies from four databases (CINAHL, Embase, MEDLINE and Web of Science). Studies were eligible if they involved interactions with human subjects and were written in English. Covidence software was used to organize the search outcomes.</p><p><strong>Results and discussion: </strong>Twenty-five studies met inclusion criteria. Identified benefits included a sense of altruism, free healthcare, financial incentives and HIV education. Risks included stigma and discrimination associated with vaccine-induced seropositivity, perceived racism and fear of delayed harms. Important descriptions of risks and benefits (e.g., magnitude and likelihood) were missing. Free healthcare and financial incentives may render participants too influenced to enter consent, which is an important ethical concern in LMICs.</p><p><strong>Conclusion: </strong>The literature was scant, highlighting a need for research on how participants in LMICs are informed about weighing risks and benefits of HIV vaccine trial participation. More in-depth description of risks and benefits is warranted. Standardized risk/benefit assessment frameworks tailored to the context of these trials in LMICs are needed.</p>","PeriodicalId":55348,"journal":{"name":"BMC Medical Ethics","volume":"26 1","pages":"75"},"PeriodicalIF":3.0000,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12224502/pdf/","citationCount":"0","resultStr":"{\"title\":\"Descriptions of risks and benefits of HIV vaccine trials in low-and middle-income countries (LMICs): an integrative review.\",\"authors\":\"Judith Shayo, Deodatus Sabas, Adamu Addissie, Eligius Lyamuya, Connie Ulrich\",\"doi\":\"10.1186/s12910-025-01235-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Human immunodeficiency virus (HIV) vaccine trials are needed in efforts to prevent infection and acquired immunodeficiency syndrome (AIDS). Like other types of research, HIV vaccine trials present benefits and risks that may or may not be anticipated by participants. Perceptions of risks and benefits often vary with contextual factors, such as sociocultural and economic variables, which are important in low- and middle-income countries (LMICs).</p><p><strong>Aims: </strong>This integrative review aimed to determine the risks and benefits of HIV vaccine trial participation reported in the LMICs from 1995 to 2024. The risks and benefits were reported by participants and potential participants during trial preparations, recruitment, actual trial participation or after trial participation. In this review we assessed on how the risks and benefits were described by the authors of the reviewed studies. We also sought to categorize these risks and benefits, consider ethical implications, identify gaps for further research, and recommend actions for policy improvement.</p><p><strong>Methods: </strong>The integrative review screened studies from four databases (CINAHL, Embase, MEDLINE and Web of Science). Studies were eligible if they involved interactions with human subjects and were written in English. Covidence software was used to organize the search outcomes.</p><p><strong>Results and discussion: </strong>Twenty-five studies met inclusion criteria. Identified benefits included a sense of altruism, free healthcare, financial incentives and HIV education. Risks included stigma and discrimination associated with vaccine-induced seropositivity, perceived racism and fear of delayed harms. Important descriptions of risks and benefits (e.g., magnitude and likelihood) were missing. Free healthcare and financial incentives may render participants too influenced to enter consent, which is an important ethical concern in LMICs.</p><p><strong>Conclusion: </strong>The literature was scant, highlighting a need for research on how participants in LMICs are informed about weighing risks and benefits of HIV vaccine trial participation. More in-depth description of risks and benefits is warranted. Standardized risk/benefit assessment frameworks tailored to the context of these trials in LMICs are needed.</p>\",\"PeriodicalId\":55348,\"journal\":{\"name\":\"BMC Medical Ethics\",\"volume\":\"26 1\",\"pages\":\"75\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-07-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12224502/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Medical Ethics\",\"FirstCategoryId\":\"98\",\"ListUrlMain\":\"https://doi.org/10.1186/s12910-025-01235-z\",\"RegionNum\":1,\"RegionCategory\":\"哲学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Medical Ethics","FirstCategoryId":"98","ListUrlMain":"https://doi.org/10.1186/s12910-025-01235-z","RegionNum":1,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 0
摘要
在预防感染和获得性免疫缺陷综合症(艾滋病)的努力中,需要进行人体免疫缺陷病毒(艾滋病毒)疫苗试验。与其他类型的研究一样,艾滋病毒疫苗试验所带来的益处和风险,参与者可能会或可能不会预料到。对风险和收益的看法往往因环境因素而异,如社会文化和经济变量,这在低收入和中等收入国家很重要。目的:本综合评价旨在确定1995年至2024年中低收入国家参与HIV疫苗试验的风险和获益。在试验准备、招募、实际参加试验或参加试验后,参与者和潜在参与者报告了风险和获益。在这篇综述中,我们评估了被综述研究的作者是如何描述风险和益处的。我们还试图对这些风险和收益进行分类,考虑伦理影响,确定进一步研究的差距,并提出政策改进的行动建议。方法:综合评价从四个数据库(CINAHL, Embase, MEDLINE和Web of Science)中筛选研究。如果研究涉及与人类受试者的互动,并且是用英语写的,那么研究就符合条件。使用covid软件组织搜索结果。结果和讨论:25项研究符合纳入标准。确定的好处包括利他主义意识、免费医疗、财政激励和艾滋病毒教育。风险包括与疫苗诱导的血清阳性相关的耻辱和歧视、被认为的种族主义和对延迟伤害的恐惧。缺少对风险和收益的重要描述(例如,大小和可能性)。免费医疗保健和财政奖励可能使参与者受到太大影响而不同意,这是中低收入国家的一个重要伦理问题。结论:文献不足,强调有必要研究中低收入国家的参与者如何被告知参与艾滋病毒疫苗试验的风险和益处。需要对风险和收益进行更深入的描述。需要针对中低收入国家的这些试验制定标准化的风险/效益评估框架。
Descriptions of risks and benefits of HIV vaccine trials in low-and middle-income countries (LMICs): an integrative review.
Human immunodeficiency virus (HIV) vaccine trials are needed in efforts to prevent infection and acquired immunodeficiency syndrome (AIDS). Like other types of research, HIV vaccine trials present benefits and risks that may or may not be anticipated by participants. Perceptions of risks and benefits often vary with contextual factors, such as sociocultural and economic variables, which are important in low- and middle-income countries (LMICs).
Aims: This integrative review aimed to determine the risks and benefits of HIV vaccine trial participation reported in the LMICs from 1995 to 2024. The risks and benefits were reported by participants and potential participants during trial preparations, recruitment, actual trial participation or after trial participation. In this review we assessed on how the risks and benefits were described by the authors of the reviewed studies. We also sought to categorize these risks and benefits, consider ethical implications, identify gaps for further research, and recommend actions for policy improvement.
Methods: The integrative review screened studies from four databases (CINAHL, Embase, MEDLINE and Web of Science). Studies were eligible if they involved interactions with human subjects and were written in English. Covidence software was used to organize the search outcomes.
Results and discussion: Twenty-five studies met inclusion criteria. Identified benefits included a sense of altruism, free healthcare, financial incentives and HIV education. Risks included stigma and discrimination associated with vaccine-induced seropositivity, perceived racism and fear of delayed harms. Important descriptions of risks and benefits (e.g., magnitude and likelihood) were missing. Free healthcare and financial incentives may render participants too influenced to enter consent, which is an important ethical concern in LMICs.
Conclusion: The literature was scant, highlighting a need for research on how participants in LMICs are informed about weighing risks and benefits of HIV vaccine trial participation. More in-depth description of risks and benefits is warranted. Standardized risk/benefit assessment frameworks tailored to the context of these trials in LMICs are needed.
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.