Social impact of preventive HIV vaccine clinical trial participation: A model of prevention, assessment and intervention
Social impact of preventive HIV vaccine clinical trial participation: A model of prevention, assessment and intervention
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DOI：
10.1016/j.socscimed.2007.10.019
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发表时间：
2008-02-01
影响因子：
5.4
通讯作者：
Lau, Chuen-Yen
中科院分区：
文献类型：
--
作者：
Allen, Mary;Lau, Chuen-Yen
预防性艾滋病毒疫苗试验的参与者可能会遇到与参加试验有关的问题，包括在人际关系、就业、教育、保健、住房、健康保险、残疾保险、人寿保险、旅行或移民方面的困难。在美国国家过敏和传染病研究所（NIAID）进行预防性艾滋病毒疫苗试验的19年中，我们开发了一种模型来预防和解决与参与研究有关的社会影响，并协助报告此类事件的研究参与者。该模式的关键要素包括：在注册前告知潜在志愿者风险；规范社会影响事件的数据收集方法；审查和跟进报告的社会影响事件；协助参与者，包括提供免费艾滋病毒检测，以区分艾滋病毒感染与疫苗诱导的艾滋病毒抗体；实施基础广泛和有针对性的社区教育计划，以获得社区支持；与科学界和卫生界进行沟通；并与政府机构、非政府机构和行业合作，探讨解决科学创新的机制。这一方法是与美国国际开发署资助的临床试验小组合作建立的，可作为预防、评估、监测和干预与参与预防性艾滋病毒疫苗临床试验有关的社会影响的模式。虽然需要进一步的研究，但该模型可以适用于不同的临床试验。Elsevier Ltd.出版。
Preventive HIV vaccine trial participants may experience problems related to trial participation, including difficulties with personal relationships, employment, education, health care, housing, health insurance, disability insurance, life insurance, travel or immigration. During the 19 years that the U.S.-based National Institute of Allergy and Infectious Diseases (NIAID) has conducted preventive HIV vaccine trials, we have developed a model to prevent and resolve social impact related to study participation and assist study participants who report such events. Key elements of the model include: informing potential volunteers of risks prior to enrollment; standardizing data collection methods on social impact events; reviewing and following-up on reported social impact events; assisting participants, including provision of free HIV testing to differentiate HIV infection from vaccine-induced HIV antibody; implementing broad-based and targeted community education programs for achieving community support; communicating with scientific and health care communities; and working with government agencies, non-government agencies and industry on mechanisms to address SI. This approach, established in collaboration with NIAID-funded clinical trial groups, serves as a model for prevention, assessment, monitoring, and intervention for social impact related to preventive HIV vaccine clinical trial participation. Although further research is necessary, this model could be adapted for use in different clinical trials. Published by Elsevier Ltd.