Workshop on Informed Consent in HIV Prevention Trials

描述（由申请人提供）：描述、地点和日期：人口理事会和国际家庭保健组织正在召开一个关于发展中国家艾滋病毒预防技术临床试验中的知情同意的讲习班。为期三天的会议将于2005年春季在纽约市人口理事会总部举行。 参与者类型：参与者将包括实施临床试验的研究人员（杀微生物剂、疫苗等）;风险沟通、行为改变沟通（BCC）材料的开发和评估以及避孕介绍方面的专家;国际等组织的成员。艾滋病疫苗倡议、杀微生物剂开发联盟、全球杀微生物剂运动和杀微生物剂国际伙伴关系;以及主要捐助者。目标：鉴于计划或正在进行的艾滋病毒预防试验越来越多，以及进行这些试验所固有的伦理和实际挑战，确保参与者真正知情并自愿参加至关重要。我们的目标是审查目前的做法，并提出改进知情同意程序的建议，包括制定一个评价框架。 将涵盖的主题：我们将审查现有的教育材料（小册子、挂图、视频）、评估理解的技术（如理解测验），以及在试验前和试验期间评估材料和过程的策略;探索社区可以提供帮助的方法（或阻碍）知情同意过程;识别通常存在问题的概念（如安慰剂、随机化和“部分有效性”），并探索改善这些问题沟通的方法。

DESCRIPTION (provided by applicant): Description, location and dates: The Population Council and Family Health International are convening a workshop on informed consent in clinical trials of HIV prevention technologies in developing countries. The three-day meeting will be held at the Population Council headquarters in New York City in the spring of 2005. Types of participants: Participants will include researchers implementing clinical trials (microbicides, vaccines, etc.); experts in risk communication, development and evaluation of behavior change communication (BCC) materials, and contraceptive introduction; members of organizations such as the International. AIDS Vaccine Initiative (IAVI), the Alliance for Microbicides Development, the Global Campaign for Microbicides, and the International Partnership for Microbicides (IPM); and key donors. Goals: Given the increasing number of HIV prevention trials planned or underway, and the ethical and practical challenges inherent in conducting these trials, it is critical to ensure that participants are truly informed and enroll voluntarily. Our goal is to review current practices and to outline recommendations for improving the informed consent process, including developing a framework for evaluation. Topics to be covered: We will review existing educational materials (booklets, flip-charts, videos), techniques for assessing comprehension (such as comprehension quizzes), and strategies for evaluating the materials and processes before and during the trials; explore ways in which the community can help (or hinder) the informed consent process; identify concepts that are typically problematic (such as placebo, randomization, and "partial effectiveness") and explore ways to improve communication about these.