疫苗 Clinical Studies Safeguards

The 疫苗App世界足球赛 Center (VRC) 临床试验 Core is devoted to the tenets of Good Clinical Practices (GCP) and the primary charge to the physician of doing no harm. 因此, VRC建立了多种保障措施,保护志愿者免受身体和社会伤害. 对临床App世界足球赛的伦理原则有系统的承诺. These conditions include

  • 社会价值
  • Scientific validity
  • Fair subject selection
  • Favorable risk-benefit ratio
  • Independent review
  • 知情同意
  • Respect for human subjects

We have established a system that incorporates the following processes to accomplish these goals:

  • Regulatory oversight
  • Scientific oversight
  • 公众监督
  • 广泛的教育和知情的同意程序
  • Personal commitment

在VRC确保志愿者安全的方法

Each study is carefully developed by a protocol team with the range of clinical trials expertise needed to conduct an ethical and scientifically sound study. 该团队由一名经验丰富的首席App世界足球赛员领导,并包括一名生物统计学家, a protocol specialist, 医生, App世界足球赛护士, laboratory 科学家们, 药剂师, 数据专家, 监管人员, and other support staff. 所有工作人员都接受训练,以合乎道德和科学严谨的方法进行App世界足球赛. 临床试验方案的制定是一个循序渐进的过程,需要进行多层审查. The review process begins with presenting the protocol to an independent group of 科学家们 not associated with the VRC, who provide advice and criticism to make sure the protocol is designed to answer an important question for human health.

All research sponsored by the U.S. 政府必须与美国的规章和指导方针保持一致.S. 卫生和公众服务部人类App世界足球赛保护办公室. 当App世界足球赛涉及到一种试验性产品的使用时, such as a vaccine, it must also be in keeping with the regulations and guidelines of the Food and Drug Administration (FDA).

When a promising vaccine is identified, 发展, 生产, FDA会在多个步骤中仔细审查评估. 试验性新药申请(IND)必须提交给FDA. 美国食品药品监督管理局 must review how the study vaccine was produced and tested for safety and potential for preventing a disease, as well as the protocol plan for administration and testing in humans before it can begin evaluation in human clinical trials.

除了 to oversight from 美国食品药品监督管理局, 临床方案必须经过App世界足球赛机构审查委员会(IRB)的审查. This is a diverse group of clinicians, 科学家们, and community members who judge the risk/benefit of the proposed study and assure that it is being conducted according to the Code of Federal Regulations and in accordance with NIH policies. IRB还审查知情同意文件,并确保其准确和完整. 如果你参加NIH的App世界足球赛,你会得到如何联系IRB的信息.

虽然协议仍处于规划阶段,但由社区咨询委员会(CAB)审查。. The VRC is supported by the Capital Area 疫苗 Effort (CAVE) which is a community-based organization that reviews the status of HIV vaccine development. 它们为疫苗评估过程提供了见解, recruitment of volunteers, 也会引起庭审参与者的担忧. CAB是地方组织,但也与国家和全球CAB互动. These organizations have the charge of advocating for the rights of the study participants and challenging the investigators and manufacturers on any areas of concern to the general public.

临床试验的关键要素之一是知情同意过程. This means that the volunteer has to be educated and informed about all the details of the study and their rights. VRC的工作人员非常重视这个过程. 对App世界足球赛来说,重要的是你要确切地了解App世界足球赛的计划和原因. App世界足球赛将对你的HIV知识进行评估, how the vaccine works, 以及在签署知情同意文件之前App世界足球赛需要什么. 即使在App世界足球赛开始后,志愿者也总是能控制接下来发生的事情. 每个受试者可以在任何时候自由地停止App世界足球赛.

App世界足球赛期间,监管和监督职能仍在继续. App世界足球赛人员需要定期向App世界足球赛发起人提交报告, 美国食品药品监督管理局, and IRB and to notify these oversight groups per the protocol guidelines if there are adverse events that occur during the study. 除了, 一个由科学家组成的独立数据和安全监测委员会(DSMB), 医生, 统计学家, 伦理学家, and community representatives evaluates the progress of studies where some subjects receive placebo rather than vaccine. 美国食品药品监督管理局, IRB, DSMB, or the investigators supervising the study all have the authority to stop the trial if there is evidence of concern for human subject protection.

The NIH institutional commitments to volunteer safety are recorded in the informed consent document. 所有的机构, 委员会, and individuals involved in oversight of the studies are fully devoted to the safety of participants as their top priority. 除了, the investigators and clinical staff of the VRC have made personal commitments to the safety and well being of anyone involved in the vaccine studies.

Preventive HIV 疫苗 Development

All vaccines are produced using molecular biology techniques that exclude the HIV virus from the manufacturing process. 因此,它是 不可能通过疫苗感染艾滋病毒. Candidate vaccines are tested in small animals and often in nonhuman primates for signs of toxicity or any evidence of harm. 除了, the candidate vaccines are often tested in monkeys to determine whether it might have the ability to protect against infection or disease. Only if the vaccine is safe and shows evidence of benefit in animal models would it be considered for testing in humans. 其他科学家也对这一概念进行了审查, and a decision for further testing is based on its comparative value relative to other vaccine concepts being developed. 因为测试将在健康状态下进行, uninfected people, 候选疫苗必须达到较高的安全性标准.

人类App世界足球赛行为的一般参考文献

The principals of ethical human research are rooted in several key commissions and reports from the mid-to-late 20th century; among them are the Belmont Report, the Declaration of Helsinki, the 纽伦堡的代码, and the 普遍的规则. These were constituted to codify the principals by which human research should be conducted and to prevent any future failure to protect human subjects.

The Belmont Report, 在1979年出版, 对美国的App世界足球赛尤其重要. It was issued by the National Commission for the Protection of Human Subjects of Biomedical App世界足球赛 which was appointed to address the failure of human subjects protection in the Tuskegee 梅毒 Study. 该报告概述了尊重个人、慈善和正义的原则. 这些原则是目前涉及人类参与者的法规的基础, 包括第45条中概述的政策, Code of Federal Regulations, 第46部分管理所有联邦资助的App世界足球赛.

The Belmont Report

贝尔蒙特报告-保护人体受试者的伦理原则和指南 provides the philosophical underpinnings for the current laws 政府erning human subjects research by establishing three fundamental ethical principles relevant to all research involving human subjects: Respect for Persons, 善行, 和正义.

  1. 的原则 Respect for Persons 承认个人的尊严和自主权, 并要求对自主权被削弱的人给予特殊保护. 这一原则要求受试者对参与App世界足球赛给予知情同意. 因为他们潜在的脆弱性, 某些受测人群得到了额外的保护. These include live human fetuses, 孩子们, 囚犯, the mentally disabled, and people with severe illnesses.
  2. 的原则 善行 requires us to protect individuals by maximizing anticipated benefits and minimizing possible harms. 因此,它是 necessary to examine carefully the design of the study and its risks and benefits including, 在某些情况下, 确定从App世界足球赛中获得益处的替代方法. App世界足球赛风险必须始终以App世界足球赛的预期收益为依据.
  3. 的原则 正义 requires that we treat subjects fairly. 例如, subjects should be carefully and equitably chosen to insure that certain individuals or classes of individuals-such as 囚犯, 老年人, 或者经济贫困的人没有被系统地选择或排斥, 除非有科学或伦理上的正当理由. 也, 除非对异常有仔细的解释, research should not involve persons from groups that are unlikely to benefit from subsequent applications of the research.

每一项原则都承载着强大的道德力量, 当它们发生冲突时,就会出现困难的伦理困境. 对…的原则的仔细和深思熟虑的应用 The Belmont Report 道德问题不一定能得到明确的解决. 然而, it is important to understand and apply the principles because doing so helps to assure that people who agree to be experimental subjects will be treated in a respectful and ethical manner.

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