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Advancing HIV Research in Pregnancy; ethics and engagement

推进妊娠期艾滋病毒研究；

基本信息

批准号：
8692370
负责人：
ANNE Drapkin LYERLY
金额：
$ 71.28万
依托单位：
UNIV OF NORTH CAROLINA CHAPEL HILL
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-08-02 至 2015-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8692370
关键词：
Address Affect Antiviral Agents Area Benefits and Risks Caring Child Clinical Research Communities Comorbidity Complex Consensus Consultations Data Development Dose Drug Kinetics Drug Resistant Tuberculosis Drug resistance Effectiveness Empirical Research Environment Ethical Analysis Ethics Fetus Foundations Goals Guidelines HIV HIV Infections HIV risk Health Individual Institutional Review Boards Knowledge Laws Legal Medical Mission Morals Participant Pharmaceutical Preparations Pharmacodynamics Pharmacologic Substance Policies Population Pregnancy Pregnancy Rate Pregnant Women Prevention Prevention strategy Preventive Process Public Health Recommendation Regulation Research Research Design Research Ethics Research Personnel Research Project Grants Risk Risk Factors Safety Schedule Science Sexual Partners Social Responsibility Solutions Structure Toxic effect Woman Women&apos s Health adjudication base burden of illness design disability drug metabolism effective therapy evidence base experience human subject minimal risk novel offspring pregnant prevent transmission process treatment strategy

项目摘要

DESCRIPTION (provided by applicant): Evidence to inform treatment and prevention strategies for the 15.9 million women infected with HIV worldwide, 390,000 in the US, and millions more women at risk for HIV infection are critically thwarted by ethical and regulatory concerns about research with women who are or might become pregnant. Concerns have led to a dearth of evidence to guide pressing areas of HIV management and prevention including dose, schedule and toxicity for women and offspring for new antivirals, treatments for drug- resistant TB, and preventive agents for women who are or might become pregnant, leading to suboptimal care. We hypothesize that the absence of an ethical framework specific to pregnancy and the risk of pregnancy, and the absence of adequate regulatory guidance, have seriously hampered research to address the needs of this population. Progress on this complex and multifaceted issue requires engaging research, ethics, regulatory and legal communities to develop consensus around a sustainable and practical way forward in HIV research and pregnancy. Led by a team of internationally recognized leaders in ethics, law, HIV and women's health and through integrated empirical and ethical analyses, this study aims to develop guidance critical to advancing the health needs of women with and at risk for HIV and their offspring through responsible inclusion in research, specifically: 1) To identify scientific prioriies in, perceived barriers to, and potential novel research design solutions to the conduct of HIV research and pregnancy through engagement with HIV investigators, experts in clinical research ethics, legal experts in human subjects regulation and pharmaceutical development, and IRB professionals; 2) To develop a conceptual ethical framework for HIV research in pregnancy that is responsive to these priorities and current barriers and that will include at minimum careful treatment of at least the meaning and interpretation of minimal risk and more than minimal risk in the context of pregnancy and potential for pregnancy; adjudication of risks and benefits among different but related parties (woman, fetus, baby, sexual partners); and, concepts of risk and harm in pregnancy that incorporate discrete medical and extra- medical risk; and 3) Based on the framework, to develop and aggressively disseminate a set of practical consensus guidance recommendations on research with HIV and pregnancy that are actionable within the current regulatory environment, whose utility and acceptability have been vetted by HIV investigators, pregnant women with or at risk of HIV, and experts in research ethics, law and regulation, and IRBs. Given the diverse groups engaged, rigorous design, and the individual and collaborative experience of the investigators, this project has the potential to shift policies and practices and redress the ethical problems that have hampered the evidence base for optimizing the health of women and offspring at risk or infected with HIV.

描述(由申请人提供)：为全球1590万感染艾滋病毒的妇女、美国的39万感染艾滋病毒的妇女以及数百万更有感染艾滋病毒风险的妇女提供治疗和预防战略的证据，由于对怀孕或可能怀孕的妇女进行研究的伦理和监管方面的担忧而受到严重阻碍。人们的关切导致缺乏证据来指导艾滋病毒管理和预防的紧迫领域，包括新抗病毒药物的剂量、时间表和对妇女及其后代的毒性，耐药结核病的治疗，以及怀孕或可能怀孕的妇女的预防性药物，从而导致次优护理。我们假设，缺乏专门针对怀孕和怀孕风险的道德框架，以及缺乏足够的监管指导，严重阻碍了解决这一人群需求的研究。在这一复杂和多方面的问题上取得进展需要研究、伦理、监管和法律界的参与，以就艾滋病毒研究和怀孕方面的可持续和切实的前进道路达成共识。这项研究由伦理、法律、艾滋病毒和妇女健康领域的国际公认领导者领导，通过综合的实证和伦理分析，旨在通过负责任地纳入研究，制定对促进艾滋病毒及其后代有风险的妇女的健康需求至关重要的指导方针，特别是：1)通过与艾滋病毒研究人员、临床研究伦理专家、人体受试者法规和药物开发方面的法律专家以及IRB专业人员的参与，确定艾滋病毒研究和怀孕进行的科学优先事项、感知障碍和潜在的新型研究设计解决方案；2)为孕期艾滋病毒研究制定一个概念性伦理框架，对这些优先事项和当前障碍作出反应，其中至少将包括：至少仔细处理怀孕和怀孕方面的最小风险和超过最小风险的含义和解释；对不同但相关的各方(妇女、胎儿、婴儿、性伴侣)的风险和利益作出裁决；以及将离散的医疗风险和医疗外风险结合在一起的怀孕风险和伤害的概念；3)在这一框架的基础上，制定并积极传播一套关于艾滋病毒和怀孕研究的实用协商一致指导建议，这些建议可在当前监管环境下采取行动，其实用性和可接受性已由艾滋病毒调查人员、感染艾滋病毒或有艾滋病毒风险的孕妇、研究伦理、法律和法规以及机构间研究机构的专家进行审查。考虑到参与的不同群体，严谨的设计，以及调查人员的个人和协作经验，该项目有可能改变政策和做法，并纠正道德问题，这些问题阻碍了优化面临艾滋病毒风险或感染艾滋病毒的妇女和子女健康的证据基础。