Collaborative IRB Review and Ethical/Educational Exchange - Boston/Durban

IRB 协作审查和道德/教育交流 - 波士顿/德班

• 批准号: 8051145
• 负责人: ELIZABETH L. HOHMANN
• 金额: $ 4.97万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-15 至 2012-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8051145
• 关键词: AIDS/HIV problem; Address; Administrator; African; Area; Attitude; Boston; Clinical Research; Clinical and Translational Science Awards; Collaborations; Communicable Diseases; Confidentiality; Electronics; Ensure; Environment; Ethical Review; Ethics; Fostering; Funding; Future; General Hospitals; Generations; Genetic Research; HIV; HIV Infections; HIV Vaccine Trials Network; Hospitals; Human; Human Subject Research; Individual; Informed Consent; Institutes; Institution; International; International Aspects; Leadership; Massachusetts; Monitor; New England; Perception; Persons; Physicians; Policies; Positioning Attribute; Privacy; Procedures; Process; Protocols documentation; Public Health; Regulation; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Research Project Grants; Secure; Sister; Site; South Africa; System; Tissue Banking; Tissue Banks; Travel; Visit; Woman; Work; abstracting; catalyst; clinical care; clinical research site; computerized; design; expectation; interest; medical schools; meetings; member; prevent; programs; social; symposium; transmission process

DESCRIPTION (provided by applicant): The Partners Human Research Committees (IRBs) in Boston MA provides ethical and scientific review of clinical research projects conducted primarily at Massachusetts General Hospital and Brigham and Women's Hospital, and also at affiliated institutions connected with the Harvard Medical School Clinical and Translational Science Award (CTSA). These institutions have a significant international research portfolio in infectious diseases, especially surrounding HIV/AIDS in South Africa. In collaboration with colleagues at the McCord Hospital, Durban, we propose a cultural and educational IRB exchange program with reciprocal visits of physician and administrative staff responsible for oversight of ethical review at both sites. We expect that this in-person exchange will foster greater mutual understanding of the pertinent social and cultural aspects of the international clinical and research environments and review processes. We will visit each other's sites, offices, and IRB meetings, and host conferences for investigators, administrators, and IRB members at both sites to address both ethical and practical issues of interest to these constituencies. Areas of particular interest that we will explore include socially stigmatizing research, attitudes and perceptions of subjects related to genetic research and tissue banking, privacy and confidentiality norms and expectations, and quality improvement and monitoring programs. We will explore sharing computerized protocol tracking and processing systems via shared secure servers. It is expected that establishing personal connections and becoming personally familiar with the environment and culture of each other's review processes will facilitate collaborative, cooperative and efficient review of NIH-funded human subjects research. PUBLIC HEALTH RELEVANCE: This project is designed to enhance the quality and timeliness of review of international research on infectious diseases, especially treatment and transmission of HIV. The work is designed to ensure prompt, timely, and appropriate ethical and scientific review of research of great importance to public health - that directed at containing and preventing HIV infection.

描述(由申请人提供)：位于马萨诸塞州波士顿的合作伙伴人类研究委员会(IRBs)主要对马萨诸塞州总医院和布里格姆妇女医院以及与哈佛医学院临床和翻译科学奖(CTSA)相关的附属机构进行的临床研究项目进行伦理和科学审查。这些机构在传染病方面拥有重要的国际研究组合，特别是在南非的艾滋病毒/艾滋病方面。与德班麦考德医院的同事合作，我们提出了一个文化和教育IRB交流计划，由负责监督这两个地点伦理审查的医生和行政人员互访。我们希望这次面对面的交流将促进对国际临床和研究环境和审查过程中相关的社会和文化方面的更多相互理解。我们将访问彼此的网站、办公室和IRB会议，并在两个网站为调查人员、管理人员和IRB成员主办会议，以解决这些选民感兴趣的道德和实践问题。我们将探索的特别感兴趣的领域包括对与基因研究和组织银行相关的主题的社会污名化研究、态度和看法、隐私和保密规范和期望，以及质量改进和监控计划。我们将探索通过共享的安全服务器共享计算机化的协议跟踪和处理系统。预计建立个人联系并亲自熟悉彼此审查过程的环境和文化将有助于对NIH资助的人类受试者研究进行协作、合作和有效的审查。 与公共卫生的相关性：该项目旨在提高对传染病，特别是艾滋病毒的治疗和传播的国际研究审查的质量和及时性。这项工作旨在确保对对公共卫生非常重要的研究--旨在控制和预防艾滋病毒感染--进行迅速、及时和适当的伦理和科学审查。