Regulatory compliance and human subjects safety

法规遵从性和人体受试者安全

• 批准号: 7979340
• 负责人: Peter A Anton
• 金额: $ 9.16万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-18 至 2010-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7979340
• 关键词: Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Complex; Conduct Clinical Trials; Contracts; Grant; Guidelines; Individual; Institution; Institutionalization; Modems; Program Development; Regulation; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Research Project Grants; Resources; Safety; Site; Technical Expertise; common rule; cost effective; expectation; human subject; institutional biosafety committee; microbicide

The regulatory issues faced by institutions performing clinical research have become increasingly more complex, placing greater demands on investigators for timely and complete compliance to federal and institutional guidelines. Most investigators do not have an expert on staffthat understands the regulatory issues involved in managing investigational research and who knows the institution's obligations under the federal rules. Although technically covered by the auspices of the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC) Data Safety Monitoring Board (DSMB) and Office of Contracts & Grants, these entities have institution-wide responsibilities and have limited resources or focused expertise for individual research projects. Clinical trials have grown in number and complexity since the institutionalization of IRBs by the federal clinical research regulation, the so-called Common Rule. Modem IRBs are facing increased demands and expectations as the burden of federal regulatory requirements and the number of clinical trials are increasing. This results in increased burdens on the investigative team to assume regulatory responsibilities. An added complexity is the diversity of sites at which clinical research is performed. The objective of the Regulatory Compliance and Subject Safety Core is to provide an infrastructure of regulatory and technical expertise to facilitate management of and maintain compliance with the regulatory responsibilities of the U-19 Projects while acting in an efficient and cost effective manner to facilitate conducting the clinical trial aspects of the four projects in the Microbicide Development Program (MDP).

进行临床研究的机构所面临的监管问题变得越来越复杂，对研究者及时和完全遵守联邦和机构指南提出了更高的要求。 大多数调查人员没有一个了解管理中涉及的监管问题的专家 调查性研究以及谁知道该机构根据联邦规则所承担的义务。尽管名义上 由机构审查委员会（IRB）、机构生物安全委员会（IBC）和数据安全委员会的支持涵盖 监测委员会（DSMB）和合同与赠款办公室，这些实体具有全机构的责任， 有限的资源或专注于个别研究项目的专业知识。自从联邦临床研究条例（即所谓的共同规则）将IRB制度化以来，临床试验的数量和复杂性都有所增加。随着联邦法规要求的负担和临床试验数量的增加，现代IRB面临着越来越多的需求和期望。这导致调查小组承担监管责任的负担增加。另外一个复杂性是进行临床研究的地点的多样性。监管合规和受试者安全核心的目标是提供监管和技术专业知识的基础设施，以促进U-19项目监管责任的管理和保持合规性，同时以高效和具有成本效益的方式行事，以促进杀微生物剂开发计划（MDP）中四个项目的临床试验方面。