Regulatory compliance and human subjects safety

进行临床研究的机构面临的监管问题变得越来越复杂，对调查人员提出了更高的要求，要求他们及时和完全遵守联邦和机构的指导方针。 大多数调查人员都没有了解管理中涉及的监管问题的工作人员专家 调查研究和谁知道机构在联邦规则下的义务。尽管从技术上讲 由机构审查委员会(IRB)、机构生物安全委员会(IBC)数据安全主持 监督委员会(DSMB)和合同与补助金办公室，这些实体在机构范围内负有责任，并 个人研究项目的资源或专业知识有限。自从根据联邦临床研究法规，即所谓的共同规则，将IRBs制度化以来，临床试验的数量和复杂性都有所增加。随着联邦监管要求的负担和临床试验数量的增加，现代IRBs面临着越来越高的需求和期望。这增加了调查小组承担监管责任的负担。一个额外的复杂性是进行临床研究的地点的多样性。监管合规和主体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，同时以高效和经济高效的方式采取行动，促进开展杀菌剂开发计划(MDP)中四个项目的临床试验方面。

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).