Regulatory compliance and human subjects safety

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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).