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Clinical research is one of the nation's most vital undertakings, leading to improved medical care; new diagnostic, preventative, and therapeutic methods; and improved quality of life for patients and their families. It is widely recognized, however, that the efficiency and effectiveness of our system of clinical research is hampered by variability in regulations and policies that pertain to the conduct and oversight of clinical research. As a result, this has created a measure of burden on the research community to understand and fulfill multiple requirements that may be redundant or even conflicting. This variability exists among various federal agencies that support and oversee clinical research, as well as among the Institutes and Centers of the NIH itself.
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The NIH has created a Clinical Research Policy Analysis and Coordination (CRpac) Program to serve as a focal point for the ongoing harmonization, streamlining, and optimization of policies and requirements concerning the conduct and oversight of clinical research. The CRpac program reflects the responsibility of the NIH, as the lead federal agency supporting clinical research, to promote the efficiency and effectiveness of the clinical research enterprise, in part by facilitating compliance and oversight.
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Some specific foci for this effort include:
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Harmonizing diverse adverse event reporting requirements
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Creating dialogue on promoting science, safety, and ethics through clinical trial design
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Clarifying the respective roles and responsibilities of Data Safety and Monitoring Boards (DSMBs) and other review mechanisms
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Clarify the methods for protecting human data and specimens in research
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Clarifying policy where variability in the application of the human subjects regulations exists
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Studying various approaches to providing informed consent and sharing best practices
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Examining the characteristics and features of various models of IRB review and considering their advantages for forms of research activities
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The program's objective is to develop and implement coordinated policies and practices reflective of the needs and points of view of NIH's varied organizational components and stakeholders. The CRpac staff works closely with Federal agencies and offices that have responsibilities concerning the oversight of clinical research, including the Office for Human Research Protections, the Food and Drug Administration, and other Federal agencies that have adopted the Federal Policy for the Protection of Human Subjects, or "Common Rule."
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For more information on the CRpac Program, contact Kelly T. Fennington, Office of Science Policy, Office of the NIH Director, (301) 435-2051, fenningk@od.nih.gov or Allan C. Shipp, Office of Science Policy, Office of the NIH Director, (301) 435-2152, shippa@mail.nih.gov. NIH welcomes comments on the CRpac Program's activities; please send comments to CRpac@od.nih.gov.
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