domingo, 15 de mayo de 2011

AHRQ Data and Safety Monitoring Policy

AHRQ Data and Safety Monitoring Policy

AHRQ issued a policy notice that sets forth the requirements for data and safety monitoring (DSM) for AHRQ-conducted or -supported research involving interventions with human subjects where there is a greater than minimal risk (45 C.F.R. 46.102 = Electronic Code of Federal Regulations: Electronic Code of Federal Regulations:), to ensure the safety of participants and the validity and integrity of the data. Studies that are exempt under the Department of Health and Human Services human subjects protection regulations 45 C.F.R. Part 46 are not subject to this policy. If research falls under the Food and Drug Administration (FDA) regulatory requirements (21 CFR 50; 21 CFR 56 = CFR - Code of Federal Regulations Title 21), the researcher must follow both HHS and FDA human subjects protection regulations, as well as this policy. The AHRQ policy specifies that a proposed DSM plan must be submitted as part of the research strategy section in the grant application or the technical approach for a contract application. Further the DSM plan must be approved by the institutional review board prior to the conduct of research involving interventions with human subjects where there is a greater than minimal risk. Effective with its publication, this policy is incorporated as part of the terms and conditions for all new awards. Release of funds for research activities is contingent upon compliance with AHRQ’s DSM policy. Select to access AHRQ’s policy: NOT-HS-11-015: AHRQ Data and Safety Monitoring Policy

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