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All clinical trials must have sufficient resources and scientific merit to be conducted at DHMC. Depending on the nature of the project there may be other Institutional Reviews Required prior to initiation.
The Committee for the Protection of Human Subjects
The Committee for the Protection of Human Subjects (CPHS) is a federally mandated committee in charge of overseeing all institutional research projects involving human participants. All research involving humans (regardless of funding) must be reviewed and approved by the CPHS prior to initiation. http://www.dartmouth.edu/~cphs/
Nationally this committee may be referred to as the Institutional Review Board (IRB). The names are synonymous.
The Trustees of Dartmouth College in alliance with: Dartmouth College (including the College of Arts & Sciences, Tuck Business School, Thayer School of Engineering, and Dartmouth Medical School), Dartmouth - Hitchcock Clinics, Dartmouth Hitchcock Alliance Hospitals, and the Department of Veteran Affairs (White River Junction, VT) have signed a contract with the federal government, called a Federal Wide Assurance of Compliance (FWA00003095), and abide by 45 CFR 46, 21 CFR 50 and 56 where applicable, and 38 CFR 16 and any additional VA specific regulations for protocols to be conducted under the auspices of the Veterans Hospital, White River Junction.
The primary mission of the CPHS is to ensure that the rights and welfare of human research participants are protected.
The CPHS has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy. Research that has been reviewed and approved by the CPHS may be subject to review and disapproval by officials of the institution. However those officials may not approve research if it has been disapproved by the CPHS.
posted: 02/10/2006
