Saint Agnes Medical Center - CLINICAL RESEARCH

CLINICAL RESEARCH

The Saint Agnes Clinical Research Center (CRC) partners with physicians to bring innovative drug and device research studies to the people of the Central Valley. The CRC conducts Phase II, III, and IV industry-sponsored clinical trials in multiple therapeutic areas including cardiology, surgery, orthopedics, oncology, gastroenterology, endocrinology and internal medicine.

Through the CRC Saint Agnes’ patients can participate in studies sponsored by the National Cancer Institute (NCI), the Department of Health and Human Services (DHHS), international pharmaceutical, and biotech companies. The CRC provides systemwide oversight for all research activities at Saint Agnes Medical Center including protocol management, human subjects’ protection (Institutional Review Board), contracts, and regulatory compliance to ensure quality, consistency and safety. Quality is always the focus of the trained research and nursing staff.

For more information, contact the Clinical Research Center at:

Phone: (559) 450-7790
Fax: (559) 450-7787
Email: clinical.research@samc.com

Institutional Review Board

The Institutional Review Board (IRB) is an administrative body established by federal law to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB 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.

The IRB is a subcommittee of the Medical Staff and is administered through the Clinical Research Center. It operates in compliance with the Code of Federal Regulations 21 CFR Parts 50 and 56, and 45 CFR Part 46, and has a federal assurance. As such, it functions independently but in coordination with other committees of the Institution. The IRB, however, makes its independent determination whether to approve or disapprove the protocol based upon whether or not human subjects are adequately protected. The IRB reports its actions to the Medical Staff Quality Council and the Medical Staff Executive Committee.

The Board meets monthly and ad hoc as needed to ensure human subject protection. It is composed of physicians, Saint Agnes administration and staff, and community members. Membership is for a two-year term, and people interested in participating are encouraged to contact the Clinical Research Center or the Chairperson for information.