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Good Samaritan Hospital
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Regional Medical Center of San Jose
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Clinical Research

The primary goal of the Good Samaritan Institutional Review Board (IRB) is to assure that the rights and welfare of human research participants are adequately protected. The IRB is dedicated to reviewing and approving research projects in a manner that minimizes risk, meets regulatory compliance and reinforces the continuing protection of research participants. The IRB membership is diverse and includes physicians, nurses, community and administrative representatives; traditionally, it meets quarterly, but “special” meetings can be convened, when necessary. Currently, there are approximately thirty (30) active investigational studies/activities in progress, involving a myriad of medical topics, conditions and diseases.

The IRB encourages researchers who are interested in conducting research to contact the IRB in advance of their commencing their research projects. Some proposals may meet the criteria for exempt from IRB review; some may be presented to the IRB Chair (vs. the entire IRB) for expedited approval. Today, the majority of professional journals no longer accept articles for publication without proof of prior IRB approval, and under the regulations, IRB approval cannot be given in retrospect; there is no mechanism by which IRBs can approve research that has already been done after the fact.

As the business of clinical trials continues to become more complicated, more difficult and faster paced, the regulations will heighten in complexity and regulatory agencies will become increasingly vigilant. IRBs, institutions and investigators must be able to adjust and continuously improve the way in which they operate. By taking a proactive stance in the preparation, organization and maintenance of the IRB Program, Good Samaritan Hospital and its Medical Staff has made an organization-wide commitment to the continual and ongoing process of protecting their research participants, reinforcing its objective of successfully balancing institutional needs and regulatory requirements, while keeping the protection of research participant rights and safety foremost in its operations.

IF ANYONE IS INTERESTED IN CONDUCTING RESEARCH AT GSH (OR IN THEIR OFFICE) for which they do need ADVANCE IRB approval, PLEASE CONTACT THE MEDICAL STAFF OFFICE AT (408) 559-2386 FOR FURTHER INFORMATION.