Information for Researchers: Supporting Physicians and Clinicians
With administrative support provided by the Wright State Research Institute (WSRI), physicians and researchers at Wright State University (WSU) and Premier Health Partners (PHP) hospitals will be freed from much of the extensive paperwork and bureaucracy that can discourage investigators from pursuing clinical research projects. Support services include:
- assistance with development of budgets;
- assistance with regulatory requirements and compliance, including help in preparing necessary Institutional Review Board (IRB) protocols and submission to the IRB;
- contract negotiation support with sponsors;
- access to specific resources within the alliance to enable execution, such as research nurse coordinators, biostatistics and any other required support; and
- back-end financial management support to minimize the time clinicians spend on trial documentation.
The alliance’s infrastructure will also be available to support and execute research and trials individually sought by investigators.
Expanded Institutional Review Board
To better position the alliance for success in expanding the number of both investigator-initiated clinical research trials and industry-sponsored clinical trials, the alliance will begin using a new, joint (WSU & PHP) local IRB, and, for industry-sponsored clinical trials, one or more commercial IRBs.
The membership of the new joint local IRB will consist of scientists from Boonshoft School of Medicine, WSU technical experts, PHP clinicians and non-scientific members.
New Clinical Trials/Studies
Effective January 1, 2012, all new IRB applications will be reviewed by the joint (WSU & PHP) local IRB. The Mimai Valley Hospital (MVH) Clinical Research Center will assist investigators with the submission process. At this time, the IRB submission process for Good Samaritan Hospital (GSH) will remain the same as it has been in the past.
Industry-sponsored studies will be able to be submitted to the commercial IRBs once agreements are fully in place. This is expected to occur in early 2012.
Existing Clinical Trials/Studies
Existing trials at MVH will continue to be managed by the MVH IRB. Renewal notices will notify researchers of next steps for submitting to the new IRB.