The Cleveland Clinic Regional IRB (CCR IRB) oversees research at the Cleveland Clinic regional hospitals: Euclid, Fairview, Hillcrest, Huron, Lakewood, Lutheran, Marymount and South Pointe Hospitals. If you are a member of the CCF staff or plan to conduct research at the CCF or CCF Family Health Centers, please contact the CCF IRB at 216-444-2924.
The role of the Institutional Review Board (IRB) is to assure the rights, safety and welfare of human subjects recruited to participate in research activities. The IRB is responsible for the review and approval of applications to conduct research involving human subjects, to assure that the risks to research subjects are minimized and participation by these subjects is done so in a voluntary, informed manner.
The IRB highly encourages all investigators, coordinators, sponsors and participants to contact the IRB for inquiries, advice or concerns at any time. The IRB provides open communications under its oversight of human research protections and will be responsive to your questions, concerns and suggestions in a confidential and professional manner.
Serious Adverse Events & Unanticipated Problems/Protocol Deviations must be reported to the IRB in a timely fashion
· Adverse Events: Adverse Event Report form and IRB policy #60
· Protocol Deviations & Unanticipated Events: Unanticipated Problem Report form and IRB policy #70
Expedited & Exempt reviews will be conducted as received by the IRB office
These may include Exemption Requests, Medical Record Reviews, minor changes to previously approved research & study closures (use the Amendment Change Closure form). Refer to the IRB policies & Procedures and the IRB forms page for complete information.
FULL BOARD REVIEW
The submission deadline is noon, fourteen working days prior to the IRB meeting
The IRB meeting date is the fourth Wednesday of the month, excepting November & December. See calendar for submission deadlines and meeting dates.
New Study Application
For full instructions, please read the IRB Policies & Procedures and New Protocol Submission section of the IRB forms page.
Continuing Review
For full instructions, please read the IRB Policies & Procedures and Continuing Review section of the IRB forms page
IRB FEES
· NO FEE for internally funded studies (paid for by a Cleveland Clinic health system department)
· No fee for federal/nonprofit granting agency sponsored research.
· $1500 fee for initial review of corporate/commercially sponsored research
· $500 for continuing review of corporate/commercially sponsored research
· $250 for amendments of corporate/commercially sponsored research that can not be expedited
The IRB prefers fees be submitted with the application for review. Contact the IRB secretary if you need an invoice.
revised 6/25/09