Research & Institutional Review Board

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All research must be approved by the IRB prior to initiating any research project

Why do I need to submit to the IRB?

Cleveland Clinic policies, developed to assure compliance with federal regulations, require that all human subjects’ research must be reviewed and approved by a Cleveland Clinic IRB prior to any research activities taking place. In other words, do not do any research until you have an IRB approval letter.

What does the IRB do?

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.

Which IRB should I use?

CCR IRB: 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.
CCF IRB: The CCF IRB oversees research conducted by members of the CCF professional staff (no matter where the research is conducted), as well as research conducted at the CCF Main Campus or CCF Family Health Centers. The CCF IRB can be contacted at 216-444-2924 or IRB@ccf.org
Case Cancer IRB: Cancer research protocols will be reviewed by the Case Cancer IRB a joint IRB partnership arrangement between CCF, Case and UH specifically for cancer research studies. You must first obtain scientific review and approval from the Case Protocol Review and Monitoring Committee (PRMC) before submitting an IRB application to the Case Cancer IRB. The procedures, forms and information about this review process can be obtained from the Cleveland Clinic Cancer Center Regulatory Office at 444-7925. The Case Cancer IRB web site is http://casemed.case.edu/ora/irb/

How do I submit to the IRB?

Refer to the IRB policies & Procedures and the IRB forms page for complete information. All forms are available on the IRB forms tab, along with references to the pertinent IRB policies. Key points are addressed below:

Exempt research is still research subject to IRB review and approval. Exemption requests are processed as received by the IRB office.
Expedited 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.
Full Board Review: Most studies requiring full board review are submitted on a New Study Application. For full instructions, please read the IRB Policies & Procedures and New Protocol Submission section of the IRB forms page.
Continuing Review: All research must be reviewed by the IRB at least annually. For full instructions, please read the IRB Policies & Procedures and Continuing Review section of the IRB forms page. Many continuing reviews will require full board review.

What if I need to make changes to approved research?

Any changes to approved research must also be reviewed & approved by the IRB. Use the Amendment Change Closure form.

What if something goes wrong during my research?

Tell the IRB. 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

What are the 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.

What if I still have Questions?

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.

revised 7/8/09