Institutional Review Board

News and Announcements

IRB Office Hours Flyer (PDF)

New NIH Policy for Funded Active Awards

A new National Institutes of Health (NIH) policy requires prior approval from the NIH awarding Institute/Center for a change that increases risk to human subjects of a NIH funded active award. The changes cannot be implemented without prior NIH approval (even after the IRB has approved the modification).

Upon approval by the IRB of the amendment, the Principal Investigator (PI) is responsible for contacting his/her pre-award office. The pre-award office will work with the PI to submit a request for approval to NIH. This must be done at least 30 days before implementing the proposed change.

The changes included the following:

  1. An addition or change to the study design or protocol that would result in the need to change the overall human subjects designation:
    • From non-human to human subject research;
    • From exempt to non-exempt human subjects research; or
    • From “No Clinical Trial” to “Includes a Clinical Trial.”
  2. New inclusion of subject populations that are covered by additional regulatory protections under the federal regulations (i.e. pregnant women, human fetuses, and neonates; prisoners; or children).
  3. Any change to the study protocol that would result in an overall increase in risk level for subjects, including physical, psychological, financial, legal or other risks.
    • Adding a new study population that would be at higher risk from existing research procedures (e.g. adding subjects with compromised immune systems to a vaccine study);
    • New study procedures that are greater than minimal risk; or
    • Creation of new clinical intervention or study arm that is greater than minimal risk.
  4. New information indicating higher level of risk (e.g. an unanticipated problem or unexpected adverse event).

The link to this new guidance can be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-129.html.

Questions should be addressed to Robin Bissell in the CWRU School of Medicine Grant and Contracts office, at medresnih@case.edu or 216-368-1654.

IRB Scope and Responsibilities

The UH Institutional Review Board (IRB) reviews all human subject research protocols that originate from:

  1. University Hospitals and Center for Clinical Research staff members,
  2. the departments housed in the Case Western Reserve University School of Medicine,
  3. the School of Nursing, Dentistry or any other department that involves patients or personnel of the hospital, as well as,
  4. all projects involving the hospital's patients or personnel, regardless of sponsor, and
  5. selected proposals as requested by the Case Western Reserve University IRB.

Statement of Compliance (PDF)

Meeting Dates and Submission Deadlines

The UH IRB consists of three boards, one of which specializes in the review of cancer research. The three committees are referred to as J Committee, M Committee and C Committee. The J Committee and M Committees meet every two weeks on Tuesdays (except holidays) at 3:30pm. The C Committee meets the 2nd and 4th Thursdays of the month (except holidays) at 2:30pm. The deadline for protocol submission is 10 days before the meeting date.

IRB Administration Office

University Hospitals
Lakeside 1400
11100 Euclid Avenue
Cleveland, OH 44106
MS: LKS 7061
216-844-1529
Fax: 216-844-1547

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