Institutional Review Board
News and Announcements
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:
- 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.”
- 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).
- 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.
- 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:
- University Hospitals and Center for Clinical Research staff members,
- the departments housed in the Case Western Reserve University School of Medicine,
- the School of Nursing, Dentistry or any other department that involves patients or personnel of the hospital, as well as,
- all projects involving the hospital's patients or personnel, regardless of sponsor, and
- selected proposals as requested by the Case Western Reserve University IRB.
Statement of Compliance (PDF)
Review of Cancer Research
University Hospitals Case Medical Center has formed a new committee, the UH Cancer IRB, which reviews all cancer or cancer-related research protocols conducted at UH. This new committee will function under the UH Federalwide Assurance, number FWA 00003937, and will meet on a regular schedule (see below for meeting schedule).
For information about the new UH Cancer IRB, or to learn more about submitting your cancer or cancer-related research study for review, please call the UH Case Medical Center IRB Administration Office at 216-844-1529.
Meeting Dates and Submission Deadlines
The biomedical IRB meets every Tuesday (except holidays) at 3:30 pm. There are two separate boards that meet every 2 weeks (J & M Committees). The deadline for protocol submission is 10 days before the meeting date.
The UH Cancer IRB meets the 2nd and 4th Thursdays of the month (except holidays) at 2:30 pm. 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