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One of the benefits of seeking care at an academic medical center such as University Medical Center is that health professionals are on the leading edge of medical research and scholarship. Many of our physicians, pharmacists, nurses and other scientists are conducting research to better understand and diagnose a variety of diseases and to develop and test new therapies and drugs, and to devise preventative interventions that have a reasonable expectation of success.
University Medical Center's Site Review Authority
The purpose of the UMC Site Review Authority (SRA) is to serve as the mechanism for approving research studies that will be conducted within any UMC facility. The SRA reviews and assesses the impact of these studies on UMC operations relative to purchased services i.e. laboratory testing, the need for UMC staffing support and general compliance with regulatory requirements e.g. HIPAA. Once approval is granted, the SRA issues a site-approval letter to the principal investigator (PI).
PROCEDURE
PIs requesting Institutional Review Board approval and wanting to use UMC as the site of their research studies must contact either Anita Crockett or Valerie Evans, co-chairs, UMC Site Review Authority (SRA), by e-mailing SRA@umcaz.edu or faxing to (520) 694-0261 using these steps:
STEP 1 - The PI is to provide IN ONE SUBMISSION the following documents in electronic format:
- WIRB Application with attachments OR PAF or PRF with VOTF for University of Arizona IRB applications
- Protocol [If there is no protocol, submit a project abstract.]
- A calendar or matrix that summarizes the activities and procedures the enrollees will be subject to, identifying those which are for research as distinct from standard of care
- A copy of the patient consent form
- Notice of Clinical Trial and/or Use of Investigational and/or Humanitarian Use Device Form including copy of FDA approval letter if relevant
- A signed UMC Confidentiality form if you are not a member of the UMC work force
- Any requests for a Limited Data Set
- Any research accommodation account requests
The following forms can be downloaded by clicking on the specific line item.
STEP 2 - The PI will receive an official UMC Site-Approval letter from the SRA to submit with their IRB application.
STEP 3 - After the PI receives IRB approval, the following forms must be submitted electronically to SRA prior to the study being initiated:
- Institutional Review Board Approval (e.g. HSPP Correspondence)
- Stamped IRB documents (e.g. Final Subject Consent and PHI forms)
D. Accommodation Account Process
When UMC site approval for the research study is given, any associated accommodation account requests will be processed within the next 48 business hours.
The PI will be notified of the initial establishment of the accommodation account but the account will not be activated until the SRA receives copies of the IRB approval letter and IRB stamped documents. Once the SRA receives these documents, the accommodation account will be activated for the same period of time as the study period approved by the IRB.
Renewal requests must also be submitted along with a copy of the IRB renewal approval letter in order for the accommodation account to be continued.
NOTE: UMC price increases may occur annually and principal investigators should develop budget requests to reflect this accordingly.
E. Western IRB Studies
PIs who wish to utilize WIRB as the IRB of record must submit an application to the University of Arizona (UA) IRB in accordance with current policy.
(see http://orcr.vpr.arizona.edu/system/files/Information%20Sheet%20-%20WIRB%20Submission%20version%2011-20-09_0.doc for more information).
The UA will assess whether oversight is appropriate and will send to the PI written confirmation of transfer of IRB oversite to WIRB. The PI submits the UA transfer of oversight letter with the required documents (Protocol, VOTF, Consent form etc.) to the UMC SRA for site approval. The PI submits all documents and U of A approval letter and UMC site approval letter to WIRB for study approval. WIRB gives approval and assigns a final number. The PI submits a copy of the WIRB approval to UMC's SRA.
F. Amendments, Renewals or Continuing Review Updates
As changes are approved by the IRB to your research projects (e.g. major amendments, renewals, continuing review updates, study closures/conclusions), PIs should provide UMC Site Review Authority copies of the IRB approvals in order to e.g. insure that all of the individuals associated with the research project have appropriate access to systems data and to receive continuing site approval from UMC.
Arizona Health Sciences Center Research Projects
Researchers at the University of Arizona Health Sciences Center have been awarded millions of dollars in grants from the National Institutes of Health, state and local agencies and private industry. Scores of research projects and clinical trials are underway at University Medical Center and allied Centers of Excellence on the Arizona Health Sciences Center campus. For example, please visit Arizona Cancer Center Clinicial Trials.
The Faculty Research page provides information on some research activities of faculty at The University of Arizona, including the UA Colleges of Medicine, Pharmacy and Nursing who practice at UMC. You can search by name or by subject, for example, "osteoporosis" or "valley fever."
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