Research & Clinical Trials
One of the benefits of seeking care at an academic 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, to develop and test new therapies and drugs, and to devise preventative interventions that have a reasonable expectation of success.
Site Review Authority at University Medical Center for UA Healthcare
PIs wanting to use UA Healthcare at UMC as the site of their research implementation must contact either Anita Crockett or Valerie Evans, Co-Chairs of the UMC Site Review Authority (SRA), by e-mail at sra@umcaz.edu or fax at (520) 694-1007. Choose the process/s that are applicable to your study.
Sections
A. UA Institutional Review Board as IRB of Record
B. Western Institutional Review Board as IRB of Record
C. Accommodation Account Process
D. Amendments, Renewals or Continuing Review Updates
E. Internal Forms That May Be Needed
Section A - UA Institutional Review Board as IRB of Record
Step 1 - For studies using the UA IRB (also includes Central IRB) as the IRB of Record, the PI is to submit electronically the following documents as attachments in one submission:
- HHSP Correspondence Form indicating UA IRB approval for the study
- Project Approval Form (either Biomedical, Social/Behavioral, Biological/Genetic Materials or Chart Review)
- Protocol
- A calendar of activities that summarizes the activities and procedures the enrollees will be subject to, identifying those which are for research as distinct from standard of care
- Stamped copy of Subject's Informed Consent (if applicable)
- Stamped copy of PHI Authorization (if applicable)
- Any research accommodation account requests (Section C and E)
- Completed form Notice of Clinical Trial and/or Use of Investigational or Humanitarian Use Device Form including copy of FDA approval letter if relevant (Section E)
- Signed UMC Confidentiality form if you are not a member of the UMC workforce (Section E)
- Any requests for a Limited Data Set (Section E)
- Any requests for Patient Lists for Research (Section E)
Step 2 - The PI will receive an official UMC Site Approval letter in PDF format from the SRA to send to the UA IRB. The approval dates on the letter will correspond to the dates found on the UA IRB approval.
Step 3 - The activation of the research accommodation account (if applicable) will then take place and will match the dates on the approval given by the IRB.
Section B - Western Institutional Review Board as IRB of Record
Step 1 - For studies using the Western IRB as the IRB of Record, the PI is to submit electronically the following documents as attachments in one submission:
- HHSP Correspondence Form indicating UA IRB facilitated review for the study
- A completed Western IRB Application Form
- Protocol
- A calendar of activities that summarizes the activities and procedures the enrollees will be subject to, identifying those which are for research as distinct from standard of care
- Copy of Subject's Informed Consent
- Copy of PHI Authorization
- Any research accommodation account requests (Section C)
- Completed form Notice of Clinical Trial and/or Use of Investigational or Humanitarian Use Device Form including copy of FDA approval letter (Section E)
- Signed UMC Confidentiality form if you are not a member of the UMC workforce (Section E)
Step 2 - The PI will receive a preliminary UMC Site Approval letter in PDF format from the SRA to send to the Western IRB.
Step 3 - When the Western IRB has approved, a copy of the approval letter must be sent to SRA so that the SRA can generate a final SRA approval letter containing the approved dates of the study. Documents containing the changes made by the Western IRB must be forwarded along with their approval letter.
Step 4 - The activation of the research accommodation account (if applicable) will then take place and will match the dates on the approval given by the Western IRB.
Section C - Accommodation Account Process
The PI can request an accommodation account be established at the time documents are submitted and the PI will be notified of the initial establishment of the accommodation account but the account will not be activated until SRA receives a copy of the IRB approval (no matter which IRB it is). The established accommodation account will then be activated for the same time period as the study period approved by the IRB.
Renewal requests must also be submitted along with a copy of the IRB renewal approval letter that contains the new time period in order for the accommodation account to be continued for that time period. (Section D)
NOTE: UMC price increases may occur annually and principal investigators should develop budget requests to reflect this accordingly.
Section D - Amendments, Continuing Reviews and Study Closures/Conclusions
As changes are approved by the IRB to your research projects (e.g. major amendments, continuing reviews and study closure/conclusions), PIs should provide to the SRA copies of the IRB approval and paperwork reflecting changes in order to:
- Ensure that all of the individuals associated with the research project have appropriate access to systems data (if needed) and
- Receive continuing site approval from UMC.
Section E - Internal Forms That May Be Needed
The following forms can be downloaded by clicking on the specific line item:
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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