The UAHS Research Administration office has recently expanded its Regulatory Support to PIs in the University of Arizona Health Sciences including the Colleges of Medicine, Nursing, Pharmacy, and Public Health. We have dedicated staff available to guide and assist with the IRB and regulatory processes involving human subjects. Regulatory services include:
- Support to PIs and research staff with preparing, finalizing, and submitting completed applications and authorizations to the IRB (local and commercial) for new projects, modifications, deferrals, partial HIPAA waivers, consent form revisions, advertising, continuing review, safety/AE and protocol deviations.
- Assistance with processing regulatory start up documents (1572, financial disclosures, protocol signature page, site contact form, etc.), obtaining signatures and returning completed documents to Sponsor.
- Protocol and Informed Consent development, support, review, and expertise for investigator-initiated studies.
- Spanish translation of consent forms or other study handouts by a certified translator.
- Maintenance of electronic files and hard copy regulatory binders for assigned studies.
- Assistance with ClinicalTrials.gov submissions including closeout and posting of results for concluded studies.
- Assistance with Retrospective Chart Review Submissions.
Together, Julie Johnson and Danielle Gartner on our team have many years of experience with local IRB policies and processes and can assist you with your regulatory needs. This service is provided to all UAHS investigators; there is no separate or additional charge for these services. Contact (520) 626-4180 or (520) 626-7114 if you have any questions or would like assistance.