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Regulatory & Compliance Support

Pharmacogenomics_MCM_7845 -webAre you involved with human subject or animal research? The Regulatory and Compliance Office at the College of Pharmacy can help you navigate the numerous institutional, state and federal requirements for conducting research at the University of Florida. We provide assistance with approvals and agreements to ensure your research complies with all applicable regulations and policies.




Services Provided

  • Institutional Review Board (IRB) and Institutional Animal Care and Use Committee (IACUC)
    Our office can help you plan, prepare and submit documents related to study review, continuing review and study closure.
  • Research Administration and Compliance (RAC)
    Our office can help obtain confirmation of services and complete billing grids and study registration and initiation checklists.
  • ClinicalTrials.gov registration and compliance
    Our office can help you obtain your NCT number and maintain your study record on clinicaltrials.gov.

  • Data Use, Data Transfer, and Material Use agreements
    Let us help you coordinate and submit requests to the Office of Technology Licensing and Privacy Office.
  • Academic Honors Submission Review
    Our office reviews student requests for academic honors and publications to ensure the research is compliant and following IRB guidelines.
  • Sponsor Data Sharing and Publication Requirements
    We can assist with the submission of data and publications to public databases.

 

Office Contact:

Ben Burkley, MS
Regulatory Research Manager
HPNP Room 3309
352-273-5283
reg&comp@cop.ufl.edu

Contact the Regulatory & Compliance Office

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Request Forms:

If you are planning to do a Quality Improvement Project, please register with the Quality Improvement Performance Registry:

https://qipr.ctsi.ufl.edu

If you are planning to do research for Academic Honors, please complete the following form:

Complete Academic Honors and Publication Form

If you are requesting Epic Access, please complete the following form:

Complete Epic Form


Requirements for participating in a research study:

Find out what training you need to complete by using the Research Training Utility: http://research.ufl.edu/rtu.html

 

In order to submit a protocol for review to the IRB you must complete the following steps:

1) Register with myIRB (our electronic IRB submission portal):

http://irb.ufl.edu/myirb/registration-3rd.html

2) Complete the required IRB & RAC training:

http://irb.ufl.edu/irb01/irb-01/trainreq.html
http://rac.med.ufl.edu/training/rbc_live/certification/

3) For assistance with your IRB submissions be sure to add Ben Burkley to your study team in myIRB:

Add study staff

Trainings and Seminars:

Registration with myIRB and Regulatory and Compliance Q & A

https://my.cop.ufl.edu/player/index.php?m=1506100016

Helpful Links:

IRB-01 Home Page:

http://irb.ufl.edu/irb01.html

myIRB:

http://irb.ufl.edu/myirb/myirb.html

Research Administration and Compliance:

http://rac.med.ufl.edu/

Research Administration and Compliance Training:

http://rac.med.ufl.edu/training/rbc_live/

Scholarly Publishing and Academic Resources Coalition (SPARC) data sharing requirements for U.S. funding agencies:

http://datasharing.sparcopen.org/

COLLEGE OF PHARMACY RESEARCH AND COMPLIANCE OFFICE POLICY

Services

 

Notice of Proposed Rule Making Summary Document:

NPRM Summary Document

For more information about the Notice of Proposed Rule Making (NPRM) to the Common Rule, click this button:

Badge reads Human Subjects Protections Update