Research Study Initiation Process


Initiating Clinical Research at Augusta University

The process for initiating clinical research at Augusta University is outlined below and can downloaded by clicking here.  This process is changing and becoming more efficient as new systems are developed and implemented.
Researchers are encouraged to refer back to this section frequently for the latest updates in the the research.
 

Highlighted Changes include the following:

1.  Required Approvals PRIOR to Submitting an IRB Application:

  • A full Biological Safety Application and Approval if the study involves:
    • Recominbant or Synthetic Nucleic Acids
    • Gene Transfer/Therapy
    • DNA Vaccines
    • Stem Cells
    • Select Agents & Toxins
  • A full Radiation Safety Application and Approval if the study involves:
    • Ionizing Radiation out of the standard of care procedures

 

2. Required Approvals PRIOR TO COMMENCING Research:

  • Biological Safety - if the study involves exposure to biological materials not specified above
  • Radiation Safety - if exposure is standard of care conducted during research
  • GR Medical Center - if the study involves patients, clinics, medical records, and/or billing information, budget approval is required
  • Chemical Safety - if the study involves Chemicals
  • Data Security & Storage - All studies must agree during IRB application to follow institutional policies and use secure research storage for all data

 


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