Send Feedback
 
ORA FAQs
Is my study eligible for submission to WIRB?

Studies which meet the following criteria are eligible for submission to WIRB:

  • Meets the NIH definition of a clinical trial: “a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices)”
  • Phase II/III/IV multicenter clinical trial
  • Designed and written by the sponsor
  • Sponsor is a for-profit entity/company
  • Sponsor holds all INDs/IDEs
  • Not previously submitted to a Clarian or IU IRB


Studies which involve any of the following are NOT eligible for submission to WIRB:

  • Planned emergency research
  • Xenotransplantation
  • Gene transfer
  • Embryonic stem cells
  • VA hospital
  • Research funds from a federal or non-profit funding agency
  • Children
  • Waivers of informed consent

 


« Return to previous FAQs page