STEPS TO STUDY ACTIVATION

Submit to IU IRB

An Institutional Review Board (IRB), sometimes called an Ethics Review Committee, is responsible for reviewing and approving, or disapproving, research with human subjects. IRBs may be associated with a research university, such as the IU IRBs, or they may be independent (sometimes called commercial or central IRBs), such as WCG, Advarra, or the NCI’s Central IRB (CIRB). All human subjects research conducted at IU or at one of its clinical partners, including IU Health and Eskenazi Health, must receive Institutional Review Board (IRB) approval before the research can begin. 

Sponsor or funding requirements may propose which IRB (IU IRBs or external IRBs such as WCG or Advarra) should review a particular study, however, the IU IRB must still agree to this plan. This means that even if you plan to use another IRB, you must first submit an application to the IU IRB to start this process (referred to as a Request to Rely). The IU IRB must approve the Request to Rely before the study may be submitted to another IRB for review.

Resources

The IU HRPP website offers a variety of resources to assist you in your IU IRB submissions, including:

  • How to determine whether your project is human subjects research
  • What level of IRB review your project might require
  • How to submit a new project for IU IRB review or how to submit a Request to Rely on another IRB
      • All IU IRB submissions are completed in Kuali Protocols, a cloud-based online IRB submission system. To access Kuali Protocols, you must have an IU computing account. If you do not already have an IU computing account, you will need an IU faculty or staff member to sponsor one for you. See the IU Affiliate Account page for more information.
  • Who may serve as a Principal Investigator (PI)
  • IRB application reference documents and IRB submission related templates (including Protocol and Informed Consent Document or HIPAA Authorization Document)
      • To obtain IRB submission related documents for oncology studies, please contact the Simon Cancer Center at crosrc@iupui.edu.

Contacts

  • For questions about the IU IRB submission and review process, contact the IU HRPP at irb@iu.edu.
  • IRB Approval is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.