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New Protocol Form

All human subjects research projects must be reviewed and approved before human subjects are recruited or involved in research activities. All projects must be presented on an IRB Application for New Protocols or, if appropriate, completion of an Application for Exemption Form.

APPLICATIONS WILL NOT BE REVIEWED BEFORE THEY ARE COMPLETE.

The following materials must be submitted in order for the application to be complete:

  • The IRB Application for New Protocols, completed, signed by the RPI, and submitted either electronically or by hard copy.
  • The complete grant application, contract, deliverables, or other documentation of funding application for externally funded research.
  • Relevant consent forms and scripts.
  • All measures, such as surveys, interview protocols, inventories, and descriptions of experiments that are not already included on the New Protocol Form under Procedures. Draft versions of these items are acceptable if the final versions are not available.
  • Recruiting Materials.
  • As applicable, please complete the Research Team Attachment Form to list all individuals engaged in the research study, including those from other institutions.
  • As applicable, documentation of permissions and approvals from outside institutions and their IRBs, or a statement about the status of these approvals, if pending.
  • As applicable, Appendix A (Research Equipment Form), with attachments.
  • As applicable, Appendix B (Drug and Chemical Usage Form and Device Usage Form), with attachments.
  • As applicable, Appendix C (Biological Materials Form), with attachments.