Mandatory Use of Click IRB

As of March 1, all work – new applications, modifications, renewals, etc. – will need to be submitted to the IRB via Click. The policies linked here may apply to studies submitted via the legacy system, studies submitted via Click IRB or both. Be sure to read the policies carefully before proceeding. For additional guidance, consult the Investigator Manual, available in the Click Library under the General tab.

All files are PDFs unless otherwise noted.

# Title Revised
- Institutional Authority Page  
IRB-1 Authority of the IRB   1/28/13
IRB-2 IRB Jurisdiction   1/28/13
IRB-3 Research Participants   1/28/13
IRB-4 IRB Membership and Term   1/28/13
IRB-5 Attendance Requirements of IRB Members   1/28/13
IRB-6 IRB Member Training   1/28/13
IRB-7 Removal of IRB Members   1/28/13
IRB-8 Meetings, Minutes and Quorum   1/29/14
IRB-9 IRB Records   1/28/13
IRB-010 IRB Review Criteria - New Studies   1/28/13
IRB-011 Full IRB Review of New Applications   1/28/13
IRB-12 See IRB-011
IRB-013 Informed Consent   1/28/13
IRB-14 Ongoing Monitoring and Continuing Review Process for Full IRB-Reviewed Studies   1/28/13
IRB-15 See IRB-011
IRB-016 Engagement in Non-Exempt Human Subjects Research Activities   1/28/13
IRB-017 Investigator and Research Team Member Training in the Protection of Human Subjects   1/28/13
IRB-18 Waiver or Modification of Informed Consent   1/28/13
IRB-019 Documentation of Informed Consent   1/28/13
IRB-020 Parental Permission and Child Assent   1/28/13
IRB-021 Informed Consent from Persons with Limited English Proficiency   6/23/15
IRB-22 Expedited Review   1/28/13
IRB-23 IRB Review of Modifications   1/29/13
IRB-24 Recruiting Potential Research Participants   8/27/14
IRB-25 Use of Investigational Products When Research Participant Enters Children's as a Second Institution   1/29/13
IRB-26 Adverse Event Reporting   1/29/13
IRB-27 Procedures for Determining Exemptions   1/29/13
IRB-28 Facilitated IRB Review for Studies Approved by the National Cancer Institute (NCI) Pediatric Central Institutional Review Board (PedCIRB)   6/3/14
IRB-29 Emergency Use of Drugs, Biologics and Devices   2/25/15
IRB-030 Reporting Incidents   5/2/13
IRB-31 Research Using Protected Health Information   1/29/13
IRB-32 Principal Investigator's Appeal Process or Processs to Request a Reconsideration   1/29/13
IRB-33 Administrative Review of Unfunded Research Proposals   1/29/13
IRB-034 Research Repositories of Human Materials and/or Data   1/29/13
IRB-35 Prohibition on the Use of Enrollment Incentives to Individuals or Institutions to Recruit Participants in Research Studies   1/29/13
IRB-36 Payments to Take Part in Research   1/8/14
IRB-37 Suspension or Termination of IRB Approval of Research   1/29/13
IRB-038 IRB Submission Standards for New and Continuing Review Applications   1/29/13
IRB-39 Research Involving Children Who Are Wards of the State   1/29/13
IRB-040 Compassionate Use of an Investigational Device   1/29/13
IRB-041 Significant/Nonsignificant Risk Determinations for Investigational Devices   1/29/13
IRB-042 Consultation Process for New Full Applications   1/29/13
IRB-043 Compensation for Injuries Sustained by Research Participants  
IRB-044 IRB Fee Policy  
IRB-045 Submission of Data to GWAS Repositories   8/9/13
OIA-001 Translational Costs for Research Documents   2/7/13
OIA-001 OIA-001 Application (DOC) 2/7/13