Institutional Review Board (IRB) Policies

Unless otherwise noted, the following policies are in PDF format.

# Title Revised
– RSS Policy & Procedure Manual Signature Page
– Institutional Authority Page
1 Authority of the IRB
2 IRB Jurisdiction
3 Human Participants of Research
4 IRB Membership and Term
5 Attendance Requirements of IRB Members
6 IRB Member Training
7 Removal of IRB members
8 Meetings, Minutes, and Quorum 12/14/06
9 IRB Records and Confidentiality
10 IRB Review Criteria – New Studies
11 Initial Review Process – Full IRB Review 06/12/06
12 Documentation of IRB Committee Action for New Studies Receiving Full IRB Review 06/12/06
13 Informed Consent
14 Ongoing Monitoring and Continuing Review Process for Full IRB Reviewed Studies
15 Final IRB Approval (or Disapproval) of New Studies 06/12/06
16 Engagement by Members of Children's Workforce in Research Activities that Require IRB Review
17 Investigator and Research Team Member Training in the Protection of Human Subjects
18 Waiver or Modification of Informed Consent
19 Documentation of Informed Consent 09/04/07
20 Parental Permission and Child Assent
21 Documentation of Informed Consent in Language Minorities
22 Expedited Review
23 IRB Review of Modifications
24 Recruiting Potential Research Participants
25 Use of Investigational Products when Research Participant Enters Children's as a Second Institution
26 Adverse Event Reporting
27 Procedures for Determining Exemptions
28 Facilitated IRB Review for Studies Approved by the National Cancer Institute (NCI) Pediatric Central Institutional Review Board (PedCIRB) 06/12/06
29 Emergency Use of Investigational Drugs, Biologics or Medical Devices 09/04/07
30 Investigations of Non-Compliance
31 Research Using Protected Health Information
32 Principal Investigator's Appeal Process or Processs to Request a Reconsideration
33 Administrative Review of Unfunded Research Proposals 10/15/07
34 Research Repositories of Human Materials and/or Data
35 Prohibition on the Use of Enrollment Incentives to Individuals or Institutions to Recruit Participants in Research Studies
36 Payments to Take Part in Research
37 Suspension or Termination of IRB Approval of Research
38 Preliminary Review Process and IRB Submission Standards 06/12/06
39 Research Involving Children Who Are Wards of the State