2018 Requirements (effective 1/21/2019)

These policies and procedures apply to protocols approved on or after January 21, 2019.

TopicsPolicies and ProceduresLast Revised
General Administration (GA)Policies and Procedures Maintenance1/15/2021
Training and Education for IRB Members and OPHS Staff7/18/2023
Training and Education for Investigators11/07/2025 REVISED
Management of OPHS Staff11/17/2009
IRB Member Conflict of Interest1/27/2014
Signatory Authority1/21/2019
Data Security7/15/2022
Data Security Guidelines and Matrix7/2022
IRB Reliance4/25/2024
Organization (OR)Composition of the IRB5/21/2021
IRB Membership1/9/2023
Duties of IRB Members10/1/2009
Function and Operations (FO)Research Protocol Submission Requirements12/20/2011
Determination of Exemption4/28/2021
IRB Meeting Administration1/21/2019
Record Retention and Disposition7/2024
Billing for IRB Services12/5/2025 NEW
Review of Research (RR)Initial Review7/29/2021
Expedited Review1/21/2019
Continuing Review1/21/2019
Amendment Review4/6/2022
Monitoring Ongoing Research1/21/2019
Categories of Action1/21/2019
Unanticipated Problems and Adverse Event Reporting9/1/2024
Suspension and Termination of Human Subjects Research11/20/2013
Protocol Deviations and Noncompliances12/6/2024
Special Considerations (SC)Pregnant Women, Fetuses and Neonates10/1/2009
Prisoners6/1/2018
Children10/1/2009
Communication and Notification (CO)Intrainstitutional Communication1/21/2019
Informed Consent (IC)General Requirements and Documentation1/21/2019
Waivers of Informed Consent1/21/2019
Assent and Parent/Guardian Permission1/21/2019
Quality Assurance (QA)Review for Purposes of Verification9/1/2007

Pre-2018 Requirements

These policies and procedures apply to protocols approved before January 21, 2019.

TopicsPolicies and ProceduresLast Revised
General Administration (GA)Policies and Procedures Maintenance1/15/2021
Training and Education for IRB Members and OPHS Staff7/18/2023
Training and Education for Investigators11/07/2025 REVISED
Management of OPHS Staff11/17/2009
IRB Member Conflict of Interest1/27/2014
Signatory Authority11/16/2009
Data Security7/15/2022
Data Security Guidelines and Matrix7/2022
IRB Reliance4/25/2024
Organization (OR)Composition of the IRB5/21/2021
IRB Membership1/9/2023
Duties of IRB Members10/1/2009
Function and Operations (FO)Research Protocol Submission Requirements12/20/2011
Determination of Exemption12/15/2015
IRB Meeting Administration5/18/2017
Record Retention and Disposition7/2024
Review of Research (RR)Initial Review7/29/2021
Expedited Review5/28/2013
Continuing Review8/28/2013
Amendment Review4/6/2022
Monitoring Ongoing Research9/1/2007
Categories of Action5/5/2017
Unanticipated Problems and Adverse Event Reporting5/5/2017
Suspension and Termination of Human Subjects Research11/20/2013
Protocol Deviations and Noncompliances12/6/2024
Grant-Protocol Review12/20/2011
Special Considerations (SC)Pregnant Women, Fetuses and Neonates10/1/2009
Prisoners6/1/2018
Children10/1/2009
Communication and Notification (CO)Intrainstitutional Communication10/1/2009
Informed Consent (IC)General Requirements and Documentation5/28/2013
Waivers of Informed Consent10/1/2009
Assent and Parent/Guardian Permission10/1/2009
Quality Assurance (QA)Review for Purposes of Verification9/1/2007