2018 Requirements (effective 1/21/2019)

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

Topics Policies and Procedures Last Revised
General Administration (GA) Policies and Procedures Maintenance 11/16/2009
Training and Education for IRB Members and OPHS Staff 8/8/2017
Training and Education for Investigators 3/14/2019
Management of OPHS Staff 11/17/2009
IRB Member Conflict of Interest 1/27/2014
Signatory Authority 1/21/2019
Data Security 10/23/2015
Data Security Guidelines and Matrix 3/2016
IRB Reliance 11/4/2014
Organization (OR) Composition of the IRB 9/8/2014
IRB Membership 8/13/2019
Duties of IRB Members 10/1/2009
Function and Operations (FO) Research Protocol Submission Requirements 12/20/2011
Determination of Exemption 1/21/2019
IRB Meeting Administration 1/21/2019
Record Retention and Disposition 12/20/2011
Review of Research (RR) Initial Review 1/21/2019
Expedited Review 1/21/2019
Continuing Review 1/21/2019
Amendment Review 1/27/2014
Monitoring Ongoing Research 1/21/2019
Categories of Action 1/21/2019
Unanticipated Problems and Adverse Event Reporting 5/5/2017
Suspension and Termination of Human Subjects Research 11/20/2013
Protocol Deviations and Noncompliances 10/24/2014
Special Considerations (SC) Pregnant Women, Fetuses and Neonates 10/1/2009
Prisoners 6/1/2018
Children 10/1/2009
Communication and Notification (CO) Intrainstitutional Communication 1/21/2019
Informed Consent (IC) General Requirements and Documentation 1/21/2019
Waivers of Informed Consent 1/21/2019
Assent and Parent/Guardian Permission 1/21/2019
Quality Assurance (QA) Review for Purposes of Verification 9/1/2007

Pre-2018 Requirements

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

Topics Policies and Procedures Last Revised
General Administration (GA) Policies and Procedures Maintenance 11/16/2009
Training and Education for IRB Members and OPHS Staff 8/8/2017
Training and Education for Investigators 3/14/2019
Management of OPHS Staff 11/17/2009
IRB Member Conflict of Interest 1/27/2014
Signatory Authority 11/16/2009
Data Security 10/23/2015
Data Security Guidelines and Matrix 3/2016
IRB Reliance 11/4/2014
Organization (OR) Composition of the IRB 9/8/2014
IRB Membership 8/13/2019
Duties of IRB Members 10/1/2009
Function and Operations (FO) Research Protocol Submission Requirements 12/20/2011
Determination of Exemption 12/15/2015
IRB Meeting Administration 5/18/2017
Record Retention and Disposition 12/20/2011
Review of Research (RR) Initial Review 7/31/2017
Expedited Review 5/28/2013
Continuing Review 8/28/2013
Amendment Review 1/27/2014
Monitoring Ongoing Research 9/1/2007
Categories of Action 5/5/2017
Unanticipated Problems and Adverse Event Reporting 5/5/2017
Suspension and Termination of Human Subjects Research 11/20/2013
Protocol Deviations and Noncompliances 10/24/2014
Grant-Protocol Review 12/20/2011
Special Considerations (SC) Pregnant Women, Fetuses and Neonates 10/1/2009
Prisoners 6/1/2018
Children 10/1/2009
Communication and Notification (CO) Intrainstitutional Communication 10/1/2009
Informed Consent (IC) General Requirements and Documentation 5/28/2013
Waivers of Informed Consent 10/1/2009
Assent and Parent/Guardian Permission 10/1/2009
Quality Assurance (QA) Review for Purposes of Verification 9/1/2007