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Institutional Review Board

POLICIES & PROCEDURES

P&P #	POLICY TITLE	DATE UPDATED
1.01	Federal, State and University Regulations Related to the IRB	02.12.2020
1.02	Definition of Human Subjects Research	02.11.2020
1.03	Administrative Oversight of the HRPP	02.06.2020
1.04	Conflicts of Interest	02.06.2020
1.05	Human Subject Protection Educational Policies and Resources	02.07.2020
1.06	Role of Ancillary Compliance Offices in HRPP Function	02.08.2020

P&P #	POLICY TITLE	DATE UPDATED
2.01	IRB Authority	02.06.2020
2.02	IRB Membership: Composition, Roles & Responsibilities and Performance	11.20.2020
2.03	Criteria for IRB Approval of Research	11.19.2020
2.04	Schedule of Meetings	11.19.2020
2.05	IRB Records	11.19.2020
2.06	IRB Protocol Review Fee Policy	11.19.2020

P&P #	POLICY TITLE	DATE UPDATED
3.01	Conducting Review of New Applications	09.13.2022
3.02	Continuing Review	02.12.2020
3.03	Modification to an Approved Protocol	02.11.2020
3.04	Post-Review Notifications	02.07.2020
3.05	Quality Assurance/Quality Improvement Projects	02.07.2020

P&P #	POLICY TITLE	DATE UPDATED
4.01	Assessment of Risks to Subjects	02.08.2020
4.02	Adverse Events & Unanticipated Problems Involving Risks to Subjects and Others	09.13.2022
4.03	Protocol Deviations & Non-compliance by Investigators	09.13.2022
4.04	Other Reportable New Information	09.13.2022
4.05	Confidentiality of Data and HIPAA Privacy Rule	02.12.2020
4.06	Research Data Protection Plan	02.08.2020
4.07	Guidance on ClinicalTrials.gov Registration	02.09.2022
4.08	Emergency Use Notification and Reporting Procedures	02.08.2020
4.09	Humanitarian Use Devices (HUD) for Clinical Treatment	06.06.2020
4.10	Use of Discarded Human Tissue	02.08.2020
4.11	Unspecified Future Research	02.08.2020
4.12	Additional Requirements for Department of Defense (DoD) Research	02.12.2020

P&P #	POLICY TITLE	DATE UPDATED
5.01	Further Investigator Responsibilities	02.07.2020
5.02	Record Keeping by Investigators	02.07.2020
5.03	Research Personnel Definition, Roles & Training	12.09.2021

P&P #	POLICY TITLE	DATE UPDATED
6.01	Informed Consent	08.18.2022
6.02	Child Assent	02.07.2020
6.03	Pregnant Partners	02.07.2020
6.04	Verbal Informed Consent and Verbal HIPAA Authorization	05.03.2021

P&P #	POLICY TITLE	DATE UPDATED
7.01	Subject Population	02.12.2020
7.02	Subject Entry Site Approval	02.07.2020
7.03	Subject Payment	02.07.2020
7.04	Recruitment & Advertisement for Subjects	06.27.2020
7.05	Educational Material for Subjects	02.07.2020

P&P #	POLICY TITLE	DATE UPDATED
8.01	IRB Reliance	12.08.2022
8.02	Relying on the NCI CIRB	12.06.2022
8.03	Relying on the PETAL cIRB	12.06.2022
8.04	Obsolete
8.05	International Research	02.07.2020
8.06	Research Conducted Outside the Jurisdiction of the State of Louisiana	02.07.2020

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