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 | 05.01.2023 |
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 | 10.01.2023 |
3.02 | Continuing Review | 10.01.2022 |
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 | 10.01.2023 |
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 | 08.22.2023 |
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 |