Skip to main content

Recently Updated Pages

1.32 Confidentiality of the Review Process

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Reviewed: 11/26/2025 1.0 Purpose The purpose of this policy is to describe the Organization’...

Updated 4 months ago by Robert A Lewis

Community Partners

Institutional Review Board (IRB) Guidebook Training

All individuals that work on human subject research projects must complete human subject research...

Updated 5 months ago by Robert A Lewis

Emergency Preparedness Resources

Institutional Review Board (IRB) Guidebook Guides

Emergency Preparedness / Continuity of Operations Plan (EP/COOP)

Updated 5 months ago by Robert A Lewis

Adverse Event Reporting

Institutional Review Board (IRB) Guidebook Procedures

Adverse Events (AEs) An Adverse Event is defined by the NIH as: Any untoward or unfavorable medic...

Updated 5 months ago by James Geiger

8.5 Noncompliance by the IRB or Other Components of the HRPP

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

Last Revised: 5/9/2023 1.0 Purpose The purpose of this policy is to describe the process for revi...

Updated 5 months ago by Robert A Lewis

8.4 Review of Noncompliance by the PI, Study Team, and/or Subjects

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for revi...

Updated 5 months ago by Robert A Lewis

7.1 Banking Human Biological Material

HRPP Policies and Procedures Section 7: Human Biologic Materials and...

Last Revised: 10/7/2025 HRPP Policy 7.1 has been merged with HRPP policy 7.2 Please refer to HRPP...

Updated 5 months ago by Robert A Lewis

4.5 Local 407 Panel Review of Pediatric Research

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last revised: 2/19/2018 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 5 months ago by Robert A Lewis

3.14 Phase I and First-in-Human Studies

HRPP Policies and Procedures Section 3: Special Issues

Last Revised: 2/5/2018 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

Updated 5 months ago by Robert A Lewis

1.33 Posting of Clinical Trial Consent Forms

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 9/18/2019 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 5 months ago by Robert A Lewis

ClinicalTrials.gov (CT.gov)

Institutional Review Board (IRB) Guidebook Procedures

Check back to this page for more updates regarding clinicaltrials.gov information. Please conta...

Updated 5 months ago by James Geiger

8.7 Reporting Incidents to Institutional Officials and Federal Agencies

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

Last Revised: 8/1/2023 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 5 months ago by Robert A Lewis

8.3 Review of Unanticipated Problems Involving Risk to the Subject or Others

HRPP Policies and Procedures Section 8: AEs, Unanticipated Problems ...

Last Revised: 8/6/2025 1.0 Purpose The purpose of this policy is to describe the process for repo...

Updated 5 months ago by Robert A Lewis

2.1 Submission for Items for Review by the IRB

HRPP Policies and Procedures Section 2: Process of Review

Last Revised: 7/19/2022 1.0 Purpose The purpose of this policy is to describe Organization’s requ...

Updated 5 months ago by Robert A Lewis

1.30 Use of the Rapid Response IRB

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 10/17/2024 1.0 Purpose The purpose of this policy is to describe the constitution o...

Updated 5 months ago by Robert A Lewis

1.23 HRPP Training Requirements

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 8/13/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 5 months ago by Robert A Lewis

1.22 Assessment of the Effectiveness and Efficiency of the HRPP

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 9/25/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 5 months ago by Robert A Lewis

1.16 ORA Record Keeping Requirements

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 01/17/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 5 months ago by Robert A Lewis

1.9 Resources Necessary to Protect Subjects

HRPP Policies and Procedures Section 1: General Human Research Prote...

Last Revised: 1/16/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 5 months ago by Robert A Lewis

Emergency Preparedness/Continuity of Operations Plan (EP/COOP)

HRPP Policies and Procedures

Last Revised: 9/1/2023 1.0 Emergency Preparedness /Continuity of Operations Plan (EP/COOP) 1.1. ...

Updated 5 months ago by Robert A Lewis