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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 2 months ago by Robert A Lewis

6.4 Emergency Use of a Test Article

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/22/2024 1.0 Purpose The purpose of this policy is to describe the requirements fo...

Updated 2 months ago by Robert A Lewis

5.5 Use of the Short Form Consent Document

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 11/30/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 2 months ago by Robert A Lewis

5.3 Use of a Remote Consent Process

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 2/9/2024 1.0 Purpose The purpose of this policy and procedure is to describe the Or...

Updated 2 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 2 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 2 months ago by Robert A Lewis

3.2 Data and Safety Monitoring

HRPP Policies and Procedures Section 3: Special Issues

Last Revised 12/22/2022 1.0 Purpose The purpose of this policy is to describe the Organization’s ...

Updated 2 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 2 months ago by Robert A Lewis

1.29 ClinicalTrials.gov Reporting

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

Last Revised: 3/20/2023 1.0. Purpose The purpose of this policy is to describe the requirements ...

Updated 2 months ago by Robert A Lewis

Frequently Asked Questions (FAQ)

Institutional Review Board (IRB) Guidebook

Below are a number of commonly asked questions. The questions will either provide an answer or wi...

Updated 2 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 2 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 2 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 2 months ago by Robert A Lewis

8.1 Review of Adverse Events and Adverse Device Effects

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

Last Revised: 10/2/2024 1.0 Purpose The purpose of this policy is to describe the process for rep...

Updated 2 months ago by Robert A Lewis

7.3 Data Registries

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

Last Revised: 4/16/2025 1.0. Purpose The purpose of this policy is to describe the Organization’...

Updated 2 months ago by Robert A Lewis

7.2 Collection, Storage and Use of Human Biological Material in Research

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

Last Revised: 9/24/2025 1.0 Purpose The purpose of this policy is to describe the Organizations r...

Updated 2 months ago by Robert A Lewis

6.3 Humanitarian Use Device (HUD)

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 5/26/2021 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 2 months ago by Robert A Lewis

6.2 Research Involving Investigational and Marketed Devices

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/23/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 2 months ago by Robert A Lewis

6.1 Research Involving Investigational and Marketed Drugs

HRPP Policies and Procedures Section 6: FDA Regulated Research/Drugs...

Last Revised: 1/24/2024 1.0 Purpose The purpose of this policy and procedure is to describe the O...

Updated 2 months ago by Robert A Lewis

5.4 Waiver of Requirement to Obtain Signed Consent Form

HRPP Policies and Procedures Section 5: Informed Consent

Last Revised: 12/11/2024 1.0 Purpose The purpose of this policy is to describe the Organization’s...

Updated 2 months ago by Robert A Lewis