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Training

Sponsored Programs Administration Guide...

SPAdmin offers a number of formal and informal educational opportunities for departmental adminis...

Updated 2 days ago by Lori A Stewart

4.4 Research Involving Children

HRPP Policies and Procedures Section 4: Vulnerable Populations

Last revised: 9/3/2025 1.0 Purpose The purpose of this policy is to describe the Organization’s r...

Updated 1 week ago by Robert A Lewis

Short Forms

Institutional Review Board (IRB) Guidebook Forms

A Short Form may be used when a subject/LAR who cannot understand English is unexpectedly encount...

Updated 2 weeks 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 2 weeks ago by James Geiger

5.7 Obtaining Informed Consent from Non-English Speaking Persons, or Persons with Additional Needs or Vulnerabilities

HRPP Policies and Procedures Section 5: Informed Consent

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

Updated 2 weeks ago by Robert A Lewis

6.5 Expanded Access to Investigational Drugs and Devices for Treatment Use

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

Last Revised: 1/23/2024 1.0 Purpose 1.1. The purpose of this policy and procedure is to describe...

Updated 2 weeks ago by Robert A Lewis

8.6 Study Hold, Suspension, and Termination

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

Last Revised: 1/20/2023 1.0 Purpose The purpose of this policy is to describe the process for stu...

Updated 2 weeks ago by Robert A Lewis

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 2 weeks 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 2 weeks 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 2 weeks 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 weeks 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 weeks 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 weeks 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 weeks 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 weeks 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 weeks 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 weeks 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 weeks 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 weeks ago by Robert A Lewis

Recruitment templates

Institutional Review Board (IRB) Guidebook Forms

HRPP policy to review: #3.5 Subject Recruitment Through Advertisements Recruitment Type Format...

Updated 2 weeks ago by James Geiger