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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

Noncompliance

Institutional Review Board (IRB) Guidebook Guidance & Resources

Study teams are responsible for reporting noncompliance to the IRB/ORA. This page serves as a gui...

Updated 4 months ago by Robert A Lewis

IRB Conference Content

Institutional Review Board (IRB) Guidebook Guidance & Resources

2025 Ethical Study Design IS Good Science (Susan Fish) The AI Middle Game: From Panic to Prop...

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 4 months ago by Robert A Lewis

Mental Health Considerations

Institutional Review Board (IRB) Guidebook Guidance & Resources

Explanation of Risks Be clear in application and ICD about risks associated with mental health a...

Updated 4 months ago by Robert A Lewis

Emergency Preparedness Resources

Institutional Review Board (IRB) Guidebook Guidance & Resources

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

Updated 4 months ago by Robert A Lewis

E-Signature Instructions

Institutional Review Board (IRB) Guidebook Guidance & Resources

The e-signature function in RSS is a way to electronically sign consent forms. It can be used if...

Updated 4 months ago by Robert A Lewis

Informed Consent Resources

Institutional Review Board (IRB) Guidebook Guidance & Resources

RSS Training for Consent Forms Consent Forms 101 Creating a Consent Form Functions within a...

Updated 4 months ago by Robert A Lewis

Relevant Links & Resources

Institutional Review Board (IRB) Guidebook Guidance & Resources

Regulations: Common Rule (45 CFR 46) eCFR: 21 CFR Part 50-Protection of Human Subjects eCFR...

Updated 4 months 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 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

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 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