CITI Program has created the resources below to help the research community understand the revisions to the Common Rule issued on 19 January 2017 and set to take effect in July 2018. They were developed with the assistance of expert authors and peer reviewers. We will be updating these resources and CITI Program courses to reflect the revisions and any regulatory changes accordingly.

 

Overview of the Final Rule Revisions
New and Revised Definitions
Comprehensive Guide to Informed Consent Changes
Secondary Research with Identifiable Information and Biospecimens
Revisions to Roles – Changes Relevant to HRPP Professionals (IRB Administrators and Staff), IRB Members, and Researchers
Changes to Exempt Determination Process
Updates to Expedited Review Procedures
Final Rule Impact on IRB and Institutional Operations

 

Overview of the Final Rule Revisions

Download all Overview materials

 

Handouts

Overview of the Final Rule Revisions

Handout 1  – Overview of the Status of Final Rule Revisions

Handout 2  – Overview of Important Changes to the Final Rule

Handout 3 – Presentation slides – Introduction

Handout 4 – Presentation slides – Overview of 46.101-46.115

Handout 5 – Presentation slides – Overview of 46.116-46.124

Handout 6 – Presentation slides – Comprehensive Overview

 

Presentations

Introduction – Provides a brief introduction and overview of the revisions to the Common Rule

Overview of 46.101-46.115 – Covers changes to sections 46.101-46.115

Overview of 46.116-46.124 – Covers changes to informed consent document and process sections

Comprehensive Overview – Provides a comprehensive review of the revisions to the Common Rule as published in the Final Rule

 

New and Revised Definitions

Download all New and Revised Definitions materials

 

Handouts

New and Revised Definitions

Handout 1 – Final Rule Revisions to Definitions

Handout 2 – Presentation slides – New and Revised Definitions

 

Presentation

New and Revised Definitions – Offers an overview of the Final Rule’s revisions to the Definitions section (46.102)

 

Comprehensive Guide to Informed Consent Changes

Download all Informed Consent Changes materials

 

Handouts

Comprehensive Guide to Informed Consent Changes

Handout 1 – New Final Rule Revisions to Informed Consent

Handout 2 – Understanding Broad Consent

Handout 3 – Presentation slides – Comprehensive Guide to Informed Consent

 

Presentation

Comprehensive Guide to Informed Consent Changes – Gives an overview of the Final Rule’s revisions to the informed consent sections (46.116 and 46.117)

 

Secondary Research with Identifiable Information and Biospecimens

Download all Secondary Research materials

 

Handouts

Secondary Research with Identifiable Information and Biospecimens

Handout 1 – Options for Conducting Secondary Research Using Information or Biospecimens Under the Final Rule

Handout 2 – Final Rule Key Concepts and Requirements for Secondary Research

Handout 3 – Secondary Research Under the Final Rule: New Consent Form Language Requirements with Examples

Handout 4 – Presentation slides – Secondary Research with Identifiable Information and Biospecimens

 

Presentation

Secondary Research with Identifiable Information and Biospecimens – Gives an overview of the options for secondary research under the Final Rule

 

Revisions to Roles – Changes Relevant to HRPP Professionals (IRB Administrators and Staff), IRB Members, and Researchers

Download all Revisions to Roles materials

 

Handouts

Revisions to Roles – Changes Relevant to HRPP Professionals (IRB Administrators and Staff), IRB Members, and Researchers

Handout 1 – Revisions to Research Roles Under the Final Rule

Handout 2 – Who Can Review? Understanding Reviewer Requirements under the Final Rule

 

Changes to Exempt Determination Process

Download all Changes to Exempt Determination Process materials

 

Handouts

Changes to Exempt Determination Process

Handout 1 – Understanding the Final Rule: Exempt Review Scenarios

Handout 2 – Overview of Changes to Exempt Determination Process

Handout 3 – New Process for Exempt Review: Limited IRB Review

Handout 4 – Presentation slides – Changes to Exempt Categories

 

Presentation

Changes to Exempt Categories – Gives an overview of the changes to exempt categories under the Final Rule

 

Updates to Expedited Review Procedures

Download all Updates to Expedited Review materials

 

Handouts

Updates to Expedited Review Procedures

Handout 1 – New Documentation Requirements for Expedited Review

Handout 2 – Expedited Review Can Be Used for Limited IRB Review

Handout 3 – What’s New With Continuing Review for Expedited Research?

Handout 4 – Presentation slides – Updates to Expedited Review Procedures

 

Presentation

Updates to Expedited Review Procedures – Gives an overview of the updates to expedited review procedures under the Final Rule

 

Final Rule Impact on IRB and Institutional Operations

Download all Final Rule Impact on IRB and Institutional Operations materials

 

Handouts

Final Rule Impact on IRB and Institutional Operations

Handout 1 – Common Rule Agencies and Departments

Handout 2 – Institutional Implementation of Final Rule

 

 

Note: These resources are based on the Final Rule and Interim Final Rule issued by the U.S. Department of Health and Human Services (HHS) at 45 CFR 46, Subpart A – “Federal Policy for the Protection of Human Subjects” (the Common Rule) on 19 January 2017 and 22 January 2018, respectively. The effective and compliance dates of the revised Common Rule were delayed for six months by the Interim Final Rule as published on 22 January 2018 (“Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects”), which are now 19 July 2018. A Notice of Proposed Rulemaking (NPRM) was published 20 April 2018 that proposes to delay the effective compliance date an additional six months until 21 January 2019. This NPRM would allow regulated parties to implement three specific provisions from the revised Common Rule during the delay period.