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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 January 2018. They were developed with the assistance of expert authors and peer reviewers. We will continue to add resources throughout the year so be sure to check back often. We will also be updating CITI Program courses to reflect the revisions by January 2018.

 

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

 

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

 

Note: These resources are based on the Final Rule as published in the Federal Register on 19 January 2017. The Final Rule is still under review. If there are any changes, the CITI Program will update these resources as applicable.