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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

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

 

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

 

Presentations

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

 

Presentations

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)

 

 

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.