Revised Common Rule

Comprehensive training covering the Final Rule updates to the Common Rule.


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About this Course

This course is intended to help the research community understand the revisions to the Common Rule issued on 19 January 2017 with a general compliance date of 21 January 2019. The course provides a detailed review of the regulatory changes to 45 CFR 46, Subpart A, “Federal Policy for the Protection of Human Subjects” (the Common Rule).

The course’s Overview of the Final Rule Revisions module provides a comprehensive review for learners across the research enterprise. This module is then complemented by nine topic-focused modules that provide in-depth review of key areas affected by the revised Common Rule.

This course is based on the CITI Program’s Final Rule Resources and meets organizational needs for succinct Common Rule update training. CITI Program’s learning management system and reporting tools help organizations easily deliver and manage this training in response to the revised Common Rule.

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Language Availability: English, Spanish

Suggested Audiences: Researchers, Research Team Members, Institutional Review Boards (IRBs), Institutional/Signatory Officials, IRB Chairs, IRB Administrators and Staff, Human Subject Protection Staff, Students

Organizational Subscription Price: Included in base subscription
Independent Learner Price: $129 per person

Course Content

Overview of the Final Rule Revisions CME/CEU Badge

Comprehensive review of the Final Rule revisions to the Common Rule, including concise, understandable descriptions of changes to 45 CFR 46.101-46.124. Discusses why federal agencies updated the regulation, when the changes are effective, and how the changes affect current practice including revisions to definitions, informed consent, exempt and expedited research, secondary research, IRB membership, IRB operations, IRB review and records, and cooperative research.

Recommended Use: Required
ID (Language): 17909 (English), 19362 (Spanish)

New and Revised Definitions CME/CEU Badge

Describes changes to the definitions section at 45 CFR 46.102. Explores and discusses terms added in other subsections of the regulation and the Preamble, including each term’s application to research.

Recommended Use: Required
ID (Language): 17910 (English), 19363 (Spanish)

Informed Consent - Changes and Additions to Consent Processes CME/CEU Badge

Reviews changes to the informed consent process based on 45 CFR 46.116 in the revised Common Rule. This includes discussing the new “reasonable person standard” and “key information” requirements, revisions to waivers and alterations of informed consent, and updates to consent requirements for screening and/or recruiting. States new requirements associated with posting of informed consent forms.

Recommended Use: Required
ID (Language): 17911 (English), 19364 (Spanish)

Informed Consent - Changes to the Documentation of Consent CME/CEU Badge

Examines new required and additional elements of consent and the overall revisions made to requirements for consent forms, signatures, and waivers. Summarizes changes made to short form informed consent and describes the new waiver of documentation.

Recommended Use: Required
ID (Language): 17912 (English), 19365 (Spanish)

Understanding Broad Consent CME/CEU Badge

Gives an overview of broad consent, including limitations and when it may be used in research.

Recommended Use: Required
ID (Language): 17913 (English), 19366 (Spanish)

Secondary Research with Identifiable Information and Biospecimens CME/CEU Badge

Discusses how secondary research may be conducted under the revised Common Rule, including which biospecimens are subject to the regulation. Explores the revisions to exemption categories and how they expand options for secondary research. Examines new consent requirements for secondary research and the new concept of broad consent for secondary research.

Recommended Use: Required
ID (Language): 17914 (English), 19367 (Spanish)

Effect of Revised Common Rule on Research Roles CME/CEU Badge

Provides an overview of how the revised Common Rule may affect institutional operations and different research roles by reviewing regulatory changes and identifying which roles are affected. States where further training and revisions to policies may be required.

Recommended Use: Required
ID (Language): 17915 (English), 19368 (Spanish)

Updates to Exemption Categories CME/CEU Badge

Describes the revised Common Rule changes to the pre-2018 exemption categories and discusses the new exemption categories. Reviews when research subject to the requirements of Subparts B, C, and D may be exempted.

Recommended Use: Required
ID (Language): 17916 (English), 19369 (Spanish)

Limited IRB Review CME/CEU Badge

Gives an overview of the new process of limited IRB review by discussing when it is required, what authorities the IRB has to conduct it, and the IRB reviewer requirements for limited IRB review. Summarizes limited IRB review as a condition of certain exempt research review requirements.

Recommended Use: Required
ID (Language): 17917 (English), 19370 (Spanish)

Updates to Expedited Review Procedures CME/CEU Badge

Explains the changes to expedited review procedures under the revised Common Rule including updates on the usage and new documentation requirements. Reviews continuing review requirements for research initially approved via expedited review.

Recommended Use: Required
ID (Language): 17918 (English), 19371 (Spanish)

CE Credits and Units

To purchase CE credits and units, you need to be affiliated with an organization that subscribes to this course or buy it as an independent learner first. Learn more about CE/CME Credits.

AMA PRA Category 1 Credit
4 Credits
(8 CE certified modules)
1 June 2018
31 May 2021
CE Credit/Hour
4 Credits
(8 CE certified modules)
1 June 2018
31 May 2021
Contact Hour
4 Credits
(8 CE certified modules)
15 March 2019
14 March 2021
Other Participants
Certificate of Participation
4 Credits
(8 CE certified modules)
1 June 2018
31 May 2021


Who should take the Revised Common Rule course?

The Revised Common Rule course is intended for HRPP and IRB professionals, IRB members and chairs, Institutional Officials (IOs), and researchers and research team members.

Ideally suited for anyone who has already completed previous Human Subjects Research (HSR)/human research protections training and needs a review of the revisions to the Common Rule.

How long does the Revised Common Rule course take to complete?

This course consists of ten modules that contain detailed content, images, supplemental materials (such as references to the revised regulation), and quizzes. Learners may complete the modules at their own pace. Each module varies in length, so learners may require different amounts of time to complete based on their familiarity and knowledge of the topic.

What are the standard recommendations for learner groups?

CITI Program allows organizations to customize their learner groups, which means they can choose the content modules their learners need to complete. We will work with your CITI Program designated administrator to determine the learner groups that best fit your organizational needs.

The standard recommendation for the Revised Common Rule course is to designate the Overview of the Final Rule Revisions module as required in every learner group. The remaining topic-focused modules may be used to supplement the overview based on learner interest, role in research, or applicability to provide specific training on the topic(s).  For example, IRB members might need all of the topic-focused modules depending on institutional policies whereas a researcher doing a records-based research project might only need modules focused on secondary research and updates to definitions and research roles, but not the consent-focused modules.

What are the advantages of CITI Program's Revised Common Rule course?

The course provides in-depth, specific, peer-reviewed training written by experts.  As a standalone course, it gives organizations greater flexibility to meet the training needs of individuals as the organization transitions to the new Common Rule’s elements. Along with CITI Program's advantages, including our experience, customization options, cost effectiveness, and focus on organizational and learner needs, this makes it an excellent choice for Revised Common Rule training.

What is the Final Rule (Revisions to the Common Rule)?

On 19 January 2017, the U.S. Department of Health and Human Services (HHS) issued a Final Rule to update the current regulations at 45 CFR 46, Subpart A - "Federal Policy for the Protection of Human Subjects" (the Common Rule).  The revisions are intended to reflect changes in the types of human subjects research being conducted and the landscape of research since the original rule published in 1974 and later revised in 1991. The changes also aim to reduce the administrative and regulatory burden of the previous rule (known as the pre-2018 Requirements), as well as better protect human subjects in research.

When are the revisions to the Common Rule effective?

The general compliance date for the revisions to the Common Rule was 21 January 2019, for all changes except cooperative research (45 CFR 46.114). Changes to cooperative research requirements are effective 20 January 2020.

There is one exception to this general compliance date. During the delay period (from 19 July 2018 – 20 January 2019), institutions were allowed to implement three specific burden-reducing provisions from the revised Common Rule for certain research. However, any research that implemented the burden-reducing provisions during the delay period must comply with the 2018 Requirements from 21 January 2019 onward (that is, be transitioned fully to the revised Common Rule requirements).

Is CITI Program updating existing modules in other courses with the Final Rule revisions to the Common Rule?

Yes, the Final Rule revisions to the Common Rule were incorporated into the existing modules across all of CITI Program’s offerings automatically (and as previously discussed in Support Center articles and announcements) on 20 January 2019. The general compliance date was 21 January 2019 based on the Interim Final Rule published 19 June 2018.

How does this standalone course (Revised Common Rule) compare to the revisions to existing CITI Program modules?

This is a separate standalone course that focuses on and explains the revisions to the Common Rule.  This course is intended to be a resource for institutions who want to train individuals who have already completed CITI Program content, such as a Human Subjects Research (HSR) course, and need an update on the revisions to the Common Rule.

Learners who complete this course will receive training only on the revisions to the Common Rule – although when appropriate comparisons between the pre-2018 requirements version of the Common Rule and the 2018 Requirements (revised Common Rule) are made. CITI Program’s HSR series remains the primary resource to address the entirety of the Common Rule, which was updated to reflect the revisions to the Common Rule on 20 January 2019.

Is this course included with the Human Subjects Research (HSR) series?

This course is included in new organizational subscriptions ordered beginning 1 January 2019 and included in base subscriptions for renewing organizations (effective on their 2019 renewal date). For organizations that would like to include this course as part of their subscription prior to their 2019 renewal date, there is an additional price ($300 per year/per site).

This course is not included in the HSR course for independent learners. Independent learners would need to purchase this course separately from HSR courses.

It this new course just meant for IRB members who want a summary of the changes, or is it meant for all researchers in general?

This course is ideal for anyone that needs to be trained on the updated Common Rule and who may have previously taken a human subjects research course. This includes researchers, research team members, IRB chairs, IRB members, IRB administrators, and others as applicable.