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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 and set to take effect in July 2018. 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 preparation for the revised Common Rule.

Note: CITI Program is monitoring regulatory developments (such as the Notice of Proposed Rulemaking to delay a further six months and allow three burden-reducing provisions) and will update the course accordingly.

Language Availability: English

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: $250 per year/per site (introductory price through 30-June-2018)
Independent Learner Price: $129 per person


Course Content


Overview of the Final Rule Revisions New Content

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)

New and Revised Definitions New Content

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)

Informed Consent - Changes and Additions to Consent Processes New Content

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)

Informed Consent - Changes to the Documentation of Consent New Content

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)

Understanding Broad Consent New Content

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

Recommended Use: Required
ID (Language): 17913 (English)

Secondary Research with Identifiable Information and Biospecimens New Content

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)

Effect of Revised Common Rule on Research Roles New Content

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)

Updates to Exemption Categories New Content

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)

Limited IRB Review New Content

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)

Updates to Expedited Review Procedures New Content

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)


FAQs


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 last revised in 1991. The changes also aim to reduce the administrative and regulatory burden of the current rule (known as the pre-2018 rule), as well as better protect human subjects in research.

When is the Final Rule effective?

The effective and compliance date of the revised Common Rule was 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”). The effective and compliance date is now 19 July 2018 for all changes except cooperative research (45 CFR 46.114). Changes to cooperative research requirements were not delayed and will be effective on 20 January 2020.

The current (also referred to as the pre-2018 rule) Common Rule remains in effect until the effective and compliance dates. Prior to the effective and compliance date, CITI Program modules will reflect the current (pre-2018) Common Rule.

Further interim rules and delays are possible. The Interim Final Rule states that it is meant to provide additional time to prepare for implementing the Final Rule, as well as time for potential further regulatory delays. A Notice of Proposed Rulemaking (NPRM) was published 20 April 2018 that proposes to delay the effective compliance date an additional six months and allow the implementation of three burden-reducing provisions during that delay period.

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 will be incorporated into the existing modules across all of CITI Program’s offerings automatically (and as previously discussed in Support Center articles and announcements) on or about the effective/implementation date. The current general effective date is 18 July 2018 based on the Interim Final Rule. However, further delay may be forthcoming from the government and we will update the modules accordingly.

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

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

Learners who complete this course will receive training only on the revisions to the Common Rule, although for context when appropriate comparisons between the pre-2018 Common Rule and the revised Common Rule are made. The CITI Program’s HSR series remains the primary resource to address the entirety of the Common Rule, and as noted will reflect the revisions to the Common Rule once those are effective.

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

This course is not included in HSR as part of the Base Subscription.

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.