2018 Common Rule

On January 21, 2019, revisions to the Federal Policy for the Protection of Human Subjects go into effect. This new version of the “Common Rule,” as it is typically known, represents the first revision to the rule since its publication in 1991.

  • The new rule is referenced as the “2018 Common Rule” by regulatory agencies and in the VCU IRB’s policies, resources, and forms.
  • The previously effective rule is referenced by the VCU IRB as the “Pre-2018 Common Rule.”

Overview of the 2018 Common Rule Changes – a summary of the major changes and their impact on VCU investigators

2018 Common Rule Conversion Instructions & Guidance – information on what to do to transition your research to the 2018 Common Rule

Resources:

  1. VCU Office of Research and Innovation Webpage

    Keep an eye on the web page’s Human Research page and the ORSP blog for updates. We are updating nearly all of our written policies and procedures, adding pages with instructions for conversion to the new rule , and updating guidance documents to address the provisions of the new rule.

  2. VCU Office of Research and Innovation Staff

    Individual Questions: ORSP staff are ready to help you understand what's changing and how it might impact your research. Contact the IRB Coordinator assigned to your study or ORSP for assistance.

    Group Presentations: Our staff is also available to present to any VCU group about the 2018 Common Rule! Contact us at ORSP@vcu.edu or 804-828-0868 to discuss how we can assist your group in understanding these changes.

  3. Office for Human Research Protections (OHRP)

    The US Department of Health and Human Services’ Office for Human Research Protections (OHRP) maintains a webpage of educational materials to assist the regulated community in understanding, implementing, and complying with the revised Common Rule. Currently, there are videos, FAQs, and guidance documents available. OHRP also has a webpage with the official regulatory text of the revised Common Rule that includes links to the details of the final rule and a timeline of the events leading to the new rule.

  4. Public Responsibility in Medicine & Research (PRIM&R)

    PRIM&R, the primary professional organization for Human Subjects Protections Professionals, maintains a publicly accessible web page “Focus on the Revised Common Rule.” The page includes a number of quick links to key regulatory updates, resources and tools, all of which help to paint a full picture of the revised rule and its impact.

  5. Collaborative Institutional Training Initiative (CITI Program)

    The CITI Program maintains a webpage with a comprehensive set of resources related to the revised Common Rule.

    VCU has added a new optional course in CITI for researchers who are interested in learning more about what the revisions include. To access CITI's Revised Common Rule course:

    1. From your CITI log-in page, click the View Courses button under Virginia Commonwealth University.
    2. Under the Learner Tools for VCU section, click Add a Course.
    3. The Revised Common Rule is under Question 17.

    The CITI Human Subjects Protection courses will also be modified on/around January 20, 2019 to update the content of the modules affected by the revised Common Rule.