What is the Common Rule? 5 Helpful Resources to Learn More

Ashley Toy
Product Marketing Manager, Forte
June 11th, 2019

Earlier this year, the Department of Health and Human Services enacted some changes to the Federal Policy for the Protection of Human Subjects, better known as the ‘Common Rule’. This policy lays out the requirements for IRBs, informed consent and Assurances of Compliance for all research involving human subjects. The updates to the Common Rule included changes to the requirements for continuing review, exemptions and informed consent.

While the Common Rule is critical to ensuring the ethical conduct of human subjects research, it can be difficult to navigate the changing requirements. We’ve compiled some helpful resources to assist in getting to know the Common Rule.

  1. HHS Guidance
    The Department of Health and Human Services (HHS) is responsible for the publishing and enforcement of the Common Rule. Their website provides helpful information about the requirements and changes to the regulations that serve as a good starting point for familiarizing yourself with the history and statutes of the Common Rule.
  1. Office of Human Research Protections Webinars
    If you’re more of a visual learner, the OHRP has put together a series of six short (30 minutes or shorter) webinars to walk you through key topics related to the Common Rule, such as informed consent, IRB review and operations, and more.
  1. Organizational Resources and Policies
    Your organization may already have some resources and policies in place regarding the Common Rule and any institution specific guidelines for how it should be handled. Look for details on your organization’s ethics, compliance or IRB website for more details, or check out similar resources from other major research institutions like the University of Michigan, UCSF or Penn State.
  1. Revised Common Rule Quick Reference Info Sheet – Advarra
    This tip sheet encompasses all of the basic info you need to know in a handy two-page guide: one with quick reference info, and another with a flow chart to help you know what studies must comply with the Common Rule regulations. Print it off and hang it up for future use!
  1. 5 Things You Need to Know About the Revised Common Rule – AAMC
    This article from the Association of American Medical Colleges highlights five key takeaways from the revised Common Rule so you can be sure you know what you need to know.

What other resources have you found helpful in learning about the Common Rule? Feel free to share in the comments.

Compliance and Regulatory

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