Advarra’s Approach to Common Rule Revisions

The Department of Health and Human Services (HHS)  has issued revisions to the “Federal Policy for the Protection of Human Subjects” (also known as the Common Rule) originally published in the Federal Register on January 19, 2017 (82 FR 7149). The initial effective date for most provisions of the Final Rule was January 19, 2018; however, that effective date has been delayed twice and is now January 21, 2019. Advarra will implement the Common Rule revisions, including the 3 burden-reducing provisions, on the new effective date of January 21, 2019.

Changes to the Common Rule are intended to modernize, simplify and enhance oversight for human subjects research. However, there has been significant confusion over the delayed implementation and whether some changes may be implemented immediately. HHS will permit institutions to implement 3 burden-reducing provisions prior to the January 21, 2019 effective date. These 3 provisions are:

• Implementing the revised definition of “research,” which deems 4 additional categories of activities not to be research
• Eliminating the requirement for annual continuing review of certain categories of research
• Eliminating the requirement for IRBs to review grant applications or other funding proposals related to the research

Over the next 6 months, Advarra will update policies, guidances, templates and IT systems to allow a smooth transition to the revised Common Rule. Advarra will provide updated information and guidance as the effective date draws nearer.

For more information, please contact Business Development.

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