Revised Common Rule Resources

OHRP has compiled a list of helpful resources related to the revised Common Rule. The revised Rule is referred to as the "revised Common Rule," the "2018 Requirements," or the "2018 Rule."

Use the links below to access these resources. Additional resources will be added to this page as they become available.

• Read the text of the revised Common Rule as it was published in the electronic Code of Federal Regulations on December 20, 2018, or download and print its corresponding unofficial PDF version
  Contact OHRP-EDU@hhs.gov for a printed hard copy
• Read the text of the revised Common Rule including the preamble as it was published in the Federal Register on January 19, 2017
• Read the Annotated Comparison of the pre-2018 Common Rule with the Revised Common Rule
• Read about the revised Common Rule including a chronological listing of the regulatory actions leading up to the general compliance date for the revised Common Rule
• Access revised Common Rule Q&As for answers to common questions and information about the transition provision in the revised Common Rule
• Access a webpage with information on the revised Common Rule’s clinical trial informed consent form posting requirement 
• Access a webpage with information about the revised Common Rule's Cooperative Research Provision (45 CFR 46.114)
• Access a webpage with updated Decision Charts that are consistent with the 2018 Requirements (i.e. the revised Common Rule)
• Access a webpage with information about the Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals
• Frequently Asked Question (FAQ) and Answer, titled “How should IRBs approach the continuing review of research that remains active beyond long-term follow-up or data analysis, but that is eligible for expedited review under categories 8(b) or 9 of the 1998 OHRP Expedited Review List in light of the new provision at §46.109(f)(1)(i) of the 2018 Requirements, which eliminates the requirement for such continuing review unless an IRB determines otherwise?”

Draft guidance documents related to the revised Common Rule:

• The Revised Common Rule Compliance Dates and Transition Provision (45 CFR 46.101(l))
• Activities Deemed Not to be Research: Public Health Surveillance, 2018 Requirements
• Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements
• When Continuing Review Is Not Required During the 6-Month Delay Period
• Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements