The updated Common Rule went into effect January 21, 2019, after two 6-month delay periods. The updated rules for cooperative research (known as single IRB regulations) are effective January 20, 2020. ASIP has prepared a summary of key provisions contained in the updated Common Rule.  Additional resources on the updated Common Rule are available through the Office of Human Research Protections (OHRP), along with a resource page devoted to educational material on this updated regulation and has a set of Q and A’s. OHRP has also provided resources, including more information on the revised Common Rule requirement to post one consent form on a publicly available federal website. NIH has issued a Notice implementing the updated Common Rule, and as part of its Grants Policy resources, NIH updated its human subjects research website . 

For NIH grant applications with a due date of January 25 or later, there are c hanges to applications and progress reports . Applications now must address age-appropriate inclusion or exclusion of individuals in the research project proposal. Progress reports for awards from applications due January 25 ^th or later must submit de-identified participant data on sex/gender, ethnicity, race and age as of the date of enrollment. NIH has expanded its Inclusion of Children Policy to individuals of all ages and the expanded policy applies to competing applications submitted for due dates January 25, 2019 or later, contract solicitations issued on or after this date, and intramural studies initiated after this date. See NIH’s guide notice and recent Open Mike blog for more information.