As outlined in a post last fall, NIH released planned updates to application instructions and review criteria language for research grant applications submitted for due dates on or after January 25, 2019.
The updates include replacing the term “scientific premise” with “the rigor of the prior research” and changing “inclusion of children” to “inclusion across the lifespan.”
In addition to changes related to application instructions and review criteria, the “Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule)” will take effect on January 21, 2019.
The planned implementation includes changes to NIH applications in the following areas:
Existing definitions of human subjects exemptions have been modified
New exemptions that relate to secondary research requiring broad consent and limited IRB review for identifiable private information and/or biospecimens (7 and 8) have been added
Domestic multi-site studies will be required to use a single IRB
These changes will apply for all applications submitted on or after January 25, 2019. Other key changes to the common rule include: removing continuous review requirements for minimal risk research and new requirements for informed consent documentation. Details on the Common Rule provisions can be found in NOT-OD-19-050.