NIH recently provided updated information for 2019 submissions.
First is the announcement of changes to R01, R03, and R21 Parent Announcements which can be found on the NIH website at
|Activity Code(s)||Title||Announcement Number|
|R01||Clinical Trial Required||PA-19-055|
|R01||Clinical Trail not allowed||PA-19-056|
|R03||Clinical Trial not allowed||PA-19-052|
|R21||Clinical Trial Required||PA-19-054|
|R21||Clinical Trial not allowed||PA-19-053|
If you are submitting an application in 2019 you will want to familiarize yourself with some changes to the instructions and review criteria which can be found in the following announcement:
Second, for due dates on or after January 25, 2019, updates include changes to:
- The rigor of the prior research, formerly Scientific Premise
- Inclusion reporting
- Protections for human subjects
Summary of Updates – please refer to the full notice for additional information.
Revisions to the application guide (https://grants.nih.gov/grants/how-to-apply-application-guide.html) will be available as of November 25, 2018.
|Form||Section||Heading||Current language||Revised language|
|Research Plan||Research Strategy||Significance||Describe the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of your application.||Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.|
|Research Plan||Research Strategy||Approach||Not Applicable||Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project.|
|Human Subjects and Clinical Trials Information||Section 2 – Study Population Characteristics||2.4 Inclusion of Women, Minorities, and Children||2. Inclusion of Children
[References to the Inclusion of Children in Clinical Research policy]
|2. Inclusion Across the Lifespan
[References to Inclusion of Children replaced with Inclusion Across the Lifespan]