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
https://grants.nih.gov/grants/guide/parent_announcements.htm
Beginning 01/05/2019:
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:
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-228.html
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Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.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]