Notice Number: NOT-OD-18-228
Key Dates
Release Date: September 14, 2018
NOT-OD-18-116
NOT-OD-16-011
NOT-OD-16-012
NOT-OD-18-227
NOT-OD-18-229
NOT-HS-19-022
Issued by
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Purpose
The purpose of this Notice is to inform the biomedical and health services research communities of planned updates to application instructions and review criteria language for research grant applications submitted for due dates on or after January 25, 2019, and for research and development contract proposals submitted in response to solicitations posted on or after January 25, 2019.
The planned updates include changes to the following areas:
- The rigor of the prior research, formerly Scientific Premise (Note: Please refer to NOT-OD-16-011 for a list of activity codes excluded from the Enhancing Reproducibility policy)
- Inclusion reporting
- Protections for human subjects
Background
The upcoming updates clarify the current application instructions and review criteria by replacing the term "scientific premise" with "the rigor of the prior research" and adding instruction and review language so that "the rigor of the prior research" is addressed under Significance and Approach. In addition, the updates include new policy requirements for the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects (NOT-OD-18-116). The exemption language within the review criteria for the Protections for Human Subjects will be updated in preparation for the implementation of the Revised Common Rule.
Summary of Updates
Revisions to the application guide will be available through the How to Apply - Application Guide website by November 25, 2018. Significant updates are indicated in the tables below:
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Describe the strengths and weaknesses in the rigor of the prior research (both published and unpublished) that serves as the key support for the proposed project.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] |
Unless stated otherwise in the Funding Opportunity Announcement, reviewers will be asked to consider the revised review questions summarized in the table below. All active Funding Opportunity Announcements with due dates on or after January 25, 2019 will be updated with the revised language or a link to the revised language by November 25, 2018.
Section |
Criteria |
Current language |
Revised language |
Scored Review Criteria |
Significance |
Is there a strong scientific premise for the project? |
Is the prior research that serves as the key support for the proposed project rigorous? |
Scored Review Criteria |
Approach |
Not Applicable |
Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? |
Scored Review Criteria |
Approach |
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of children, justified in terms of the scientific goals and research strategy proposed? |
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address: 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed? |
Additional Review Criteria |
Protections for Human Subjects |
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will |
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will |
Additional Review Criteria |
Inclusion of Women, Minorities, and Individuals Across the Lifespan |
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. |
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. |
Note:
- Refer to NOT-OD-18-229 for updates to Career Development Award application instructions and review criteria language.
- Refer to NOT-OD-18-227 for updates to Fellowship Award application instructions and review criteria language.
Resources
- Inclusion Across the Lifespan - Policy Implementation website
- NIH Enhancing Reproducibility website (will be updated by November 25, 2018)
Inquiries
Please direct all inquiries to:
For questions about enhancing reproducibility contact: [email protected]
For questions about inclusion across the lifespan contact: [email protected]
For questions about NIH protections for human subjects in research contact: [email protected]
For questions about AHRQ protections for human subjects in research contact: [email protected]
and Human Services (HHS)
