Dear Colleagues,

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Dear Colleagues,
NIH has been active in updating its policies, procedures and forms. Please consider the following topical
announcements and reminders when crafting your applications, progress reports, and administering your
awards.
The updates focus on the following areas:
1. Rigor and transparency in research
2. Vertebrate animals
3. Inclusion reporting
4. Data safety monitoring
5. Research training
6. Appendices
7. Font requirements
8. Biosketch clarifications
9. New form added: PHS Assignment Request Form
10. Changes to Post-Award Forms and Instructions
11. Revised SF424 Application Guides and Supplemental Instructions
12. Publication of the Revised NIH Grants Policy Statement
13. Research Performance Progress Reports (RPPR)
14. NIH salary cap update
15. ASSIST – expanded options
1. Rigor and transparency in research
The NIH has informed the biomedical research community of updates to application instructions and
review language intended to enhance the reproducibility of research findings through increased scientific
rigor and transparency.
These updates focus on four areas deemed important for enhancing rigor and transparency:
1) the scientific premise forming the basis of the proposed research,
2) rigorous experimental design for robust and unbiased results,
3) consideration of relevant biological variables, and
4) authentication of key biological and/or chemical resources.
The basic principles of rigor and transparency and the four areas of focus apply to the full spectrum of
research, from basic to clinical. Investigators will need to consider how all four areas apply to their
proposed research. Likewise, reviewers will assess whether these areas have been appropriately addressed
by the applicant through revised language defining the peer review criteria.
Implementation: this update will be deployed in two phases. Please see the following NIH notice for
details including timelines with phased implementation: NOT-OD-16-004
Other links and resources related to Rigor and Transparency requirements:
 NOT-OD-016-011: Implementing Rigor and Transparency in NIH & AHRQ Research Grant
Applications
 NOT-OD-16-012: Implementing Rigor and Transparency in NIH & AHRQ Career Development
Award Applications
 NOT-OD-16-004: NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms
for 2016 Grant Applications
 NOT-OD-15-103: Enhancing Reproducibility through Rigor and Transparency
 NOT-OD-16-031: Updates to NIH & AHRQ Research and Performance Progress Reports (RPPR) to
Address Rigor and Transparency
 Website on Rigor and Reproducibility: http://grants.nih.gov/reproducibility/index.htm
 FAQs on Rigor and Reproducibility: http://grants.nih.gov/reproducibility/faqs.htm
 NIH presentation on Rigor and Reproducibility:
https://grants.nih.gov/reproducibility/module_1/presentation.html
2. Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract
Proposals (NOT-OD-16-006):
This Notice is to inform potential applicants and offerors that the requirements of the Vertebrate Animals
Section (VAS) of grant applications, cooperative agreements and contract proposals has changed. The
changes have been made to remove redundancy with Institutional Animal Care and Use Committee
review while meeting the requirements of the Public Health Service Policy on Humane Care and Use of
Laboratory Animals.
Implementation: These requirements, as applicable, will take effect for all grant applications except
Fellowship (F series) and Training (T series) grants for due dates on or after January 25, 2016, and will
take effect for all applications for due dates on or after May 25, 2016. For contracts, see individual
Requests for Proposals (RFPs) for details.
Please read further for details: NOT-OD-16-006
3. Inclusion of Children in Clinical Research: Change in NIH Definition (NOT-OD-16-010)
For the purposes of inclusion policy, the age of a child will be defined as individuals under 18 years old
instead of under 21 years old, the current NIH definition of a child for inclusion policy considerations.
Implementation: Starting with applications/proposals submitted for due dates on or after January 25,
2016.
Please read further for details: NOT-OD-16-010
4. Data Safety Monitoring Plans (NOT-OD-16-004)
Application packages will include a dedicated line for loading a Data Safety Monitoring Plan document
when clinical trials are anticipated. There is no change in policy, a DSMP must be loaded if a clinical
trial, but the formset itself will have a dedicated line.
Implementation: proposals with due dates of May 25, 2016 and beyond
5. Research Training

New Research Training Table Formats for 2016. Affects Training Grant applications and progress
reports (RPPR) (NOT-OD-16-007).
Implementation: Training grant applications submitted for due dates on or after May 25, 2016; already
implemented for RPPRs.

Advanced Notice of Coming Requirements for Formal Instruction in Rigorous Experimental Design
and Transparency to Enhance Reproducibility: NIH and AHRQ Institutional Training Grants,
Institutional Career Development Awards, and Individual Fellowships (NOT-OD-16-034)
Implementation of these requirements will be as early as FY 2017 but will not be in 2016 as indicated in
NOT-OD-16-004.
6. Appendix policy
The NIH is reevaluating the current appendix policy. A notice describing specific appendix policy
changes will be issued by spring 2016.
7. Font requirements
NIH announces additional flexibility regarding the fonts used in PDF attachments included in grant
applications (NOT-OD-16-009).
Implementation: For applications submitted for due dates on or after May 25, 2016
Please read further for details: NOT-OD-16-009
8. Biosketch clarifications
NIH clarifying biosketch instructions (NOT-OD-16-004)
Clarifications include:
 Indicating that a URL for a publication list is optional and, if provided, must be to a government
website (.gov) like My Bibliography
 Allowing publications (peer-reviewed and non-peer-reviewed) and research products to be cited in
both the personal statement and the contributions to science sections
 Explicitly stating that graphics, figures and tables are not allowed
Implementation: effective for applications submitted for due dates on or after May 25, 2016
9. New form added: PHS Assignment Request Form
New Form for PHS Awarding Component and Peer Review Requests (NOT-OD-16-008). Applicants
who want to communicate requests pertinent to the assignment and initial peer review of applications
must use a new PHS Assignment Request Form.
Implementation: effective for applications submitted for due dates on or after May 25, 2016
10. Changes to Post-Award Forms and Instructions
NIH & AHRQ Announce Upcoming Changes to Post-Award Forms and Instructions (NOT-OD-16-005).
Some of the new policies require additional data collection and updates to the NIH post-award forms.
Implementation: NIH will have system support and guidance for these updates in place by the targeted
effective dates listed in NOT-OD-16-005. Current forms can be used until revised forms are available (see
NOT-OD-15-146).
11. Revised SF424 Application Guides and Supplemental Instructions
These are available for application due dates on and between January 25, 2016 and May 24, 2016 (NOTOD-16-029)
12. Publication of the Revised NIH Grants Policy Statement (Rev. 11/2015) for FY 2016
See Summary of Significant Changes HERE
Notable changes:


During a no-cost extension period, key person effort levels may be reduced without NIH prior
approval
All invention disclosures must be submitted via iEdison
Please review the full notice: NOT-OD-16-030
13. Progress Reports (RPPR)

Updates to NIH & AHRQ Research Performance Progress Reports (RPPR) to Address Rigor and
Transparency (NOT-OD-16-031) National Institutes of Health; Agency for Healthcare Research and
Quality
Applicability: all NIH awardees submitting annual progress reports (RPPR)
Effective date: For RPPRs due on or after January 25, 2016
More information:
Website on Rigor and Reproducibility: http://grants.nih.gov/reproducibility/index.htm
FAQs on Rigor and Reproducibility: http://grants.nih.gov/reproducibility/faqs.htm
NIH presentation on Rigor and Reproducibility:
https://grants.nih.gov/reproducibility/module_1/presentation.html

Clarifying Publication Reporting Instructions for Research Performance Progress Reports (RPPR)
and Renewal Applications (NOT-OD-15-091)
This Notice clarifies which publications should be included in progress reports and renewal applications
for institutional training, career development, and related awards.
14. NIH Salary Cap update
Notice on Salary Limitation on Grants, Cooperative Agreements, and Contracts (NOT-OD-16-045). This
Notice provides information regarding the salary limitation for NIH grant and cooperative agreement
awards and extramural research and development contract awards (referred to here as grants). For FY
2016, the Consolidated Appropriations Act, 2016 (Public Law 114-113), signed into law on December
18, 2015, restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale.
The Executive Level II salary is currently set at $183,300, increasing to $185,100 effective January 10,
2016.
15. ASSIST expanded options
Now an Option for All NIH Competing Grant Applications and Some Post-award Administrative Actions
(NOT-OD-16-042). NIH has reached its goal to open up ASSIST as an option for the preparation,
submission and tracking of all single-project grant applications to NIH (NOT-OD-15-044).
Contact Gwen Swan, Pre-award research administrator at OGCA with any ASSIST questions.
Sincerely,
Jim Ayres
Assistant Director, CRA
Office of Grant & Contract Administration
Research Administration Building
70 Butterfield Terrace
University of Massachusetts
Amherst, MA 01003
(413) 577-1594 FAX (413) 577-1595
http://www.umass.edu/research/
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