Update on NIH Funding from UMass OGCA

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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:

 

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 - DSMP must always 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 (NOT-OD-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:

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 proposal related ASSIST questions.

Best wishes for a fruitful and happy new year.

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