December 21, 2015

NIH Notices: For 1/25/16 due dates, revised SF424 Application Guides including new REQUIRED attachment | Revised FY16 Grants Policy Statement

MU Grants Community,

Please take note of the following NIH announcements. Should you have questions about the applicability of this guidance to current or anticipated projects, please contact your OSPA Pre-Award or Post-Award staff.

Effective for proposal with due dates on or after January 25, 2016:
Revised SF424 (R&R) Application Guides and Supplemental Instructions (NOT-OD-16-029)

Rigor and Transparency*
Change: Updated application requirements and review language to enhance reproducibility of research findings through increased scientific rigor and transparency. These changes will take effect for most research grant applications (including small business and complex research grant applications), but will not impact institutional training and individual fellowship applications until a later date. Changes include:
  • Updates to application guide instructions for preparing your research strategy attachment 
  • Use of a new required attachment: "Authentication of Key Resources Plan” (uploaded in Other Attachments section of R&R Other Project Information form) 
  • Additional rigor and transparency questions reviewers will be asked to consider when reviewing applications
See the attached summary and NOT-OD-16-011 and NOT-OD-16-012.

Vertebrate Animals*
Change: Removing 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. Changes include:
  • Updated guidance on criteria to be addressed (description of procedures; justifications; minimization of pain and distress; and euthanasia) 
  • A description of veterinary care is no longer required 
  • Justification for the number of animals has been eliminated 
  • A description and justification of the method of euthanasia is required only if the method is not consistent with AVMA Guidelines for the Euthanasia of Animals 
See NOT-OD-16-006. Note: This change does not apply to AHRQ applications.


Definition of a Child*
Change: Redefined age of a child for the purposes of NIH's inclusion policy to individuals under 18 years old instead of under 21 years old.

See NOT-OD-16-010. Note: This change does not apply to AHRQ applications.


Research Training
Change: Updated requirements and instructions for several attachments on the PHS 398 Research Training Program Plan form to reflect recent policy guidance and reduce applicant burden. Changes include:
  • "Recruitment and Retention Plan to Enhance Diversity" - applicants will be asked to focus on recruitment 
  • "Human Subjects" - applicants must describe how the institution will ensure that trainees only participate in exempt human subjects research or non-exempt human subjects research that has IRB approval; no longer necessary to provide a list of potential grants trainees may work on and associated IRB information 
  • "Vertebrate Animals" - applicants must describe how the institution will ensure that trainees only participate in vertebrate animal research that has IACUC approval; no longer necessary to provide a list of potential grants trainees may work on and associated IACUC information
  • "Progress Report" - requirement to report on publications that arose from work conducted by the trainee while supported by the training grant will be moved to the Just-in-Time process

*Policy also applies to contracts. See individual contract Requests for Proposals (RFPs) for details.


Revised NIH Grants Policy Statement for FY 2016
(NOT-OD-16-030)
NIH has published a revised NIH Grants Policy Statement (NIHGPS, rev. 11/2015). This revision is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2015. This revision supersedes, in its entirety, the NIH Grants Policy Statement (03/2015) as a standard term and condition of award. Previous versions of the NIHGPS remain applicable as a standard term and condition for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2015. A “Significant Changes” document summarizes the revision: http://grants.nih.gov/grants/policy/nihgps/Significant_Changes_NIHGPS_Oct2015.pdf