National Institutes of Health and Significant Changes for 2016 Grant Applications

The National Institutes of Health (NIH) recently released changes to their policies, instructions and forms for grant applications. The changes will be effective in two phases. The planned changes focus on: rigor & transparency in research, vertebrate animals, inclusion reporting, data safety monitoring, research training, appendices, font requirements and biosketch clarifications.

Phase 1 changes are effective for applications submitted for due dates on or after January 25, 2016.  This phase implements a subset of policy changes using the existing FORMS-C and updated instructions.  The changes include:

• Updates to instructions for preparing the research strategy to include information on reproducibility.
• New “Authentication of Key Biological and/or Chemical Resources” attachment.
• Updated guidance on criteria for the use of vertebrate animals.
• Redefined age of children for NIH research from under 18 years old.
• Updated requirements for research training: 
  • Recruitment and retention plan to enhance diversity.
  • Restriction on trainee participation on research involving human subjects.
  • Restriction on trainee participation on research involving vertebrate animals.
  • Requirement to report on publications that arose from work conducted by trainee.

Phase 2 changes are effective for applications submitted for due dates on or after May 25, 2016.  This phase will require the use of new FORMS-D.  These include:

• New “Plan for the Instruction in Methods for Enhancing Reproducibility” attachment required
• Vertebrate animal changes made in Phase 1 will now be required for training & individual fellowship applications
• New “Inclusion Enrollment Report” form which will replace the “Planned Enrollment Report and Cumulative Inclusion Enrollment Report”
• New “Data Safety Monitoring Plan” required for proposals that include clinical trials
• Research training table format updated
• Reevaluating the current appendix policy – changes will be issued in spring
• New PHS Assignment Request Form for consistency in application referral information
• Updated font guidelines
• Biosketch clarifications

                
Not all changes are listed here.  Anyone submitting a proposal to the National Institutes of Health for programs with due dates after January 25 and/or May 25, 2016 should review the updated requirements carefully prior to preparation.  Be sure to use the correct application guide when preparing your proposal.  You should plan additional time to make changes from previous submissions.