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COVID-19: Information from SPA/OSP/CGA

SUMMARY of NIH Changes Effective January 2017

The National Institutes of Health has released a revised version of their Revised NIH Grants Policy Statement for FY 2017.  A full copy of the NIHGPS can be found at https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf. This revision supersedes, in its entirety, the NIH Grants Policy Statement (October/November 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, 2016.

Final Research Performance Progress Report: NOT-OD-17-022

Beginning January 1, 2017, NIH will replace the Final Progress Report (FPR) with the Final Research Performance Progress Report (F-RPPR). On or after January 1, 2017 NIH will NO LONGER accept FPRs.

eRA Final Reminder to Update Your Browsers By November 30th

eRA is updating access to all its publicly-accessible websites to use “https only” secure connections per federal mandate (OMB M-15-13).   You may need to update your browser to continue using eRA modules. A list of browsers and versions that will still work following the update are:

Changes to Appendix Materials: NOT-OD-16-129

NIH eliminates most appendix materials that are submitted with applications. The new policy is effective for application due dates on or after January 25, 2017.

Allowable Appendix Materials are as follows:

For all applications:

  • Blank informed consent/assent forms
  • Blank surveys, questionnaires, data collection instruments
  • FOA-specified items 
    • Applications submitted without required appendix materials will be considered incomplete and will not be reviewed.

For Clinical Trials (all of the above plus the following):

  • Clinical trial protocols
  • Investigator’s brochure from Investigational New Drug (IND)

Reminder: Applications will be withdrawn and not reviewed if they are submitted with appendix materials that are not allowed and/or required by the FOA.

Post Submission Material: NOT-OD-16-130

Allowable Post-Submission Materials for All Applications submitted on or after January, 25, 2017:

  • Revised budget page(s) (e.g., due to new funding or institutional acquisition of equipment)
  • Biographical sketches (e.g., due to the hiring, replacement, or loss of an investigator)
  • Letters of support or collaboration due to the hiring, replacement or loss of an investigator
  • Adjustments resulting from natural disasters (e.g., loss of an animal colony)
  • Adjustments resulting from change of institution [e.g., Program Director/Principal Investigator (PD/PI) moves to another university]
  • News of professional promotion or positive tenure decision for any PD/PI or Senior/Key Personnel
  • Approval by the NIH Stem Cell Registry of a human embryonic cell line(s) after submission of the application (see NOT-OD-12-111)
  • Videos, within defined limits, that demonstrate devices and experimental data with a temporal element, which refers to the need to show how something functions or occurs over time, or demonstrates movement or change.  Applicants must follow the directions in NOT-OD-12-141 for submitting videos to accompany grant applications
  • Other post-submission materials specified in the FOA for which the application was submitted or in a special Guide Notice.
  • News of an article accepted for publication since submission of the application, which must include only:
    • List of authors and institutional affiliations
    • Title of the article
    • Journal or citation (if available)

NIH Policy on Single IRB for Multi-Site Research: NOT-OD-16-094

Effective for receipt dates on and after May 25, 2017:

  • Domestic sites participating in multi-site studies involving non-exempt human subjects research funded by the National Institutes of Health (NIH) will use a single Institutional Review Board (sIRB) to conduct the ethical review required by the Department of Health and Human Services regulations for the Protection of Human Subjects.

Clinical Trials NOT-OD-16-147 effective September 27, 2017

“NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials.”  Clinical trials will no longer be accepted through “parent” FOA announcements.

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