NIH Grants Policy Statement – Oct. 2018

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The revised NIH Grants Policy Statement (NIHGPS, rev. 10/01/2018) represents an update to the October 2017 version and is applicable to all NIH grants and cooperative agreements beginning on or after October 1, 2018. While the update does not introduce any new material for the first time, it incorporates new and modified requirements, clarifies certain policies, and implements changes in statutes, regulations, and policies that have been implemented through appropriate legal and/or policy processes since the previous version of the NIHGPS dated October 2017. The 10/01/2018 revision supersedes, in its entirety, the NIH Grants Policy Statement (October 2017) as a standard term and condition of the award.

 

Notable Policy Changes: Implements new policies and clarification of existing policies announced in the NIH Guide since October 2017, and listed at Grants Policy & Guidance.

 

  1. Part 1: NIH Grants – General Information:
    1. Chapter 1 – Glossary: Micro-purchase Threshold definition – updated micro-purchase threshold to $10,000
  2. Part II: Terms and Conditions of NIH Grant Awards
    1. Chapter 4 – Public Policy Requirements, Objectives and Other Appropriation Mandates
      1. Section 4.1.15.11, NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research, added. (per NOT-OD-18-003)
      2. Section 4.1.15.7 Inclusion of Individuals Across the Lifespan as participants in Research Involving Human Subjects. Policy has been updated to state that individuals of all ages, including children (i.e. individuals under the age of 18) and older adults, must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific or ethical reasons not to include them. (per NOT-OD-18-116)
      3. 4.1.15.8 Inclusion of Women and Minorities as Subjects in Clinical Research and Reporting Sex/Gender, Racial and Ethnic Participation. Updated to include a requirement that recipients conducting applicable NIH-defined Phase III clinical trials ensure results of valid analyses by sex/gender, race, and/or ethnicity are submitted to Clinicaltrials.gov.
      4. 4.1.34 Federal Awardee Performance and Integrity Information System (FAPIIS), and 4.1.35 Mandatory Disclosures. Updated to more clearly state the requirements of 45 CFR 75.113 for disclosing data to the HHS Office of Inspector General
  1. Chapter 7 – Cost Consideration
    1. 7.4 Reimbursement of Facilities and Administrative Costs. Updated to more clearly state the existing requirement that if a consortium is with a for-profit entity, such as a small business, the organization must have an established F&A cost rate before they can charge F&A costs.
  2. Chapter 8 – Administrative Requirements
    1. 8.1.2.11 Provide Subawards Based on Fixed Price Amounts. Updated to note the distinction between dixed amount Subawards and fixed rate agreements.
    2. 8.2.4 Inventions and Patents. Updates language to implement the new regulatory requirements (changes to 37 CFR 401, per NOT-OD-18-233)
    3. 8.3.4.2 Approval Requirements. Update Simplified Acquisition Threshold to $250,000. (per NOT-OD-18-219)
    4. 8.4.1.1 Non-Competition Continuation Progress Reports. Updated previous references to the Inclusion Management System to reflect use of new Human Subjects System (HSS), effective June 9, 2018 (per NOT-OD-18-179)
    5. 8.6.4 Submission of Closeout Documents. Updated to online current requirements for electronic submission
  3. Chapter 11 – Ruth L. Kirschstein National Service Awards
    1. 11.3.3.4 Recruitment Plan to Enhance Diversity. Updated to reflect updated Diversity Statement
    2. 11.3.6.2 Trainees. Updated to state the request for part-time training must be signed by the trainee, the AOR and the training grant PD/PI. The request for part-time training must provide a justification of the need for a reduced level of effort and the expected duration of the period of part-time training.

REVISED OCTOBER 2018. This document applies to all NIH grants and cooperative agreements for budget periods beginning on or after October 1, 2018

PDF version available at: https://grants.nih.gov/grants/policy/nihgps/nihgps.pdf

Summary of Significant Changes to the NIH GPS for October 2018 Version (https://grants.nih.gov/grants/policy/nihgps/Significant_Changes_NIHGPS_Oct2018.pdf)