Changes to add or remove federal funding to an already approved study may impact previous regulatory determinations and require additional considerations, including:

  • Whether a study needs continuing review:
    • If adding Federal funding to a pre-2018 study that does not have continuing review, continuing review may now be required.
    • If removing Federal funding from a pre-2018 study that DOES have continuing review, it may now qualify for excusal from future continuing review.
    • Study teams will be informed of any changes to the continuing review status during the pre-review process.
  • Whether a Certificate of Confidentiality is automatically granted:
    • Any study adding NIH funding is now granted an automatic CoC, which protects data collected once the NIH funding is in place.
    • Likewise, removing NIH funding means that new data collected after NIH funding has ended will no longer be protected by the terms of the CoC.
    • Study teams should review all consent documents to ensure CoC language is up to date and accurate.
  • Whether single IRB review is now required (please contact RELIANT):
    • Adding new federal funding to a multi-site or collaborative research project may require single IRB review. The Reliant team will work with study teams to confirm whether the sIR mandate applies and what may be required.
  • Whether the NIH Data Management and Sharing Plan applies:
    • Effective for applications starting January 25, 2023 and after, all NIH-supported researchers producing scientific data will be expected to submit a data management & sharing plan as part of their proposals. See Research Data Services for additional information.
    • IRB consent and protocol templates also include guidance on data sharing requirements.
    • Research teams are responsible for determining when the NIH DMSP applies to their new grant and for updating IRB materials accordingly. Study teams should also consider whether current or past subjects may need to be reconsented if their data will be used or shared in new ways.