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NIH Requirements and Changes Effective January 25, 2022

NIH eRA Commons ID Requirements on/after 1/25/2022

For all due dates on or after 01/25/2022, per NIH, will require all individuals listed on the R&R Senior/Key Personnel form to have an eRA Commons ID.

  • This new requirement applies to all Senior/Key Personnel and Other Significant Contributors proposed in NIH applications.
  • CU Boulder will not create Commons IDs for non-CU personnel. Non-CU personnel can set up Commons IDs with their employing entity or, if unrelated to an entity non-CU personnel must complete all the required registrations as though they are an organization following .听NIH recommends starting the registration process for unaffiliated individuals at least six weeks prior to a deadline to allow plenty of time to address unforeseen issues along the way.
  • Missing Commons ID will cause an ERROR beginning 1/25/2022 at submission and will prevent proposal submission.
  • POC for Questions: Proposal Analyst assigned to your department

NIH Forms G Updates 鈥 Proposals Due on/after 1/25/2022

NIH will require use of FORMS-G forms/applications for grant application due dates on or after 01/25/2022. NIH鈥檚 High-Level Form Change Summary . OCG鈥檚 NIH FORMS-G Checklists are currently forthcoming, with an expected release of the updated checklists planned before the new year on the .

POC for Questions: Proposal Analyst assigned to your department

A summary of some the changes and links to details include:

Biosketch

Use of new Biosketch templates will be required, with the following changes to the requirements:

  • Two options for creating a NIH Biosketch: (recommended by CU) or Word template. .
  • Section A: Applicants may choose to include details on ongoing and completed research projects from the past three years that they want to draw attention to. Formatting samples provided in .
  • Section B: Section B has been renamed 鈥Positions, Scientific Appointments, and Honors鈥. List in reverse chronological order all current positions and scientific appointments both domestic and foreign, including affiliations with foreign entities or governments.
    • For foreign appointments, supporting documentation will need to be provided at the Just-In-Time (JIT) phase as detailed under Other Support.
  • Section D: 鈥淩esearch Support鈥 removed for non-Fellowship Biosketches. Included on Fellowship Biosketches as 鈥淪cholastic Performance鈥.

Other Support

Use of new Other Support templates will be required, with the following changes to the requirements:

  • The updated . SciENcv is still not able to be used for Other Support creation but is forthcoming from NIH. Use of the Word template is required.
  • For details on what to include (all resources made available to a researcher in support of or related to research endeavors), see Disclosing Other Support requirements for NIH.
  • In-Kind Contributions Section: Separated from funded projects. Provide Active and Pending In-Kind contributions for all senior/key personnel. Enter in-kind entries grouped together based on the "Status of Support" and in order of Active and Pending Support from top to bottom. If there is no associated effort level, zero effort can be listed but an estimated dollar value must be listed; effort and dollar value cannot both be zero.
  • Signature and Submission: The completed Other Support form must be converted to a PDF, electronically signed by the researcher (to certify that the information disclosed is accurate, current, and complete), flattened and combined with all Other Support documents into a single document for submission. Typed names and wet signatures are not accepted.
  • Supporting Documentation: For Other Support submissions that include foreign activities and resources, and/or had included foreign appointments in their Biosketch, researchers are required to submit copies of contracts, grants or any other agreement specific to senior/key personnel foreign appointments and/or employment with a foreign institution as supporting documentation. If they are not in English, recipients must provide translated copies. This supporting documentation must be provided as part of the Other Support PDF following the Other Support Format page.
  • Immediate Notification of Undisclosed Other Support: If you discover that other support has not been disclosed to NIH, please alert your OCG Proposal Analyst or Grant Officer so that NIH will be updated immediately.

URLs

Clarification that Hyperlinks and URLs are not allowed outside of the References Cited and Biosketch documents. Biosketches only allow a URL to a full list of the individual鈥檚 published work that must be a government (.gov) website.

Human Subjects and Clinical Trials Information

Updated instructions:

  • Updated instructions for Delayed Onset Study/ies - must also include information regarding how the study will comply with the single IRB (sIRB) policy if sIRB is applicable.
  • Additional instructions regarding mentor or co-mentor statement related to Clinical Trials Research Experience.

Human Specimens and/or Data

Clarified instructions for providing an explanation for any use of human specimens and/or data not considered to be human subjects research.

Senior/Key Personnel and Other Significant Contributors (OSCs)

All Senior/Key Personnel and OSCs listed on the R&R Senior/Key Person Profile (Expanded) form will be required to have an eRA Commons ID.

R&R Detailed Budget 鈥 Other Direct Costs

Seven additional blank lines/fields have been added to the Other Direct Costs section of the R&R detailed budget, allowing for more specific identification of costs that will better align with the Budget Justification.

Fellowships

Changes to how to request Childcare Costs as part of the proposal.