UW Research

National Institutes of Health (NIH)

Contents

Application Planning

Application planning resources:

Training Grants Guidance

NIH Data Management & Sharing Planning (DMS)

The new NIH Data Management & Sharing Policy (DMS Policy) has some significant impacts for NIH proposals submitted for due dates on or after Jan. 25, 2023.

Does this Policy Apply to My Research Project?

Determine if the proposed research is subject to the DMS policy.

UW Data Management & Sharing Resources:

NIH Systems: Access & Roles

NIH Systems require 2 Factor authentication as well as assignment of specific roles.

ORCID IDs and the eRA Commons Personal Profile Requirement

Individuals supported by research training, fellowship, research education, and career development are required to have ORCID IDs linked to their eRA Commons Personal Profile.

eRA Commons and Roles

eRA Commons users, based on their role, can conduct a variety of business in Commons and will use the eRA Commons throughout the life of an NIH award.

Commons Roles at the UW

Those with Scientific Roles (Program Directors, Principal Investigators, Scientist, Post-Doc, Graduate Students, Undergraduate Students, Project Personnel) should only have one eRA Commons role for the life of their research career. Individuals switching to the UW from another institution who already have a scientific role in the eRA Commons can have their Commons profile affiliated with the UW.

Change, Update, or Affiliate a Commons Account

If you need to update, change, or affiliate eRA Commons login or account credentials for yourself or member of your UW team: Contact your department administrator with the eRA Commons ‘AO’ role. If no local administrator is available, contact osp@uw.edu.

Administrative Roles:

AO – Administrative Official

UW Department or unit administrator who sets up and modifies eRA Commons accounts for others within their unit. They also can set up the SCIENTIST PROJECT_PERSONNEL role for external Senior/Key Personnel who must be listed on an application when their institutions are not be registered in the Commons.

  • Signing Authority (SO) creates this account.
  • Create accounts for others or can remove an account (except SOs account).
  • Edit accounts which the AO created.
  • Review documents.
  • Cannot receive delegated authority from a PI.

ASSTAssistant to a PI
Department or unit staff member to whom a PI delegates tasks in the eRA Commons. Although the NIH website identifies the PI as completing most of the tasks, in reality, the ASST role may handle most of them.

  • Receive delegated authority from the PI
  • View award status
  • Initiate, edit, and route RPPRs
  • For Training Grants: An ASST user can perform PD/PI, xTrain training appointment functions.
    • Prepares training grant forms
    • A user with the ASST role cannot submit Training Grant appointments.

BO – Business Official
This role is used by the UW’s Grant and Contract Accounting (GCA) staff members within xTrain. It is not equivalent to the Signing Official (SO) role. xTrain is NIH’s system to manage appointments for awarded Training Grants. This role is held by GCA staff members who are authorized to submit Termination Notices in xTrain.

SO – Signing Official
Role within the UW Office of Sponsored Programs. OSP Staff Members are authorized to submit actions on behalf of the University within eRA Commons.

  • A grantee institution’s Signing Official has authority to legally bind a grantee institution for grant matters.
  • Update institutional information.
  • Submits non-SNAP RPPRs, extension requests, and Just-in-Time (JIT)

Scientific Roles:

PI – Principal Investigator

UW individuals active as PI or co-investigator on an application, including fellows applying for individual fellowships (NIH F-series). The PI role is needed to complete the grant administration process and to delegate certain responsibilities to another individual. PI’s can only access information about grant(s) on which they are the designated PI.

  • This role is called the PI role but is used for Program Directors (PD) as well.
  • The PD/PI selects and appoints Trainees, amends appointments, and initiates Termination Notices.
  • A Multi-PI can perform the same actions as the Contact PI.
  • Only a department administrator with the Administrative Official (AO) role or the Signing Authority (SO) role can create a PI account. The only SO role at the UW is the Office of Sponsored Programs (OSP).

TRAINEE

Individual assigned as a trainee on a UW institutional training grant (NIH T-series)

  • A person appointed to and supported by an institutional Kirschstein-NRSA or non-NRSA research training award. This role is required for all trainees whether the trainee on the T32 is a pre- or postdoctoral trainee.
  • The trainee responds to an auto-generated e-mail from eRA commons to create this role once a PI or ASST begins the appointment process for the trainee.

SCIENTIST and PROJECT_PERSONNEL

UW Department AOs should give these roles to external collaborators whose institutions are not registered in the Commons and who need a Commons account to be listed as Senior/Key Personnel on a UW application

UNDERGRADUATE, GRADUATE_STUDENT, and POSTDOC

Facilitate reporting for those participating on NIH awards

Contact OSP if you have questions osp@uw.edu

NIH Application Submission System & Interface for Submission Tracking (ASSIST)

OSP submits your proposal in ASSIST and monitors progress to eRA Commons.

  1. Use eRA Commons Login and prepare your proposal in ASSIST
  2. Change the status of your ASSIST application to “all components final”.
  3. Validate the application in ASSIST and resolve any issues.
  4. On your eGC1, answer “No” on the Ready to Submit (RTS) question.
  5. Route it to OSP with draft science.
  6. If you need to make changes or add a final version of science, change the status of your ASSIST application to “work in progress”
  7. Run the validation checks again if you make changes to the core or project sections of the applications.
  8. Once your application is FINAL and ready to submit to NIH, change the status in ASSIST to “Ready for Submission”.
  9. Change your eGC1 Ready to Submit (RTS) question to ”Yes”

NIH Designation of Multiple PIs

NIH uses the term “Multiple PD/PI” (not co-PI). The UW PD/PI listed as PI on the eGC1 will be the contact PD/PI, responsible for communication between NIH and the rest of the leadership team.

Applications that involve more than one PD/PI must include a Leadership Plan that describes roles, responsibilities and working relationships of identified PD/PIs. All PD/PIs must certify an assurance statement.

Who is considered an investigator and needs to disclose Significant Financial Interest at the UW?

Budget Development

Review guidance on:

Supporting Documentation

Compliance

A variety of non-financial compliance areas common in UW research. Review Additional Considerations as well as relevant topics . More information on relevant Compliance topics for your NIH proposal:

NIH Training Grant Compliance Best Practices

Human Subjects Protocol Approval

All research involving human subjects requires review by the Human Subjects Division (HSD). When a federal training grant supports trainees involved in human research, the grant PI provides any formal documentation of human subjects approval the funding agency requires (such as an HSD determination of Delayed Onset Human Research). If documentation is not required, OSP can release the funding with the PI’s assurance that no human subjects research will occur without IRB approval.

A DOHR determination does not need to be renewed unless required by the funding agency. See Delayed Onset Human Research (DOHR) for information about how to apply for or renew a DOHR.

Progress Reports and Continuation Funding

The progress report typically includes all IRB protocol numbers for faculty research involving a trainee. Because NIH may ask for this information, early collection and updating of IRB protocol numbers tied to the training grant is recommended. Due to database limitations, HSD is not able to provide this information to the PI. When the continuation funding is received by OSP they will verify that the DOHR determination is current.

Human Subjects Training

Senior/key personnel on NIH-funded human subjects research must complete training in human subjects protections.

Animal Use


Protocol Approval

All research involving vertebrate animals requires review by the Institutional Animal Care and Use Committee (IACUC). The Office of Animal Welfare (OAW) supports the IACUC and helps to facilitate the protocol review process. Additionally, OAW is the unit responsible for verifying IACUC approval for sponsored projects that include animal work. This is accomplished by performing a side-by-side review of the grant proposal and the related IACUC protocol(s).

At the proposal stage, if animal involvement is anticipated within the period of award, or if it is not yet determined, then indicate “yes” for the use of vertebrate animals on the R&R Other Project Information Form, and in the proposal describe the animal research components. This applies to animal work that will be performed at UW or at any other performance site/collaborating institution.

Similarly, indicate “yes” for vertebrate animals on the eGC1 for situations where trainees and projects are not yet identified (e.g., a new submission without a progress report), and provide a statement of assurance that trainees who are recruited and decide to use animals will have their work submitted to the IACUC and approved under their mentor’s protocol prior to initiation.

If animal projects are already known or if the training grant is a continuation and some trainees are already working with animals, identify the relevant projects and IACUC protocol approval date(s) in the proposal. On the eGC1, cite the UW IACUC protocol number(s) and indicate if an amendment will be required to cover the proposed animal research. Be sure to also include the names of faculty mentors who might take trainees along with their associated IACUC protocol number(s) and approval date(s).  If animal work will be carried out at any other institutions or locations, also include the performance site and any current IACUC protocol information for the other locations.

If an award is made, vertebrate animals cannot be used until a Vertebrate Animals section (PHS 398 Research Plan Form, Vertebrate Animals) and verification of IACUC approval has been submitted to NIH. It is recommended that the PI reach out to OAW upon notice of a potentially fundable score, and provide:

  1. a copy of the proposal
  2. a copy of the eGC1 (or simply add “animal subjects” as a watcher in SAGE)
  3. a list of the pertinent IACUC protocols
  4. new IACUC protocol if needed, or amendments to approved protocols that are necessary for covering the work described in the proposal (all protocol items must be submitted in UW’s electronic protocol management system, Hoverboard, which requires a user account to access).

OAW will compare the work described in the grant with the cited IACUC protocol(s). If all work in the grant is covered in the protocol(s), a congruence letter verifying IACUC approval will be issued. If not, an amendment to the protocol will be required and this can take time to review and approve.

Progress Reports and Continuation Funding

Note: OAW no longer reviews non-competing renewals/progress reports. If there have been any changes to trainees or their projects, it is the responsibility of the PI to include those changes in the approved protocol(s). Upon request, OAW can provide an updated congruence letter.

As part of the non-competing progress report for continuation funding, NIH requires the identification of trainee projects. NIH specifies that identification means grant number, PI, and project title. Any significant changes to animal work, including changes to performance sites, should also be described in the progress report. The awardee institution is responsible for maintaining documentation of IACUC approvals for all trainee research projects and providing this information to NIH if requested.

The eGC1 for the progress report must include all IACUC protocol numbers for a faculty mentor’s research under which a trainee has participated in the last year, or will participate in during the next award period. Early collection and updating of all relevant IACUC protocol numbers and approval dates is recommended. It is a good idea to maintain a spreadsheet linking each trainees with relevant protocol numbers and approval dates.

Animal Use Training

All individuals working with animals must be approved on an IACUC protocol and appropriately trained prior to performing animal work. To be added to a protocol, trainees must complete basic training requirements, including a species-specific hands-on lab, a facility orientation, and enroll in the occupational health program for animal users. Procedure specific training and certification may also be required depending on the particular project. Once basic training has been completed, the mentor must submit an amendment to add the trainee to their protocol in HoverBoard, UW’s electronic protocol management system. Contact the Animal Use Training Program (auts@uw.edu) for advice regarding specific courses and/or certifications needed for the planned animal work.

Financial Conflict of Interest (FCOI)


As with all research activities at UW, Investigators on NIH Institutional Training Grants are required to be in compliance with the Financial Conflict of Interest Policy, GIM 10. This includes completing the online FCOI training and disclosing Significant Financial Interests (SFIs) in the Financial Interest Disclosure System (FIDS).

Supporting GIM 10 compliance on Training Grants can be challenging because they are more likely to have personnel changes than other grant types, including within individual project periods. Specifically, trainees that the Principal Investigator may designate as Investigators, those responsible for design, conduct, or reporting of the research (see GIM 10 for complete definition), will need to be added to the PI, Personnel & Organizations page of the eGC1 for the current period and complete the associated requirements prior to beginning their research activities. This applies to Mentors added to the Grant as it is ongoing, as well, or may require updating the Investigator status on the eGC1 for Mentors identified at time of application on the eGC1, as they are paired with Trainees.

Guidance for NIH Institutional Training Grants

Submit an Application

NIH proposals should be submitted via Grant Runner or ASSIST. Check to see if your specific NIH opportunity can be submitted via UW’s SAGE Grant Runner.

Just-in-Time (JIT) / Post Submission

Just-In-Time (JIT) materials typically include current protocol numbers and Other Support. NIH will communicate either directly with the PI or with OSP to request this information. The PI must prepare and then submit the JIT materials to OSP for review, concurrence and submission to NIH.

A summary statement or letter from the Scientific Review Officer may include a detailed response requesting supplemental information to address concerns or issues or it may simply be a request for updated materials. At the direction of the request and consistent with NIH’s policy on Post-submission of application materials.

All responses to NIH for additional information must route through OSP for review, concurrence, and submission to NIH. Review more NIH Post Submission Guidance.

Review more detailed UW guidance on Other Support.

Preparing NIH Training Grants and Just-in -Time Materials

To maximize your efficiency in responding to a JIT notification, call your Program Officer to get the score of your proposal. If the score is in the fundable range, then you should call your Grants Management Specialist (GMS) to get verification of what materials exactly should be turned in for the JIT. Only the GMS is authorized to accept JIT documentation, so make sure to talk to them directly. Typically the request is for IACUC and IRB protocols.

For Training Grants an applicant may submit:

  • Profiles of students who have been or will be supported by the training grant.
  • Applicant pool, admissions, enrollment past trainee achievements (if renewal).

According to the NIH grants policy statement documentation of “Other Support” is not specifically requested for Program Directors, training faculty, and other individuals involved in the oversight of training grants since applicable information is collected in other sections of a training grant application.

Advance Spending

If appropriate, and the UW unit allows, Advances are often set up to help handle pre-award spending.

Training Grants and Advance Spending

According to NIH policy, pre-award costs are not allowable charges for stipends or tuition/fees on institutional training grants since these costs may not be charged to the grant until a trainee has actually been appointed and the appropriate paperwork submitted to the NIH awarding component.