All research involving human subjects requires review by the Human Subjects Division (HSD). If federal training grant funding will support trainees who will do work involving human subjects, the grant PI must provide any formal documentation about human subjects approval (such as a Delayed Onset Human Research determination from HSD) that is required by the funding agency. However, if the documentation is not required by the funding agency, OSP can release the funding if the PI provides OSP with an assurance that no human subjects research will occur without IRB approval.
If a DOHR was required for the initial year of funding, a renewal of the DOHR at the end of the year is required only if the funding agency requires it. To obtain renewal, the PI provides HSD with updated information using the DOHR form.
Progress Reports and Continuation Funding
The progress report typically includes all protocol numbers for a faculty mentor’s research under which a trainee participates. Because NIH may ask for this information, early collection and updating of all relevant 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
Individuals who are engaged in federally-funded research that involves human subjects must complete training on the Protection of Human Research Subjects (PHRS). The requirement is described on the HSD training webpage.
If, at the proposal stage, animal involvement is anticipated within the period of award, but plans are indefinite and it is not possible to describe the use of animals, the PI checks “Yes” to animal use and in the Research Plan, Item 12, provides an explanation and when it is anticipated that animals will be used.
Before activities with animals begin, the applicant must provide all of the information required by 5.5, Research Plan, Item 12, Vertebrate Animals, with verification of current IACUC approval, to the awarding component for prior approval. IACUC approval must have occurred within the past three years to be considered current.
If a PI does want to include in the grant proposal a list of the faculty mentors who might take trainees and the associated IACUC (Institutional Animal Care and Use Committee) protocol numbers and approval dates, the PI ensures that the Office of Animal Welfare (OAW) is able to review the institutional training grant proposal alongside the listed protocols before the proposal is finalized and submitted.
Once the PI has a potentially fundable score, the PI needs to provide OAW:
- a copy of the proposal
- a copy of the eGC1 (or simply add “animal subjects” as a watcher in SAGE)
- a list of the pertinent IACUC protocols
- new IACUC protocol requests if needed, or changes to approved protocols that are necessary for covering the work described in the proposal
If OAW reviewed the proposal at submission time per a PI request, then at the time of fundable score, notify OAW and they will update the approval dates or list and provide a letter.
Protocol Numbers for Noncompeting Continuation Progress Reports
As part of the non-competing progress report for continuation funding, NIH requires the identification of, and IACUC review dates for, NRSA institutional grants. NIH specifies that Identification means grant number, PI, and project title. In addition to the NIH required information, OSP requires PIs to provide UW protocol numbers when completing the new eCG1 that is part of the progress report.
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 with all protocol numbers recorded.
Animal Use Training Program
For individuals who will be engaged in research that involves animals, the mentor submits a request to the IACUC to add the trainee to their protocol. Certain training requirements and enrollment in the Occupational Health Program for animal users must be completed prior to approval to work with animals. Contact OAW staff for advice regarding specific courses and/or certifications needed for the planned animal work.
Financial Conflict of Interest (FCOI)
At the proposal stage of PHS training grants, the PI and all UW personnel who have been designated as Investigators by the PI must complete the UW online FCOI training and disclose all of their financial interests that qualify as Significant Financial Interests (SFIs) in the UW Financial Interest Disclosure System (FIDS).
It may not be possible at the proposal stage to individually identify all of the personnel who will be responsible for the design, conduct or reporting of research under the training grant (the definition of “Investigator”). While many potential faculty mentors may be listed in the proposal, some may never be involved in any research under the training grant. And while the proposal may request funding for a specific number of trainees, those trainees may not have been individually identified at the proposal stage. Likewise, it may not be possible at this stage for the PI to identify who might be an Investigator once an award is made and trainees are appointed.
At the time of award, the PI and all UW personnel who have been designated as Investigators by the PI must have completed training, disclosed their SFIs, and be subject to a financial conflict of interest management plan where necessary before they may be paid from, or begin research under, the training grant.
Regardless of an individual’s designation as an Investigator on the training grant, all research projects conducted under the training grant (by trainees and their mentors) must have been reviewed for financial conflict of interest and had management plans established, where necessary, as described in GIM 10 “Financial Conflict of Interest Policy.”