UW is the Lead or Coordinating Site
The lead or coordinating site is usually the institution that receives the grant or contract directly from a funding agency and then establishes subawards or subcontracts with the participating sites. The lead PI is the PI in whose name the overall grant application was submitted to the funding agency and who is responsible for overall management and coordination of the study across all participating sites. If there is no clear lead site or PI identified as part of the funding structure, it will be important to identify which site will serve as the lead for the role of coordinating single IRB (sIRB) review responsibilities. The lead has specific responsibilities related to the sIRB, described below.
Grant or contract preparation
For federally-funded studies subject to the single IRB requirement, the lead PI should:
- Select the IRB that will serve as the sIRB for the project. The PI must confirm the acceptability of the selected IRB, including the use of the UW IRB as the sIRB, with HSD prior to submitting the proposal to the funding agency.
- Identify and budget for any costs associated with sIRB review. Include any sIRB fees and sIRB-related personnel costs in the grant budget, as well as appropriate budget justification information. Consult the PHS G.300 – R&R Budget Form for information about where in the budget form to put this information for NIH-funded studies.
- Obtain preliminary confirmation from all participating sites that they are willing to rely upon the selected sIRB.
- The participating site PI is responsible for contacting the appropriate office at their institution, obtaining confirmation of the institution’s willingness to rely on the selected sIRB, and communicating the confirmation to the lead PI.
- The UW lead PI may wish to provide participating site PIs with a template letter of support, to assist in obtaining and documenting the confirmation. Note that NIH does not require letters of support from participating institutions about their use of sIRB.
- Provide any required information in the funding application. NIH no longer requires a single IRB plan as part of submission, but will require the name of the single IRB of record during Just-in-Time. PIs should follow any instructions given by other funding agencies or in the notice of funding opportunity for information to be provided.
Consult with HSD about selecting the sIRB prior to submitting the funding application. HSD recommends that you do this prior to obtaining confirmation from participating sites about their willingness to rely on the selected sIRB. HSD cannot guarantee its willingness to support the use of a non-UW sIRB that has been selected or the use of the UW IRB as the sIRB without its consultation and approval.
After assessing the acceptability of the proposed IRB, HSD will typically provide the UW investigator with a letter of support. This should be retained for study records. If desired, a copy can be included in the grant proposal.
If your funding commitment includes the involvement of non-UW institutions (for example, Seattle Children’s or Fred Hutch) in obtaining consent, collecting identifiable data from research participants or conducting research procedures, each of these organizations will need to agree to the sIRB arrangement and to provide their own confirmation of the agreement.
Study set up and management
When the grant is awarded study set-up requires formally establishing the sIRB arrangement as well as setting up the personnel and structure for handling the lead site responsibilities.