UW is the Lead or Coordinating Site
The lead or coordinating site is the site that (usually) receives the grant or contract directly from NIH 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 NIH and who is responsible for overall management and coordination of the study across all participating sites. The lead has specific responsibilities related to the single IRB, described below.
Grant or contract preparation
NIH requirements. NIH requires the lead PI to:
- Select the IRB that will serve as the single IRB (sIRB)
- Include any sIRB fees and sIRB-related personnel costs in the grant budget, as well as appropriate budget justification information. See the PHS G.300 – R&R Budget Form for information about where in the budget form to put this information.
- Obtain confirmation from the participating site investigator that his/her institution is willing to rely upon the specific identified IRB.
- The participating site PI is responsible for contacting the appropriate office at his/her institution, obtaining confirmation of the institution’s willingness to rely on the 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.
- Prepare a Single IRB Plan for the grant/contract application.
- Fill out the grant application forms as required by NIH. See Section D “NIH Grant Application/Contract Proposal Preparation” of the NIH FAQ Single IRB Policy and Multi-site Research and (for specific details) Section 3.2 of the PHS Human Subjects and Clinical Trials Information Form Application Guide.
UW requirements. Consult with HSD about selecting the sIRB prior to submitting the grant. HSD recommends that you do this prior to obtaining confirmation from participating sites about their willingness to rely on the selected IRB. HSD cannot guarantee its willingness to support the use of a sIRB that has been selected without its consultation and approval.
After assessing the acceptability of the proposed IRB, HSD will provide the UW investigator with an email or emailed letter of support. This should be retained for study records. If desired, a copy can be included in the grant proposal.
If your grant commitment includes the involvement of regional non-UW institutions or organizations (for example, Seattle Children’s or Northwest Kidney Centers) 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 the lead PI with confirmation of the agreement.
Study set up
When the grant is awarded study set-up requires formally establishing the single IRB arrangement as well as setting up the personnel and structure for handling the lead site responsibilities.