NIH mandated the use of single IRBs for multi-site research in January 2018 for all competing NIH grant applications (new, renewal, revision, or re-submission). Since management of activities at participating sites requires considerable IRB effort, NIH encourages the budgeting of direct costs for these activities.
Effective for NIH grant submissions after June 1, 2021, the University expects investigators to budget direct costs fees when PITT serves as the single IRB for multi-site research. Investigators or their research coordinator/grants administrator must contact the PITT IRB at least four weeks in advance of the grant due date to arrange for the development of a budget and letter of support, as described in the guidance, "Pitt IRB Serves as the IRB of Record for a Multi-Site Study".
Funding for the IRB obtained through grants will be used to augment staffing and to facilitate more rapid processing of protocols. The PITT IRB reserves the right to decline service as single IRB for multi-site NIH-supported studies that do not budget appropriately for this service.
In addition, the signatory agencies to the Common Rule also now require the use of a single IRB mechanism for multi-site research. The PITT IRB can serve as single IRB for these studies (if permitted by the funding agency) provided that the activity is funded through grant or departmental sources. A budget must be prepared prior to initiating a request for the PITT IRB to serve as single IRB for any multi-site study. Investigators are encouraged to contact their funding agency prior to proposal submission to determine if single IRB fees can be included in the budget.
Please direct questions about these requirements to: firstname.lastname@example.org.