The Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research acknowledges that additional guidance is needed and will be issued before May 25, 2017, when the policy becomes effective.
The following are some of the topics NIH says will be addressed in future guidance:
- how costs associated with single IRBs may be charged as direct vs. indirect costs,
- considerations in the selection of the sIRB,
- the content of the single IRB plan that must be submitted with applications and proposals,
- process for applicants/offerors to submit a request for an exception and process for NIH review of the request for exception,
- roles and responsibilities of the single IRB and participating sites,
- model authorization agreement that lays out the roles and responsibilities of each signatory,
- models for gathering and evaluating information from all the reliant sites about community attitudes and the acceptability of proposed research, and
- a model communication plan that identifies when and which documents are to be completed and shared with those involved so each may fulfill their responsibilities.