Research Newsletters

Central IRBs Are Now Available for UNMC Studies

The UNMC IRB allows the use of Central IRBs (CIRBs) under certain circumstances. Currently the use of three CIRB processes is routinely allowed:

  • NCI CIRB for oversight of oncology trials sponsored by the NCI National Cooperative Groups
  • Greater Plains Collaborative (GPC) PCORI studies
  • NEW—Chesapeake IRB, an independent commercial IRB, for review of certain categories of commercially sponsored clinical studies

There are also other less frequently used instances where a CIRB may be used. Federally funded studies requiring the use of a CIRB process or other consortiums or collaborative groups sponsored by academic medical centers may, upon case by case review, be allowed to use a CIRB.

Researchers now have the option to use Chesapeake IRB for review of Phase II/III, III and IV commercially sponsored research. You can still use the UNMC IRB for oversight of your study, you are not required to use Chesapeake, but it is available. The sponsored agreement must include language allowing Chesapeake IRB to work with the sponsor on issues in the protocol as well as to bill the sponsor directly for their services. Gail Paulsen and Kristi DeHaai in the IRB office are the gatekeepers for use of Chesapeake IRB. They will verify for Chesapeake IRB when all the institutional requirements have been met. (e.g. P&T, SRC, IBC, CITI, COI, Pathology Approval, Contract Execution, etc.).

For Questions contact Gail Paulsen (402-559-3853 or email.)

 

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