UNMC Sponsored Programs Administration (SPA)

Tips for Regulatory Compliance

SPAdmin recommends that PIs carefully plan for the submission of protocols.  Before grant and contract funds can be released, SPAdmin requires documentation of approval from the appropriate compliance committees.  PIs are encouraged to stay informed about timelines and the processes involved in obtaining approvals.

Planning

• Consult the sponsor’s guidelines to ensure you are following the appropriate timetable for their program.  Some sponsors require approval before a proposal is submitted.
• If you anticipate that a protocol might cause concern on the part of the Regulatory Affairs for ethical or risk/benefit reasons, or if it is above average in complexity (e.g. Phase I clinical trial), SPAdmin strongly encourages you to submit your protocol to the Office of Regulatory Affairs (e.g., IRB, IACUC, Biosafety) before sending your application to an external sponsor.  Early submission allows adequate time should the committee table your protocol or require you to modify the protocol.
• Cancer related protocols involving human subjects must be submitted directly to the Protocol Office of the Cancer Center Scientific Review Committee (SRC).  SRC approval is required before IRB approval can be granted.
• Protocols involving the use of investigational or marketed drugs must be submitted directly to the Pharmaceutical and Therapeutics (P&T) Committee.  IRB approval is contingent upon P&T review and approval.
• Often, a single protocol has multiple titles.  To add a new title to an existing protocol (e.g. IRB, IACUC), an investigator may amend the protocol.  When preparing an amendment, the Office of Regulatory Affairs cautions investigators to carefully consider whether other elements of the protocol, in addition to the title, should be modified.

Timelines

• The NIH uses a “Just-in-Time” policy for IRB and IACUC approval. IRB and IACUC approval are not required prior to NIH peer review of an application, however, grants cannot be awarded without IRB and IACUC approval.
• The NSF requires that verification of IACUC approval be received at the agency within 60 days after the deadline date for the proposal. If the IACUC approval is not received when due, the application may be considered incomplete and deferred to the next review cycle. Many agencies follow the policy of the NSF in allowing a 60-day grace period for receipt of the project’s IACUC approval.

Special Considerations

• Because contracts are legally binding, the university mandates that the title of the IRB protocol(s) and the contract study title match precisely.  SPAdmin strongly recommends that grant titles also precisely match the related IRB protocol(s).  Exact titles allow SPAdmin to link your protocol and sponsored project without your help.
• The title of IACUC protocol(s) and the contract study title do not need to match precisely. Investigators are not required to add titles to protocols that match those on grants proposals--a protocol needs only one title.
• Before submitting an application for funding to an external agency on proposals utilizing ESCs, UNMC's ad hoc  Embryonic Stem Cells Scientific Review Committee (ESC-SRC) must complete its review and the IRB must review and approve the use of ESC.
• In a limited number of cases, a process is in place at the NIH entitled "Accelerated Review" (e.g. AIDS applications). This shortened time period at the NIH necessitates that all applications must have both IACUC and IRB approval prior to the time of application.