Funding Source Document (FSD) Review Policies

Funding source document (FSD) must be submitted with the IRB application.

NIH requires review of funding application with reference to the human subjects research activity that it supports. The review must include all parts of the FSD that might directly or indirectly affect the conduct of human research-including but not limited to specific aims, methods, human subjects, budget, personnel, and facilities. See NIH guidance.

FHCRC extends NIH funding review requirements to all types and sources of funding, including industry contracts and private foundation funding.

When to Submit

• All new IRB applications must include the FSD if the activity is funded by an outside resource. If the FSD is not submitted, the IRB application is incomplete and will not be reviewed until the FSD is supplied.
  
• When adding a new funding source and/or deleting a funding source to/from an existing IR file, submit a protocol modification form and funding source supplement with the FSD attached. If adding and/or deleting a funding source is in addition to other modifications, a separate protocol modification form is not required. However, the protocol modification form must clearly mention the FSD addition or deletion.
  • Protocol Modification Form updated July 01, 2009
  • Funding Source Supplement updated November 16, 2009
• If adding a new funding source and/or deleting a funding source to/from an existing IR File at the time of continuation review, submit a protocol modification form with the FSD attached.
  • Continuation Review Information updated July 01, 2009
• If the new funding source involves an industry sponsored agreement, an Industry Sponsorship Form must be completed and submitted along with the Application for Review Form to the IRB. For a copy of the form and further information, please visit the Shared Resources RTO's website. When the final contract is signed, a copy of the contract must be submitted to the IRB for review with a copy of the most currently proposed consent form(s).
  
• When a Competitive Renewal Proposal has been awarded, please submit a copy of the proposal for IRB review along with the face page,  protocol modification form and funding source supplement.
  
• If the CRR lacks a requested FSD, it is incomplete and will not be reviewed until the FSD is supplied. This can cause a lapse in IRB approval.

What to Submit

• Face Page: Please submit a copy of the "Face Page" of the Funding Source which includes the following required information:
  • Name of the Principal Investigator listed on the FSD
  • Title of the Proposal
  • Name of the Funding Agency
  • Support Dates
  
  
• Grant applications: Full copy of most recent competing application (new, competing renewal, supplement, etc.). "Full" is everything but appendices. "Full" means the face page, personnel, budget, facilities pages as well as scientific and human subjects sections. "Specific aims" section is not sufficient, nor is a progress report from a non-competing continuation. Individual salaries may be blacked out, but the overall budget information must be provided. For program project grants, submit the relevant project(s), from the most recent competing application.
  
  Please note: if the competing application does not reference the IR file (that is, if the IR number was added to the funding source in subsequent years) then in addition to the competing application please submit also the non-competing application/progress report that first references the IR file.
  
  
• Contracts: three parts-1) study protocol; 2) investigator brochure (if one exists); 3) the contract/research agreement (which is usually the only source of information about budget and about statements re: indemnification for adverse events).
  
  For clinical trials, the study protocol and investigator brochure are already part of the IRB application, so only contract/research agreement needs to be submitted. (However, if new contract support is added, all elements of the new FSD do need to be submitted for review, unless already received as part of a modification request).
  
  All other sponsored research must submit all three parts of the FSD, as relevant.
  
  
• Exceptions:
  • Center Core Grant and Comprehensive Cancer Grant do not need to be submitted.
  • PSOC (NSABP or GOG) and similar studies where FHCRC's involvement is as a performance site for a nationally coordinated study. (However, PSOC drug trials do need FSD review.)
  • Cooperative files do not need FSD review, since the IRB of record reviews the FSD.