This section of the Investigator Manual outlines different application types including training/core grants, SDACs, PDA, HUDs and HDEs, expanded access and emergency use applications.

Study teams should use the non-protocol-based application in ARROW to select these application types.

Umbrella Grants, Training Grants, & Core Grants

While umbrella grants and training or core grants do not themselves constitute human research, funding agencies may require IRB review, nonetheless. These applications can only be used for approval of a grant itself and cannot be used to cover any human research activities, which must be submitted as separate IRB applications. Study teams should use the non-Protocol Based Application in ARROW and select the umbrella grant application type option when seeking IRB review.

Note that “umbrella protocol” has a different meaning and use. Please see the section on Umbrella Protocols for more information.

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Analysis Center Applications

Analysis center studies apply to situations where the UW’s role is limited to analysis of data, samples, or images on behalf of a multi-site study. These are studies that do not qualify for an exempt or not human research determination. Analysis centers do not cover establishment of tissue banks or databases at the UW.

For FDA-regulated analysis center studies, IRB approval will likely be required. If there is federal funding, our analysis center work will be subject to Single IRB requirements. If there is no federal funding, UW’s analysis center work can be covered via reliance on the central IRB reviewing the main study OR via the local submission of an analysis center application in ARROW. Analysis center applications are submitted via the non-Protocol-Based Application in ARROW even if the study has a standalone protocol.

For non-FDA regulated SDACs, it may be the case that SDAC work at UW Madison will not require local IRB coverage. Please reach out to RELIANT to discuss your SDAC study.

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Humanitarian Use Device (HUD/HDE)

IRB review and approval is required before a HUD can be used for clinical care. You can refer to HRP-323 – WORKSHEET – Criteria for Approval HUD for additional information regarding the criteria that the IRB uses to review and approve HUD uses. This worksheet also includes criteria for informed consent. The clinical use of a HUD is not considered Human Research but must still be submitted for review and approval by the IRB prior to clinical use (with the exception of emergency use, which should follow the emergency use process).

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Protocol Development Activities (PDA)

An application for Protocol Development Activities (PDA) may be used to release extramural grant funds for activities in preparation of a human subjects research study (e.g., hiring staff, developing study instruments). The PDA is used to obtain IRB certification that described activities do not meet the definition of “human subjects research”. PDA certification is not IRB approval or an exemption; therefore many sponsors that require IRB approval will not accept a PDA. Please confirm with the sponsor that a PDA will be accepted prior to initiation in ARROW.

PDAs are only used when required by the external sponsor (PDAs are not required for intramural funding). For questions related to award setup for human subjects protocols, see RSP’s Award Acceptance and Setup guidance.

There are two circumstances when a PDA should be requested for release of funding:

  • You have received a “just-in-time” (JIT) requesting IRB approval, you do not yet have IRB approval and are unlikely to obtain it prior to the given deadline, and the program officer of the funding agency has indicated that a PDA will suffice.

    If the program officer indicates that a PDA is insufficient, inquire whether a letter from the IRB with an expected date for study review will suffice. Contact the IRB Directors for more information.
  • Your funding proposal does not include conducting human research immediately (e.g., within two months), you need funding to conduct activities to prepare for the human subjects component, the external funder requires institutional documentation of the delay in human subjects research activities, and the funder has indicated that a PDA will suffice.

Outside of the above circumstances, for release of funding from RSP when human subjects activities will not begin immediately:

  • If the human subjects activities will start within 6 months or less, you should begin an application in ARROW and, on the Funding page, use the chooser to add the funding source administered through RSP. The IRB application will be linked in RAMP within 24 hours. You must submit the application within 6 months to the IRB to avoid the system automatically moving the submission to a withdrawn state.

    You must also complete the Principal Investigator Attestation within RAMP to certify that no human subjects research activities will begin absent an approved protocol and provide an anticipated start date for human subjects research activities.
  • If the human subjects activities will not begin for at least 6 months or more, you must complete the Principal Investigator Attestation within RAMP to certify that no human subjects research activities will begin absent an approved protocol and provide an anticipated start date for human subjects research activities.

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