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 Protocols, Training Grants, & Core Grants
While umbrella protocols 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 protocol application type option when seeking IRB review.
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 applications 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.
Analysis center applications should be submitted using the non-Protocol-Based Application in ARROW even if they have a standalone protocol.
Emergency/One-Time/Compassionate Use
Expanded Access of Investigational Medical Products (non-emergency)
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).
Protocol Development Activities (PDA)
If you receive a request from a funder for IRB approval or review of a grant and human research will not be conducted immediately under the grant, you should use the Protocol Development Activities (PDA) form in ARROW. The PDA can be used when:
- Research activities involving human subjects are planned for the future but have not been finalized (e.g., the grant incorporates a planning stage);
- When an agency or organization requires IRB approval of the study in concept; and
- When you have received a “just-in-time” requesting documentation of IRB approval. Only planning activities that do not involve human subjects can be covered by this administrative approval.
Not all funders will accept PDA approval in lieu of IRB approval for a human research study, so you are encouraged to consult with your funder before submitting a PDA application in ARROW.