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, and 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.

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

Emergency Use of an Investigational Medical Product (insufficient time to obtain IRB approval prior to the proposed date of use):

Clinicians should notify the IRB of the proposed use prior to the actual use or, if not feasible because of an emergent situation, within five days of the use. Please notify the IRB as follows:

  • During business hours (Monday-Friday, 8AM-5PM), notify the IRB of the proposed emergency use by email (irbdirector@hsirb.wisc.edu and csrogers@wisc.edu) and include the following information:
    • Description of how the use meets the criteria outlined in HRP-322 – WORKSHEET – Emergency Use.
      • Summary of the patient’s diagnosis and treatment history;
        and
      • Date and/or timing of the proposed use; and
    • Attach the following as appropriate:
      • Draft consent document. Use HRP-506 – TEMPLATE CONSENT DOCUMENT – Emergency or Compassionate Device Use to prepare your consent document.
      • For drugs or biologics only, documentation of approval of the use from the FDA (or include in the email the date when the request was submitted to the FDA).
      • For devices only, a concurrence letter from an independent physician that states that use of device is warranted and no other reasonable alternative treatments are/were available.
    • If the IRB chair concurs with the request and agrees it meets applicable IRB requirements, the treating physician will receive an acknowledgement via email.
    • If the IRB chair determines that sufficient time exists for the convened IRB to review the request, the treating physician will need to submit an expanded access application in ARROW and treatment will be allowed to begin following IRB approval of the application.
    • Outside business hours, clinical judgement prevails over the need for administrative procedures. Emergency use of an investigational medical product in one patient outside IRB business hours may proceed as follows:
      • For a drug or biologic, notify the PRC (Pharmaceutical Research Center).
      • Notify the IRB of the use by voicemail (608.263.2362) and email (irbdirector@hsirb.wisc.edu).
      • The application will then be reviewed by the convened IRB to determine a) whether the use met the criteria for emergency use of an investigational medical product per the FDA and b) that informed consent was obtained or met the criteria for exception to the requirements for informed consent.
    • If not completed before use, a treatment use application must be submitted in ARROW within 5 days of the emergency use. This application will be reviewed by the convened IRB to determine whether the convened board agreed with the IRB Chair’s assessment or additional information should be provided to the patient (or their representatives).
    • As a reminder, the emergency use of a test article, other than a medical device, is a clinical investigation, the patient is a participant, and the FDA may require data from an emergency use to be reported in a marketing application.

Expanded Access of Investigational Medical Products (non-emergency)

Once the appropriate expanded access route has been identified and the FDA and drug/biologic/device manufacturer contacted, treating teams will need to submit an application through ARROW for prospective IRB approval, just as they would for research studies. This application will be reviewed by the convened IRB and approval granted before the use can proceed.

See the following Toolkit documents:

HRP-325 – WORKSHEET – Compassionate Use of an Unapproved Medical Device

HRP 023-SOP-All Emergency Use, Compassionate Use (Device Only) and IRB Waiver for Individual Patient Expanded Access (Drug Only) Review

HRP 027-SOP- All Emergency Use, Compassionate Use (Device Only) and IRB Waiver for Individual Patient Expanded Access (Drug Only) Post-Review.

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).

Proposal Development Activities

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:

  1. Research activities involving human subjects are planned for the future but have not been finalized (e.g., the grant incorporates a planning stage);
  2. When an agency or organization requires IRB approval of the study in concept; and
  3. 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.