Investigators/Physician Providers: Use this Checklist as a guide, or complete it and submit it with your applicationof an Expanded Use protocol (for example: Treatment IND/IDE, Treatment Use, Single Use IND/IDE, Compassionate Use).For help with this process, consult with the Director, NOHSP or your IRB Chair. IRB Chair/Reviewer: Reference this Checklist in addition to the Checklist for Review of Devices or of Drugs to assure compliance with all applicable policies and regulations.

Date:

Investigator/Physician:

Protocol Title:

Decision / Review Items
Except where noted, all items are required. / Comments
.
Documentation of FDA waiver from IRB review is attached. Expedited IRB review is requested. / Y
N
NA / If yes, Expedited review is permitted.
If no, or NA, review by the convened IRB is required.
Treatment Protocol is included. / Y
N / Comment:
IND/IDE application and FDA correspondence is included, / Y
N / Comment:
Application for Initial IRB Review is completed and includes information about:
The specific type of expanded access program, e.g., Treatment IND, Single Patient IND that is being proposed.
Whether the purpose is to provide this unapproved treatment to a single patient or to a group of patients isyet to be determined. / Y
N / Comment:
The Applicable addendum is attached:
Investigational Drugs and Biologics
Investigational Devices / Y
N / Comment:
Parental Permission/Informed Consent using either:
Nemours Expanded Access template
Sponsor template that includes language similar to:
  • Sponsor: This is the holder of the IND/IDE and should match the Application Form.
  • Nemours Contact information: Including the Investigator/Physician in charge, the IRB Chair, The Director, NOHSP and other Nemours clinical contacts.
  • Purpose: Because other treatment options have not been effective, this program provides a way to receive an investigational drug. Information about the effectiveness and safety of the drug will be collected and submitted to the FDA by the Sponsor.
  • Risks (largely unknown, not approved, efficacy and safety not demonstrated)
  • Benefits (avoid offering unreasonable hope when benefit is not assured)
  • Payment for treatment with investigational product (clearly state the cost and whether insurance will cover, what will happen if insurance does not cover)
/ Y
N / Comment:
The Nemours template “what information about me will be used” and the signature page are in the Parental Permission form. Or
A separate HIPAA Authorization for Research is attached. / Y
N / Comment:

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