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Human Research Protection Program

Expanded Access Requests at the Medical College of Wisconsin

FDA regulations ordinarily require prior approval from FDA and an IRB for research use of an unapproved or "investigational" drug, biologic, or device. Exceptions to this rule apply in very limited cases, including life-threatening emergencies.

Expanded Access

Policies on Conventional Expanded Access Requests

Expanded Access Request Resources

Emergency Use

Policies on Emergency Use of Investigational Devices, Drugs and Biologics

Emergency Use Request Resources

Emergency Use HRPP Office Notification

Call (414) 955-8337 or (414) 955-4415 and email the MCW HRPP Office as soon as the decision to use an unapproved or investigational drug, device or biologic is made, prior to the treatment or procedure if at all possible. 

HRPP office hours are Monday-Friday 8 a.m. - 5 p.m. If the use happens after office hours, call (414) 955-8439 and leave a message with call back number.

Consent Form Templates

Treatment Use Template (DOCX)
This template (Emergency/Treatment Use) is for treatment uses involving investigational drugs/devices/biologics for the treatment of patients not in a clinical trial.

Emergency Use ICF Template (DOCX)
This template (Emergency Use) is for treatment uses involving investigational drugs/devices/biologics for the treatment of patients not in a clinical trial. This template is to be used for the treatment of patients in a life-threatening situation where prior IRB review and approval is not feasible.

HUD Template (DOCX)
This template is for use of a Humanitarian Use Device. Please contact the IRB office prior to use of this template.

EFIC Template (DOCX)
For projects involving planned emergency research. Consent prior to these interventions is waived because of the condition of the subject and urgency under which procedures need to take place. Template is to be used for obtaining consent for continued participation.

Expanded Access/Emergency Use at Children's Wisconsin

For Expanded Access/Emergency Use submissions that involve Children's Wisconsin, additional information that may be required can be found on the CW HRPP Internal Website (CW Connect access required) or on the CW Investigator Resources webpage.

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