RSPP & IRB humanitarian use

What is humanitarian use?

Permission to treat a patient with a humanitarian use device (HUD) allows doctors to use a HUD before it has Food and Drug Administration (FDA) approval.

Doctors can use the HUD to treat or diagnose a disease or condition that affects fewer than 8,000 individuals in the United States per year. A HUD can be used only when no comparable, FDA-approved device is available. A HUD allows patient care, not for research purposes.

If you want to use a HUD for a research study, you should submit the Aurora IRB Protocol Submission Form. See our research forms.

What is a humanitarian device exemption (HDE)?

The FDA can grant a humanitarian device exemption (HDE) to device manufacturers. With an HDE, companies can market a HUD before research has proven its effectiveness. There must be evidence that the HUD is not likely to cause harm to patients.

An IRB must approve your HUD request before you use the HUD to treat a patient at Aurora. Under an approved HUD request, it is expected that you use the device to treat a patient according to its approved labeling and indications.

Off-label use of HUDs is part of the treatment plan for a patient as part of the physician’s practice of medicine. Such uses do not require submission to the Aurora IRB.

Humanitarian use: what to know before you begin

Before submitting an application for IRB review of a humanitarian use device, please review the following information:

• Use and billing requirements: This document is required reading before using a HUD. It summarizes Aurora and FDA policies on HUD use, consent, billing and reporting. Download Aurora health care compliance department guidance: use and billing of humanitarian use devices (HUD) [PDF]. (You must be connected to Aurora’s internal network to download this file. If you’re having trouble accessing it, contact us.)
• Aurora policy: Our policies and procedures explain how our IRB reviews HUD requests. HUDs are included in SOPs 1-4:
  • SOP 1 – Initial submission requirements & processes [PDF]
  • SOP 2 – Review of initial submission [PDF]
  • SOP 3 – Post-approval responsibilities & submissions PDF]
  • SOP 4 – Review of post-approval submissions [PDF]
• FDA HDE document: This manual provides FDA guidance on HUD use to HDE holders, IRBs, clinical investigators and FDA staff. Download Humanitarian device exemption (HDE) regulation: questions and answers [PDF].

Forms for humanitarian use devices

After you have reviewed the above information, you may proceed with your application for IRB review of a humanitarian use device.

To ask our IRB to review your request to use a HUD in patient care, please download and submit the following forms:

• Request for review: Download Request for use of HUD for non-research purposes [DOC].
• Patient consent: Aurora policy no longer requires you to submit a HUD consent form automatically with the application. If the IRB finds that the information included in the manufacturer’s HUD brochure is appropriate, a HUD consent is not required. If you do need the consent form, you can download the HUD consent template [DOCX].

After using the HUD, you’ll submit a final report to our IRB. With the same form, you can request continuing use of the HUD beyond the approval period. Download HUD application for continuing review/final report [DOC].

Contact the RSPP/IRB office

We’re here to answer your research documentation questions. Contact us

IRB approval of research

Find out the steps you need to take to get IRB approval of research. IRB approval process

Policies

Want to know about our research policies and procedures? Learn about our policies

Resources

Download templates for IRB application, informed consent and more. IRB forms and templates