RSPP & IRB emergency use
What is emergency use?
When a doctor delivers an unapproved treatment in a life-threatening emergency, it is classified as emergency use. Emergency use is not research. If prospective IRB approval cannot be obtained, the emergency use must be reviewed by our IRB as soon as possible (within five days of use).
Aurora Health Care’s Research Subject Protection Program (RSPP) has provisions in place to offer patients medications and devices that haven’t yet received Food and Drug Administration (FDA) approval. Any such use is considered expanded access. Expanded access also includes compassionate use.
When is emergency use needed?
To qualify as emergency use, all of these conditions must apply:
- The patient has a life-threatening disease or severely debilitating condition that requires immediate use of an unapproved treatment (investigational drug, device or biologic).
- No standard acceptable alternative treatment is available.
- Time is too short to obtain IRB approval.
- The doctor has substantial reason to believe the treatment will benefit the patient.
How to use & report emergency use
When using an unapproved treatment on an emergency basis, the treating physician should:
- Contact the RSPP office to determine if our IRB can meet before emergency use of a treatment is needed. Email us at irb.office@aurora.org or call 414-219-7744.
- Prepare an informed consent document. Contact the RSPP office for an Emergency Use Consent Template. Submit this template to the RSPP Office for review before the emergency use. If time does not allow for RSPP Office review of the consent form, the physician administering the investigational article must ensure appropriate elements of informed consent as noted at 21 CFR 50.25 are included.
- Obtain informed consent from the subject or the subject’s legally authorized representative, if possible. If informed consent is not possible, contact the RSPP office immediately for further instruction.
- Within five days of use of the investigational agent, complete an emergency use report DOCX] and submit the report, along with the Emergency Use – Exception from Informed Consent Certification (if applicable), to the RSPP Office.
If you anticipate a subsequent use of the same investigational agent by the same physician, you must obtain prospective IRB approval (see submission requirements).
See the RSPP SOP 1 [PDF] for more information.
Aurora & FDA policies for emergency use
Read guidance and policies about emergency use of devices and treatments:
- Aurora emergency use SOPs:
- FDA policy: Read FDA’s information sheet on Emergency use of investigational drug or biologic.
Forms for emergency use
Within five days of emergency use of an investigational treatment, you should submit reports of the usage for IRB review.
- Emergency use report [DOCX]
Contact the RSPP/IRB Office
We’re here to answer your research documentation questions. Contact us
Compassionate use
Learn how to request nonemergency use of an investigational therapy. Compassionate use
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