Read the following instructions regarding Emergency Use protocol.
Retrieve the form by clicking the certification link at the bottom

If you are considering using this policy, please contact the COMIRB Compliance Officer (303-724-1065) or Director (303-724-1058) for further information. 

Emergency use is the use of an investigational drug, device, or biologic on a human subject in a life-threatening situation where no standard acceptable treatment is available and where there is insufficient time to obtain COMIRB full board approval.

In such a case, the investigator must submit a report of emergency use of an investigational drug, device or biologic to COMIRB within 5 working days of or immediately before its use.  A report of emergency use with a test article should be submitted using the Emergency Use Request Form, to ensure that the investigator addresses all required issues.  The form should be submitted along with a copy of the consent form that was (or is about to be) signed by the subject or the subject’s authorized representative.

A COMIRB chair reviews the documentation and determines whether the regulatory criteria for emergency use have been (or are about to be) met.

Some sponsors may require COMIRB Chair concurrence (agreement) that emergency use criteria will be met before they will supply the investigational drug or device.  In this case, the documentation can be submitted immediately prior to the use to obtain concurrence (agreement).

If you are unsure about whether emergency use of a particular investigational drug or device has occurred previously at your institution, please contact the COMIRB Compliance Officer at 303-724-1065. 

PLEASE NOTE that when any subsequent use of the investigational drug or device by anyone in the same Institution (including the VAMC, DHHA, The Children’s Hospital, University of Colorado Hospital, Colorado Prevention Center) is anticipated, submission of a protocol and consent and COMIRB review and approval are required.    

However, this type of emergency use cannot be planned ahead of time and used to avoid submission of a protocol.
Informed consent is still required except in the following conditions (all four conditions MUST be met before proceeding):

1. life-threatening situations necessitating use of the test article
2. subject is unable to provide effective consent
3. there is insufficient time in which to obtain consent from the subject or their legal representative
4. there is no available alternative method of approved or generally recognized therapy of equal or greater likelihood of saving the subjects life

In emergency use circumstances in which it is not feasible to obtain informed consent prior to the use of the investigational drug or device, the investigator must provide documentation from an independent physician that states that all four points listed above are present.  This documentation may be provided by use of the Emergency Use Addendum for Waiver of Consent Form.

I certify that I have read the instructions above and that I have called the COMIRB Compliance Officer to verify that the drug, device or biologic I am using has not been used previously in an emergency situation at this institution.

Ceding to Another IRB - Process

Authorization Agreement B - Ceding to Another IRB