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Submissions For Special Cases

Ceding, WIRB, Humanitarian Use, Compassionate Use, Emergency Use

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Western Institutional Review Board (WIRB) submissions

Investigators who have "opted-in" may be eligible to have their industry sponsored protocols reviewed by WIRB (Western IRB).

Please refer to the following instructions for opting-in, eligibility and submitting protocols to WIRB. Studies involving the VA are currently not eligible for WIRB review. Contact the WIRB Office at 303-724-1011 with questions.

Requesting COMIRB cede to an outside IRB

COMIRB may allow affiliated investigators to use an outside IRB under certain conditions. Please refer to the following instructions for ceding to an outside IRB, and the standard operating procedure on relationships between COMIRB and non-affiliated sites.

Please click here for instructions on how to request that COMIRB cede to an outside IRB.

COMIRB is the IRB for a non-affiliated institution

COMIRB may agree to serve as the IRB of Record for non-affiliated institutions under certain conditions. Please refer to the following instructions for requesting that COMIRB be in the IRB of record, and the standard operating procedure on relationship between COMIRB and non-affiliated sites.

1. The investigator must first contact Warren Capell, COMIRB Director, at 303-724-1058 to request permission for the external site to rely on COMIRB for IRB review.

2. The external site may need to have a current Federalwide Assurance (FWA) on file with OHRP. The external site must add the COMIRB panels to its FWA.

3. An IRB Authorization Agreement A form must be signed by the external site's signatory official. The PI will then send the form to Astrid Eder, Senior Regulatory Analyst, at 303-724-1034 who will obtain the signature of the UCD signatory official.

4. Non-affiliated investigators will be required toobtain a POI number, complete COMIRB training, and complete a Conflict of Interest disclosure.

5. The PI must submit an Expedited or Full Board application including Attachment A. Non-affiliated investigators for whom COMIRB provides IRB oversight must be listed on the Application Form.

Emergency Use of an investigational drug or device

FDA defines Emergency Use as the use of an investigational drug or biological product with a human subject in a life-threatening situation in which not standard acceptable treatment is available, and in which there is no sufficient time to obtain COMIRB approval. Also the activity cannot be a systematic investigation designed to develop or contribute to generalizable knowledge. NO safety or effectiveness data should be collected on the drug or device (other than mandatory adverse event reporting to the Sponsor and/or FDA). If all conditions described in 21 CFR 56.102(d) exist then the emergency exemption from prospective COMIRB approval found at 21 CFR 56.104 (c) may be utilized.

Informed consent and documentation of consent in accordance with FDA regulations 21 CFR 50.20, 25, 27 are required unless the criteria for the exception to the requirement for consent are met. The COMIRB must be notified within 5 working days when an emergency exemption is used. COMIRB defines one use per institution as one use per legal entity. Any subsequent use of the test article at the same institution (or legal entity) is subject to COMIRB review and a protocol must be submitted for approval by the full board. This notification must not be construed as an approval for the Emergency Use by the COMIRB. A COMIRB panel Chair will review the report to verify that circumstances of the emergency use conformed to FDA regulations.

Please refer to the following FDA guidance on Emergency Use of drugs and devices for emergency IND / IDE procedures.

Drugs: The Emergency Use of an unapproved investigational drug or biologic requires an IND. If the intended subject does not meet the criteria of an existing study protocol, or if an approved study protocol does not exist, the usual procedure is to contact the manufacturer and determine if the drug or biologic can be made available for the Emergency Use under the company's IND.

The need for an investigational drug or biologic may arise in an emergency situation that does not allow time for submission of an IND. In such a case, FDA may authorize shipment of the test article in advance of the IND submission. Requests for such authorization may be made by telephone or other rapid communication means [21 CFR 312.310(d)]. FDA contact information for Emergency Use of a drug is available online.

Devices: Prior approval for shipment or Emergency Use of the investigational device is not required, but the use should be reported to FDA by the IDE sponsor via a supplement within 5 working days from the time the sponsor learns of the use.

Emergency Use does not require prospective COMIRB review. The investigator must submit all required paperwork to COMIRB within five working days of the Emergency Use.

The second Emergency Use at the institution of the drug or device in question will require the submission of a protocol for full board review. Please contact Erin Coons, COMIRB Compliance Officer (303-724-1551) or Warren Capell, COMIRB Director (303-724-1058) to verify any previous uses of the drug or device.

1. Compile all supporting documents:

  • A. Complete the Emergency Use Request Form.
  • B. Protocol
  • C. Consent form (clean or signed by the patient) or waiver of consent addendum
  • D. Investigational brochure

2. Fax or hand-deliver one copy of each document to COMIRB. Campus mail is not recommended for Emergency Use submissions:

Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045

The investigator will receive documentation of the review from COMIRB. Unanticipated problems involving the drug or device must be reported to COMIRB. Please refer to the Unanticipated Problem instructions. The submission of a protocol for full board review is required within 90 days of the second use of a drug or device. Failure to comply with this requirement will be reported to the FDA as non-compliance.

Compassionate Use of devices

If you are considering using this policy for the first time, please contact the COMIRB Compliance Officer (303-724-1551) or Director (303-724-1058) for further information.

Individual Expanded Access Use (Compassionate Use) with a device occurs when a health care provider may wish to use an unapproved device to help a patient suffering from a serious disease or condition for which there exists no other alternative therapy. If the patient is in a life-threatening situation, the Emergency Use documents should be used. Note that this process may be used only for devices; there is no similar process for drugs.

In such a case, the investigator must submit a report of Compassionate Use of an investigational device to COMIRB within 5 working days of or immediately before its use. A report of Compassionate Use with a device should be submitted using the Compassionate 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. One form must be submitted for each patient treated with the device.

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

Unlike Emergency Use of an unapproved device, prior FDA approval is needed before Compassionate Use occurs. In order to obtain Agency approval, the sponsor should submit an IDE supplement requesting approval for a protocol deviation under section 21 CFR 812.35(a) in order to treat the patient. The IDE supplement should include:

(1) A description of the patient’s condition and the circumstances necessitating treatment,

(2) A discussion of why alternative therapies are unsatisfactory and why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition,

(3) An identification of any deviations in the approved clinical protocol that may be needed in order to treat the patient; and

(4) The patient protection measures that will be followed. (See below)

The following patient protection measures must be in place prior to use of the device:

(1) Informed consent from the patient or a legal representative must be obtained,

(2) Clearance from the institution as specified by their policies,

(3) Concurrence of a IRB Chair,

(4) An independent assessment from an uninvolved physician; and

(5) Authorization from the IDE sponsor, if an approved IDE exists for the device.

If the request for this use is approved by the FDA, the treating physician is required to devise an appropriate schedule for monitoring the patient. The patient should be monitored to detect any possible problems arising from the use of the device. Following the use of the expanded access use of the device, a follow-up report should be submitted to FDA as an IDE supplement (usually by the sponsor) in which summary information regarding patient outcome is presented. A follow-up report must also be submitted to COMIRB no later than 12 months after the initial review. If any problems occurred as a result of the device use, these should be discussed in the supplement and reported to COMIRB as soon as possible.

Any subsequent use of the test article at the institution is subject to FDA review. FDA may allow the treatment of additional patients by way of the Compassionate Use procedure, or may require prospective IRB approval of a Treatment IDE protocol.

1. Compile all supporting documents:

  • A. Complete the Compassionate Use Request Form.
  • B. Consent form (clean or signed by patient)
  • C. Investigational brochure
  • D. Authorization from the sponsor
  • E. Letter of concurrence from an independent physician
  • F. IDE supplement to be submitted to FDA from sponsor

2. Submit one paper copy to COMIRB at:

Anschutz Medical Campus
MS F490 (Building 500)
13001 E. 17th Place, Room N3214
Aurora, CO 80045

3. The investigator will receive documentation of the review from COMIRB.

4. Unanticipated problems involving the device must be reported to COMIRB. Please refer to the Unanticipated Problem instructions.

5. A follow-up report must be submitted no later than 12 months after the initial review.

Humanitarian Use Devices

Please click here for Humanitarian Use Devices (HUDs) Guidance.

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