STANDARD OPERATING PROCEDURE (SOP)                                            IRB-034


ORIGINAL DATE:        6/25/04
EFFECTIVE DATE:       7/6/04
REFERENCE:            FDA's Investigational Device Exemption Polices and Procedures,
NEXT REVIEW:          7/6/05

OBJECTIVE:    To provide guidance on IRB approval of compassionate use of an investigational medical

Definition: The FDA recognizes that there are circumstances when an investigational device is the only
option available for a patient faced with a serious, albeit not life-threatening, condition (hereinafter referred
to as "compassionate use"). In these circumstances, FDA uses its regulatory discretion in determining
whether such use of an investigational device should occur.

Procedures: (refer to the FDA IDE Policies and Procedures, "Individual Access to Investigational Devices
Intended for Serious Diseases",

Prior FDA approval is needed before compassionate use occurs. The sponsor must submit to the FDA an
IDE supplement requesting approval for a protocol deviation under section 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 less than satisfactory 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. (These measures are discussed under the
          Emergency Use Guidance.)

If the request for the compassionate use is approved by the FDA, the patient must be monitored to detect
any possible problems arising from using the device. The attending physician must devise an appropriate
schedule for monitoring the patient, taking into consideration the investigational nature of the device and
the specific needs of the patient. Following the compassionate use of the device, a follow-up report should
be submitted to FDA as an IDE supplement in which summary information regarding patient outcome is
presented. If any problems occurred as a result of device use, these should be discussed in the supplement.

FDA expects the physician to follow subject protection procedures. These include:
    1.   obtaining an independent assessment by an uninvolved* physician;
    2.   obtaining informed consent from the patient or a legal representative;
    3.   notifying institutional officials as specified by institutional policies (see procedure below);
    4.   notifying the Institutional Review Board (IRB); and
    5.   obtaining authorization from the IDE holder, if an approved IDE for the device exists.

    *Uninvolved physician is an expert in the field, but is not actively involved in care of the subject
    nor has a conflict of interest as defined by Columbus Children’s Hospital.

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Once the FDA approves the request, the attending physician has the following duties:

       notify the IRB of the plan to treat the patient under the FDA compassionate use approval;
       submit to the IRB (i) a copy of the IDE supplement, as described above, (ii) a copy of the FDA
        approval notice, (iii) a copy of the consent form used, and (iv) the patient monitoring plan. The
        IRB will acknowledge receipt of these documents and place them in the corresponding
        investigational device file. The IRB will notify institutional officials;
       report to the IRB within 3 business days any serious adverse events occurring as a result of the use
        of the device (see SOP# IRB-011, Serious Adverse Event Reporting and Review);
       submit to the FDA, as an IDE supplement, a follow-up report that presents a summary of
        information regarding patient outcome, including a discussion of any problems that occurred as a
        result of use of the device;
       submit to the IRB a copy of the final follow-up report that is submitted to the FDA; and
       submit to the IRB a copy of the clinical summary letter for each of the patient’s follow-up visits.


IRB Chair Signature                                       Date

CCRI Medical Director Signature                           Date

CHI Medical Director Signature                            Date

Review/Revision Dates: 10/26/04

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