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HRPP Policy - Humanitarian use devices
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
This policy applies to clinicians under the oversight of the IU IRBs wishing to use a Humanitarian Use Device (HUD) for treatment or diagnosis, and the IU IRBs approving the use of the HUD.
This policy does not apply to clinical investigational use of a HUD (see Figure 1, Overview of regulatory procedures, referenced in FDA Guidance: Humanitarian Device Exemption (HDE) Regulation: Questions and Answers; Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff). Use of a HUD is considered to be part of a clinical investigation if safety and effectiveness data will be collected on the HUD for the purpose of supporting a premarket approval (PMA) application. If use of a HUD is considered part of a clinical investigation, the use is considered research and research personnel must follow all policies and procedures applicable to human subjects research.
This policy does not apply to situations in which use of a HUD is necessary to save the life or protect the well-being of a patient and there is not sufficient time to request IRB approval (see Figure 1). In these situations, clinicians must follow the procedures outlined in the IU HRPP Policy on Emergency Use of Investigational Test Articles.Back to top
A HUD may only be administered in facilities under the oversight of an IRB acting in accordance with 21 CFR 56, including continuing review of the device, and only when use of the HUD has been approved by the IRB. In order to utilize a HUD for treatment or diagnosis, IRB approval must be obtained prior to use. Once approved, the HUD may be used only for the indications approved by the IRB.
In reviewing a request for HUD use, the IRB must consider the risks to patients as described in the product labeling, ensure the risks are minimized, and evaluate whether the risks are reasonable in relation to the proposed use of the device. The IRB has the discretion to approve use of the HUD for off-label indications given sufficient justification from the clinician(s).Back to top
The use of a HUD must be initially reviewed at a convened IRB meeting and approved before the device can be used. To facilitate initial review, the HUD application must be submitted via KC IRB, with the following documentation attached:
- The HUD manufacturer's product labeling, clinical brochure, and/or other pertinent manufacturer informational materials
- HUD manufacturer's patient information packet, if available, which should be provided to patients
- The FDA HDE approval letter
Research informed consent and authorization documents are not applicable and should not be submitted, as use of a HUD under this policy is not considered research.
All facilities which will utilize the HUD must be listed on the Protocol tab in KC IRB, and any clinician wishing to access the device must be listed on the Personnel Tab in KC IRB.
The IRB must conduct continuing review/renewal of the use of the HUD within the appropriate time frame as specified by the IRB at time of initial review, or use of the HUD must cease until such time that it can be reviewed. Renewal information must be submitted via KC IRB and review may be conducted via the expedited procedure.
Clinicians should track and report the following at the time of renewal:
- The number of patients who received the HUD for all clinicians listed on the protocol since the last review
- Summary of minor deviations and/or noncompliance since the last IRB review
- Statement whether adverse events have occurred in excess of the expected frequency and level of severity as documented in the HUD manufacturer's product labeling, clinical brochure, and/or other pertinent manufacturer informational materials
- Summary of actual benefits experienced by enrolled HDE patients
- Any relevant information, published or unpublished, since the last IRB review, that may impact patient safety or continued use of the HUD, especially information about the risks associated with the HUD. Relevant information may include literature publications, audits, patient complaints, or interim findings.
If modifications to the initial IRB approval are needed to allow for additional indications, either FDA-approved or justified by the clinicians, the clinician(s) should submit an amendment to the existing protocol via KC IRB describing the modifications and the rationale.
Reportable Events must be reported to and reviewed by the IRB in accordance with the IU HRPP Policy on Reportable Events.
Individuals found to be in violation of this policy may be subject to sanctions related to the clinical use of the HUD at Indiana University's affiliates, including withdrawal of IRB approval.Back to top
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