What's New? (2012)
This page offers some of the most recent news-worthy topics, helpful regulatory tips, and updates to IRB/ORI policy, procedures, and guidelines for IRB Members and others involved in human research.
In order to receive electronic issues of the IRB Review Newsletter, or to receive a hard copy of past issues, contact the Office of Research Integrity at 859-323-2446 or e-mail Belinda.Smith@uky.edu and provide your name, e-mail address, department, campus address and phone number.
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- 4/10/12: IRB Review Newsletter [PDF]
- Sponsor-Investigator Training now on CITI
- Department of Defense Supported Research
- 2012 Human Research Protection Regional Conference
- 2/1/12: IRB Review Newsletter [PDF]
- Humanitarian Use Device (HUD): Clinical Care Under IRB Review
- VAMC IRB Contacts
- More Secure Survey Software
- Time to Renew? (HRP Training)
- Upcoming Events
- 1/19/12: Regulatory Reminder: Humanitarian Use Device (HUD)
The UK IRB has asked that the following reminders and resource links be provided to health care providers who are or have been involved with the use of a Humanitarian Use Device (HUD).
IRB APPROVAL
Food and Drug Administration (FDA) allows HUDs to be marketed but FDA regulations require HUD use (even clinical use) to occur with IRB approval and oversight.
- According to FDA regulations (21 CFR 814.124a), a HUD may be administered only to patients at health care facilities having a duly constituted IRB. The health care provider at such facilities is responsible for obtaining IRB approval before use of the HUD and for clearly labeling and storing the device to ensure accountability and traceability and prevent use outside of designated sponsor or IRB restrictions/ limitations.
- HUD regulatory requirements vary depending on weather the situation involves clinical use of a HUD according to approved labeling, emergency or compassionate use, or investigational use. The UK IRB HUD SOP outlines the various use requirements.
- Serious adverse events and deaths that a device has or may have caused or contributed to must be reported to the Humanitarian Device Exemption (HDE) holder/FDA and the IRB (Medical Device Reporting 21 CFR 803).
USE IRB APPROVED DOCUMENT (Modified O.R. Permit or Standard Consent Form) FOR INFORMED CONSENT
Obtain Informed Consent AS APPROVED by the IRB.
- The healthcare provider obtains informed consent from the patient according as approved by the IRB which may range from a modified operating permit with an IRB stamp to a standard research informed consent if the HUD is being used for investigational purposes.
- Informed consent must be obtained by study personnel listed on the protocol and using the IRB approved document.
- In considering information to provide in informed consent, the healthcare provider may include information from the HDE holder’s patient information packet which may be obtained by selecting the HDE number on the FDA HDE website.
EMERGENCY OR COMPASSIONATE (OFF-LABEL) USE
Emergency or off-label compassionate use of a HUD requires IRB chairperson's concurrence and 5 day report to the IRB.
- ***EMERGENCY USE*** Physicians should be cognizant that FDA has made a determination of safety and probable benefit for use of the HUD only within its approved indication(s). If a HUD is used outside its approved indication(s) in an emergency or compassionate situation, the UK IRB requires prospective IRB review and informed consent in a format appropriate for emergency or compassionate use.
For emergency use, the health care provider or investigator follows the same procedures that govern emergency use of an unapproved device (21 CFR 814.124); that is obtaining IRB chairperson’s concurrence, informed consent from the patient or legally authorized representative; and a written report submitted to the IRB within five (5) working days of use including identification of patient involved, the date on which the device was used, the reason for use, and outcome of use.
Emergency use in a situation where obtaining the patient’s informed consent is not possible requires regulatory conditions (21 CFR 50.23) be met and documented. Such instances should be included in the request to the IRB chairperson along with a corroborative assessment from an independent qualified physician. If use is required to preserve the life of the patient and time is not sufficient to obtain the assessment and chairpersons concurrence, the independent MD evaluation must be included in the five (5) day report.
DETAILED GUIDANCE AND RESOURCE DOCUMENTS
For detailed requirements and guidance see: