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From the Chairs' Desk

From the Chairs' Desk

Use of an Investigational Drug in an Emergency Situation

 

The need for an investigational drug may arise in an emergency situation that does not allow time for submission of an IND in the usual manner. In such cases, the FDA may authorize shipment of the drug for a specified use [21 CFR 312.36]. Except in extraordinary circumstances, such authorization will be conditioned on the sponsor making an appropriate Emergency Use IND submission as soon as practicable after receiving the authorization. Prospective IRB review is required unless the conditions for exemption are met [21 CFR 56.104(c) and 56.102(d)]. Informed consent is required unless the conditions for exception are met [21 CFR 50.23]. 

 

·         21 CFR 56.102 (d) Definition of Emergency Use of a Test Article - Emergency use means the use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval.

·         21 CFR 56.104(c) Exemptions from IRB requirement - Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review.

 

A request to the FDA for such authorization may be transmitted to FDA by telephone or other rapid communication means. For investigational biological drugs regulated by the Center for Biologics Evaluation and Research, the request should be directed to the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, 301-827-2000. For all other investigational drugs, the request for authorization should be directed to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 301-827-4570. After normal working hours, EST, the request should be directed to the FDA Office of Emergency Operations (HFA-615), 301-443-1240.

Analyst Notes

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Analyst Lock-down Time

 

If you call or send a message to your managing analyst and don’t hear back within one business day, the analyst may be in lock-down.  Analyst lock-down (which lasts 3 business days) occurs when the analyst is drafting review communications from the last IRB meeting.   Because of time constraints and our commitment to getting response communications out in a timely manner, we are unavailable during this time for other business.
 
Attached is a link to how our analyst teams are divided.  If your analyst is not available, you are welcome to contact another analyst on her team: http://www.ohsu.edu/xd/research/about/integrity/irb/board_information.cfm

Research Administration:

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Information about the Genetic Information Nondiscrimination Act

  

The IRB has posted a DHHS fact sheet and a revised genetic consent form template which now includes a statement describing the discrimination protections afforded by the Genetic Information Nondiscrimination Act (GINA).
 
GINA is a Federal law that prohibits discrimination in health coverage and employment based on genetic information. GINA, together with already existing nondiscrimination provisions of the Health Insurance Portability and Accountability Act, generally prohibits health insurers or health plan administrators from requesting or requiring genetic information of an individual or an individual's family members, or using such information for decisions regarding coverage, rates, or preexisting conditions. GINA also prohibits employers from using genetic information for hiring, firing, or promotion decisions, and for any decisions regarding terms of employment. The parts of the law relating to health coverage (Title I) generally will take effect between May 22, 2009, and May 21, 2010, and those relating to employment (Title II) will take effect on November 21, 2009.
 
GINA does not replace or conflict with Oregon’s existing genetic privacy laws. 
 
The DHHS fact sheet on GINA can be found on the IRB’s genetic research page at: http://www.ohsu.edu/xd/research/about/integrity/irb/genetic.cfm#docs
The updated genetic consent form template can be downloaded at: http://www.ohsu.edu/xd/about/services/integrity/policies/research.cfm#hsf

eIRB: Helpdesk

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Upcoming Changes- FDA pages (approved and unapproved drugs)

 
The FDA pages will be updated in the next eIRB upgrade. The pages will include better descriptions of FDA regulated products, clearer questions, and more relevant help text. One of the new features is a series of questions called “Determining if this is an Unapproved Use of an FDA-Approved Drug.”
 
Remember that for FDA approved drugs the IRB requires a current drug package insert or other relevant drug information or brochure. Investigational (Unapproved) drugs require a current investigator’s drug brochure (IDB).  These must be uploaded to the eIRB application and include information regarding toxicity, previous animal/human studies and bibliography. If the IND holder is an OHSU investigator the IND application must also be included in your submission.
 
An application to the Institutional Biosafety Committee (IBC) is required if recombinant DNA or infectious agents are involved. Please see the IBC Human Gene Transfer web page for more information http://www.ohsu.edu/xd/research/about/integrity/ibc/index.cfm.