IRB
Hurricane/Disaster Plan
The key elements of the Ochsner IRB disaster plan:
1. To protect the ability to perform expedited and full panel reviews:
· The IRB Chair or designee will be available either onsite as essential personnel or by email & internet access to complete required expedited reviews.
· The IRB Administrator will
o Develop a disaster communications list of IRB members prior to each hurricane season that has alternate phone numbers and email addresses where they may be reached if evacuated.
o Send a pre-hurricane season newsletter to IRB members explaining the disaster plans for telephone meetings if regular meetings are disrupted due to evacuations or disasters; and the alternate time plans if the meetings cannot be held at the scheduled time even via telephone. PIs will be notified as needed prior to evacuations about presenting to the IRB meetings by telephone when needed.
2. To protect continuity in FDA regulated studies where drugs or devices are involved:
· Prior to hurricane season the IRB Administrator will send out a newsletter to the Ochsner Research Community (PI’s, CRC’s, Research Administration) reminding them that during hurricane season they should be especially mindful of maintaining a list of subjects involved in drug/device studies along with their contact information so they can be contacted with phone numbers or email that work even if they are evacuated out of the region. CRC’s should ensure that the list of subjects is up to date in EPIC and OMIS.The PIs should have this list with them if and when they have to evacuate. In addition, the disaster phone and emails for the IRB and OGM will be shared, along with plans for a Baton Rouge Research Command Center if it is required.
3. To protect communications with regulatory authorities:
· The IRB Chair will notify the FDA and OHRP about Ochsner’s research situation if a disaster occurs.
4. To keep subjects informed about what to do in a disaster with their research drug or device when an evacuation or other disaster has occurred that disrupts normal operations:
· PIs should discuss the emergency process with drug and device subjects and ensure contact information is up-to-date, including numbers and emails. This should occur at a study visit prior to hurricane season and throughout the hurricane season.
· PIs should give an IRB approved disaster communications card for research subjects to all subjects in their studies who are taking study drugs or have study devices implanted.
· PIs should be informed of how to contact essential personnel in the IRB/OGM/Pharmacy/Compliance in a disaster situation when normal means of communication are not working due to an evacuation or major disaster.
o The June IRB Newsletter will focus each year to disaster planning to protect human subjects who are on drug or device trials
5. To keep the IRB Office in good communications internally:
· The IRB Administrator will send a memo prior to hurricane season with essential contact information on IRB Office staff / IRB Chair / IRB members to the IRB Office staff & Chair
· In the days prior to any severe storm with an expected evacuation, the IRB Administrator will collect and send an email to the IRB staff and chair with potential evacuation plans (where they will likely be) and any updates to the pre-season emergency communications listing
G:\RES\IRB\Disaster Plan June 2013