Guidance for Safety Reporting to Quorum After Recent Hurricanes

This site contains the most up-to-date resources on human subject protection reporting for research sites in the impacted areas affected by Hurricane Harvey or Hurricane Irma.
Quorum Review IRB recognizes the severity of the situation confronting your research site. Severe disasters—such as recent hurricanes in the U.S. southeast—impose additional challenges to clinical research and, specifically, the protection of human subjects.

 

Temporary Disaster Policy

If the disruption caused by Hurricane Harvey or Hurricane Irma causes a lapse in required reporting to Quorum, we will consider the report prompt if received within 10 days of the time normal clinic activities resume, whenever that may be.

Additional Resources

To access the Quorum Handbook, log in to the OnQ Portal and navigate to the “Resources” section.

You can also visit the “Help and Training” section of the OnQ Portal (login required) and locate a document titled
“Safety Reporting,” under the “Guidelines” heading.

Regulatory and Policy Information

Federal regulations, as well as Quorum policies, allow for intentional changes in approved research activities without prior approval whenever such a change is necessary to eliminate an apparent immediate hazard or is otherwise clearly within the best interest of participants.

Any such changes that may be warranted during the current disaster should be reported to Quorum at the earliest possible opportunity. In the instance of Harvey and Irma, Quorum requires that regular reporting should resume within 10 days of the time normal clinic activities restart, whenever that may be.

Contact Information

If you need immediate assistance, please contact our Client Support team by emailing clientsupport@quorumreview.com or calling (206) 448 4082 and selecting Option 1.

Additionally, we are monitoring our social media accounts for hurricane-related communications. We are available on Twitter (@QuorumReview) and LinkedIn (Quorum Review – Independent Review Board).

You can direct-message us on either platform to receive assistance related to the conduct of research and human subject protection during severe disasters.

Building Community After Disaster

Our help goes beyond human subject protection to building community dedicated to the well-being of all people. To support those affected by Harvey, Quorum has made a donation to the Hurricane Harvey Relief Fund and the Hurricane Irma Relief Fund.

Our thoughts and prayers are with all those who have suffered losses as a result of these devastating storms.

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