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Impact of Recent Extreme Weather on Clinical Research and Human Subject Protections

September 14th, 2017

Hurricanes Harvey, Irma and Maria have devastated many areas in the US and Puerto Rico, and more extreme weather is possible during this late summer hurricane season. Schulman IRB is committed to providing IRB support and oversight to local IRBs and researchers that have been impacted by the storms.

While OHRP and FDA have not yet released statements addressing the storms’ effects on IRB operations and human subject protections, Schulman has reviewed OHRP’s past statements regarding Hurricane Katrina and Superstorm Sandy and suggests the following actions:

 

IRB Support

In the event your local IRB is unable to oversee research activities due to the storms’ effect, the institution should consider reasonable attempts to suspend or refer research to another IRB. Information on submitting a transfer of IRB oversight to Schulman can be found here.

Ongoing Research

For ongoing research, past OHRP guidance suggests subjects may be able to receive interventions temporarily at other facilities, provided that these locations were not initially selected as research sites and that they will only administer study interventions on a one-time or short-term basis.

Unanticipated Problems Involving Risks to Human Subjects or Others

Past OHRP guidance states that a major storm’s disruptions to human subject protections programs do not constitute unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, or suspension or termination of IRB approval. If you have questions regarding reportable events, additional information is available here.

Status Reporting

If you are a researcher who currently is unable to prepare your ongoing review submission documents, please contact Schulman promptly at 513-761-4100 or email Ongoing Review. Schulman will assess the information you are able to provide and determine whether sufficient information is available for continuing review.

If you have any additional questions regarding the effects of Hurricanes Harvey, Irma, Maria and other extreme weather systems on human subject protections, please contact your Study Manager or call 513-761-4100.

*9/29/17: This article has been updated to acknowledge the impact of Hurricane Maria.

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