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.

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Will Quorum be applying the Common Rule to all studies?

No, Quorum will not be applying Common Rule across the board. Quorum will be adhering to the Common Rule for all federally-funded studies and will continue to follow FDA regulations for studies subject to FDA oversight.

What standards for review will Quorum employ for ongoing research begun prior to 2018?

Quorum will apply the pre-2018 rule for ongoing research begun (including research initially approved by an IRB) prior to January 18, 2018.

One exception is continuing review: ongoing research that meets the regulatory criteria (e.g., it is in follow-up or data analysis) will be eligible to forego continuing review so long as the study does not re-open.

How will Quorum address Common Rule consent form requirements?

Quorum is able to review and edit consent forms for studies submitted under the 2018 Common Rule. In addition, Quorum has revised our existing consent form templates to accommodate the new elements (e.g. concise summary of key information) put forth under this Final Rule.

Will Quorum be responsible for posting consent forms to the public federal website as required for federally funded studies?

No, the sponsor and site are ultimately responsible for compliance with this requirement however, Quorum will be happy to work with clients to ensure that consent forms meet the criteria for posting (e.g. contain the requisite information and suggestions for redaction?)

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