Common Rule FAQ - Testing | Quorum Review IRB
The forthcoming Common Rule regulation changes usher in exciting opportunities for the future of clinical research. Along with the updates Quorum is making to bring our submission processes into compliance with the new rule by Jan 22, 2018, there are new service enhancements available to our clients. These include broad consent, limited IRB review, and new continuing review options. For more information on Common Rule regulation changes, please see below, and feel free to reach out to us if you have a question that is not answered here.
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.
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?)
Is there a scenario where Quorum would want to retain authority to redact information from the consent (e.g. IRB contact information) for consents that need to be publically posted?
Will Q Consent be able to accommodate updates to the Common Rule?
Yes, Q Consent functionality is readily able to accommodate Common Rule requirements.
What is broad consent?
Broad consent is a non-study specific consenting avenue that can be utilized for both exempt and non-exempt secondary research use of identifiable private information or identifiable specimens (including storage and maintenance of specimens for such use).
Will Quorum offer review of broad consent?
Yes, Quorum will be offering review of studies requesting broad consent. Please note Quorum will not be providing oversight for tracking: whether, how, and when broad consent was obtained at either the sponsor, site, or participant.
Will Quorum be offering review for all categories of exempt research?
Yes, Quorum will be providing review for all categories of research including those utilizing limited IRB review as well as broad consent.
What is limited IRB review?
Limited IRB review is focused around reviewing studies (certain categories of exempt research) to ensure adequate privacy and confidentiality safeguards, especially for exempt research utilizing individually identifiable information / biospecimens.
How will limited IRB review be conducted?
Quorum will be utilizing expedited review procedures to conduct limited IRB review for each of the implicated new exempt research categories. Depending on the category of exemption being requested this may include: reviewing privacy and confidentiality, as well as if broad consent was appropriately obtained.
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