Common Rule FAQ | 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 19, 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.
Which forms will be updated in accordance with Common Rule requirements?
- Central Study Questionnaire (CSQ)
- Single Site Study Questionnaire (SSSQ)
- Site Information Questionnaire (SIQ)
- Waiver of Documentation of Informed Consent
- Waiver or Alteration of Informed Consent
- Human Subject Research Determination Request and Exempt Determination Request
Important Note: For all Common Rule impacted studies (i.e. federally funded studies), we are unable to accept any previous versions of these forms after January 19, 2018. For studies that are not federally funded, Quorum will continue to accept the previous versions of these forms until March 31, 2018.
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 started (including research initially approved by an IRB) prior to January 19, 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 forgo 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).
Will Q Consent eIC be able to accommodate updates to the Common Rule?
Yes, Q Consent functionality is readily able to accommodate electronic informed consent (eIC) 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 offer review of studies requesting broad consent.
Will Quorum offer review for all categories of exempt research?
Yes, Quorum will provide 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.
Note: HHS plans to release guidance in the future, establishing standards for this category of review. Quorum policies and procedures will be in line with guidance when it is issued.
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 requested, this may include reviewing privacy and confidentiality, as well as if broad consent was appropriately obtained.
Will Quorum apply Common Rule criteria when reviewing continuing review?
Yes, Quorum will have flexibility to accommodate requests for continuing review under the newly promulgated criteria for continuing review. We will also offer pre-2018 criteria for continuing review for ongoing research that commenced prior to the Final Rule.
Will Quorum be offering review services under the sIRB mandate?
Yes, as a central IRB, Quorum has longstanding capabilities to accommodate sIRB review of multicenter research, including negotiation and execution of reliance agreements for participating sites.
If the research qualifies–Phase IV studies often do, as do Retrospective Chart Reviews and surveys–we’ll rely on expedited review to review and oversee your study, saving you and your participants valuable time.
Questions? Please reach out!
If you have questions or concerns please contact the Client Support team by e-mail at ClientSupport@QuorumReview.com or by phone at (877) 472-9883 (option 1).Email Us