Common Rule FAQ | Quorum Review IRB

Common Rule FAQ

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 21, 2019, 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
  • Phase I Healthy Participant Studies – Generic Screening Consent Form Questionnaire
  • Federal Funding Addendum

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 21, 2019. As a courtesy for studies that are not federally funded, Quorum will partner with you to accept previous versions of submission forms until March 22, 2019.

Will Quorum be applying the Common Rule to all studies?

No, Quorum will not be applying the new Common Rule (i.e. 2018 Requirements) 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.

See here for the old Common Rule (“Pre-2018 Requirements”) versus new Common Rule (“2018 Requirements”): https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

 

What standards for review will Quorum employ for ongoing research begun prior to 2019?

Quorum will apply the pre-2018 rule for ongoing research started (including research initially approved by an IRB) prior to January 21, 2019.

 

How will Quorum address Common Rule consent form requirements?

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

 

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

No, the research sponsor is 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).

 

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.

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.  

Will Quorum offer review for all categories of exempt research?

Yes, Quorum will provide review for all categories of exempt research, including those utilizing limited IRB review as well as broad consent.

 

Will Quorum apply Common Rule criteria when conducting continuing review?

Yes, Quorum will have flexibility to accommodate requests for continuing review under the new Common Rule. Quorum will continue to apply the pre-2018 criteria for continuing review of ongoing research that commenced prior to the Final Rule’s effective date.

 

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.

 

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).

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