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Response of Quorum Review to Congressional Testimony

This past week, the research community has been shocked by much of the testimony presented at a recent Congressional subcommittee hearing involving a “sting” of several small IRBs. We want to assure our researchers, funding agencies and sponsors that we have mechanisms in place to ensure that Quorum Review conducts thorough and appropriate reviews of study submissions:

  • Quorum is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). As such, Quorum has demonstrated to AAHRPP that Quorum has policies and procedures in place to ensure that our Board is trained, our Board understands our regulatory and ethical obligations and our Board conducts thorough reviews of submissions.
  • Quorum has had repeated clean audits by the FDA.
  • Quorum is a member of the Consortium of Independent Review Boards (CIRB), whose members agree to abide by a voluntary, self-imposed Code of Ethics for independent IRBs. CIRB has worked with the office of Rep. DeGette and CIRB supports her proposed legislation, “Protection for Participants in Research Act of 2008".
  • Some of the processes that Quorum has in place to ensure a quality review of study submissions include:
    • Quorum has strict documentation requirements for study submissions;
    • Quorum’s Board members have several days to review a new protocol prior to the Board meeting;
    • Quorum staff persons, including regulatory counsel and consent form editors, participate in the review of new protocol submissions; and
    • Quorum staff persons conduct an independent license verification of investigator submissions.
  • Archived Quorum Board Rosters Now Available at the Quorum OnQ Portal for Sponsors and Sites!
  • Developing Translations of Study Materials with Quorum Review

As a note, in response to customer requests, Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Lisa Newmark in Customer Relations lnewmark@quorumreview.com if you’d like more information about this process.

Here at Quorum Review our Board members and staff care deeply about the safety of study participants. Please accept our assurance that we will continue to strive to conduct thorough and compliant ethics reviews of the studies under our oversight.

Sincerely,

Arri Burgess
Director, Customer Relations
Quorum Review IRB
T | 206-448-4082
F | 206-448-4193
aburgess@quorumreview.com
www.quorumreview.com