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  1. What is Quorum Review’s Federal Wide Assurance (FWA) number?

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    An independent IRB does not need to obtain a separate Federal Wide Assurance (FWA). It is generally accepted that the IRB is not actively engaged in the research nor is it a direct recipient of federal funds. Consequently, the IRB can be considered a sub-contractor and as such should be listed on the Sponsor’s FWA form as the IRB of record.

    To designate Quorum as an IRB of Record on the FWA, simply include “Quorum Review IRB” and Quorum’s IRB registration number IRB00003226 on the FWA.

    For more information on Federal Wide Assurances, visit the U.S. Department of Health and Human Services website at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html. Please contact Quorum Review IRB’s Initial Study Support team for clarification or assistance regarding these requirements.

  2. I am interested in choosing Quorum as my IRB but my institution still wants to be aware of what is happening with my study. Is this possible?

    Comments Off on I am interested in choosing Quorum as my IRB but my institution still wants to be aware of what is happening with my study. Is this possible?

    Quorum’s OnQ Portal offers convenient access to all site approval documents, consent forms, formal acknowledgments, and other IRB correspondence. A site may grant access to anyone that they would like, and this is an excellent way to keep the Institution involved in what is happening with your study.

  3. What is Quorum Review’s Federal Wide Assurance (FWA) number?

    Comments Off on What is Quorum Review’s Federal Wide Assurance (FWA) number?

    An independent IRB does not need to obtain a Federalwide Assurance (FWA). An FWA is required for institutions that are engaged in research conducted or supported by a federal agency (such as HHS.) An IRB itself is not engaged in the research nor is it a direct recipient of federal funds. However, an FWA requires the institution to list all IRBs that review research for the institution. All IRBs must be registered with OHRP before they can be listed on an institution’s FWA. Therefore, when an institution wishes to use the services of an independent IRB, it must add the IRB to its FWA as an IRB of Record using the IRB’s OHRP registration number. More information is available at http://www.hhs.gov/ohrp/assurances/assurances/filasurt.html

  4. My institution’s IRB has jurisdiction over my site. Can my site be reviewed by Quorum?

    Comments Off on My institution’s IRB has jurisdiction over my site. Can my site be reviewed by Quorum?

    Your site can be reviewed by Quorum if your Institution is willing to waive jurisdiction. With your submission, please include either Quorum’s Institutional Jurisdiction Waiver Form or an Institutional Authorization Agreement (IAA). Quorum also will accept the template IAA posted on the OHRP website . Please be sure to respond appropriately to questions 18. a., b., and c. of the Site Information Questionnaire.

  5. I am interested in choosing Quorum as my IRB but my institution still wants to be aware of what is happening with my study. Is this possible?

    Comments Off on I am interested in choosing Quorum as my IRB but my institution still wants to be aware of what is happening with my study. Is this possible?

    Quorum’s OnQ Portal offers convenient access to all site approval documents, consent forms, formal acknowledgments, and other IRB correspondence. A site may grant access to anyone that they would like, and this is an excellent way to keep the Institution involved in what is happening with your study.