Quorum Review Inc. - Additional Services - institutional partnerships

By: Quorum Review  09-12-2011

Subject protection is of critical importance, yet every day institutions are being asked to do more with less. IRBs within institutions are looking for ways that they can expand their current capacity and improve their review cycle timelines without increasing costs. Some institutions are looking for secondary supplier alternatives while others are looking to focus on research and outsource the IRB function all together.

Quorum Review IRB can help. Quorum is an AAHRPP accredited independent ethics review board that offers customized processes for the ethics review of institutional research.

And in a world in which budgets are shrinking, Quorum Review offers the efficiencies and reliability of one of the largest ethics review organizations in the nation.

Quorum is committed to our relationships with institutions. To that end, Quorum has developed an Institutional Start-Up Package. The goal of this package is to make it easy for you and your institution to establish a relationship with Quorum Review. Once the relationship is established, we can work with your institution when you are ready—on a study-by-study basis or more globally. To obtain a copy of Quorum’s Institutional Start-Up Package please contact Quorum’s Business Development Team at


to download the package.

As Indicated


Q.    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

. Please be sure to respond appropriately to questions 18. a., b., and c. of the Site Information Questionnaire.

Q.    My study is Federally Funded. Does Quorum review Federally Funded Research? >>

Quorum reviews Federally Funded studies. There are additional submission requirements for any federally funded studies, for more information on what is required please see the

section of this website.

Q.    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

Q.    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.

Q.    I am only allowed to use an Accredited IRB. Is Quorum accredited? >>

Yes, Quorum is AAHRPP Accredited.

Q.    Quorum is not the central IRB for my site – may I still choose Quorum? >>

Yes. Quorum offers a wide range of options. If Quorum is not the Central IRB, you may choose to submit as a Single Site. Please see Quorum’s Single Site page for more information.

Other products and services from Quorum Review


Quorum Review Inc. - Additional Services - prereview

This conference call will involve the following parties: a sponsor representative and other pertinent parties to help give general feedback about the protocol or consent form, the IRB Chairman, and a representative from Quorum's Study Management, Initial Study Support, and Regulatory departments.


Quorum Review Inc. - Additional Services - services

For studies with tight timelines, this service can often save valuable time during consent form negotiation. Quorum has built out many processes to better accommodate the unique needs of institutions. Quorum Review IRB is a full-service independent review board.


Quorum Review Inc. - Additional Services - IRB determination

Some research activities that involve human subjects may be exempt from IRB review under certain conditions pursuant to 45 CFR 46.101(federally funded projects), 21 CFR 56.104(FDA regulated studies), and the Tri-Council Policy Statement (TCPS 2), Article 2. Q. Who should I contact if I have questions about completing an Exemption Determination Request. An applicant may therefore apply to Quorum Review for an exemption determination.


Quorum Review Inc. - Additional Services - federally funded studies

Certificates of Confidentiality allow investigators to refuse to disclose identifying and sensitive information obtained as part of research, in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.



For research recruitment purposes, an investigator may wish to use already collected PHI in order to contact potential participants or may collect and record PHI via telephone screens before the potential research participants visit the research site (called a "Partial Waiver". It may not be practical for an investigator to obtain a signed HIPAA Authorization prior to the use and disclosure of a participant’s PHI.


Quorum Review Inc. - Additional Services - translation

When submitting a new study to Quorum, sponsors, CROs and single sites may request our translation services in the Central Study Questionnaire, Single Site Study Questionnaire, or Principal Investigator Generated Study Questionnaire. When you select Quorum to manage your translations in addition to reviewing your study, we can ensure quality standards are met and translations are completed in a timely manner.