Minimal Risk Studies

Study Start-Up Process

Welcome to the Quorum study start-up process. We are committed to working with you to make the submission process as straightforward as possible.

Quorum Review IRB offers a separate review process for some Phase IV/post-marketing studies and other types of minimal risk research that can be reviewed using an expedited review procedure. At Quorum, we call such studies "Qualified Minimal Risk” or "QMR."

To qualify as QMR, a protocol must meet certain minimal risk and other regulatory requirements. Specifically, Quorum is permitted to use the expedited review procedure to conduct the review of research if (1) the research appears on the Federal Register list of categories of research which may be reviewed by expedited review, and (2) the research involves no more than minimal risk. (For more information, see 63 Federal Register 60353 (November 9, 1998) at http://www.fda.gov/oc/ohrt/irbs/expeditedreview.html)

Studies that are determined by the IRB to be QMR have shorter forms and fewer submission requirements. QMR studies with 50 sites or more also enjoy discounted fees.

It is important to note that the QMR designation is not granted until AFTER the Board has reviewed the protocol and consent form and determined that the study qualifies as QMR. 


To consider a study for QMR, a sponsor must complete and submit the "Qualified Minimal Risk Study Submission Form" with the initial protocol submission.

Standard protocol submission requirements:

• Study protocol
• All proposed consent forms (in electronic Microsoft Word format)
• Investigator’s brochures, package inserts, or device background literature for all primary and comparator drugs/devices
• Central Study Questionnaire
• Device Study Submission form (as applicable)
• Proposed study-wide advertisements and recruitment materials
• Proposed study-wide participant study materials (diaries, questionnaires, written study instructions, etc.)

After the Board has reviewed the protocol and consent form, the Board’s determination regarding your QMR request will be communicated to you by your Study Manager.

If the study is QMR qualified, principal investigators may submit a modified version of the site questionnaire, which is shorter than the standard site questionnaire and has been specifically tailored to ask questions pertinent to minimal risk studies. This form must be used in order for the site to be processed according to "minimal risk” guidelines.

Depending on the site and study, the supplemental materials (e.g., for an additional facility or audit information) may still be required.

Required

F-020 - Exemption Determination Request
If an applicant would like Quorum Review to make a determination regarding whether research is exempt from review, this form should be submitted. The protocol must also accompany the Exemption Determination Request Form.

F-053 - Qualified Minimal Risk Study Site Information Questionnaire
This form is a required element of an investigator's Qualified Minimal Risk initial site submission to Quorum Review.

F-054 - Qualified Minimal Risk Study Submission Form
In order to apply to be a Qualified Minimal Risk study, an initial protocol submission should include this form.

As Indicated

F-013 - Central Study Questionnaire
When a Sponsor or CRO chooses Quorum as the Central IRB for the study, this form should be completed and submitted as part of the initial protocol submission.

F-019 - Device Study Submission Form
Device studies require completion of a Quorum Review Device Study Submission Form at the time of initial study submission to Quorum.

F-025 - Board Meeting Schedule
This schedule provides a complete listing Quorum's meeting dates and submission deadlines for the entire year.

F-042 - Waiver of Documentation of Informed Consent Submission Form
This form is required if a Waiver of Documentation of Informed Consent will be necessary.

F-043 - Waiver or Alteration of Informed Consent Submission Form
This form is required if a Waiver or Alteration of Informed Consent will be necessary.

F-052 - Qualified Minimal Risk Site Submission Checklist
This guidance document provides a comprehensive listing of the materials that an investigator needs to provide to Quorum in a Qualified Minimal Risk initial site submission.

Guidance

G-034 - Consent Form Development Guide
This guide briefly describes Quorum Review's consent form editing process.

G-035 - Consenting Research Participant Guidelines
This document contains some guidelines on consenting research participants, including sections on the informed consent process, the Principal Investigator's signature, Non-English speaking research participants, Illiterate participants, enrollment of minors, revised consent forms, and compliance with HIPAA privacy protections.

G-039 - Consent Form Versioning Guidelines
This guidance document helps customers understand Quorum Review's version management system for consent forms. Quorum issues consent form versions which are whole numbers, pointed or alpha-numeric.

G-043 - Handbook for Quorum Review IRB (Requires an OnQ Portal Account)
The Handbook provides a guide for using Quorum Review IRB as an ethics review board. It contains policies, procedures, and guidelines to be used in preparing materials for Board review, as well as information on managing ongoing research activities, continuing and periodic review, and closing.

G-091 - Central Study Submission Checklist
This guidance document provides a comprehensive listing of the materials that a sponsor/CRO needs to provide to Quorum in an initial study submission.