Minimal Risk Studies for Sites

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 learn more about QMR studies, see our FAQ regarding minimal risk studies.

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. Additionally, for QMR sites there are no requirements for sites to submit CVs along with their QMR-Site Information Questionnaire (QMR -SIQ),This form (QMR-SIQ) must be used in order for the site to be processed according to "minimal risk" guidelines.

Depending on the site and study, the following supplemental materials may still be required.

• Letters of explanation (as required by the Site Information Questionnaire)
• Compensation schedule attachment (Please see Compensation Template if sponsor has not provided one)
• Conflict of Interest Statement
• Documentation of any audits from regulatory agencies (FDA, Canada Ministry of Health, etc.) within the past three years
• Institutional Jurisdiction Waiver Form (or an Institutional Authorization Agreement)
• State law documentation
• Advertising and recruitment materials
• Written sponsor approval for advertising and recruitment materials
• Tracked, electronic copy for unique consent form
• Written sponsor approval for unique consent form
• Rationale for requested changes for unique consent form

Required

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.

As Indicated

F-016 - Institutional Jurisdiction Waiver Form
Formal document by which an institution waives local IRB jurisdiction of a particular study to Quorum Review IRB.

F-030 - Compensation Template
This is a compensation attachment to the Site Information Questionnaire that may be used when sites will be compensating varying amounts for each visit.

F-031 - Conflict of Interest Statement
This form is an attachment to the Site Information Questionnaire, and should be used to report any conflict of interest at a study site and to indicate how it will be managed. This form applies to the principal investigator, all members of the study staff, and the immediate family members (spouse, domestic partner, dependent child, etc.), of the principal investigator and study staff. The Principal Investigator may attest for all individuals on one form.

F-034 - Institutional Authorization Agreement
Formal document by which an institution (typically, one with an FWA) waives local IRB jurisdiction of a particular study to Quorum Review IRB.

Supplemental

F-026 - California Experimental Subject's Bill of Rights - English
The Experimental Subject's Bill of Rights is provided by Quorum as a service to California sites. This bill of rights is not required by any other state at this time.

F-027 - California Experimental Subject's Bill of Rights -Spanish
This is the translated Spanish version of the Experimental Subject's Bill of Rights. This document is provided by Quorum as a service to California sites. This bill of rights is not required by any other state at this time.

Guidance

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.

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.