Initial Review Using the Expedited Procedure- PRO120   

Procedure
 

Investigator Responsibilities

Submits one copy of the following information to the OIRB in sufficient detail to evaluate and make a determination that the protocol satisfies the approval criteria (see 45 CFR 46.111 and, if applicable, 21 CFR 56.111 and any other funding agency regulations, as applicable):

• Completed FOR200 IRB Application eForm.  Principal investigators who are students must identify the faculty advisor/course instructor’s name, and contact information.
• Includes the Office of Sponsored Programs proposal number (whether intramural or extramural), if applicable;
• Informed consent document(s), if applicable, to enroll subjects or collect biological specimens (if research is NIH-sponsored and being conducted by an OHRP-recognized Cooperative Protocol Research Program, include a copy of the NIH-approved sample informed consent document);
• The complete DHHS-approved protocol (when one exists);
• Sponsor’s protocol, if applicable;
• Investigator’s Brochure, package insert or device information, if applicable;
• Form FDA 1572, if applicable;
• Documentation of IRB approval from other site(s) engaged in research, if applicable;
• Sponsor billing form, if applicable;
• Questionnaires, surveys, or scripts to be used with participants, if any;
• Release of Pathologic Materials for materials obtained from Department of Pathology (FOR215, FOR216), or a specimen release form or approval letter if the study involves obtaining pathological or diagnostic specimens from another department.  The head of the department responsible for providing the specimens should sign the approval letter;
• Release of Drugs for Human Research Use form signed by the appropriate pharmacy (FOR217 UAB or FOR218 Children’s Hospital) for all drugs used in the protocol;
• FOR205 Protocol Oversight Review Form or other departmental approvals, as applicable;
• Advertisements or other recruitment materials, if applicable;
• Special approvals, if applicable; and
• Additional materials relevant to the research.

OIRB Responsibilities

Administrative Staff:

• Receives the Initial Submission for review.
• Enters protocol information into the electronic system.
• Assigns the submission to the IRB Chair (or designees), including:
  • All written requests made to the principal investigator or contact by review staff;
  • Comments made by reviewing staff; and
  • Responses from principal investigator.
• Submits list of approved protocols using the expedited procedure with the materials to the convened Board once a month.

Reviewing Staff:

• Performs preliminary review to determine whether the research satisfies the criteria for expedited review procedure (see OHRP Categories eligible for expedited review).
• Checks investigators’ training status.
• Documents comments on GUI308 preliminary review worksheet and includes in the file.
• Reviews details of the management plan for any identified financial conflicts of interest.
• Prepares correspondence to send to Principal Investigator regarding IRB review and determinations from expedited review.
• Documents the rationale needing continuing review on research that otherwise would not require continuing review.
• Schedules initial applications that do not meet the criteria for expedited review and approval for convened IRB review.

IRB Responsibilities

IRB Chair (or designee):

• Reviews the application and verifies that the research meets the requirements for review via expedited procedures (see OHRP Categories eligible for expedited review).
• Receives limited IRB review materials for Exemption Categories 2 and 3 (UAB has not adopted Exempt categories 7 and 8.) and documents the determinations under 46.111(a)(7).
• Reviews the memorandum with the details of the management plan, for any identified financial conflict(s).
• Uses the GUI329 (b) Criteria for Approval Tool to determine whether the research meets the criteria at 45 CFR 46.111, and Subpart D if applicable; 21 CFR 56.111 if applicable; 21 CFR 56 Subpart D, if applicable; and the Procedure for Review of Decisionally Impaired Adults Involved in Human Subjects Research (PRO125), if applicable.
• Refers research protocols that cannot be approved by the above procedure to review staff to schedule for convened IRB review.
• Completes review of all materials including modifications to receive approval before issuing approval. 

Convened IRB:

• Approves the list of protocols that received approval by the expedited procedure;
• Reviews research approved by the expedited procedure for convened IRB review if requested to do so by any IRB member;
• Reviews research referred by the IRB Chair (or designee) or experienced IRB reviewer and not approved by the expedited procedure (see PRO122 Procedure for Initial Review of Proposed Research at the Convened IRB Meetings);
• Contacts the reviewing staff to obtain additional information about any expedited protocol on the list of approved protocols presented once a month.