Procedure

Investigator Responsibilities

Submits one copy of the following information in sufficient detail for the IRB 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 new FOR200 Human Subjects Protocol (HSP) application certified electronically by the principal investigator;
Information to link to the grant or contract in the electronic research administration (ERA) system, if the protocol is federally funded;
Notification that all ICH-GCP requirements should be followed or the extent or limit to which the UAB IRB must follow ICH-GCP during its review;
Completed FOR205 Protocol Oversight Review Form (PORF), accompanied by any other written review materials required by the PI’s department to satisfy departmental review and approval requirements; Informed consent document(s) (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);
FOR209 HIPAA authorization or request to waive (in whole or in part) of HIPAA authorization requirements for research using protected health information, if applicable; Questionnaires, surveys, or scripts to be used with participants, if any;
Memorandum documenting that the research satisfies Children’s Risk Level of 45 CFR 46 Subpart D if applicable, and 21 CFR 56 Subpart D if applicable;
The complete DHHS-approved protocol, if applicable;
Sponsor’s protocol, if applicable;
Investigator’s Brochure, if applicable;
Any recruitment materials or advertisements to be used in the proposed research (i.e., materials intended to be viewed by participants);
Form FDA 1572, if applicable;
Any “special approval” forms applicable to the proposed research including:
- Release of Drugs for Human Research Use Pharmacy Form (FOR217 required for UAB, Kirklin Clinic, FOR218 required for TCHA),
- Radiation Safety Committee approval,
- Institutional Biosafety Committee approval,
- Release of Pathologic Materials Form (FOR215 Anatomic and/or FOR216 Clinical Pathology),
- Verification of Notification of Proposed Research for protocol-related performance sites,
- Documentation of IRB approval from other site(s) engaged in research, if applicable,
- Documentation/verification of the sponsor’s injury compensation policy,
- Sponsor billing form, or
- Waiver of compliance billing language;
Additional materials relevant to the research.

Investigators will provide additional information and materials as requested by the IRB and OIRB staff in order for the IRB to complete its review. The investigator may be requested to:

Attend the IRB meeting to provide information on any aspect of the trial;
Present information in a certain format or summary form;
Identify other IRB-approved protocols that describe the proposed research;
Certify that the grant application or proposal is consistent with any corresponding IRB protocols or submit protocol amendments to reconcile any differences; or
Provide details on the proposed populations involved in the research including anticipated number of enrollees, population characteristics such as race, gender, and ethnicity, and the inclusion/exclusion criteria.

OIRB Responsibilities:

Administrative Staff:

Receives the submission in the electronic system and assigns it to the appropriate OIRB staff member;
Conducts a pre-review of all new submissions for inclusion of required materials and notifies Investigator and contact of any deficiencies;
Prepares agenda for each IRB meeting and reviews with OIRB staff assigned to the meeting.

Provide information to the IRB about details of the fCOI management plan, if applicable;

Sends communication to OIRB staff assigned to the convened IRB meeting regarding meeting materials.
Distributes the meeting agenda with links to all review materials to IRB members one week in advance of the meeting to allow adequate review in accordance with Timing of Document Distribution Procedures (see PRO145 Procedure for Timing of Document Distribution for IRB Meetings).
Enters protocols scheduled for IRB review into the ERA system.
Drafts and issues communication of IRB action and stamped informed consent document to Investigator following review by appropriate OIRB staff.
Enters final actions into the ERA system.
Prepares draft minutes of the IRB meeting for review by management staff.
Generates report to Conflict of Interest Review Board.
Sends IRB minutes including actions on the protocols receiving initial review.

Reviewing Staff:

Reviews protocols and completes the IRB Reviewer Sheet eForm (FOR243) prior to meeting.
Documents comments on GUI308 initial administrative review checklist and includes in the protocol record.
Documents IND exemption using GUI347 (IND Exemptions Checklist for Reviewers) if FOR230 (Drug Review Sheet) indicates no IND or no FDA exemption letter is submitted.
Reviews management plan if investigator identifies conflict of interest on application;
Makes Primary Reviewer(s) assignments (see PRO143 Procedure for IRB Member Selection for Convened Meeting).
Answers inquiries from IRB members prior to convening of meeting;
Takes notes on IRB actions for each protocol during convened meeting along with protocol analyst;
Reviews issues communication on behalf of the IRB to the Investigator; and
Reviews responses from the Investigator to the IRB’s communication “additional information required”. May issue approval or refer to the IRB Chair for determination of approval or schedule for response review by the convened IRB.

IRB Responsibilities

Each IRB member receives and is expected to review all protocol materials in enough depth to discuss the information at the convened meeting:

The complete initial convened review application submitted by the Investigator
Informed consent document(s) including NIH-approved sample informed consent document, if applicable
Copies of all research instruments (e.g., surveys, questionnaires)
Any advertising or recruiting materials
Memorandum of details of financial conflict of interest management plan, if applicable
If research is being conducted at UAB and the VA, all VA regulations must be applied

Primary Reviewer(s) receive and review the above materials as well as the following additional materials in depth to present the protocol to the convened IRB meeting:

The sponsor’s protocol and Investigator’s Brochure, if applicable
Copies of all Notifications of Research Participation from all performance sites, if applicable
NIH-funded grant application or contract
Other materials submitted by investigator:
Reviews in accordance with the applicable regulations and completes the IRB Reviewer Sheet eForm (FOR243) to document comments and determinations

The IRB determines that the materials are acceptable to undergo review and perform substantive review in accordance with the criteria in 45 CFR 46.111, 21 CFR 56.111, and any other funding agency regulations, as applicable.

Primary Review(s) provide a comprehensive review and leads the discussion of assigned protocols
For protocols proposing to enroll vulnerable subjects the IRB reviews according to 45 CFR 46 Subparts B, C, and D if applicable, and 21 CFR 56 Subpart D if applicable
Takes action on the protocol by simple majority vote and assigns and documents the protocol to one of the following classifications:
- Approved - No modifications required. Research activity meets 45 CFR 46.111 or 21 CFR 56. 111.
- Additional Information Required - May be used when there are specific modifications required by the IRB to be reviewed by one experienced IRB member by the expedited review procedure before formal approval can be issued; cannot be used for modifications or clarifications that are related to the regulatory criteria for approval.
- Deferred for Response - IRB requested clarification to the human subjects protocol. The response to the IRB will be reviewed at a convened meeting of the IRB before formal approval can be issued. The entire protocol submission (protocol, grant/funding application, sponsors’ protocol, appropriate departmental approvals and informed consent document) will be available to the IRB for the review of the response.
- Disapproved - The research did not meet 45 CFR 46.111 or 21 CFR 56. 111.
The IRB assigns a review period of no more than 1 year from date of approval or more frequently in accordance with policy on convened IRB review.

Chair or designee:

Reviews responses from the investigator to the IRB’s memorandum for protocol “additional information required”. May approve by the expedited procedure or indicate response does not meet the criteria for expedited review approval and should be scheduled for convened IRB review.