Procedure for Initial Review of Proposed Research at the Convened IRB Meetings - IRB PRO122

Procedure for Initial Review of Proposed Research at the Convened IRB Meetings - IRB PRO122

Abstract:
This procedure lists the responsibilities of the investigator, IRB and OIRB for conducting the initial review of proposed research at the convened IRB meetings.
Effective Date:
10/24/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:
UAB Human Research Protection Program

HRPP Document: PRO122
Effective Date: 3/30/07
Revision Date: 8/31/07, 3/10/10, 10/24/10, 7/30/11
Subject: Procedure for Initial Review of Proposed Research at the Convened IRB Meetings

PROCEDURE

Investigator Responsibilities

An investigator 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 signed by the principal investigator (PI);
  • Grant or contract, 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 for alteration to or waiver (FOR211 in whole or FOR212 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;
  • Additional materials relevant to the research;
  • 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:
    • Special populations supplemental forms pertaining to vulnerable subjects (FOR220 pregnant women, fetuses, neonates; FOR221 prisoners; FOR222 children);
    • 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;
    • Waiver of compliance billing language.

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;
  • 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.

IRB Responsibilities

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

  • The complete initial convened review application submitted by the Principal Investigator;
  • Informed consent document(s) including NIH-approved sample informed consent document, if applicable;
    • Special populations supplemental forms pertaining to vulnerable subjects (FOR220 pregnant women, fetuses, neonates; FOR221 prisoners; FOR222 children);
    • Reviewer comment forms to document comments;
  • Copies of all research instruments (e.g., surveys, questionnaires);
  • Any advertising or recruiting materials.
  • Primary Review Team members 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:
    • Drug Review Sheet (FOR230);
    • Device Review Sheet (FOR229);
    • Reviews in accordance with the applicable regulations and makes a determination.

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 Team provides 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;
  • After initial review the IRB takes action on the protocol by simple majority vote and assigns the protocol to one of the following categories:
    • Approved—No modifications required. Research activity meets 45 CFR 46.111 or 21 CFR 56. 111;
    • Approved with Limited Modifications—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;
    • Deferred—The entire protocol submission (protocol, grant/funding application, sponsors’ protocol, appropriate departmental approvals and informed consent document) was insufficient and will need to be rewritten, resubmitted and re-reviewed by the convened IRB;
    • 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 “approved with limited modifications”. 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.

OIRB Responsibilities:

The Clerical Staff:

  • Logs all materials received in the log book;
  • Sends communication (letter) of IRB actions, approval form, and stamped informed consent document to Principal Investigator.

The Administrative Staff:

  • Makes Primary Review Team assignments (see PRO143 Procedure for IRB Member Selection for Convened Meeting);
  • Reviews all new submissions for inclusion of required materials and notifies principal investigator and contact of any deficiencies;
  • Prepares agenda for initial reviews after submission deadline and reviews with OIRB Director;
  • Prepares protocol file;
  • Distributes materials to OIRB senior staff assigned to the convened IRB meeting;
  • Prepares, copies and forwards materials for distribution to IRB sufficiently 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);
  • Sends communication (letter) of IRB actions, approval form, and stamped informed consent document to Principal Investigator;
  • Sends a copy of the IRB minutes including actions on the protocols receiving initial review.

The Senior Staff:

  • Reviews protocols prior to meeting;
  • IRB Chair for determination of approval or schedule for response review by the convened IRB.

The Administrative Staff:

  • Enters protocols scheduled for IRB review into information system database;
  • Drafts letter of IRB action to Principal Investigator for review by senior staff and/or Chair;
  • Enters final actions into the information system database;
  • After final approval is issued, enters date issued into IRB database and mails approval and stamped approved informed consent document(s);
  • Prepares draft minutes of the IRB meeting for review by the senior staff;
  • Generates report to Conflict of Interest Review Board.

Approved on July 30, 2011 by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Denise Ball, CIP
OIRB Interim Director