Section VIII:

Review Types/Process

WPP #: VIII-3

Title 3:

Initial Review - Full Board

Effective Date:

09-24-14

Revision History:

06-20-00; 06-07-04; 06-07-04; 12-06-04; 06-21-06; 02-05-07; 01-15-08; 04-22-14

Policy Statement

All proposed projects that involve human subjects and that satisfy the definition of research must be reviewed prior to the activity beginning. This review is called “initial review.” The types of initial review are exempt, expedited and full. Full Board review of research is exercised when the research does not meet the criteria for exemption review or expedited review or otherwise is determined to necessitate review at the convened full board meeting of the IRB membership. Full board review is described within this WPP.

The VCU IRB conducts all full board review processes in accordance with 45 CFR 46. The convened IRB may be a forum for discussion and reviewer guidance of protocols under exempt or expedited review. Such discussion does not change the review levels of such protocols without a vote by the convened IRB.

Description and Procedures

  1. Panel Composition:

    In order to conduct research via Full Board review, the panel must meet the requirements described in VCU IRB WPP VII-5.

  2. Reviewer Expertise:

    The designated reviewer (primary and secondary reviewers) must, together, have the appropriate scientific knowledge and experience, as well as experience and understanding of issues affecting any vulnerable populations included in the research (in accordance with VCU IRB WPP IV-5). Primary and secondary reviewer assignments are initially made by the VCU ORSP staff, based upon area of expertise. Assignments are subject to the approval of the Chairperson or designee. If staff detect that a reviewer may not be available or have the expertise required, they contact the chairperson to obtain a consultation recommendation. Please see also VCU IRB WPPs#: VII-5 and IV-2 regarding the use of consultants.

  3. Full Board Meeting Actions:

    The primary and secondary reviewers and other attending panel members receive review materials in sufficient time prior to the meeting to allow for adequate review. This includes, but is not limited to, the full protocol, consent document, recruitment materials and investigator’s brochure/drug labeling.

    1. Each protocol will be assigned to a primary reviewer who will be responsible for a full review of all materials, and will lead the discussion of the protocol, the complete grant application (as applicable) and the risk/benefit ratio.
      1. When applicable, the reviewers and attending members of the IRB are provided with and review the DHHS-approved sample consent document (when one exists) as well as the complete DHHS-approved protocol (when one exists).
    2. Each protocol will be assigned to a secondary reviewer, whose major responsibility is to review the consent document and recruitment materials and provide input for panel discussion.
    3. If the reviewers disagree with the necessity for full board review for a given protocol, the reviewers may recommend expedited review or exempt review by notifying IRB staff of their recommendation.
    4. If there is any protocol-related information requiring clarification, the primary and/or secondary reviewers may contact the principal investigator (or appropriate designee) directly.
    5. Reviewer comments are presented by the primary and secondary reviewers. Comments are documented in writing and made available to the IRB Coordinator. This documentation addresses and prepares for comprehensive discussion of the following, as appropriate:
      1. Confirmation that the research meets the criteria for review found at 45 CFR 46.111 and 21 CFR 56.111;
      2. Confirmation that the research meets the requirements found at Subparts B, C and D, when applicable, and the precise information justifying each of the determinations;
      3. Confirmation that the research meets the requirements for informed consent, including consent alterations or waivers, and the precise information justifying each of the determinations;
      4. Confirmation that the research meets the requirements for assent, including whether the permission of one or both parents is required, if applicable;
      5. Review of any recruitment procedures, including advertisements;
      6. A risk level determination or other justification to warrant full board review;
      7. Approval period dates (if less than annual continuing review is recommended) or detailed limitations to approval periods (such as limitations to enrollment numbers prior to reporting back for continuing review).
    6. A full and complete discussion regarding ethical concerns and issues impacting research subjects takes place prior to a motion of the IRB, a second motion, and a final vote.
    7. The actions of the panel are recorded by the IRB Coordinator and communicated in writing to the principal investigator.
  4. Additional Guidance:

    Please refer to the following WPPs and internal citations, especially concerning vulnerable populations, for additional guidance relative to the protocol specifications:

References

HHS 45 CFR 46.108(b)
HHS 45 CFR 46.109(e)
VCU IRB WPP#: IV-5
VCU IRB WPP#: VII-2
VCU IRB WPP#: VII-5
VCU IRB WPP#: XIV-1
VCU IRB Submission Form
Full Board Review Sheet