Section VII:

General Operations

WPP #: VII-2

Title 2:

Activities of the Full Board (Combines previous WPPs VII-1,2,3,4,5,6)

Effective Date:

09-24-14

Revision History:

06-20-00; 08-29-00; 06-07-04; 04-30-06; 04-22-14

Policy Statement

The ORSP ensures that IRB panel meetings are prepared for and conducted in a consistent manner in order to meet federal and institutional requirements. The IRB will review research at full board meetings except when expedited review procedures are used.

Description and Procedures

  1. Review Submissions and Determination of Type of Review:

    All review submissions (including initial review applications, applications for continuation, change in research, reports of unanticipated problems, or applications for study closure) are screened in the ORSP. The screening process is completed prior to assignment to a panel meeting or expedited reviewer.

    At initial review, one of three types of review (Exempt, Expedited and Full Board) can be requested by the PI. Regardless of the review type requested by the PI, the VCU IRB will determine the review type based on the criteria outlined in 45 CFR 46 or 21 CFR 56. (See WPP VIII-1, VII-2 and VII-3 for more information on the review types.)

  2. Meeting Scheduling:

    Each IRB Panel is scheduled to meet at least once per month. Individual meetings may be cancelled by the Director of the ORSP, following consultation with the Chairperson, due to: 1) insufficient applications requiring full board review, 2) University holiday, 3) inability to secure a quorum for attendance, or 4) other reasons (such as inclement weather) that make a scheduled meeting unnecessary or otherwise inappropriate.

    For an updated listing of deadlines for submission and panel emphasis areas, see the Submission Deadlines and Meeting Dates section of the VCU IRB webpage.

  3. Meeting Agendas and Document Distribution:

    Each convened meeting of the VCU IRB Panels will have an agenda clearly showing the topics and items the Panel will consider at the meeting. Agendas will remain as part of the official record to assist location of a specific item or action in the minutes of the meeting. Corrected agendas will be provided to IRB members if changes are made subsequent to the agenda being distributed.

    All materials necessary to review convened submissions and verify that the approval criteria are met are distributed to reviewers and attending IRB members in sufficient time prior to the meeting to allow for adequate review. This includes the preliminary meeting agenda, minutes, pre-review forms and all submitted materials, including but not limited to the full protocol, consent document, recruitment materials and investigator’s brochure/drug labeling.

  4. Calling to Order, Quorum, Teleconferencing and Voting Requirements:

    1. Requirements for Calling the Meeting to Order:

      The VCU IRB Panel meeting is called to order by the chairperson only when a quorum of members is in attendance. The meeting ends or is suspended whenever a quorum of members is no longer present for deliberations. A quorum is also required to review research and vote.

    2. Requirements for Quorum:

      A quorum requires a majority of the voting members or alternates of the Panel to be present. IRB staff determine when quorum is met, and document quorum status in the meeting minutes. The following special conditions apply to achieving and retaining quorum:

      1. At least one scientific and one non-scientific member must be present at all meetings.
      2. At least one physician member must be present when research activities involving drugs, biologics or devices are being considered.
    3. Voting Requirements:
      1. Only members and alternates may vote.
      2. No one may vote who has a conflict of interest with respect to the research under consideration.
      3. Votes by proxy are not allowed.
      4. A favorable vote of the majority of the members/alternates present is required to approve research activities.
    4. Requirements for Teleconferencing:

      If necessary, individual IRB members may participate in the meeting via telephone conference call, or meetings may be conducted exclusively via telephone conference call only if the following conditions are met:

      1. Each member must have received all pertinent material prior to the meeting
      2. Each participating member must be able to actively and equally participate in the discussion of all protocols reviewed during the teleconference
  5. Motions

    During a convened meeting of an IRB panel, any voting member may motion for an action of the panel using one of the following motions (descriptive phrases define the purpose of the motion, which may be referred to by number):

    1. Approved: defined as approved as is, with no further action requested or required.

    2. Approved on condition that the investigator does one or more of the following:
      1. Make precise language changes to the research protocol or supporting documents
      2. Confirm specific assumption or understandings on the part of the IRB regarding how the research will be conducted (e.g., confirmation that the research excludes children)
      3. Submit additional document(s) (e.g., documentation of clinical privileges or certificates of training completion)
      4. Make substantive changes to the protocol or supporting documents along with clearly stated parameters that the changes must satisfy.

      The approval assumes that if all of the conditions are satisfied, the study meets all of the conditions for approval documents in 45 CFR 46.111 and applicable subparts B, C, and D.

      The IRB motion must include:

      1. The conditions that must be met in order to approve the study; and
      2. Name the individual(s) designated to review the response on behalf of the IRB. The designated individual(s) must have the appropriate expertise and qualifications to determine that the conditions have been met and the study adheres to the criteria for approval outlined in 45 CFR 46.111 and applicable subparts.

      The designated individual(s) will take one of the following actions:

      1. Approve the study if the response is satisfactory; or
      2. Refer the study to the convened panel for additional review if the response is not satisfactory.
    3. Tabled: defined as the requirement that modifications and/or additional information must be provided before the IRB is able to determine that the study meets the criteria for approval specified in 45 CFR 46.111 and applicable subparts. Responses must be returned to the full panel for further review.

    4. Disapproved: defined as not approved by the panel for reasons specified in a Letter of Disapproval.

    5. Suspended: the suspension of previously approved research is defined as temporarily discontinuing any interventions with human participants for research purposes. [See WPP#: VI-3 for more information on the suspension process, including the process for investigations and see WPP#: VIII-8 for information regarding suspension reporting requirements].

    6. Termination: the termination of previously approved research is defined as indefinitely (possibly permanently) discontinuing any interventions with human participants for research purposes. [See WPP: VI-3 for more information on the termination process, including the process for investigations and see WPP#: VIII-8 for information regarding termination reporting requirements].

    7. Other Motions: The IRB may make additional motions as outlined below:
      • Unanticipated Problem: The IRB may determine that an event meets the criteria of an unanticipated problem involving risk to subjects or others. See WPP VIII-7 Required Reporting of Unanticipated Problems Involving Risk for further information.
      • Noncompliance: The IRB may determine that an event meets the definition of general noncompliance or serious and/or continuing noncompliance. See WPP VIII-9 Investigations of General, Serious or Continuing Non-Compliance for further information.
      • Acknowledgement: The IRB may vote to acknowledge reports of deviations, adverse events, unanticipated problems or noncompliance. An acknowledgement motion may be made in addition to another motion when the IRB has determined further information or modifications are required. Additionally, an acknowledgement motion may be accompanied by a separate determination.

References

45 CFR 46
21 CFR 50
21 CFR 56
45 CFR 46.108(b)
45 CFR 46.111
OHRP Guidance on IRB Approval of Research with Conditions