Section IV:

IRB Panel Organization, Composition, and Responsibilities

WPP #: IV-4

Title 4:

Responsibilities of IRB Chairperson and Vice Chairpersons

Effective Date:

07-01-16

Revision History:

6-20-00; 11-12-01; 06-07-04; 12-03-04; 04-28-06; 06-21-06; 09-01-09, 10-1-13; 10-22-13; 09-24-14

Policy Statement

To describe the responsibilities of the IRB Chairpersons and Vice Chairpersons.

Description

The following persons have direct responsibilities on behalf of the VCU IRB, including those described:

  1. Panel Chairpersons/Vice Chairpersons:

    The IRB Chairperson manages the IRB and the matters brought before it according to FDA and DHHS regulations pertaining to the rights and welfare of research subjects. The IRB Chairperson is responsible for conducting meetings in an efficient and orderly fashion with respect given to the opinions of all members. Robert's Rules of Order may be used as a guidebook for conducting the meeting. Should an IRB Chairperson not be available to conduct panel business, the vice chairperson serves on his/her behalf. Should neither the chairperson nor the vice chairperson be available, either may designate an IRB staff member or senior board member to assume his/her responsibilities during the period of absence.

    Specific responsibilities include:

    Ongoing:

    1. Maintain a thorough understanding of federal regulations pertaining to human subject protections, federal guidance, the VCU IRB Written Policies and Procedures, and other applicable state, and local regulations.
    2. Screen (or defer to the primary reviewer to screen) all on-site SAEs via expedited review to determine which of the following is necessary: (1) take immediate action to address the safety of subjects and/or (2) call an emergency meeting of the Panel or (2) present to the full board at the next scheduled Panel meeting.
    3. Assist with review of SAE/AE and Unexpected problems affecting the safety of subjects as necessary.

    Prior to Each Meeting:

    1. Approve IRB meeting schedule through ORSP.
    2. Coordinate coverage of Vice Chairperson when not able to serve as Chairperson for the meeting (and notify ORSP).
    3. Review items for agenda (Full board submissions, expedited items etc.)
    4. Oversee primary and secondary reviewer assignments made by panel administrators to ensure appropriate scientific expertise.
    5. Assist the Primary and Secondary Reviewers with any concerns in preparing for the meeting, as necessary.
    6. Assist with the selection of a consultant, as necessary.

    During the IRB Meeting:

    1. Conduct the meeting in an efficient and orderly fashion with respect to all members of the IRB and in accordance with the VCU IRB Written Policies and Procedures (using the support of the ORSP staff and directors).
    2. Lead the Primary Reviewer to present a clear and concise overview of the research and discussion of relevant changes and/or questions.
    3. Lead the Secondary Reviewer to present a clear and concise review of any consent documents and subject recruitment materials. Encourage the Secondary Reviewer to record any additional changes required by the Panel directly on his/her copy of the documents where scripted. Non-scripted changes and requested clarification should be noted on the document (where practicable).
    4. Lead the IRB to discuss specific findings, as required by regulation where vulnerable populations are involved, e.g. children, prisoners, pregnant women and fetuses.
    5. Call for a motion for IRB action.
    6. At time of the motion, request that the specific elements pertaining to the motion be clearly repeated for the record.
    7. Ensure that the IRB administrators have understood and documented the basis of any motion and vote of the IRB.

    After the IRB Meeting:

    1. Review correspondence to investigators and study teams to ensure the IRB administrators have documented requested changes and other stipulations.
    2. Approve IRB correspondence prior to it being provided to investigators and study teams.

    Overall (Leadership Attributes/Expectations):

    1. The ability to conduct meetings of the IRB in an efficient, expeditious and fair manner.
    2. Attentiveness to the details and requirements of the Federal regulations and VCU IRB policies.
    3. Application of the requirements to foster ethically and scientifically sound research.
    4. The ability to set a tone of openness that encourages dialogue in IRB meetings.
    5. Respect for the diverse backgrounds, perspectives and sources of expertise of all IRB members, especially for the contributions of the non-scientists, and the ability to foster such respect among the IRB members.
    6. The confidence and courage to uphold IRB judgments that may not always be popular with principal investigators.
    7. Investment of adequate time, interest and commitment to provide guidance and expertise to IRB members, scientists and others.
  2. Responsibility

    It is the responsibility of the Chairperson/Vice Chairpersons to ensure that the above obligations are met and to report to the ORSP and/or the signatory official of the institution where the need for additional resources arises.

    References

    WPP VII-9 Appeal of IRB Decisions