Section IV:

VCU IRB Organization, Composition, and Responsibilities

WPP #: IV-2

Title 2:

IRB Member Responsibilities and Conflicts of Interest

Effective Date:

09-24-14

Revision History:

06-20-00; 11-12-01; 06-07-04; 06-21-06; 02-05-07; 08-27-13; 05-27-14

Policy Statement

VCU will constitute a sufficient IRB system to effectively fulfill regulatory requirements, protect human subjects, and facilitate research. IRB membership will be constituted in accord with regulatory requirements defined in 45 CFR 46.107 and 21 CFR 56.107. IRB members agree to carry out specific responsibilities related to their roles on the IRB panels.

Procedures and Guidance

  1. Membership

    Member Diversity (Scientific/Nonscientific and Overall):
    Membership is selected to assure appropriate diversity, including representation by multiple professions, multiple ethnic backgrounds, both genders, and to include both scientific and non-scientific members.

    Each Panel of the VCU IRB has at least five members including:

    1. at least one member whose primary concerns are in scientific areas
    2. at least one member whose primary concerns are in nonscientific areas
    3. at least one member who is not otherwise affiliated with the institution (and who is not part of the immediate family of a person who is affiliated with the institution). (NOTE: One IRB member may fulfill both criteria of non-scientist and non-affiliate at the same meeting).
    4. When a study involves a population vulnerable to coercion or undue influence, the IRB will include at least one member who is knowledgeable about or experienced in working with such participants
    5. At least one member who represents the general perspective of participants

    A member will not be designated as an unaffiliated member until he/she or an immediate family member has been unaffiliated with VCU for a period of three years. If a member's status has changed, Office of Research Subject Protection (ORSP) will inform the Office of Human Research Protections (OHRP) of the change in the IRB membership.

    Chairperson Appointments:
    The Institutional Official (or delegate) appoints the Panel Chairpersons. Appointments are for a one year term with an automatic annual renewal. Ending of a term should be accompanied by written notice. Justification is not required for notice of a Chairperson’s term end (by either party). The VCU IRB Panel roster (developed and maintained by the ORSP) serves as the official documentation of chairperson appointment.

    General Membership and Vice Chairperson Appointments:
    The institutional signatory official (or delegate) appoints the Vice Chairpersons of the IRB panels, the general members and alternate members. Appointments are for open terms and should be ended by written notice. Justification is not required for notice of membership term end (by either party). The VCU IRB Panel roster (developed and maintained by the ORSP) serves as the official documentation of membership appointment.

  2. IRB Member Responsibilities

    General Responsibilities:
    While serving an IRB appointment, members have the following responsibilities:

    • complete all required VCU human subject protections training and seek additional training where necessary to maintain an effective understanding of human subject protection regulations,
    • complete the state-required Statement of Economic Interests on an annual basis as directed by the VCU Office of Integrity and Compliance
    • complete assigned reviews in a timely fashion as assigned by the Chairperson and Panel Administrator,
    • review panel meeting agenda prior to the convened meeting, ensuring that all materials are reviewed for familiarity of protocol and be prepared to participate and contribute to discussion,
    • speak freely to discuss their point of view and listen respectfully regarding studies under review,
    • participate openly in appropriate discussions, and motioning and/or voting to approve, disapprove, require modifications, or table each submission during the IRB meetings,
    • maintain confidentiality of protocols, decisions, and discussions both inside and outside of Panel meetings,
    • work collegially with investigators and other IRB members to facilitate human subjects’ protections,
    • if IRB member is also a research investigator, research conducted must be ethical and must maintain IRB studies in good standing,
    • announce conflicts of interest with research under review and recuse themselves from the review of studies where conflicts of interest exist or may appear to exist,
    • as a primary member, attend 75% of scheduled panel meetings and notify Panel Administrator when unavailable to attend meetings or conduct reviews. Meetings can be attended via teleconference if necessary,
    • as an alternate member, attend at least 2 meetings per year as either a voting or non-voting member,
    • provide prior notice of intention to resign from the IRB to the Panel Chairperson and the Director of ORSP

    The Responsibilities of IRB Members serving as Primary Reviewer Include:
    Full Board Reviews:

    • conducting a full and thorough review of all materials related to the assigned protocol,
    • contacting the Panel Administrator and/or Chairperson if additional expertise/consultation may be necessary,
    • requesting (along with the Secondary Reviewer and/or Chairperson) additional information from the Principal Investigator such as documents, or clarification prior to the Panel Review. As appropriate, the Primary Reviewer should coordinate with the Secondary Reviewer in regard to working with the Principal Investigator to revise documents (protocol, consents, and advertisements) prior to a meeting to facilitate review,
    • requesting (along with the Chairperson and Panel Administrator), Secondary Reviewer that the Principal Investigator (or designee) attend or be available during the panel meeting to aid in the review,
    • preparing for and leading the discussion of the protocol, the complete grant application (as applicable), and whether the research meets the criteria for IRB approval,
    • coordinating review comments/questions with the secondary reviewer, if appropriate,
    • presenting specific written recommendations for panel action, including changes and/or questions to the Panel Administrator prior to the Panel meeting,
    • recording any scripted (specific) changes requested/required directly onto relevant documents to facilitate communication to investigators and accurately capture IRB requirements

    For Expedited Reviews:

    • conducting a complete review of all materials related to the assigned protocol,
    • working with the Principal Investigator or designee to obtain clarifications, modifications, and necessary changes for a thorough review in order to determine if the research meets the criteria for IRB approval,
    • the reviewer may determine a study meets the criteria for an exemption or referring studies. Additionally, referring the IRB Panel for informal discussion or for full board review.

    For Exempt Reviews:

    • conducting a complete review of all materials related to the assigned protocol.
    • working with the Principal Investigator or designee to obtain clarifications, modifications, and necessary changes for a thorough review in order to determine if the research qualifies for exemption.
    • If exempt review criteria are not met, then changing the study review category to expedited review when appropriate and continues the review. Additionally, studies may be referred to the IRB Panel for informal discussion or for full review.

    The Responsibilities of IRB Members serving as a Secondary Reviewers include:
    Full Board Reviews

    • conducting a full review of all materials related to the assigned protocol,
    • working with the Primary reviewer prior to the Panel meeting as needed to complete the review,
    • contacting the Panel Coordinator and/or Chairperson if additional expertise/consultation may be necessary,
    • preparing for and leading the discussion of the informed consent document or alternative document/request and recruitment procedures,
    • discussing pertinent review comments/questions with the primary reviewer, if appropriate, and
    • presenting specific written recommendations for panel action, including changes and/or questions to the Panel Coordinator prior to the Panel meeting,
    • recording any scripted (specific) changes requested/required directly onto relevant documents to facilitate communication to investigators and accurately capture IRB requirements

    A secondary reviewer may be requested to assist in the review of an expedited protocol when the research appears to require additional subject matter expertise, but the research does not exceed minimal risk criteria. Similarly, a third reviewer or consultant may be requested to assist in the review of a full board protocol depending on the need for content expertise.

  3. Member Compensation

    The Institutional Official (or designee) manages compensation standards for service related to duties of Chairpersons, Vice Chairpersons, IRB members, non-affiliate members and consultants.

  4. Member Liability

    IRB members function as employees and agents of VCU. As such, when acting in accordance with federal, state, and local regulations and the VCU IRB Written Policies and Procedures, their actions are covered by the University’s self-insurance policy, which protects individuals serving on all University committees.

  5. Alternate Members

    Alternates, if appointed, are designated for specified member(s) by the ORSP, in consultation with the Panel Chairpersons. If both the alternate and the member attend a meeting, only one of these two may vote. In these cases, the minutes reflect who is in attendance as a voting member. Alternate members with adequate experience may be designated to conduct expedited and/or exempt reviews.

  6. Evaluation of Members and Chairpersons

    Members and Chairpersons will be evaluated periodically and no less than every three years to determine if the responsibilities of the appointment are being sufficiently met. Each will be asked to complete a self-evaluation and data will be collected regarding numbers of reviews completed and meetings attended. Chairpersons and ORSP administration will review member evaluation results and determine follow-up action as necessary. The Senior Chairperson and ORSP Director will evaluate Panel Chairpersons and make recommendations to the Institutional Official as needed. Chairpersons will review panel rosters to ensure the membership represents the expertise and diversity necessary to effectively review the research portfolio.

    In addition to the formal evaluation process, Panel Chairpersons and the ORSP Director have the authority to review IRB member performance and make recommendations to the Institutional Official regarding membership appointments and terminations. Members have the right to appeal any membership decisions they believe have been determined unjustly to the IRB Leadership and Enhancement Committee.

  7. IRB member Conflict of Interests

    No IRB member involved in the design, conduct, or reporting of the research activity under review will participate in an exempt, expedited or full Panel review or determinations except to provide information. Additionally, Individuals who are responsible for business development are not permitted to carry out day-to-day operations of the review process nor serve as members or ex-officio members on the IRB. An IRB member is considered to have a conflicting interest when the member, the member’s spouse, or any of the member’s dependent children have any financial interest related to the sponsor, product or service being tested in the research as defined in the Virginia Commonwealth University Conflict of Interest Policy. Members should also consider whether they have non-financial conflicts of interest with study investigators or the study itself that may impact objective review. Examples of non-financial conflicts held by members may include: philosophic or moral objection to the study itself, supervisory or subordinate positions relative to the principal investigator, participation in a promotion or tenure evaluation relative to a protocol investigator, or service on a graduate student investigator’s committee for the research. Members holding a financial or non-financial conflict of interests with the study or investigators shall:

    1. Announce the presence of a conflict and disqualify themselves from accepting a protocol review or participating in a convened Panel review, except to provide information on request
    2. Leave the meeting during the discussion and the vote on any motion to approve, require changes, or disapprove the research in question (Note: When a person with a conflict of interest leaves the room he/she cannot be counted towards a quorum. If the quorum is lost, the protocol will be tabled. Those who dismiss/absent themselves during a meeting will be noted/identified as doing so, in the minutes.)
    3. If an IRB member is unsure whether he or she has an actual or perceived conflict of interests with the research under review, the general recommendation is to discuss with the Panel Chairperson and request recusal from protocol review if the presence or appearance of conflict remains unclear.

References

WPP# IV-4: Responsibilities of Senior Chairperson, Chairpersons/Vice Chairpersons
WPP# III-3: Meeting Guests
WPP# IV-5: Use of Consultants for IRB Review
Virginia Commonwealth University Conflict of Interest Policy