Element II.2.D.

The IRB or EC should have policies and procedures describing the conduct of meetings of the convened IRB or EC. These policies and procedures should allow the IRB or EC to carry out its functions effectively and consistently according to applicable laws, regulations, codes, and guidance and the organization’s policies and procedures.

The IRB or EC should have policies and procedures for developing the meeting agenda and describing functions of the meeting agenda. This should include how the volume of the agenda is controlled or limited to allow for adequate time for discussion of all items on the agenda. If the agenda is used for purposes such as informing members of research protocols or plans approved using the expedited procedure, or identification of member conflict of interest, these uses should be described in policies and procedures.

Meeting agendas should be designed to allow for adequate discussion of each item on the agenda, resolution of controverted issues, and IRB or EC determinations.

The process of IRB or EC review takes time. The definition of timely review depends on organizational culture and the expectations of researchers and those involved with the IRB or EC. Reviews should be timely within the context of the organizational culture.

IRB or EC meetings should be scheduled regularly based on the volume of research to be reviewed. The schedule should promote timely review or re-review of research.

The establishment and maintenance of quorum is essential for the IRB or EC to review and approve research during a meeting. This involves not only appropriate numbers of members, but composition (e.g., a non-scientist must be present). Policies and procedures should describe who determines quorum is established and how it is documented at the beginning and during a meeting.

The widespread use of technology in IRB or EC meetings has necessitated the development of policies and procedures to integrate the use of these technologies in the conduct of meetings and in accordance with any legal or regulatory requirements. This includes policies and procedures for teleconferencing or videoconferencing, or the use of technology or other materials to meet responsibilities, such as displaying and confirming the criteria for approval of research.

Policies and procedures should describe how votes are taken and recorded. For example, votes may be taken by a show of hands, voice vote, or electronic polling. An affirmative vote may be by majority or by consensus.

The role of the IRB or EC chair and vice-chair, if any, should be described in policies and procedures, including whether they vote and have any specific role.

Regulatory and guidance references

DHHS: 45 CFR 46.108(b), OHRP Guidance on Written Institutional Review Board (IRB) Procedures
FDA: 21 CFR 56.108
ICH-GCP: 3.3.2
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)
AAHRPP Tip Sheet: Review of Research by the Convened IRB or EC
AAHRPP Tip Sheet: Review of Research involving Prisoners and the Role of the Prisoner Representative

Required written materials

Essential requirements:
1. Policies and procedures describe the conduct of meetings by the convened IRB or EC:
  1. The timing and scheduling of IRB or EC meetings, including:
    1. The timing of document distribution before convened IRB or EC meetings.
    2. Limits placed on the number of items on the agenda, if any.
    3. Other functions of the agenda, e.g., informing IRB or EC members of research protocols approved using the expedited process.
  2. Policies and procedures describe requirements for convened meetings:
    1. A majority of IRB or EC members has to be present.
    2. At least one member whose primary concerns are in non-scientific areas has to be present.
    3. For research to be approved it has to receive the approval of a majority of members present at the meeting.
    4. If quorum is lost during a meeting, the IRB or EC cannot take votes until the quorum is restored.
    5. When the convened IRB or EC reviews research involving prisoners, the prisoner representative is present.
    6. At least one unaffiliated member is generally present at convened meetings. This may be accomplished by:
      1. Requiring an unaffiliated member as part of quorum.
      2. Placing an attendance requirement on the unaffiliated member (e.g., attend 10 of 12 meeting per year).
      3. Documenting the general attendance of the unaffiliated member (e.g., minutes indicate attendance at 10 of 12 meetings).
    7. At least one member who represents the perspective of participants is generally present at convened meetings. This may be accomplished by one of the following:
      1. Requiring a member who represents the perspective of participants as part of quorum.
      2. Placing an attendance requirement on the member (e.g., attend 10 of 12 meeting per year).
      3. Documenting the general attendance of the member (e.g., minutes indicate attendance at 10 of 12 meetings).
    8. If the IRB or EC reviews research that involves categories of participants vulnerable to coercion or undue influence, one or more individuals who are knowledgeable about or experienced in working with such participants are present.
  3. Policies and procedures describe who determines quorum is established and how it is documented.
  4. Policies and procedures state that if quorum is lost during a meeting, the IRB or EC cannot take votes until the quorum is restored.
    1. If required members (e.g. non-scientific) leave the room and quorum is lost votes cannot be taken until the quorum is restored, even if half of the members are still present.
  5. Policies and procedures describe the use of any materials or technology used to conduct meeting or meet regulatory requirements. For example, all members have laptop computers to access materials; handouts, posters, or projections contain the criteria for approval; or meetings are conducted over the Internet.
  6. Policies and procedures describe how votes are taken and documented, and what constitutes approval.
  7. Policies and procedures describe the role of the chair and vice-chair, if there are vice-chairs:
    1. Voting responsibilities.
    2. Role of the chair and vice-chair prior to, during, and after the meeting.

Common types of materials that may be used to meet the element

Policies and procedures
Meeting materials

Outcomes

The IRB or EC conducts convened meetings according to policies and procedures.
IRB or EC members receive materials in enough time prior to the meeting to review them.
The IRB or EC meets regularly to promote timely reviews.
Meeting agendas allow for adequate discussion and determinations for all research under review.
During a meeting, the IRB or EC votes and takes actions only when there is a quorum.
The chair and vice-chair, if any, fulfill their roles according to policies and procedures.

Proceed To: Element II.2.E.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

Element II.2.D.