Part 1 – IRB Meetings and Structure

The IRB and Meetings

The Institutional Review Board must be compromised with the following make up:

  • At least one scientist
  • At least one non-scientist
  • At least one member that is not affiliated with the institution (the “community member”)

An individual may fill more than one of these roles if applicable. Further, if research regularly involves vulnerable populations such as children or prisoners, it is important to keep on the board an individual who is trained and knowledgeable about dealing with these populations.

In order for a meeting to approve protocols, it must have quorum present. This is defined as more than half of the board (for instance, of boards with 8 people, 5 must be present for quorum to be established). This is defined as voting members. If a specific protocol is being voted on and a member recuses themselves from the vote, the number of board members voting on that item must still meet quorum for it to be approved. Also, a non-scientist member must be in attendance for a meeting to proceed.

It is especially important to note that the community member of the board (one who is not affiliated with the organization) must be impartial and not swayed by the concerns of the institution. This individual’s key role is to speak on behalf of the community that the institution is based in and address concerns from a perspective similar to a research subject.

Business that will be encountered during IRB meetings include approving minutes from the previous meeting, approving new study proposals, reviewing continuing review documents, approving modifications, ruling on non-compliance or unanticipated problems, hearing reports on current research projects, or updating the board on studies that were approved by partial review.

Members may cast the following votes:

  • Approve as submitted
  • Approve with stipulations or changes
  • Defer
  • Table
  • Disapprove

 

Under normal circumstances, board members are not able to abstain from votes except when recusing oneself. If a study is approved with stipulations or changes, this means that the required changes will be communicated to the PI and after proof is submitted to the IRB chair or a designated alternate, they will receive approval and be given their approval documents. This does not require another meeting of the board.

Studies are generally presented by a designated presenter on the board that will give a summary and insight into the study before discussion begins. This will generally be communicated in advance.

It is important to note that what is discussed in an IRB meeting is considered confidential and should not be communicated outside the board meeting. However, it is acceptable to ask for information from a PI before the meeting starts to inform one’s decision. A PI may be present at the discretion of the chair to answer questions during a presentation of an agenda item, but deliberations and votes must be done in private.

 

The IRB Chair

The chairperson of the Institutional Review Board should be a respected, experienced member of the institution and have the skills necessary to both facilitate the board and its discussions and oversee its activates. The Chair will usually be the one conducting and facilitating meetings and is tasked with assuring the training and evaluation of board members, as well as the development of IRB policies. The Chair will often be the point of contact to institutional officials, federal agencies, the general public and will be the one to meet the needs of auditors from outside agencies.

The Chair is the first point of contact in issues such as Unanticipated Problems, reports of noncompliance and funding and grant concerns. They further have the default responsibility of assuring the minutes and agendas for meetings are created and properly circulated and also being the authorizing member for expedited review requests and modifications not requiring a full board convening, though these duties may be delegated.

A Chairperson’s expertise and oversight is integral to the functioning of a board. They must be intimately knowledgeable with human research regulations and the Belmont Report, and be able to interpret them to assure there is no noncompliance with any regulations at the federal, state, local, agency and institutional levels.