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Quorum and Voting in IRB Meetings


Hello, my name is Angela Hvitved and I’m
a Public Health Advisor in the Division of Education and Development at OHRP. This tutorial will explain some of the requirements
for convened IRB meetings, including quorum requirements for convening an IRB meeting
and voting at a convened meeting. After completing this tutorial, you should
have a better understanding of the regulations regarding convening and conducting IRB meetings
and how to apply them. This tutorial is the second of a series. You may also wish to view the first one, which
covers IRB membership requirements. Let’s get started! Human subjects research that requires IRB
review may be reviewed at a convened IRB meeting or, if it qualifies for expedited review,
by the IRB Chair or an experienced IRB member or members designated by the IRB Chair. This tutorial focuses on the requirements
for reviewing research at convened meetings. The HHS regulations at 45 CFR part 46 section
108(b) set out the minimum membership requirements for a convened IRB review meeting. These are commonly referred to as the quorum
requirements. To establish quorum at a convened meeting,
a majority of the IRB members must be present, including at least one member whose primary
concerns are in nonscientific areas. In addition, if the IRB will be reviewing
research involving prisoners, there are additional requirements that will be addressed later
in this tutorial. Without meeting the quorum requirements, the
IRB cannot review or take action on any research protocols. Each IRB must have a minimum of 5 members,
including at least one member whose primary concerns are in scientific areas (scientist
member), one member whose primary concerns are in nonscientific areas (nonscientist member),
and one member who is not affiliated with the institution aside from serving on the
IRB (unaffiliated member). The regulations require that a majority of
the IRB members be present for a convened meeting. The minimum number of members that must be
present to meet this requirement is determined by the number of regular voting members, commonly
referred to as primary members, listed on the IRB roster. This means that more than half of the total
number of primary members listed on the IRB roster must be present for a convened meeting
to proceed. The term “primary member” is used to distinguish
them from individuals who are designated as alternates, a concept that we will explain
in a moment. For now, it’s sufficient to know that any
alternates must be listed on the IRB roster, but they do not count when determining how
many members are needed to constitute a quorum. In order to ensure that full board meetings
can be convened when one or more of the primary members are unavailable, or to meet a need
for a specific area of expertise, IRBs often include individuals on the IRB roster to serve
as alternates to the primary members. When an alternate attends and participates
in a meeting in place of a primary member who is not present, she or he counts toward
fulfilling quorum requirements. For example, consider an IRB that has a total
of 11 primary members and 3 alternates on its roster. They will use the number of primary members
(11 in this case) to determine the minimum number of members who must be present to fulfill
quorum. The majority of 11 members is 6, so 6 members
must be present to establish quorum for a convened meeting. Alternates may count towards quorum only when
replacing primary members who are not present. A nonscientist member must be present at every
convened IRB meeting. Without a nonscientist member, the meeting
cannot proceed, even if enough members are present. • If an IRB has a total of 10 primary members
on its roster, more than half must be present to establish quorum, so at least 6 members
are required. • Remember, the regulations also require
that at least one of the members in attendance be a nonscientist. • Note that the IRB Chair is a member and,
if present, counts toward quorum. To help meet the requirement that a nonscientist
member be present, IRBs may include more than one nonscientist in their membership, or designate
one or more alternates for the nonscientist member who can fill in when that member is
not available. Although the regulations require that the
IRB membership also include at least one scientist and one unaffiliated member, those members
do not have to be present for the purpose of meeting quorum requirements. The IRB needs to include a prisoner or prisoner
representative if it is reviewing research involving prisoners under Subpart C. OHRP
recommends that a prisoner representative have a close working knowledge, understanding,
and appreciation of prison conditions from a prisoner’s perspective. This person cannot be a consultant, and must
be listed on the IRB roster. This person may be listed as a primary member
or alternate. The prisoner representative’s presence for
the purpose of meeting quorum requirements is only necessary when reviewing research
involving prisoners. Note that when reviewing research involving
prisoners, a majority of the primary IRB members listed on the roster (excluding the prisoner
representative) must not be associated with the prison or prisons involved, outside of
their membership on the IRB. The regulations also set out requirements
for reviewing and voting on research protocols. After reviewing each protocol, the convened
IRB can: 1) Approve the research
2) Require modifications to secure approval 3) Disapprove the research, or
4) Table the research for action at another time According to the regulations, in order for
the research to be approved, it must receive the votes of the majority of members present
at the meeting. There may be circumstances when some members
choose to abstain when voting on a protocol, for example, they may not feel adequately
informed to make a decision, or are genuinely undecided. Members who participated in a protocol’s
review but abstained from voting are still considered to be members present at the meeting. Therefore, they count toward quorum and for
calculating what constitutes a majority vote for approving a research study. • Consider an IRB with a total of 7 primary
members on its roster. It convenes to review several research protocols,
none of which involve prisoners. • The Chair is in attendance, along with
the nonscientist member, and 3 additional primary members
• Are the quorum requirements met for this IRB to proceed with the meeting? • Yes. The quorum requirements are met because a
majority of the IRB membership is present, in this case 5 of the 7 members, including
a nonscientist member. Here’s another example to consider. • An IRB has a total of 11 primary members
on its roster • At a convened IRB meeting, 5 primary members
are in attendance, including a nonscientist member
• Are the quorum requirements met for this IRB to proceed with the meeting? • No. At least 6 of the 11 members (that is, more
than half of 11) must be in attendance, including a nonscientist member, for the quorum requirements
to be met. At the next meeting, the quorum requirements
are met when 7 of the 11 primary members are present, including a nonscientist. • This convened IRB reviews and discusses
a research protocol submitted by Dr. Lee. The 7 members voted as follows:
o Approve: 4 o Disapprove: 2
o Abstain: 1 • Was Dr. Lee’s study approved by the
IRB? • Yes. The study was approved by the IRB because
a majority of the members present at the meeting, 4 of the 7 in this case, (where the abstaining
member counts as one of the 7 members present), voted to approve the study. • The convened IRB then moves on to review
Dr. Brown’s research. The 7 members voted as follows:
o Approve: 3 o Disapprove: 2
o Abstain: 2 • Was Dr. Brown’s research approved by
the IRB? • No. According to the regulations, for Dr. Brown’s
research to be approved by the convened IRB, at least 4 of the 7 members present at the
meeting, in other words, the majority of those present must have voted to approve the protocol. Even though there were more approvals than
disapprovals, the research falls short of receiving the approval of a majority of those
members present at the meeting. • Remember that the members who abstain
when voting on a protocol still count toward quorum and calculating what constitutes a
majority vote for approving a research study Certain circumstances may require additional
attention when determining quorum and counting votes for IRB actions. These special circumstances include:
• When alternates for primary members are present
• When IRB administrators or staff (who are not IRB members) are present
• When members have a conflict of interest and recuse themselves
Let’s consider each of these situations. As discussed earlier, IRBs may designate alternates
for some or all of their primary members to ensure that full-board meetings can be convened,
even if one or more of the primary members are unavailable. How an institution selects and identifies
alternates is left to the institution’s discretion but convened meetings must still
meet the quorum requirements, whether the attendees are primary members or alternates. For example, an IRB may designate one or more
alternates for their nonscientist members. If a primary nonscientist member cannot attend
a meeting, one of the nonscientist alternates can fill the seat vacated by the primary member
and be counted toward the quorum requirements. Just as alternates cannot count toward a quorum
unless they are replacing a primary member who is not present, alternates also cannot
vote unless they are replacing a primary member at the meeting. If institutional policy allows, alternates
may attend the meeting and participate in the discussion even when they are not serving
in place of a primary member, (similar to how a consultant might participate). Note that even if alternates are not serving
in their capacity as an alternate, and therefore do not count for quorum or voting purposes,
OHRP recommends that their attendance at the meeting be documented. IRB administrative staff who are not IRB members
may participate in IRB meetings to facilitate the conduct of the meetings, for example,
to document discussion, record votes, etc. However, they cannot count toward quorum or
vote with the IRB if they are not listed as members. Note that IRB staff may serve as IRB members
as long as they meet the qualifications and requirements for IRB membership that are described
in the regulations and they are listed as members on the IRB roster. An IRB member who has a conflict of interest
with a particular research protocol may not participate in the IRB’s review of that protocol,
except to provide information requested by the IRB. The conflicted member must recuse herself
or himself from the discussion of the research protocol, and cannot count toward a quorum
or vote with respect to that protocol. Note that this is quite different from the
situation when a member abstains from voting, in which case, the abstaining member’s presence
counts toward establishing quorum and calculating what constitutes a majority vote for approving
a research study. A recusal on the other hand, has the same
effect as if the member were not in attendance. The recused member does not count toward quorum
or any vote calculations. If a member’s recusal breaks the quorum,
the IRB cannot proceed with review or voting as it pertains to the affected protocol or
protocols. When this occurs, the meeting cannot proceed
until a quorum is re-established. • Consider an IRB with a total of 11 primary
members. • Eight members are present at a meeting,
including a nonscientist. Quorum is met and the IRB proceeds with the
convened meeting. • The IRB has 5 research protocols to review. When they get to the third protocol, Dr. Shan,
who is a co-PI on the protocol and also a member of the IRB, recuses herself from participating. Can the IRB continue with the review of this
protocol? • Yes, the IRB can proceed because there
are still seven members present at the meeting, which is more than half of 11, including a
nonscientist. • Note that when voting on this protocol,
though, what constitutes a majority vote needs to be adjusted. Following Dr. Shan’s recusal from the review,
only 7 members remain to participate in the convened IRB meeting. According to the regulations, research must
be approved by the majority of those members present. In this case then, the research can be approved
when at least 4 of the 7 members vote in favor of this protocol (whereas, if Dr. Shan were
not recused, there would be 8 members present, and a vote of 5 of those members would be
needed to approve it). • This was how the convened IRB, without
Dr. Shan, voted: o Approve – 3
o Disapprove – 2 o Abstain – 2
• Was Dr. Shan’s research approved by the IRB? • No. Even though there were more approvals than
disapprovals, Dr. Shan’s research couldn’t be approved because it was not approved by
at least 4 of the 7 members present at the meeting, or a majority of those present. • Let’s consider a slightly different
scenario with the same IRB. What if only six of the 11 members had been
present at the start of the meeting? Could the IRB proceed with reviewing Dr. Shan’s
protocol after her recusal? • No, the IRB could not continue with the
review of this protocol. The quorum would be lost when Dr. Shan recused
herself, assuming an alternate was not available to participate in her place. • The IRB administrator might propose to
move Dr. Shan’s protocol to a later meeting in which case, could the IRB continue to review
the remaining 2 research protocols? • Yes, because a quorum would be re-established
since Dr. Shan would no longer need to recuse herself, assuming she has no other conflicts
with the remaining protocols. • The IRB minutes should reflect when the
quorum is lost in a meeting and when it is restored. Although there is no regulatory requirement
that a recused member who has a conflict leave the room during the IRB meeting while other
members review the protocol, OHRP recommends this as best practice. Note that according to the regulations, institutions
must abide by their own policies regarding the IRB’s initial and continuing review
procedures, regardless of whether the institution’s policies go beyond what the regulations require. So, if an institution’s IRB policy requires
that recused members with a conflict of interest leave the room, the institution must follow
this policy in order to be compliant with the regulations. Finally, a quorum also may be broken under
other circumstances, such as when a member has to leave the meeting early. Again, when this occurs, the meeting cannot
proceed until a quorum is re-established. Consider this example,
• At today’s meeting, 6 of the 11 primary members are present, including a nonscientist
• Quorum requirements are met because a majority of members are present, including
a nonscientist • Halfway through the meeting, one of the
members is called away to handle a medical emergency
• Can the IRB meeting continue? • No, the quorum is lost because 5 is not
more than half of 11. All IRB activity must stop until the quorum
is restored. • The IRB minutes should reflect when quorum
is lost in a meeting and when it is restored (if it is). Sometimes non-members attend IRB meetings. For example, an IRB may invite experts or
consultants with competence in specific areas to advise the committee on issues that require
expertise beyond that of the IRB’s membership. These experts are not considered IRB members
and cannot count toward a quorum or vote with the IRB on any actions. The same is true for other observers, such
as: • future IRB members in training
• students • volunteers
• community observers • IRB administrative staff (who are not
listed as members on the roster), or • investigators conducting research on IRB
operations The regulations do not prohibit observers
from attending a convened IRB meeting, although institutional policies might. Observers or consultants may participate in
discussion at an IRB meeting, but they cannot count toward a quorum or vote on any proposals. When non-member experts participate in a convened
meeting, it must be documented in the minutes. This concludes our review of the quorum and
voting requirements for convened IRB meetings. We hope you found it helpful. We’ve focused on the major aspects of the
quorum and voting requirements, but encourage you to consult the regulations and OHRP’s
guidance for more information, particularly the “IRB Registration Process FAQs” on
the OHRP website. v

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