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Meetings

A. Meetings

1. Regular Meetings

Generally, the NGHS IRB meets on a monthly basis.

2. Called Meetings
When necessary, the IRB Chair may call additional meetings. To schedule a "called meeting" a written agenda, when possible, should be provided to IRB members at least 24 hours in advance.


3.Quorum & Voting
  • Convened Meetings:
    A majority of members or their alternates, including at least one physician and one nonscientific member, constitutes a quorum and is necessary to conduct business.

    45 CFR 46.108(b)

  • Approval requires a majority of the quorum. An alternate has the same voting rights and responsibility as the member being replaced. The number of votes will be recorded but names will not be used unless so requested by the member.

    45 CFR 46.108(b)

  • Failure of Quorum During Meeting
    Should the quorum fail during a meeting (i.e., those with conflicts being excused, early departures) the meeting should be terminated from further votes until the quorum can be restored.

 

4.  Conflict Of Interest
Members cannot vote if they have a conflict of interest. Members are required to abstain for studies in which they have some conflict of interest. If the member is also the principal investigator, the member may contribute to the discussion but must leave once the vote has been called.

45 CFR 46.107(e)

Members are deemed to have a conflict of interest if:

  1. They are receiving financial backing from the same Institute of the NIH or sponsoring corporation or organization or a competing corporation, or if
  2. They have a "significant" equity position in the sponsoring company or a direct competitor of that company, or if
  3. They are the principal investigator or sub-investigator or are involved in the study under discussion.
5.Telephonic Participation
Whenever possible, IRB meetings should take place with all participating IRB members physically present. However, circumstances sometimes warrant conducting meetings via telephone conference call. Official Board actions may be taken at a meeting in which members participate via telephone provided that each:
  • Has received all pertinent material prior to the meeting, and
  • Can actively and equally participate in the discussion of all protocols
Minutes of such meetings should document that these two conditions have been satisfied in addition to the usual regulatory requirements (i.e. attendance; initial and continued presence of a majority of members, etc.).
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