108.1 Organization Policy on Quorum, Voting Status of IRB Alternate Members, and IRB Member Attendance

April 2016

QUORUM AND IRB ALTERNATE MEMBERS

The Organization will follow general corporate law guidelines using total board membership when considering quorum and alternate voting.  A meeting cannot proceed without a quorum, which is one more than half the total committee membership. At least one non-scientific member is needed for a quorum. Members may attend IRB meetings via teleconferencing.  Alternate members may substitute for IRB members who are unable to attend a meeting. Alternates may vote for an identified primary member in the primary member’s absence.  The minutes of the convened meetings will identify when an alternate substitutes for a primary member and votes at the meeting.

The following examples illustrate this principle.  Assume a 5 member IRB in all cases.

Example A:

            3 primary members present

  • 2 scientific
  • 1 non-scientific

            2 vacancies

  • If a non-affiliated member is available, this person would fill the first vacancy
  • Any identified alternate member could fill the second vacancy
  • If a non-affiliated member is not available, any identified alternate member may fill the two vacancies

Example B:

3 primary members present

  • 3 scientific

2 vacancies

  • 1 vacancy must be filled by an identified non-scientific member to meet the quorum requirement
  • If a non-affiliated member is available, this person would fill the second vacancy
  • If a non-affiliated member is not available, any identified alternate member may fill the second vacancy

Example C

2 primary members present

  • 1 scientific
  • 1 non-scientific

3 vacancies

  • If a non-affiliated member is available, this person would fill the first vacancy
  • Any identified alternate member may fill the second and third vacancies
  • If a non-affiliated member is not available, any identified alternate member  may fill any of the three vacancies

Vote Counts and Attendance
 

Member attendance will be recorded at each meeting and the meeting minutes shall identify individuals who serve as an alternate member for a primary member.  The presence of any member “attending” via teleconference will be recorded in the attendance records.  Total attendance will be correlated with the vote counts for accuracy.  The Director of OHSR Operations will submit a quarterly attendance report to the Vice Dean for Clinical Investigations.

Unaffiliated members are expected to attend 80% of their convened IRB meetings a year.  Unless there is a last minute emergency or illness and a substitute cannot be found, there will be an unaffiliated member at every IRB meeting.  The attendance of the unaffiliated members will be documented in the meeting minutes.  Unaffiliated members are non-scientific members and represent the general perspective of subjects.

VOTING
 

The JHMI IRB Chair (or Co-Chair) will call each application or item of business, call on the primary reviewer to present the application, call for discussion, and then call for the vote. Members will vote orally or by a show of hands (depending on the Chair’s preference). The final action on an application (approval, approval with administrative changes, tabled, disapproval) will be determined by a majority vote of the voting members.