IRB Member Roster and Quorum- PRO101   

 

 

Abstract: 
This procedure describes the responsibilities of the OIRB and the IRB in relation to maintaining the IRB member roster and quorum.

Effective Date: 3/30/2007

 

Review/Revised Date: 5/16/2019

 

Category: Research

 

Policy Owner: Vice President for Research

Policy Contact:

 

   
 
 

 

PROCEDURE TO MAINTAIN IRB MEMBER ROSTER
 

OIRB Responsibilities


Management staff:

  • Maintains a current roster of all active IRB members for each IRB;
  • Gathers and maintains the following information for each member of the IRB:
    • Name of the member
    • Gender
    • Earned degrees
    • Representative capacity
      • Scientific or Non-scientific
      • Affiliated or Non-affiliated
      • Vulnerable populations representative
    • Experience or credentials (e.g., professional capacity, licenses, certifications)
    • Membership status
      • Voting
      • Alternate, including for whom alternate may substitute
    • Other information as needed for efficient administration of the IRB;
  • Obtains and files CV/resume on each IRB member every 3 years;
  • Maintains a list of completed training for each member annually;
  • Files registration update with OHRP whenever the membership changes.

 

Director:

  • Reviews the membership roster with respect to regulatory requirements and UAB policy at least annually or at the time of membership changes.

 

IRB Responsibilities


IRB member:

  • Provides the OIRB with a CV or resume to be filed in the OIRB every 3 years.
  • Maintains current IRB and ICH GCP training.

 

PROCEDURE TO MAINTAIN A QUORUM
 

OIRB Responsibilities


Administrative staff:

  • Independently monitor and document in the minutes that IRB quorum of at least eight members is present at the beginning of the meeting;
  • Continue to monitor and document that the quorum is maintained;
  • Alerts the IRB Chair if there is a loss of quorum (e.g., member with conflicts excused, early departures, loss of all non-scientists, loss of all unaffiliated members, loss of all members who represent the general perspective of subjects);
  • Record the IRB action and the vote in the minutes, checking that there is a total of equal to or greater than eight members.

 

IRB Responsibilities


IRB Chair: 

  • Calls the meeting to order when quorum (eight or more voting members) is established;
  • Suspends business including discussion and voting when the quorum is lost;
  • Following loss of quorum, resumes business when quorum is re-established.