Procedure for Documentation of Convened IRB Proceedings - IRB PRO146

Procedure for Documentation of Convened IRB Proceedings - IRB PRO146

Abstract:
This procedure outlines the responsibilities of the OIRB and the IRB for documentation of convened IRB proceedings.
Effective Date:
10/24/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:
UAB Human Research Protection Program

HRPP Document:     PRO146
Effective Date:   3/30/07
Revision Date:  11/26/08, 3/10/10, 4/19/10, 10/24/10
Subject:  Procedure for Documentation of Convened IRB Proceedings

PROCEDURE

OIRB Responsibilities

The Senior Staff:

  • Takes notes during the convened meeting to supplement notes taken by the technical writer;
  • Reviews initial draft of IRB determination letters;
  • Reviews finalized draft of IRB minutes at the same time the convened IRB reviews.
  • Corrects any errors in final approved minutes.

The Administrative Staff:

  • Audio tapes proceedings;
  • Documents the Chair’s request to identify conflicting interests;
  • Documents that each participating member has received all the relevant materials prior to the meeting to allow adequate time for review and to request additional information, as needed;
  • Documents all actions taken by the IRB;
  • Documents separate deliberations, actions, and votes for each protocol undergoing initial review, continuing review, or review of modifications including discussions that the appropriate approval criteria were met;
  • Documents vote on actions including the total number of members voting for, against, and abstaining, and the regular or alternate status of voting members;
  • Documents names of members who abstain from voting or absent themselves from the meeting due to a conflicting interest or otherwise;
  • Documents attendance at the meeting for each action, satisfaction of quorum requirements, and presence of any consultants, guests or non-voting members, which may include an investigator invited to provide additional information on their trial;
  • Documents investigator invited to provide additional information on their trial was not present during the deliverations and vote of the IRB;
  • Documents the basis for requiring changes in research or deferring or disapproving a research protocol;
  • Documents discussions and resolutions of controverted issues;
  • Documents key information provided by consultants;
  • Documents justification of any deletion or substantive modification of information concerning risks or alternative procedures contained in the DHHS-approved sample informed consent document that was approved by the IRB;
  • Documents, on initial and continuing reviews, the degree of risk and the approval period (review interval) to reflect the determination of which protocols require continuing review more often than annually, as appropriate to the degree of risk;
  • Documents protocol specific findings required by local policy and applicable regulations for:
    • Waiver of informed consent process (See PRO153 Procedure for Approving a Waiver or Alteration of the Consent Process and the Waiver of Consent Documentation);
    • Waiver of documentation of informed consent (See PRO153);
    • Research involving pregnant women, human fetuses, and neonates (see POL032PRO132 policy, procedure on pregnant women, human fetuses, and neonates in research);
    • Research involving prisoners as participants (see POL033PRO133 policy, procedure on prisoners in research);
    • Research involving children (see POL008PRO108 policy, procedure on children in research);
    • Research involving transplantation of fetal tissue;
    • Research involving non-significant/significant determinations;
    • Research involving cognitively impaired (see PRO125 Procedure for Review of Decisionally Impaired Adults Involved in Human Subjects Research);
  • Documents review and makes any necessary revisions to the initial draft of minutes;
  • Prepares initial draft of the IRB determination letters and minutes of the meeting for review by another administrative staff person (technical writer) in accordance with documentation requirements listed above;
  • Files a copy of the final approved minutes in the IRB records;
  • Places a copy of all written communications of IRB actions to investigators in protocol files;
  • Reviews the initial draft of the IRB minutes.
  • Prepares revised minutes for IRB review.

The Clerical Staff:

  • Distributes finalized draft minutes of meetings to the same IRB for approval at the third subsequent meeting and the senior staff member present at that meeting;
  • Distributes finalized draft minutes of meetings to the same IRB for approval at a subsequent meeting;
  • Sends a copy of the approved minutes to the Institutional Official for review;
  • Saves minutes into electronic storage format.

IRB Responsibilities

Each IRB member:

  • Reviews the draft minutes of meetings;
  • Comments on revisions as appropriate;
  • Votes on approval of minutes.
  • Reviews changes made to minutes previously approved.

IRB Chair:

  • Reviews any changes made to minutes previously approved by the IRB;
  • Returns revised minutes to senior staff for scheduling for review at next convened IRB meeting.

Approved on October 29, 2010 , by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
IRB Director