Documentation of Convened IRB Proceedings- PRO146   

 

 

Abstract: 
This procedure outlines the responsibilities of the OIRB and the IRB for documentation of convened IRB proceedings.

Effective Date: 3/30/2007

 

Review/Revised Date: 2/12/2020

 

Category: Research

 

Policy Owner: Vice President for Research

Policy Contact:

 
   
 
 

 

Procedure
 

OIRB Responsibilities


Management Staff:

  • Takes notes during the convened meeting to supplement notes taken by the administrative staff.
  • Reviews finalized draft of IRB minutes/initial draft of IRB determination letters.

 

Administrative Staff:

  • Audio tapes proceedings. Audio recordings are destroyed following the completion of the minutes for each meeting.
  • 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, recusing, and abstaining, and the voting status of members.
  • Documents names of members who abstain from voting, absent themselves from the meeting or recuse themselves due to a conflicting interest or otherwise.
  • Documents attendance at the meeting for each action, satisfaction of quorum requirements, affiliation, vulnerable population representative(s), community representative(s), and presence of any consultants, guests or non-voting members.
  • 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 the rationale for conducting continuing review on research that otherwise would not require continuing review.
  • 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 POL032, PRO132 policy, procedure on pregnant women, human fetuses, and neonates in research);
    • Research involving prisoners as participants (see POL033, PRO133 policy, procedure on prisoners in research);
    • Research involving children (see POL008, PRO108 policy, procedure on children in research);
    • Research involving transplantation of fetal tissue;
    • Research involving non-significant/significant risk device determinations; and
    • 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 the protocol analyst in accordance with documentation requirements listed above.
  • Files a copy of the final approved minutes in the IRB records.
  • Sends written communications of IRB actions to investigators from the protocol record.
  • Prepares minutes for IRB review.
  • Corrects any errors in final approved minutes.
  • Schedules finalized draft minutes of meetings to the same IRB for review and approval at a subsequent meeting for the IRB Chair to present.
  • Distributes minutes with the meeting agenda.
  • Saves minutes into electronic storage format.

 

IRB Responsibilities


IRB member(s):

  • Reviews the drafted meeting minutes.
  • Recommends 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;