The Christ Hospital IRB Number: 1.04

Submitted By: Becky Riddell Effective Date: 02/09

Reviewed By: Steve Roberts, MD & M. Jennings, MD Revision/Review Date: 03/15

Approved By: Steve Roberts, MD______

(II.5.B)

STANDARD OPERATING PROCEDURE

IRB Meeting Minutes / Conducting IRB Meeting

POLICY:

A standard format has been established for conducting IRB meetings and for recording minutes of the meetings. Minutes of meetings are to be kept indefinitely.

REFERENCE:

45 CFR 46.115(a)(2); 21 CFR 115 (a)(2)

PROCEDURE

I. Taking Minutes / Conducting the Meeting (Minutes are recorded by the IRB Coordinator; the meeting is conducted by the Chair or Associate Chair)

·  Date and place of the meeting are recorded in the minutes.

·  Attendance of members present, members absent and guests is recorded. Members must sign a meeting sign-in sheet upon entering the meeting room, and must indicate if they have a conflict of interest concerning any study on the agenda by checking the appropriate box on the sign in sheet. If there is a conflict, he/she must leave the room during discussion and voting for that particular study.

·  The “Call to Order” and record of quorum are documented. Quorum is called when one half of the voting IRB membership is present, plus one. There must be at least one community representative and one scientific member present. The chair will ensure that a quorum is maintained during the course of the meeting. If at any time quorum is lost (due to a member leaving the meeting for any reason, including conflict of interest on a particular study), discussion of research protocols will be suspended until such time as the quorum is regained.

·  Approval of the previous meeting minutes is recorded along with any changes if necessary.

·  The agenda shall be followed unless unforeseen circumstances necessitate change in the agenda schedule.

·  New protocol presentation: Typically, the PI or a representative is present at the meeting to present the protocol and answer any questions. The IRB Primary Reviewer, who has given the protocol thorough review as outlined in the reviewer checklist, will lead further discussion and ask the presenter any questions or request clarification. The PI or representative is excused and continued discussion takes place. During discussion, the Chair will lead the IRB to work toward resolution of any issues of concern. Unresolved issues could be reason for disapproval. Based on review and discussion, the Chair will call for a vote. In order for research to be approved, it must receive the approval of a majority (more than half) of the members present at the meeting. Proxy voting is not permitted.

·  Presentation of each new protocol is recorded in the minutes. The Board discussion, action and required amendments are also recorded.

·  The vote and outcome must be documented (approved, approved as amended, denied, tabled).

·  Votes for each protocol as numbers for, against, or abstaining must be recorded

·  When an alternate member replaced a primary member.

·  The basis for requiring changes in research

·  The basis for disapproving research

·  A written summary of the discussion of controverted issues and their resolution

·  Justification of any deletion or substantive modification of information concerning risks or alternative procedures contained in the DHHS-approved sample consent document

·  The names of IRB members who leave the meeting because of a conflicting interest along with the fact that a conflicting interest is the reason for the absence. (documenting that the member is absent is not enough. Minutes should indicate that the member is absent because of conflicting interest.)

·  Unless documented in the IRB records, determinations required by the regulations and protocol-specific findings justifying those determinations for:

o  Waiver or alteration of the consent process

o  Research involving pregnant women, fetuses, and neonates

·  The rationale for significant risk/non-significant risk device determinations

·  All additional business (i.e., amendments, continuing review reports, compliance issues, closures, etc.) discussed at the meeting is recorded in the same fashion. NOTE: It is not sufficient to record “following discussion, on motion made and seconded, the protocol and informed consent were approved 6-0”. Evidence of the IRB discussion must be documented.

II. Correspondence from IRB to Investigator

·  Following review and approval of the minutes by the IRB Chair, correspondence to investigators is prepared using the text of the minutes to communicate IRB decisions.

·  All IRB required amendments to new protocols for approval are included in the correspondence to the investigator.

·  A 12-month approval (unless determined to be sooner based upon risk/benefit assessment by the IRB) is included in the letter. Approval date is the date of convened meeting, and expiration date is the first day of the month, 12 months later. (Example: A study is approved at the March 6, 2007 meeting. The approval expires on March 1, 2008.)

·  If approval is granted contingent upon minor edits to the protocol or consent, an activation letter is sent to the investigator after the required changes have been made, and received and reviewed by the IRB Chair. The approval date is the date of the originally convened full board meeting, not the date that changes were approved by the Chair.

·  If it is determined that major changes are required to the protocol or consent, it may be necessary to table approval for these changes and they must be brought back for full board approval. In this case, if the changes are then reviewed and approved by the full board, the approval date is the date of the re-convened full board meeting, not the date of the meeting where the study was originally reviewed. The study may not be activated until the activation letter has been received by the investigator from the IRB.

III. Meeting Records: The following are kept on file in the appropriate “Minutes” binder for each meeting of the IRB:

·  Agenda

·  Sign-in Sheet

·  Meeting minutes with signature of the Chair

·  Chairman’s report

·  Any other pertinent documents

REVISION HISTORY:

Date Revised / Reason For Change / Revised By
10/19/09 / Addition of criteria documented in minutes / Becky
04/14/10 / Addition of determining serious or continuing non-compliance / Becky

Policies/SOP 1.04 Meeting Minutes Page 4 of 4