Conduct & Expectations of IRB Members

June CE 2013

Objectives

• Review IRB Member Guidelines: Conduct & Expectation of IRB Members

• Review motions and voting options for submissions being reviewed during the meeting.

• Review eBridge RSVP locations, Meeting Agendas and Meeting Minutes

Conduct & Expectation of IRB Members

• IRB Member Service is voluntary and important to the success of the IRB Committees here at MCW/FH.

• Complete and maintain IRB CITI Training (group 3) and complete annual COI IRB Member disclosure.

• IRB Members are expected to attend 75% of convened meetings – Each Committee has approx. 12-16 members which place quorum

around 7-9 to conduct the business of the meeting.• IRB Members need to arrive on-time

– IRB Meetings frequently start with Continuing Education and cover topics identified by IRB Committees, HRPP Office to further provide guidance or refresher of expectation & practice.

Conduct & Expectation of IRB Members

• IRB Members who are assigned to review a submission must complete & upload their checklist at least 24 hours prior to the meeting.– By uploading a completed checklist, this allows the

IRB C2 to address or communicate with the study team any issue as identified by the IRB reviewers.

– If reviewers have questions, please contact either the C2 or the Study team

Conduct & Expectation of IRB Members - Motions

• Primary Reviewers when presenting their review should end with a proposed motion. This will allow discussion to move forward in the meeting. – Ex. for CPR: I recommend this CPR & project be approved << or with minor

modification for the items I’ve noted>> for 1 year <<or 9 months, 6 months because of xyz reason>>

– Ex. for AME: I recommend this amendment be approved <<or with minor modifications or tabled for the following reasons>>

– Ex. for new Protocol: (after hearing secondary reviewer’s report): I recommend this project be <<approved, approved with mods, tabled or disapproved>> for <<timeframe>>.

– Ex for RE: I recommend this RE is <<Acknowledged or tabled to have the PI/Sponsor respond to our questions>> In addition I believe this event <<meets>><<does not meet>> the criteria for <<UPIRSO, Serious Noncompliance or Continuing Noncompliance>>

Conduct & Expectations for IRB Members – Voting Options

• Voting Options for motions– Yea/In favor: This means you are in favor of the motion as presented– Nay/Opposed: This means you are against the motion as presented– Abstain: You do not have enough information to vote on the motion

such as an unanswered question. This should be rare as those questions should be brought up during the discussion of the motion. If you are arriving late – see Not Participating

– Recuse: Those members who have a COI or are absent during a significant portion of the meeting and do not enough information to weigh-in on the vote.

– Not Participating: This is an administrative action when you arrive late or are absent during a significant portion of the meeting and do not enough information to weigh-in on the vote.

Conduct & Expectations for IRB Members – Voting Options

• What if I don’t agree with the motion being made? – If you have voiced your concerns, and questions and

still you do not agree with the proposed motion, Vote “Nay” or “all those opposed”. It is ok to have split votes on the Committees.

– It is not appropriate to vote as “Abstain”, if you do not agree with a motion as it has been made. Only if you do not have enough information in either support or against the motion would abstaining be OK

Conduct & Expectations for IRB Members – Annual Evaluations

• IRB Members will be evaluated on an annual basis (Jan-Dec)

• Evaluations will solicit comments from the IRB C2 along with the IRB Chair

• The comments along with information from the Research Compliance Audits will be tallied together for review by the HRPP Director and recommendations made.

• IRB members will receive their evaluations back as feedback once reviewed by both the IRB Chair & HRPP Director

Key eBridge Locations

• How to RSVP • Review of Meeting Agenda– If not assigned as a reviewer, IRB members should

review checklists and familiarize themselves with the agenda items.

• Review of Meeting Minutes

Questions?