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Best Practices for Institutional Review Board Meetings

Robert Hood

03/30/2008 10:36 pm

IRB reviewer help: Best Practices for Institutional Review Board Meetings

Prior to the meeting

Prepare for the meeting

  • Consider setting time aside the day the agenda is released to review the agenda; agendas are typically complete 10 days prior to the meeting
  • Identify the studies for which you are primary or secondary reviewer; contact staff as soon as possible if you believe you are not competent to review the study
  • Identify any conflicts of interest, and prepare to disclose after the minutes from the previous meeting have been approved and prior to discussion of any studies on the current meeting's agenda
  • Complete reviews and upload comments at least 48 hours prior to IRB meetings.
    • By completing reviews in advance, staff may be able to arrange a clarification or revision from the research site prior to the meeting
    • Review studies by reading the materials indicated below, based on your role as a committee member or as the primary / secondary reviewer
  • Please print the meeting agenda and your completed reviewer comment forms to bring to the meeting

What documents do you need to review?

Initial Reviews:

Everyone should review the following documents for initial review:

  • The Initial IRBWise Application
  • Proposed consent documents
  • Recruitment materials

If you are Primary or Secondary Reviewers for initial review:

  • The Initial IRBWise Application
  • Proposed consent document.
  • Recruitment materials
  • The full protocol
  • Any relevant grant applications
  • The investigators brochure (when one exists)
  • The DHHS-approved sample informed consent document (when one exists)
  • The complete DHHS-approved protocol (when one exists)

Continuing Reviews:

Everyone should review the following documents for continuing review:

  • The Initial IRBWise Application
  • The Continuing Review IRBWise Application
  • The current consent documents
  • Any newly proposed consent documents

If you are Primary or Secondary Reviewers for continuing review:

  • The Initial IRBWise Application
  • The Continuing Review IRBWise Application
  • The current consent documents
  • Any newly proposed consent documents
  • The complete protocol including any protocol modifications previously approved by the IRB

Review of Amendments:

Everyone should review the following documents for review of amendments:

  • The IRBWise Amendment Application
  • All changed/modified documents
During the meeting

Primary / Secondary reviewer presentation of the study and discussion by the convened IRB

1. As the primary reviewer, provide a summary for your colleagues on the committee. As the primary / secondary reviewer, you have reviewed all documents associated with a study, and you have been selected as primary / secondary reviewer based on your expertise, and your ability to:

  • Explain the hypothesis and the purpose of the study, and give your professional opinion of the importance of the study in a way that is understandable to non-scientists as well as colleagues with different backgrounds
  • Describe the location and enrollment, paying particular attention to inclusion of vulnerable populations; if the study includes vulnerable populations, note that you will include protocol specific findings justifying their inclusion in the study as part of your review
  • If you are reviewing the study at continuing review, summarize the progress of the study and any noncompliance (such as expiration) or other problems during the past review period

2. Talk through your review, discussing each question on the reviewer comment form. It is not necessary to read the question, or read your answer on the reviewer comment form verbatim.

3. If vulnerable populations are included, address their inclusion and make required protocol-specific findings by using the reviewer comment forms for vulnerable populations.

4. Summarize any major and minor concerns. The Chair will ask the Secondary reviewer to complete these same steps 1-4, and then will ask reviewers for their recommendations prior to committee discussion.

5. The full committee will discuss the study. Other committee members should raise questions and concerns at this point.

6. After discussion by the full committee, the Chair will call for a motion. Normally this is made by the primary reviewer, and seconded by the secondary reviewer.

Sample motions:

  • Approve protocol as greater than minimal risk [or: not greater than mimimal risk] for not more than 12 months
  • Approve protocol as greater than minimal risk for not more than 12 months pending verification of IRB required changes by the chair
  • Defer study

To approve a study with changes to be verified by the Chair, the changes can only be minor, and not impact any of the IRB's required determinations. If the IRB does not have sufficient information to determine that all regulatory criteria have been met, the study should be deferred.

Write out major concerns using actionable phrases that can be addressed by researchers. Be as specific as possible.

After the meeting

Review minutes and plan for the next meeting

The goal is to have minutes complete and letters sent no later than 4 business days after a meeting (providing timely response after meetings is the single most important factor when researchers are asked to evaluate the quality of IRBs)

  • Staff completes minutes and emails to board members for review approximately 48 hours after the meeting (usually by Friday afternoon after a Wednesday meeting).
  • Reviewers should check minutes and email any corrections of fact in the minutes to staff no later than 48 hours after minutes are distributed (or 2 business days, if this falls over a weekend or holiday)
  • Minutes as revised are approved by the Chair
  • Minutes are voted on at the next convened meeting

Check your schedule for the next 3 months and verify you can attend. The expectation is that reviewers attend meetings; contact staff immediately if you will not be able to attend any meeting in the next 3 months. By checking your schedule 3 months in advance after each meeting you help staff plan for absences and ensure quorum.

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