Hints for Doing a Thorough Board Member Review without Nitpicking or Wasting Time

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Hints for Doing a Thorough Board Member
Review(without Nitpicking or Wasting Time)

• Maureen Brinkman, RN, MS, CCRC
• SC, Pediatric Cardiology
• U of U IRB Member 2003-2006

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Its a 3-way balancing act between

• Protecting our research subjects (volunteers),
  giving consideration to the Investigator fairly
  and finding time to do both EVERY month.

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IRB Member Handbook by R. Amdur, MD (with my
modifications)

• 1. Review your assignments as soon as you
• get them.
• 2. Get your questions answered
• before the meeting.
• 3. Consult with IRB staff, PI, SC and/or other
• IRB members (esp. your co-reviewer) if
• you have concerns.

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Getting Started (my way)I tried to do this as
soon as I received my assignments.

• First, each month read the minutes of the last
  meeting, especially sections that were about
  studies you reviewed or that were controversial.
• Let your IRB coordinator know if there are
  errors and mention at the meeting that you
  submitted corrections.

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Assess the Agenda

• Lapsed studies or those close to expiration
  should have first priority
• Continuing Reviews (aka Renewals)
• Amendments
• Tabled studies
• New studies (as time permits)
• Go through the whole list to look for any COIs
  (notify your IRB coordinator)
• Studies in your specialty areas

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Quick Check of Assignments

• Number of assignments
• Position on the Agenda
• Primary vs. secondary reviewer
• Expertise of the other reviewer?
• Level of expertise outside my comfort zone
  (notify your IRB coordinator)
• Overwhelmed? Dont wait until its too late
• (notify your IRB coordinator right away)

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Consent Process Requirements

• Will the participant understand the consent form?
• Will the prospective participant have enough time
  to think about whether or not to say yes?
• Will the prospective participant be coerced into
  participating?
• Who can give consent?
• Only the participant?
• A legal representative or guardian?

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Consent Form Requirements

• Background section
• Does the form state that this is a research
  study?
• What are the purposes of this research?

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Consent Form Requirements

• Procedures section
• How long will the participant be in the study?
• What procedures will be done?
• Which procedures are experimental and which are
  standard of care?

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Consent Form Requirements

• Alternative Procedures section
• Are there other courses treatments that might be
  advantageous to the participant?

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Consent Form Requirements

• Risks section
• What are the risks of participating?
• Medical risks of the procedures
• Psychological risks of a positive test result,
• answering sensitive questions, etc.
• Confidentiality risks
• Reproductive risks to a pregnant
• woman and/or fetus.

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Consent Form Requirements

• Benefits section
• What are the reasonable benefits of
  participating?
• Sometimes there are no benefits to the
• participant.
• Compensation is not considered
• a benefit.

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Consent Form Requirements

• Confidentiality and Authorization sections
• How will the participants information be
  protected?
• Who will have access to the participants PHI?
• Authorization can be revoked
• the participant will be
• withdrawn from the study.

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Consent Form Requirements

• Person to Contact section
• IRB statement
• Who should the participant contact for
• Questions, concerns, complains
• If he/she is injured by being in the study
• What if the participant does not feel comfortable
  contacting the PI?
• The participant should know that
• he/she can call the IRB.

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Consent Form Requirements

• Research-Related Injury section
• Is medical treatment and compensation available
  if the participant is injured by being in the
  study?
• Standard text has been developed
• for this section.
• Different for U of U, PCMC,
• VA, Shriners.

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Consent Form Requirements
Voluntary Participation section

• Participation is voluntary.
• The participant can say no or stop
  participation at any time.
• Stopping will not affect the care and will cause
  penalty.

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Consent Form Requirements
Costs Compensation section

• Does the participant have to pay for the
  procedures?
• Will someone else pay for the procedures?
• Will the participant get paid to be in the study?

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Consent Form Requirements
Other sections

• Are there any unforeseeable risks?
• Can the PI withdraw the participant from the
  study?
• What if significant new information arises during
  the research study?
• How many people will be enrolled in this study?

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Consent Form Requirements
Possible Signatures

• Participant
• Parent(s)
• Legally Authorized Representatives
• Person Obtaining Consent
• PI
• Witness

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Additional Considerations

• Tissue Banking
• Genetic Testing
• Reportable Diseases
• Placebo Use

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Continuing Reviews

• What to look for in the Renewal Application
• 1. Study Status
• - active
• - closed to enrollment, but tx ongoing
• - closed to enrollment, F/U only
• - closed to enrollment, data analysis only
• 2. Study Progress
• - Description is thorough and honest
• - Justification to continue is provided

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Continuing Reviews

• Enrollment Information
• Numbers are reasonable or discrepancies are
  adequately explained.
• Enrollment has not exceeded the approved or
  there is a request and justification for the
  increase.
• Determine if there are unexpected events that may
  indicate a need for change to the protocol or
  consent.

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Continuing Reviews

• Points to remember (mine)
• This study has already been reviewed by one or
  more previous Boards.
• This study has already been reviewed by staff
  members in successive years.
• Your main focus should be on any important
  changes to safety issues or IRB protection of
  human subjects guidelines since last review and
  on study progress.

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Continuing Reviews

• Points to consider before requesting a change
• Did you notice something really important that
  was previously overlooked?
• Would the change help protect the rights and/or
  welfare of the research subjects?
• Do you feel certain that without the change, you
  would not feel comfortable approving the renewal?

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Amendment Reviews

• Review the amendment request and then verify that
  the changes have been made to the applicable
  documents.
• Does the amendment significantly change the
  purpose, objectives, or design of the study?
• If yes, the whole study may need to be
  re-evaluated.
• If a new risk is identified
• Has it already been addressed in the consent
  form?
• Should current participants be re-consented or
  otherwise informed of the new risk?

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New Study Application Reviews

• The most important thing to remember is that
  these are the hardest and most time consuming
• and
• Most of the work has to be done before the full
  board meets.

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New Study Applications (my way)

• Scratch paper or note pad
• Read the application first
• If theres an Assent, read it first, then the PPF
• Read the consent next
• Read the Protocol summary
• Take notes as you go, looking for discrepancies
  or things you dont understand
• Now read the full protocol and the supporting
  documents
• Re-read (scan) the consent

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New Study Reviews (contd)

• Study design
• Study sponsor (Industry vs. Investigator
  Initiated vs. government sponsor)
• Call around if you need to
• Start the reviewer checklist
• Watch for any points you might have
• missed (the checklist may give you clues)
• Make comments on the checklist (if you cant make
  at least one comment (good or bad), you probably
  dont really get it).

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New Study Reviews (contd)

• Remember your charge as a Board Member
• (considering both ethics and the regulations)
• by asking yourself these questions
• If I qualified to be in this study, would I want
  to participate or let a member of my family
  participate?
• Will the study population be able to understand
  the consent document?

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New Study Reviews (contd)

• If you answered no to any of those questions,
  you owe to yourself, the investigator, and the
  patient volunteers you care about to get some
  answers and clarifications and it should be done
  before the Board meeting.
• Get more information from the IRB staff (they can
  contact the PI for you, too), the study
  investigator/coordinator, another reviewer, or
  the citizen rep on your panel.
• If you still would answer one or more of those
  questions with a no, then the full board will
  need to discuss it once you make your
  recommendation to them at the meeting.

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New Study Reviews (contd)

• Remember
• Read the consent document for consistency and
  readability. The pre-review by the IRB staff
  will usually catch any required elements that are
  missing.
• Of course, we all like to see what is familiar
  and this makes it easier for us, but there is no
  requirement that the consent be done according to
  our IRB guidelines (only that all required
  elements are included will be discussed later).
  Most consents follow our guidelines, but try to
  be flexible for studies that use a different
  format for whatever reason.

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Reconsidering a Previously Tabled Study

• Does the new information provided by the
  Investigator answer the Boards concerns at the
  prior meeting?
• If not, did the Board clearly articulate the
  essential information needed?
• If either of the above is a no answer, would 1
  or 2 phone calls clear it up before the next
  meeting?
• (You sure dont want to
• have to table it again.)

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Reconsidering a PreviouslyTabled Studies

• If you still have major concerns that would
  prevent a recommendation to approve with changes
  specified, perhaps the Investigator should be
  invited to the meeting to answer questions.

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Requesting Revisions

• Make descriptive and specific revision requests.
• If you dont have enough information to be
  specific, the study should be tabled.
• If you dont have enough information, ask pointed
  questions so you get the right answer.
• The IRB staff can help you re-word or re-phrase
  content in the consent form.
• Write revisions in a way that you would want to
  receive them.

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Presenting Your Review

• Also remember
• When you present your study to the Board, if you
  have written-up your brief description on the
  checklist well, you can just read it.
• State your recommendation to the Board and try to
  present your rationale like a list of easy points
  to understand and discuss if necessary.
• Use your citizen reps as needed they are a great
  resource!

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The End! Any questions? Thanks!