Hints for Completing a Thorough Board Member Review

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  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Technical and scientific terms must be adequately explained using common or lay language. The consent form should be translated for non-English speakers.
  • Hints for Completing a Thorough Board Member Review

    1. 1. 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
    2. 2. It’s a 3-way balancing act between… <ul><li>Protecting our research subjects (volunteers), giving consideration to the Investigator fairly and finding time to do both EVERY month. </li></ul>
    3. 3. IRB Member Handbook by R. Amdur, MD (with my modifications) <ul><li>1. Review your assignments as soon as you </li></ul><ul><li> get them. </li></ul><ul><li>2. Get your questions answered </li></ul><ul><li> before the meeting. </li></ul><ul><li>3. Consult with IRB staff, PI, SC and/or other </li></ul><ul><li>IRB members (esp. your co-reviewer) if </li></ul><ul><li>you have concerns. </li></ul>
    4. 4. Getting Started (my way) I tried to do this as soon as I received my assignments. <ul><li>First, each month read the minutes of the last meeting, especially sections that were about studies you reviewed or that were controversial. </li></ul><ul><li>Let your IRB coordinator know if there are errors and mention at the meeting that you submitted corrections. </li></ul>
    5. 5. Assess the Agenda <ul><li>Lapsed studies or those close to expiration should have first priority </li></ul><ul><li>Continuing Reviews (aka Renewals) </li></ul><ul><li>Amendments </li></ul><ul><li>Tabled studies </li></ul><ul><li>New studies (as time permits) </li></ul><ul><li>Go through the whole list to look for any COIs (notify your IRB coordinator) </li></ul><ul><li>Studies in your specialty areas </li></ul>
    6. 6. Quick Check of Assignments <ul><li>Number of assignments </li></ul><ul><li>Position on the Agenda </li></ul><ul><li>Primary vs. secondary reviewer </li></ul><ul><li>Expertise of the other reviewer? </li></ul><ul><li>Level of expertise outside my comfort zone (notify your IRB coordinator) </li></ul><ul><li>Overwhelmed? Don’t wait until it’s too late: </li></ul><ul><li>(notify your IRB coordinator right away) </li></ul>
    7. 7. Consent Process Requirements <ul><li>Will the participant understand the consent form? </li></ul><ul><li>Will the prospective participant have enough time to think about whether or not to say ‘yes’? </li></ul><ul><li>Will the prospective participant be coerced into participating? </li></ul><ul><li>Who can give consent? </li></ul><ul><ul><li>Only the participant? </li></ul></ul><ul><ul><li>A legal representative or guardian? </li></ul></ul>
    8. 8. Consent Form Requirements <ul><li>Background section: </li></ul><ul><li>Does the form state that this is a research study? </li></ul><ul><li>What are the purposes of this research? </li></ul>
    9. 9. Consent Form Requirements <ul><li>Procedures section: </li></ul><ul><li>How long will the participant be in the study? </li></ul><ul><li>What procedures will be done? </li></ul><ul><li>Which procedures are experimental and which are standard of care? </li></ul>
    10. 10. Consent Form Requirements <ul><li>Alternative Procedures section: </li></ul><ul><li>Are there other courses treatments that might be advantageous to the participant? </li></ul>
    11. 11. Consent Form Requirements <ul><li>Risks section: </li></ul><ul><li>What are the risks of participating? </li></ul><ul><ul><li>Medical risks of the procedures </li></ul></ul><ul><ul><li>Psychological risks of a positive test result, </li></ul></ul><ul><ul><li> answering sensitive questions, etc. </li></ul></ul><ul><ul><li>Confidentiality risks </li></ul></ul><ul><ul><li>Reproductive risks to a pregnant </li></ul></ul><ul><ul><li> woman and/or fetus. </li></ul></ul>
    12. 12. Consent Form Requirements <ul><li>Benefits section: </li></ul><ul><li>What are the reasonable benefits of participating? </li></ul><ul><ul><li>Sometimes there are no benefits to the </li></ul></ul><ul><ul><li>participant. </li></ul></ul><ul><ul><li>Compensation is not considered </li></ul></ul><ul><ul><li>a benefit. </li></ul></ul>
    13. 13. Consent Form Requirements <ul><li>Confidentiality and Authorization sections: </li></ul><ul><li>How will the participant’s information be protected? </li></ul><ul><li>Who will have access to the participants PHI? </li></ul><ul><li>Authorization can be revoked – </li></ul><ul><li>the participant will be </li></ul><ul><li>withdrawn from the study. </li></ul>
    14. 14. Consent Form Requirements <ul><li>Person to Contact section </li></ul><ul><li> & IRB statement: </li></ul><ul><li>Who should the participant contact for: </li></ul><ul><ul><li>Questions, concerns, complains </li></ul></ul><ul><ul><li>If he/she is injured by being in the study </li></ul></ul><ul><li>What if the participant does not feel comfortable contacting the PI? </li></ul><ul><ul><li>The participant should know that </li></ul></ul><ul><ul><li>he/she can call the IRB. </li></ul></ul>
    15. 15. Consent Form Requirements <ul><li>Research-Related Injury section: </li></ul><ul><li>Is medical treatment and compensation available if the participant is injured by being in the study? </li></ul><ul><ul><li>Standard text has been developed </li></ul></ul><ul><ul><li>for this section. </li></ul></ul><ul><ul><li>Different for U of U, PCMC, </li></ul></ul><ul><ul><li>VA, Shriner’s. </li></ul></ul>
    16. 16. Consent Form Requirements <ul><li>Participation is voluntary. </li></ul><ul><li>The participant can say ‘no’ or stop participation at any time. </li></ul><ul><li>Stopping will not affect the care and will cause penalty. </li></ul>Voluntary Participation section:
    17. 17. Consent Form Requirements <ul><li>Does the participant have to pay for the procedures? </li></ul><ul><li>Will someone else pay for the procedures? </li></ul><ul><li>Will the participant get paid to be in the study? </li></ul>Costs & Compensation section:
    18. 18. Consent Form Requirements <ul><li>Are there any unforeseeable risks? </li></ul><ul><li>Can the PI withdraw the participant from the study? </li></ul><ul><li>What if significant new information arises during the research study? </li></ul><ul><li>How many people will be enrolled in this study? </li></ul>Other sections:
    19. 19. Consent Form Requirements <ul><li>Participant </li></ul><ul><li>Parent(s) </li></ul><ul><li>Legally Authorized Representatives </li></ul><ul><li>Person Obtaining Consent </li></ul><ul><li>PI </li></ul><ul><li>Witness </li></ul>Possible Signatures:
    20. 20. Additional Considerations <ul><li>Tissue Banking </li></ul><ul><li>Genetic Testing </li></ul><ul><li>Reportable Diseases </li></ul><ul><li>Placebo Use </li></ul>
    21. 21. Continuing Reviews <ul><li>What to look for in the Renewal Application </li></ul><ul><li>1. Study Status </li></ul><ul><li>- active </li></ul><ul><li>- closed to enrollment, but tx ongoing </li></ul><ul><li>- closed to enrollment, F/U only </li></ul><ul><li>- closed to enrollment, data analysis only </li></ul><ul><li>2. Study Progress </li></ul><ul><li>- Description is thorough and honest </li></ul><ul><li>- Justification to continue is provided </li></ul>
    22. 22. Continuing Reviews <ul><li>Enrollment Information </li></ul><ul><ul><li>Numbers are reasonable or discrepancies are adequately explained. </li></ul></ul><ul><ul><li>Enrollment has not exceeded the # approved or there is a request and justification for the increase. </li></ul></ul><ul><li>Determine if there are unexpected events that may indicate a need for change to the protocol or consent. </li></ul>
    23. 23. Continuing Reviews <ul><li>Points to remember (mine) </li></ul><ul><ul><li>This study has already been reviewed by one or more previous Boards. </li></ul></ul><ul><ul><li>This study has already been reviewed by staff members in successive years. </li></ul></ul><ul><ul><li>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. </li></ul></ul>
    24. 24. Continuing Reviews <ul><li>Points to consider before requesting a change: </li></ul><ul><ul><li>Did you notice something really important that was previously overlooked? </li></ul></ul><ul><ul><li>Would the change help protect the rights and/or welfare of the research subjects? </li></ul></ul><ul><ul><li>Do you feel certain that without the change, you would not feel comfortable approving the renewal? </li></ul></ul>
    25. 25. Amendment Reviews <ul><li>Review the amendment request and then verify that the changes have been made to the applicable documents. </li></ul><ul><li>Does the amendment significantly change the purpose, objectives, or design of the study? </li></ul><ul><ul><li>If yes, the whole study may need to be re-evaluated. </li></ul></ul><ul><li>If a new risk is identified: </li></ul><ul><ul><li>Has it already been addressed in the consent form? </li></ul></ul><ul><ul><li>Should current participants be re-consented or otherwise informed of the new risk? </li></ul></ul>
    26. 26. New Study Application Reviews <ul><li>The most important thing to remember is that these are the hardest and most time consuming </li></ul><ul><li> and </li></ul><ul><li>Most of the work has to be done before the full board meets. </li></ul>
    27. 27. New Study Applications (my way) <ul><li>Scratch paper or note pad </li></ul><ul><li>Read the application first </li></ul><ul><li>If there’s an Assent, read it first, then the PPF </li></ul><ul><li>Read the consent next </li></ul><ul><li>Read the Protocol summary </li></ul><ul><li>Take notes as you go, looking for discrepancies or things you don’t understand </li></ul><ul><li>Now read the full protocol and the supporting documents </li></ul><ul><li>Re-read (scan) the consent </li></ul>
    28. 28. New Study Reviews (cont’d) <ul><li>Study design </li></ul><ul><li>Study sponsor (Industry vs. Investigator Initiated vs. government sponsor) </li></ul><ul><li>Call around if you need to </li></ul><ul><li>Start the reviewer checklist </li></ul><ul><li>Watch for any points you might have </li></ul><ul><li>missed (the checklist may give you clues) </li></ul><ul><li>Make comments on the checklist (if you can’t make at least one comment (good or bad), you probably don’t really “get it”). </li></ul>
    29. 29. New Study Reviews (cont’d) <ul><li>Remember your charge as a Board Member </li></ul><ul><li>(considering both ethics and the regulations) </li></ul><ul><li>by asking yourself these questions: </li></ul><ul><li>If I qualified to be in this study, would I want to participate or let a member of my family participate? </li></ul><ul><li>Will the study population be able to understand the consent document? </li></ul>
    30. 30. New Study Reviews (cont’d) <ul><li>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. </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>
    31. 31. New Study Reviews (cont’d) <ul><li>Remember: </li></ul><ul><li>Read the consent document for consistency and readability. The pre-review by the IRB staff will usually catch any required elements that are missing. </li></ul><ul><li>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. </li></ul>
    32. 32. Reconsidering a Previously Tabled Study <ul><li>Does the new information provided by the Investigator answer the Boards concerns at the prior meeting? </li></ul><ul><li>If not, did the Board clearly articulate the essential information needed? </li></ul><ul><li>If either of the above is a “no” answer, would 1 or 2 phone calls clear it up before the next meeting? </li></ul><ul><li>(You sure don’t want to </li></ul><ul><li>have to table it again.) </li></ul>
    33. 33. Reconsidering a Previously Tabled Studies <ul><li>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. </li></ul>
    34. 34. Requesting Revisions <ul><li>Make descriptive and specific revision requests. </li></ul><ul><ul><li>If you don’t have enough information to be specific, the study should be tabled. </li></ul></ul><ul><li>If you don’t have enough information, ask pointed questions so you get the right answer. </li></ul><ul><li>The IRB staff can help you re-word or re-phrase content in the consent form. </li></ul><ul><li>Write revisions in a way that you would want to receive them. </li></ul>
    35. 35. Presenting Your Review <ul><li>Also remember: </li></ul><ul><li>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. </li></ul><ul><li>State your recommendation to the Board and try to present your rationale like a list of easy points to understand and discuss if necessary. </li></ul><ul><li>Use your citizen reps as needed: they are a great resource! </li></ul>
    36. 36. The End! Any questions? Thanks!

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