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Regulatory Oversight Overview


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A slideshow created for faculty in our department for review of clinical research oversight

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Regulatory Oversight Overview

  1. 1. IRBs for physicists Kellie Bodeker, CCRC, B.Sc. Department of Radiation Oncology
  2. 2. Today, we’re going to review <ul><li>What oversight is, </li></ul><ul><li>When we need oversight approval, </li></ul><ul><li>Jargon critical to this approval, </li></ul><ul><li>What is needed to apply for approval, and, </li></ul><ul><li>Things of which to be aware. </li></ul>
  3. 3. HIPAA <ul><li>“Your health information cannot be used or shared without your written permission.” </li></ul><ul><li>Conversations are protected between physicians and nurses </li></ul><ul><li>There are no restrictions on the use or disclosure of de-identified health information </li></ul><ul><li>How do you obtain de-identified information? </li></ul>~
  4. 4. HIPAA exceptions <ul><li>Quality assessment & improvement activities </li></ul><ul><li>Competency assurance </li></ul><ul><li>Medical reviews & audits </li></ul><ul><li>Research is not listed as an exception… …so how do you get information? </li></ul>~
  5. 5. Research defined by HIPAA <ul><li>Any systematic investigation designed to develop or contribute to generalizable knowledge </li></ul><ul><li>HIPAA is waived for research if: </li></ul><ul><ul><li>[the researcher] obtains…waiver of individuals’ authorization for the use or disclosure of protected health information…approved by an Institutional Review Board , OR </li></ul></ul><ul><ul><li>… information is solely to prepare a research protocol… the researcher will not remove any protected health information from the covered entity , OR </li></ul></ul><ul><ul><li>… research on the protected health information of decedents (you have to be alive to be a research subject) </li></ul></ul>~
  6. 6. This means…to publish or research <ul><li>No LANTIS or IPR </li></ul><ul><li>No ‘white board’ in the clinic work room </li></ul><ul><li>No respiratory gating copies for Waldron </li></ul><ul><li>No MVCBCT images for Bylund </li></ul><ul><li>No copying RT treatment plans for Bayouth </li></ul><ul><li>No using RT plans to verify another type of plan </li></ul>You can still use these for quality control or teaching
  7. 7. So you need an “IRB” <ul><li>IRB actually means “Institutional Review Board” </li></ul><ul><li>Slang means “approval by institutional oversight committee s ” </li></ul><ul><ul><li>PRMC (Cancer Center), an NCI delegate </li></ul></ul><ul><ul><li>MRPC (medical radiation) </li></ul></ul><ul><ul><li>P & T (pharmacy & therapeutics) </li></ul></ul><ul><ul><li>NRC (nursing research) </li></ul></ul><ul><ul><li>Institutional Review Board (the final entity) </li></ul></ul><ul><ul><li>Others include IBC, GCRC, & conflict of interest </li></ul></ul><ul><ul><li>Any of them have the power to sink you </li></ul></ul>
  8. 8. Research-speak <ul><li>Standard of care </li></ul><ul><li>Prospective </li></ul><ul><li>Retrospective </li></ul><ul><li>Quality review </li></ul><ul><li>Delegate </li></ul>
  9. 9. Standard of care <ul><li>The treatment you would get walking in off the street </li></ul><ul><li>Can refer to Iowa or national care </li></ul><ul><li>Deviation from standard of care </li></ul><ul><ul><li>Can’t bill for it </li></ul></ul><ul><ul><li>Can’t use images for treatment </li></ul></ul><ul><ul><li>Poses a risk to patient </li></ul></ul><ul><ul><li>Unproven efficacy </li></ul></ul><ul><ul><li>Unproven interactions with radiation (i.e., 2DG) </li></ul></ul><ul><ul><li>Not FDA approved </li></ul></ul><ul><li> </li></ul>
  10. 10. Prospective Studies <ul><li>“I want to try something new…” </li></ul><ul><li>Evaluate efficacy or side effects </li></ul><ul><li>Hypothesis driven </li></ul><ul><li>Informed consent required (non-negotiable) </li></ul><ul><li>Takes 2 to 4 months for approval </li></ul>
  11. 11. Retrospective <ul><li>“I think I see a trend…” </li></ul><ul><li>Data must already exist from clinical care </li></ul><ul><li>Publishing manuscript, submitting a grant </li></ul><ul><li>Can be in response to a quality issue, concern, or audit (i.e., publish those results) </li></ul><ul><li>No physician needed </li></ul><ul><li>No consent needed </li></ul><ul><li>Only the IRB (or chair) is involved </li></ul><ul><li>Typically takes 2 weeks for approval </li></ul>
  12. 12. Quality Controls <ul><li>A merger between both worlds </li></ul><ul><li>No hypothesis, no protocol </li></ul><ul><li>Verifying a device or technique against published standards </li></ul><ul><li>Only submit to IRB </li></ul><ul><li>Consent still required </li></ul><ul><li>Example: MRI (Muruganandham) </li></ul>
  13. 13. Delegate <ul><li>Acts on your behalf </li></ul><ul><li>Not the same as a research team member </li></ul><ul><li>You must grant authority through HawkIRB </li></ul>Jane Hershberger
  14. 14. What do you need: prospective <ul><li>A standardized NCI protocol </li></ul><ul><ul><li>Clinical trials team can provide template, or </li></ul></ul><ul><ul><li>Clinical trials team can research & write with you </li></ul></ul><ul><li>Provide to the clinical trials team: </li></ul><ul><ul><li>Background, significance, rationale, procedures, references </li></ul></ul><ul><li>Must have an attending physician on the trial </li></ul><ul><ul><li>Provides adverse events, concomitant care </li></ul></ul><ul><li>Painful, complicated, long process with a lot of players </li></ul>
  15. 15. What do you need: retrospective <ul><li>Just supply the crux of your content </li></ul><ul><ul><li>What you’re looking at and why </li></ul></ul><ul><ul><li>What you hope to accomplish </li></ul></ul><ul><ul><li>Background (brief) </li></ul></ul><ul><ul><li>References </li></ul></ul><ul><li>The range of dates for the data </li></ul><ul><li>About how many patients (be generous) </li></ul><ul><li>No physician, no protocol, very simple </li></ul><ul><li>Hardest part is privacy & confidentiality </li></ul>
  16. 16. So, how do I get an IRB? <ul><li>You can do it </li></ul><ul><ul><li>Use your HawkID and password </li></ul></ul><ul><li>By proxy (delegate) </li></ul><ul><ul><li>Kellie AND Jane </li></ul></ul><ul><ul><li>Resident or graduate student </li></ul></ul>
  17. 17. Assign both Kellie (bodekerk) & Jane (hershbergerj)
  18. 19. Writing an IRB application <ul><li>Choose your own adventure </li></ul><ul><ul><li>Prospective, retrospective but always biomedical </li></ul></ul><ul><ul><li>Dependent upon answers, different questions are triggered </li></ul></ul><ul><li>Speak plainly </li></ul><ul><ul><li>Staffed with individuals who specialize in protecting subjects, not in radiation or oncology </li></ul></ul><ul><li>Let’s begin… </li></ul>
  19. 20. At the start <ul><li>Provide a short summary of the purpose and procedures of the study proposed. </li></ul><ul><ul><li>Keep it very, very simple and keep jargon out. </li></ul></ul><ul><ul><li>The simpler it is, the faster it is approved </li></ul></ul><ul><li>Specify your research question/hypotheses </li></ul><ul><li>Background and significance and/or preliminary studies </li></ul><ul><li>Literature cited </li></ul>
  20. 21. Your research team <ul><li>Designate your research team: </li></ul><ul><ul><li>Must be certified in human subjects </li></ul></ul><ul><ul><li>Must be at the U of I </li></ul></ul><ul><ul><li>Can link a research ID to the patient name </li></ul></ul><ul><ul><li>If they’re not listed, they can only access anonymized data </li></ul></ul><ul><ul><li>Cannot change P.I. until after approval </li></ul></ul><ul><li>Designate your funding </li></ul><ul><ul><li>Retrospective typically is departmental </li></ul></ul><ul><ul><li>Declare conflict of interest </li></ul></ul>
  21. 22. Then…decide your project type <ul><li>Regular or expedited review </li></ul><ul><li>Request a waiver of consent for retrospective studies </li></ul>
  22. 23. Waiver of consent (retrospective)
  23. 26. <ul><li>The IRB believes there is no such thing as a risk-free study </li></ul><ul><li>Breech of confidentiality & privacy are real risks and must be addressed. </li></ul>
  24. 27. Privacy & confidentiality <ul><li>Jane or Kellie can complete </li></ul><ul><li>“ Templated text” </li></ul>
  25. 28. You have to name names for each and every IRB application
  26. 29. Statistics <ul><li>Don’t panic </li></ul><ul><li>Don’t go overboard </li></ul><ul><li>More important for prospective studies for subject justification </li></ul>This is a feasibility study, to determine trends and/or if it is even applicable/possible. If a trend is seen, a larger study will be requested with statistical justification provided by the Biostatistics Core of the HCCC.
  27. 30. And when we’re done? <ul><li>Close the IRB </li></ul><ul><ul><li>When the manuscript has been published </li></ul></ul><ul><ul><li>No rebuttal </li></ul></ul><ul><ul><li>Done with all the data, never need to see it again </li></ul></ul><ul><li>Data generated </li></ul><ul><ul><li>If you can never trace it back to the subject, you can keep it on your shelf and use it </li></ul></ul><ul><ul><li>Must be wholly de-identified </li></ul></ul><ul><li>Data is destroyed after IRB closed 3 years </li></ul><ul><ul><li>IRB can audit you any time during those years </li></ul></ul>
  28. 31. Thank you…