Beyond the IRB LUFT


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Beyond the IRB LUFT

  1. 1. Beyond the IRB:Reviewing Projects with Respect to Organizational Risk and Benefits Harold S. Luft, PhD Palo Alto Medical Foundation Research Institute Community Based, Not For Profit
  2. 2. The “Back Story” We observed within our data for PCPs o Use of E&M codes 99213 vs. 99214 varied o Not explained by department or division o Patterns were consistent, not random Designed a research project to explore why o PCP and practice factors might explain IRB members raised concerns: o Risks to the organization o Lack of consent of the study subjects (the PCPs) o Approval was quite problematic (3-cycles) Community Based, Not For Profit
  3. 3. The Simple Answers IRBs are charged with protecting human subjects o "Citizens United" notwithstanding, organizations are not human subjects, hence IRBs have no authority Physicians are human subjects, but their identities are hidden from the researchers, so not a problem to use data about de-identified MDs Although true, these are not really adequate answers Community Based, Not For Profit
  4. 4. Fundamental Nature of the Concerns IRBs are fundamentally about protecting people from the potential risks incurred by being subjects in a research study The concerns being raised here arose not from the risks of the research process, but from potential findings resulting from the researchThis suggests a different solution may be needed Community Based, Not For Profit
  5. 5. Issues in Addressing the Concerns Potential risks could be of substantial magnitude, albeit low in probability of occurrence o IRB members, however have little expertise in making such assessments, nor the ability to “accept" the risk Regardless of who assesses the risks: o Waiting until results are known means “prior approval” of publication—highly problematic for journal editors o "Go/no go" decisions at the IRB review stage may mean being unable to execute an already funded project o "Go/no go" decisions at the submittal stage may mean being able to focus only on very low risk (i.e., uninteresting) projects Community Based, Not For Profit
  6. 6. What Would We Like to Have? A process for early-stage consideration of potential projects by key organization "stakeholders" An ability for concerns (and support) to be voiced Assurance that the appropriate people are given a "heads up" when necessary A process that does not have a "review and approve" step before publication …and it should be simple and quick for all involved Community Based, Not For Profit
  7. 7. A First Approach: Create the ACCORD Advisory [not controlling or approving] Committee [separate from the IRB] Consulting on [offering very useful input] Organizational [focus is not on research subjects] Risk and [there may be a wide range of risks] Dissemination [sometimes it’s just the message] Community Based, Not For Profit
  8. 8. Key Stakeholders Business Strategy—e.g., pricing, contracting Legal/regulatory—e.g., often issues of "wording" Compliance—e.g., incidental findings Quality of care—e.g., incidental findings Operations—e.g., non-interference by the study Medical Group—e.g., notifications, sensitivities Risk management—e.g., on-going issues Organizational image—e.g., "heads up" Community Based, Not For Profit
  9. 9. Process Before submitting a proposal for funding, or to IRB if just internal funding, PI electronically submits a form o Highlighting potential risks and benefits in each area o PAMFRI Director reviews and may cycle back to PI o Or may decide that no review by ACCORD is needed ACCORD members then get a notice of a review o Add comments and "scoring" o 2-week turnaround is the goal (no meetings) Any member can issue a “stop” o These are identifiable to all members and the PI o Otherwise, the project moves forward Community Based, Not For Profit
  10. 10. Scoring Overall Assessment (choose 1): 1. Serious concerns—come talk to me 2. Some concerns—my comments indicate problems and may offer potential solutions for the PI to consider 3. a) Not weighing in or b) No problems identified 4. Risks are identified and appropriately managed 5. Potential value to us—significant benefits, enthusiastic LOS Action Requested (choose 1): 1. Return (revised) before moving forward 2. I’d like to review manuscript(s) for comments before submittal 3. Give a “heads up" to Public Affairs before publication 4. No further action needed, Public Affairs is optional Community Based, Not For Profit
  11. 11. Current Status Enthusiasm about the concept Site is up and running One proposal has gone through the process o More of a beta test than real Process is not yet mandatory New IRB review processes, however, will expect an ACCORD "OK" Stay tuned Community Based, Not For Profit
  12. 12. Questions? Community Based, Not For Profit