Research Administration

1. Beyond the IRB:
Reviewing Projects with Respect to
Organizational Risk and Benefits
Harold S. Luft, PhD
Palo Alto Medical Foundation
Research Institute
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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)
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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
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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 research
This suggests a different solution may be needed
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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
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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
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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]
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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"
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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
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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
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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
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12. Questions?
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