PRESENTATION NAME

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BeyondCompliance
The Role of Institutional Culture in
PromotingResearchIntegrity Gail Geller, ScD,
MHS Alison Boyce, MA Jeremy Sugarman, MD, MPH,
MA Johns Hopkins Berman Institute of Bioethics
ICTR Grant 101872
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Overview

• Background
• Description and findingsfromproject
• Implications for a research agenda

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BackgroundT.I.E.S Trust, Integrity, and Ethics
in Science

• Yarborough M, Fryer-Edwards K, Geller G, Sharp
  RR. Transforming The Culture Of Biomedical
  Research From Compliance To Trustworthiness
  Insights From Nonmedical Sectors. Acad Med
  200984 472-477.
• Conference
• Airline industry
• Meat industry
• Nuclear power industry
• Jurisprudence
• Literature Review
• Patient safety

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BackgroundInsights from T.I.E.S

• Enhancing trustworthiness depends on improving
  relationships and accountability
• Internal relationships are as important as
  external ones
• To improve internal relationships, minimize
  hierarchy
• Were all in this together
• To improve accountability
• Maximize openness Communication is often neither
  sufficiently open nor blame-free
• Transcend compliance You can follow all the
  rules and still not get it right

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Background Culture of SafetyHudson, P. Applying
the lessons of high-risk industries to health
care. Qual Safe Health Care. 2003 12 i7-i12.

• Generative
• 
  Proactive
• Calculative
• Reactive
• 
  Application to
• Pathological biomedical
  research?

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BackgroundLiterature on organizational culture
and research integrity

• NIH needs assessment (2001)
• ORI (2002) and IOM (2002) reports
• Anderson et al., 2007 Ferguson et al., 2007
  Davis et al., 2007 Martinson et al., 2006
  DeVries et al., 2007
• Commentary Theoretical work
• E.g. Rhodes Strain, 2004

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BackgroundHopkins CTSA

• Research Ethics Achievement Program (REAP)
  Berman Institute of Bioethics
• Needs Assessment

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Methods

• Phase I Surveys
• ICTR Research retreat
• Research staff lunchtime talk
• Nurses retreat and clinical unit
• Phase II Course on Research Ethics
• Course evaluations, small groups
• Phase III In-depth discussions with senior
  research personnel
• Semi-structured, one-on-one meetings

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Findings Safety and openness in clinical vs.
research settings
Agree Agree Disagree Disagree
N N
I would feel safe being treated as a patient here 42 67 8 13
I would feel safe being a research participant here 29 46 11 17
In this clinical area, it is difficult to speak up if I perceive a problem in patient care 13 21 38 60
In this institution, it is difficult to speak up about problems in research protocols 9 14 23 37
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Surveys Qualitative Data

• Perceived discrepancies in competencies by
  position in hierarchy
• Staff insufficient PI involvement in
  conducting the research and lack of study
  coordinators medical knowledge
• Staff lack of understanding of protocols by
  protocol coordinator
• PI Im concerned about students doing
  international research

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C.O.R.E. EvaluationsPerceived Discrepancies in
Need for Training and Oversight

• Faculty I was familiar with the material
• Fellow Faculty should be required to attend the
  second half
• Fellow All members of research team should be
  encouraged to take this course
• Faculty I will supervise my students and staff
  more closely

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Discussions with Senior Research Personnel
Discrepancy in who is responsible for what?

• Most regulatory officials think that
  investigators are responsible for compliance.
• A few IRB chairs think the IRB is responsible for
  compliance.
• The only rule that investigators need to
  remember is to adhere to their approved
  protocoleverything else is the IRBs job.

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C.O.R.E. EvaluationsAccountability Maximizing
openness

• (A group of fellows only) is a great venue to
  ask open questions without fear of punishment or
  humiliation
• Reporting problems comes at a huge personal
  loss

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C.O.R.E. EvaluationsAccountability Transcending
compliance

• Relationships with the IRB can feel adversarial,
  not like a partnership
• sometimes the institution gets mired in detail
  and loses sight of whats important

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Discussions with Senior Research Personnel
Relationships Minimizing hierarchy

• The IO controls the research ethics climate
• The IRB chairs want more control in deciding how
  the IRB operates
• Who serves on the IRB and for how long

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Towards a future research agenda
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Insights from our project

• Empirical support for T.I.E.S. recommendations
  and questions/hypotheses for future research
• How can we strengthen confidence/perceived
  competence between those at different levels in
  the hierarchy?
• Would redressing power differentials in the
  hierarchical structure help to reduce the
  culture of compliance and fears of retribution?
• Would more open and blame-free communication
  encourage accountability?

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Toward a future research agenda

• Overcome limitations of a single-institution
  study with small sample sizes
• Conduct national study through the CTSA
  Consortium to
• Develop measures for assessing progress with
  regard to an internal culture of trustworthiness
• Validate findings

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Thanks to

• Daniel Ford
• Mark Hughes
• David Levine
• REAP
• Jeremy Sugarman
• Mary Catherine-Beach
• Joseph Carrese
• Nancy Kass
• Debra Mathews
• Marie Nolan
• Holly Taylor
• Peter Terry
• Larry Wissow

• TIES
• Patient Safety group
• Brian Sexton
• Lori Paine
• Daniel Doyle
• ICTR/Berman Institute of Bioethics
• JHU participants