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BeyondCompliance The Role of Institutional Culture in PromotingResearchIntegrity Gail Geller, ScD, MHS Alison Boyce, MA Jeremy Sugarman, MD, MPH, MA – PowerPoint PPT presentation

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Title: PRESENTATION NAME


1
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
2
Overview
  • Background
  • Description and findingsfromproject
  • Implications for a research agenda

3
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

4
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

5
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?

6
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

7
BackgroundHopkins CTSA
  • Research Ethics Achievement Program (REAP)
    Berman Institute of Bioethics
  • Needs Assessment

8
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

9
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10
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
11
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

12
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

13
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.

14
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

15
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

16
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

17
Towards a future research agenda
18
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?

19
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

20
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
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