Title: PRESENTATION NAME
1BeyondCompliance
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
2Overview
- Background
- Description and findingsfromproject
- Implications for a research agenda
3BackgroundT.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
4BackgroundInsights 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
5Background 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?
6BackgroundLiterature 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
7BackgroundHopkins CTSA
- Research Ethics Achievement Program (REAP)
Berman Institute of Bioethics - Needs Assessment
8Methods
- 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(No Transcript)
10Findings 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
11Surveys 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
12C.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.
14C.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
15C.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
16Discussions 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
17Towards a future research agenda
18Insights 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?
19Toward 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
20Thanks 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