BeyondComplianceBeyondCompliance

The Role of Institutional Culture in PromotingResearchIntegrity

Gail Geller, ScD, MHSAlison Boyce, MAJeremy Sugarman, MD, MPH, MAJohns Hopkins Berman Institute of Bioethics

ICTR Grant #101872

OverviewOverview

I. Background

II. Description and findingsfromproject

III. Implications for a research agenda

BackgroundBackgroundT.I.E.S: Trust, Integrity, and Ethics in T.I.E.S: Trust, Integrity, and Ethics in Science 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 2009;84: 472-477.

Conference:• Airline industry• Meat industry • Nuclear power industry • Jurisprudence

Literature Review:• Patient safety

BackgroundBackgroundInsights from Insights from T.I.E.ST.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:

• “We’re 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”

Generative

Proactive

Calculative

Reactive Application to

Pathological biomedical research?

BackgroundBackgroundLiterature on organizational culture Literature on organizational culture and research integrityand 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

BackgroundBackgroundHopkins CTSAHopkins CTSA

Research Ethics Achievement Program (REAP) – Berman Institute of Bioethics

Needs Assessment

MethodsMethods› 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

Agree 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

Perceived discrepancies in competencies by position in hierarchy

Staff: “insufficient PI involvement [in conducting the research] and lack of study

coordinator’s medical knowledge”

Staff: “lack of understanding of protocols by protocol coordinator”

PI: “[I’m concerned about] students doing international research”

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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”

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 protocol…everything else is the IRBs job.”

“(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”

“Relationships with the IRB can feel adversarial, not like a partnership”

“sometimes the institution gets mired in detail and loses sight of what’s important”

› 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

Empirical support for T.I.E.S. recommendations and questions/hypotheses for future research

1.How can we strengthen confidence/perceived competence between those at different levels in the hierarchy?

2.Would redressing power differentials in the hierarchical structure help to reduce the ‘culture of compliance’ and fears of retribution?

3.Would more open and blame-free communication encourage accountability?

Toward a future research Toward a future research agendaagenda• Overcome limitations of a single-

institution study with small sample sizes

• Conduct national study through the CTSA Consortium to:

1 Develop measures for assessing progress with regard to an internal culture of trustworthiness

2 Validate findings

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