BeyondCompliance

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 2009;84: 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: “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”

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

10. Findings: Safety and openness in clinical vs. research settings

11. Surveys: Qualitative Data 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”

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 protocol…everything 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 what’s 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