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. I.Background II.Description and findingsfromproject III. Implications for a research agenda

3. 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. 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. Generative Proactive Calculative Reactive Application to Pathological biomedical research?

6. › 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.  Research Ethics Achievement Program (REAP) – Berman Institute of Bioethics  Needs Assessment

8. › 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. AgreeDisagree N%N% I would feel safe being treated as a patient here 42 67 813 I would feel safe being a research participant here 29 46 1117 In this clinical area, it is difficult to speak up if I perceive a problem in patient care 132138 60 In this institution, it is difficult to speak up about problems in research protocols 91423 37

11. 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. 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.  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. “(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. “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. › 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

18. 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?

19. Overcome limitations of a single-institution study with small sample sizes Conduct national study through the CTSA Consortium to: 1Develop measures for assessing progress with regard to an internal culture of trustworthiness 2Validate findings

20.  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