1. ORI Conference on Research on Research Integrity May 16, 2009 An Inventory of RCR Instructional Activities and Training Materials in the CTSA Consortium Elizabeth Heitman, PhD Elizabeth Heitman, PhD Center for Biomedical Ethics and Society Center for Biomedical Ethics and Society Vanderbilt University Medical Center Vanderbilt University Medical Center James M. DuBois, PhD, DSc Alexander A. Kon, MD Department of Health Care Ethics Department of Pediatrics Saint Louis University (WUSTL CTSA) University of California, Davis Debie Schilling Nicholas H. Steneck, PhD Clinical & Translational Science Center Research Ethics & Integrity Program UC Davis Health System University of Michigan

2. 2 Disclosure and Acknowledgements The members of the Educational Materials group have no financial conflicts of interest to disclose related to this project. The members of the Educational Materials group have no financial conflicts of interest to disclose related to this project. This work was made possible by a supplement award to Grant # UL1 RR024146 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. The Delphi project was funded by a grant from the Office of Research Integrity to Dr. DuBois. This work was made possible by a supplement award to Grant # UL1 RR024146 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. The Delphi project was funded by a grant from the Office of Research Integrity to Dr. DuBois. We are grateful for the participation of the many experts who served on the 4 Delphi panels and the members of the CTSA institutions who participated in the survey. We are grateful for the participation of the many experts who served on the 4 Delphi panels and the members of the CTSA institutions who participated in the survey.

3. Clinical and Translational Science Award (CTSA) Consortium Funded by National Center for Research Resources (NCRR) Funded by National Center for Research Resources (NCRR) First round of funding in 2006 First round of funding in 2006 Now 39 academic health centers in 23 states Now 39 academic health centers in 23 states Goal to fund ~ 60 sites Goal to fund ~ 60 sites Most 2009 awards pending Most 2009 awards pending

4. CTSA Replaces Other Federal Grants General Clinical Research Centers (GCRCs) General Clinical Research Centers (GCRCs) Institutional research training programs Institutional research training programs e.g., K30, T32, T12 e.g., K30, T32, T12

5. CTSA Structure

6. Aims of the CTSA Program: Improve the way that biomedical research is conducted across the country Improve the way that biomedical research is conducted across the country Reduce the time that it takes for laboratory discoveries to become clinical treatments Reduce the time that it takes for laboratory discoveries to become clinical treatments Engage communities in clinical research Engage communities in clinical research Train the next generation of clinical and translational researchers Train the next generation of clinical and translational researchers

7. www.ctsaweb.org

8. Research Ethics in the CTSA All CTSA sites have a funded research ethics component All CTSA sites have a funded research ethics component Significant variability or activities under and support for the research ethics component Significant variability or activities under and support for the research ethics component Key personnel effort versus cost sharing Key personnel effort versus cost sharing Effort ranges from 0.1 to > 3 FTEs Effort ranges from 0.1 to > 3 FTEs

9. Four groups responsible for research ethics and RCR education: Education and Career Development Key Function Committee (ECD KFC) Education and Career Development Key Function Committee (ECD KFC) Clinical Research Ethics Key Function Committee (CRE KFC) Clinical Research Ethics Key Function Committee (CRE KFC) Regulatory Knowledge Key Function Committee (RK KFC) Regulatory Knowledge Key Function Committee (RK KFC) CTSA Consortium Child Health Oversight Committee CTSA Consortium Child Health Oversight Committee

10. Clinical Research Ethics Key Function Committee (CRE-KFC) 1 voting member from each CTSA site 1 voting member from each CTSA site NIH members (1/3 of total committee) NIH members (1/3 of total committee) Others may join as non-voting members Others may join as non-voting members

11. CRE KFC Subcommittees Educational Materials Educational Materials Operations Operations Consultation Consultation Governance (temporary) Governance (temporary) Pediatric Research Ethics Workgroup Pediatric Research Ethics Workgroup (under Child Health Oversight Committee) (under Child Health Oversight Committee) Alternative IRB Model Pilots Alternative IRB Model Pilots (under Regulatory Knowledge KFC) (under Regulatory Knowledge KFC) Research on Research Ethics (new) Research on Research Ethics (new)

12. Educational Materials Subcommittee Alexander Kon (UC Davis) Alexander Kon (UC Davis) James DuBois (SLU/Washington U) James DuBois (SLU/Washington U) Elizabeth Heitman (Vanderbilt) Elizabeth Heitman (Vanderbilt) Nicholas Steneck (U Michigan) Nicholas Steneck (U Michigan) Jon Merz (U Penn) Jon Merz (U Penn) John Sadler (UT-Dallas) John Sadler (UT-Dallas) Rhonda Kost (Rockefeller) Rhonda Kost (Rockefeller) Ross McKinney (Duke) Ross McKinney (Duke) Richard Sharp (Case Western) Richard Sharp (Case Western)

13. Education and Career Development KFC Defining Core Competencies for Trainees Nick Steneck offered to draft ethics/RCR competencies. Nick Steneck offered to draft ethics/RCR competencies. CRE Education Materials Group Proposed: CRE Education Materials Group Proposed: 8 Core Competencies in Clinical Research Ethics 8 Core Competencies in Clinical Research Ethics 10 Core Competencies in RCR/Research Integrity 10 Core Competencies in RCR/Research Integrity

14. Competencies under Review Too many competencies? Too many competencies? Difference between ethics and RCR? Difference between ethics and RCR? Need active, measurable verbs (Bloom’s taxonomy) Need active, measurable verbs (Bloom’s taxonomy) How many levels of competence? How many levels of competence?

15. Competencies under Review Standard Progression Standard Progression Masters-level competencies Masters-level competencies Doctoral-level competencies Doctoral-level competencies CTSA Progression CTSA Progression MS MS MD MD PhD PhD MSCI / MPH MSCI / MPH Postdoctoral fellowship Postdoctoral fellowship Junior faculty Junior faculty Senior faculty Senior faculty

16. Supplemental Award Project Team Alexander Kon (UC Davis) Alexander Kon (UC Davis) Debie Schilling (UC Davis) Debie Schilling (UC Davis) James DuBois (SLU/Washington U) James DuBois (SLU/Washington U) Elizabeth Heitman (Vanderbilt) Elizabeth Heitman (Vanderbilt) Nicholas Steneck (U Michigan) Nicholas Steneck (U Michigan)

17. One-Year Supplemental Award RCR activity survey at 38 CTSA sitesRCR activity survey at 38 CTSA sites Inventory novel educational materialsInventory novel educational materials Available online through CTSpediaAvailable online through CTSpedia Indexed and searchableIndexed and searchable Textbook content analysisTextbook content analysis White paper on RCR education for clinical and translational researchersWhite paper on RCR education for clinical and translational researchers

18. Email survey sent t o 3 identified KFC members at each CTSA: Clinical research ethics KFCClinical research ethics KFC Education and career development KFCEducation and career development KFC Regulatory knowledge KFCRegulatory knowledge KFC Responses from all 38 CTSAs – 79 total 1-5 respondents per CTSA 18

19. Main survey questions: Do you have an RCR course under your CTSA? Do you have an RCR course under your CTSA? Who is primarily responsible for RCR education under your CTSA? Who is primarily responsible for RCR education under your CTSA? Who is required to take the CTSA RCR course? Who is required to take the CTSA RCR course? What format do you use for RCR training? What format do you use for RCR training? What materials do you use for RCR training? What materials do you use for RCR training? What original RCR training materials have you developed for use within your CTSA? May we post them? What original RCR training materials have you developed for use within your CTSA? May we post them? 19

20. Who is primarily responsible for RCR education? Who is primarily responsible for RCR education? Specific responses under analysis Specific responses under analysis Conflicting responses among multiple responses from individual CTSAs Conflicting responses among multiple responses from individual CTSAs No clear sense of “ownership” of RCR education at many CTSAs or across CTSAs No clear sense of “ownership” of RCR education at many CTSAs or across CTSAs

21. Do you have an RCR course under your CTSA ? N = CTSA Yes 24 (63%) Outside CTSA 9 (24%) No RCR 1 ( 3%) Other 4 (10%) I don't know 0

22. Who is required to take the CTSA RCR course? Trainees (T32, K12, K30) 31 (82%) All PIs 12 (32%) All research personnel 9 (28%) All residents 10 (26%) All post-docs 21 (55%) Other 18 (47%)

23. What format do you use for RCR training? In-person course 34 (90%) On-line training course 19 (50%) CITI RCR 11 Other online 7 No answer 1 Other (journal club, etc.) 9 (24%)

24. What textbook do you use for RCR training? Beach, 1996 2 ( 5%) Bulger et al., 2002 2 ( 5%) W/HHMI, 2006 4 (11%) Emanuel et al. 2003 4 (11%) Macrina, 2005 6 (16%) NAS, 1995 4 (11%) Shamoo & Resnik, 2003 4 (11%) Steneck, 2007 6 (16%) Other 3 ( 8%) No textbook19 (50%)

25. What original RCR training materials have you developed for use within your CTSA? May we post them? Syllabus or reading list20 (53%) PowerPoint presentation 20 (53%) Cases for discussion19 (50%) Video 5 (13%) OK to post20 (53%)

26. RCR Education Materials From CTSAs for Clinical and Translational Research on CTSPedia http://twiki.library.ucsf.edu/do/view/CTSpedia/WebHome

27. Eight* textbooks, one online course, and all submitted original materials are being indexed, using 53 topics in 7 core areas from DuBois et al. Delphi survey (under consideration for J Res Admin, Fall 2009) Content Analysis for Key Topics

28. Ongoing activities to be completed by July 1, 2009 : CTSPedia Research Ethics website development CTSPedia Research Ethics website development White paper: Standards for RCR education for clinical and translational research and necessary support White paper: Standards for RCR education for clinical and translational research and necessary support Second supplement? Second supplement?