ORI Conference on Research on Research Integrity ORI Conference on Research on Research Integrity May 16, 2009 May 16, 2009 An Inventory of RCR An Inventory of RCR Instructional Activities Instructional Activities and Training Materials and Training Materials in the CTSA Consortium 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 James M. DuBois, PhD, DSc Alexander A. Kon, MD Alexander A. Kon, MD Department of Health Care Ethics Department of Health Care Ethics Department of Pediatrics Department of Pediatrics Saint Louis University (WUSTL CTSA) Saint Louis University (WUSTL CTSA) University of California, Davis University of California, Davis Debie Schilling Debie Schilling Nicholas H. Steneck, PhD Nicholas H. Steneck, PhD Clinical & Translational Science Center Clinical & Translational Science Center
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ORI Conference on Research on Research Integrity May 16, 2009 An Inventory of RCR Instructional Activities and Training Materials in the CTSA Consortium.
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ORI Conference on Research on Research Integrity ORI Conference on Research on Research Integrity May 16, 2009May 16, 2009
An Inventory of RCR Instructional An Inventory of RCR Instructional Activities and Training Materials Activities and Training Materials
in the CTSA Consortiumin the CTSA Consortium
Elizabeth Heitman, PhDElizabeth Heitman, PhD
Center for Biomedical Ethics and SocietyCenter for Biomedical Ethics and Society
Vanderbilt University Medical CenterVanderbilt University Medical Center
James M. DuBois, PhD, DScJames M. DuBois, PhD, DSc Alexander A. Kon, MD Alexander A. Kon, MD Department of Health Care EthicsDepartment of Health Care Ethics Department of Pediatrics Department of PediatricsSaint Louis University (WUSTL CTSA) Saint Louis University (WUSTL CTSA) University of California, Davis University of California, Davis
Debie SchillingDebie Schilling Nicholas H. Steneck, PhD Nicholas H. Steneck, PhD Clinical & Translational Science Center Research Ethics & Integrity ProgramClinical & Translational Science Center Research Ethics & Integrity ProgramUC Davis Health SystemUC Davis Health System University of Michigan University of Michigan
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Disclosure and AcknowledgementsDisclosure and Acknowledgements
• The members of the Educational Materials group have no The members of the Educational Materials group have no financial conflicts of interest to disclose related to this financial conflicts of interest to disclose related to this project. project.
• This work was made possible by a supplement award to This work was made possible by a supplement award to Grant # UL1 RR024146 from the National Center for Grant # UL1 RR024146 from the National Center for Research Resources (NCRR), a component of the Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for National Institutes of Health (NIH), and NIH Roadmap for Medical Research. The Delphi project was funded by a Medical Research. The Delphi project was funded by a grant from the Office of Research Integrity to Dr. DuBois.grant from the Office of Research Integrity to Dr. DuBois.
• We are grateful for the participation of the many experts We are grateful for the participation of the many experts who served on the 4 Delphi panels and the members of who served on the 4 Delphi panels and the members of the CTSA institutions who participated in the survey.the CTSA institutions who participated in the survey.
Clinical and Translational Science Clinical and Translational Science Award (CTSA) ConsortiumAward (CTSA) Consortium
• Funded by National Center for Research Resources (NCRR)Funded by National Center for Research Resources (NCRR)• First round of funding in 2006First round of funding in 2006• Now 39 academic health centers in 23 statesNow 39 academic health centers in 23 states• Goal to fund ~ 60 sitesGoal to fund ~ 60 sites• Most 2009 awards Most 2009 awards pendingpending
CTSA Replaces Other Federal GrantsCTSA Replaces Other Federal Grants
• General Clinical Research Centers General Clinical Research Centers (GCRCs)(GCRCs)
• Institutional research training programs Institutional research training programs • e.g., K30, T32, T12e.g., K30, T32, T12
CTSA StructureCTSA Structure
Aims of the CTSA Program:Aims of the CTSA Program:
• Improve the way that biomedical research Improve the way that biomedical research is conducted across the country is conducted across the country
• Reduce the time that it takes for laboratory Reduce the time that it takes for laboratory discoveries to become clinical treatments discoveries to become clinical treatments
• Engage communities in clinical research Engage communities in clinical research
• Train the next generation of clinical and Train the next generation of clinical and translational researchers translational researchers
www.ctsaweb.orgwww.ctsaweb.org
Research Ethics in the CTSAResearch Ethics in the CTSA
• All CTSA sites have a funded research All CTSA sites have a funded research
ethics componentethics component
• Significant variability or activities under and Significant variability or activities under and
support for the research ethics componentsupport for the research ethics component
• Key personnel effort versus cost sharingKey personnel effort versus cost sharing
• Effort ranges from 0.1 to > 3 FTEsEffort ranges from 0.1 to > 3 FTEs
Four groups responsible for research Four groups responsible for research ethics and RCR education:ethics and RCR education:
• Education and Career Development Key Education and Career Development Key Function Committee (ECD KFC)Function Committee (ECD KFC)
• Clinical Research Ethics Key Function Clinical Research Ethics Key Function Committee (CRE KFC)Committee (CRE KFC)
• Regulatory Knowledge Key Function Committee Regulatory Knowledge Key Function Committee (RK KFC)(RK KFC)
• CTSA Consortium Child Health Oversight CTSA Consortium Child Health Oversight CommitteeCommittee
Clinical Research Ethics Clinical Research Ethics Key Function Committee (CRE-KFC)Key Function Committee (CRE-KFC)
• 1 voting member from each CTSA site1 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 membersOthers may join as non-voting members
• Pediatric Research Ethics Workgroup Pediatric Research Ethics Workgroup • (under Child Health Oversight Committee)(under Child Health Oversight Committee)
• Alternative IRB Model PilotsAlternative IRB Model Pilots• (under Regulatory Knowledge KFC)(under Regulatory Knowledge KFC)
• Research on Research Ethics Research on Research Ethics (new)(new)
Responses from all 38 CTSAs – 79 totalResponses from all 38 CTSAs – 79 total
1-5 respondents per CTSA1-5 respondents per CTSA18
Main survey questions: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 Who is primarily responsible for RCR education under your CTSA? 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 What original RCR training materials have you developed for use within your CTSA? May we developed for use within your CTSA? May we post them?post them? 19
Who is primarily responsible for RCR Who is primarily responsible for RCR education? education?
• Specific responses under analysisSpecific responses under analysis
• Conflicting responses among multiple Conflicting responses among multiple responses from individual CTSAsresponses from individual CTSAs
• No clear sense of “ownership” of RCR No clear sense of “ownership” of RCR education at many CTSAs or across education at many CTSAs or across CTSAsCTSAs
Do you have an RCR course under Do you have an RCR course under your CTSA ? your CTSA ? N = CTSAN = CTSA
Yes Yes 24 (63%)24 (63%)
Outside CTSA 9 (24%)Outside CTSA 9 (24%)
No RCR No RCR 1 ( 3%) 1 ( 3%)
Other Other 4 (10%) 4 (10%)
I don't knowI don't know 0 0
Who is required to take the CTSA Who is required to take the CTSA RCR course?RCR course?
What original RCR training materials have What original RCR training materials have you developed for use within your CTSA? you developed for use within your CTSA?
May we post them?May we post them?
Syllabus or reading listSyllabus or reading list 20 (53%)20 (53%)