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

2

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

CRE KFC SubcommitteesCRE KFC Subcommittees

• Educational MaterialsEducational Materials• OperationsOperations• ConsultationConsultation• Governance Governance (temporary)(temporary)

• 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)

Educational Materials SubcommitteeEducational 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)

Education and Career Development KFC Education and Career Development KFC Defining Core Competencies for TraineesDefining 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 Ethics8 Core Competencies in Clinical Research Ethics

• 10 Core Competencies in RCR/Research Integrity10 Core Competencies in RCR/Research Integrity

Competencies under ReviewCompetencies under Review

• Too many competencies?Too many competencies?

• Difference between ethics and RCR?Difference between ethics and RCR?

• Need active, measurable verbs Need active, measurable verbs

(Bloom’s taxonomy)(Bloom’s taxonomy)

• How many levels of competence? How many levels of competence?

Competencies under ReviewCompetencies under Review

Standard ProgressionStandard Progression

• Masters-level Masters-level competenciescompetencies

• Doctoral-level Doctoral-level competenciescompetencies

CTSA ProgressionCTSA Progression • MSMS• MDMD• PhDPhD• MSCI / MPHMSCI / MPH• Postdoctoral fellowshipPostdoctoral fellowship• Junior facultyJunior faculty• Senior facultySenior faculty

Supplemental Award Project TeamSupplemental 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)

One-Year Supplemental AwardOne-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 White paper on RCR education for clinical and translational researchersclinical and translational researchers

Email survey sent tEmail survey sent to 3 identified KFC o 3 identified KFC members at each CTSA: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 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?

Trainees Trainees (T32, K12, K30) (T32, K12, K30) 31 (82%)31 (82%)

All PIs 12 (32%)All PIs 12 (32%)

All research personnel 9 (28%)All research personnel 9 (28%)

All residents 10 (26%)All residents 10 (26%)

All post-docs 21 (55%) All post-docs 21 (55%)

Other 18 (47%) Other 18 (47%)

What format do you use for RCR training?What format do you use for RCR training?

In-person course In-person course 34 (90%)34 (90%)

On-line training course On-line training course 19 (50%)19 (50%)

CITI RCR CITI RCR 1111

Other online Other online 7 7

No answer No answer 1 1

Other (journal club, etc.)Other (journal club, etc.) 9 (24%) 9 (24%)

What textbook do you use for RCR training?What textbook do you use for RCR training?

Beach, 1996 Beach, 1996 2 ( 5%) 2 ( 5%)Bulger et al., 2002 Bulger et al., 2002 2 ( 5%) 2 ( 5%)W/HHMI, 2006 W/HHMI, 2006 4 (11%) 4 (11%)Emanuel et al. 2003Emanuel et al. 2003 4 (11%) 4 (11%)Macrina, 2005Macrina, 2005 6 (16%) 6 (16%)NAS, 1995NAS, 1995 4 (11%) 4 (11%)Shamoo & Resnik, 2003Shamoo & Resnik, 2003 4 (11%) 4 (11%)Steneck, 2007Steneck, 2007 6 (16%) 6 (16%)OtherOther 3 ( 8%) 3 ( 8%)No textbookNo textbook 19 (50%)19 (50%)

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%)

PowerPoint presentation PowerPoint presentation 20 (53%)20 (53%)

Cases for discussionCases for discussion 19 (50%)19 (50%)

Video Video 5 (13%) 5 (13%)

OK to postOK to post 20 (53%)20 (53%)

RCR Education Materials From RCR Education Materials From CTSAs for Clinical and Translational CTSAs for Clinical and Translational

Research on CTSPediaResearch on CTSPedia

http://twiki.library.ucsf.edu/do/view/CTSpedia/WebHomehttp://twiki.library.ucsf.edu/do/view/CTSpedia/WebHome

Eight* textbooks, one online course, and all Eight* textbooks, one online course, and all

submitted original materials are being submitted original materials are being

indexed, using 53 topics in 7 core areas indexed, using 53 topics in 7 core areas from DuBois et al. Delphi surveyfrom DuBois et al. Delphi survey

(under consideration for (under consideration for J Res Admin, J Res Admin, Fall 2009)Fall 2009)

Content Analysis for Key Topics

Ongoing activitiesOngoing activitiesto be completed by July 1, 2009to be completed by July 1, 2009::

• CTSPedia Research Ethics website CTSPedia Research Ethics website developmentdevelopment

• White paper: Standards for RCR White paper: Standards for RCR education for clinical and translational education for clinical and translational research and necessary supportresearch and necessary support

• Second supplement?Second supplement?