A “Can Do” Approach to RCR Compliance Lessons Learned and Strategies Going Forward Marty Welsch, HR/RCR Coordinator Diane Rees, IT Professional, Research Services Colorado State University

Where Are You From? (as of Sunday) A. ColoradoB. East Coast C. West CoastD. No Coast E. Undecided

What Do You Do? A. Pre-AwardB. Post- Award C. Regulatory Compliance D. Information Technology E. Cost Accounting/Auditing

Today’s Objectives Introduction: What the charge was and why? Trainee Identification and Training Opportunities Challenge of Integration of RCR Activities Lessons Learned & Strategies Moving Forward

Brief Background of Responsible Conduct of Research (RCR) NSF RequirementNIH Requirements January 4, 2010 America COMPETES Act of 2007 Invest in innovation through R&D Make the nation more competitive by improving math & science education F2F Training Established training schedules Career level specific training Nine recommended core competencies

Going for the Gold

CSU enrollment: – 26,500 resident-instruction students – Freshman class size of 4500 – 3,600 graduate students 1,500 faculty (970 tenure-track) 4,400 staff – 130 FTE in the Office of the VP for Research – 26 FTE in Sponsored Programs/7.5 FTE in Research Services – 7.5 FTE in RICRO (Research Integrity & Compliance Review Office) FY10 Research Expenditure by Sponsor – Total Federal = $211 mil (HHS>NSF>DoD>NASA>DoE) – Non-Federal = $49 mil – Total Research = $303 mil

Key to Success: Collaboration RCR Sponsored Programs Research Services RICROProvostOVPR Graduate School Researchers

RCR Organization Chart RCR Director Dr. Kathy Partin RCR Coordinator Marty Welsch

Lucky!

Exciting & Overwhelming Challenges

How many? NIH funded trainees – Department – Name – Job Title – PI Same information for NSF trainees

Identifying the Trainees RCR Office Office of Research Services IT support for the Vice President for Research division

Identifying the Trainees NSF Policy: “Implementation Plan: Effective January 4, 2010, NSF will require that, at the time of proposal submission to NSF, a proposing institution's Authorized Organizational Representative certify that the institution has a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research.... institutions are responsible for verifying that undergraduate students, graduate students, and postdoctoral researchers supported by NSF to conduct research have received RCR training.”

Identifying the Trainees NIH Policy: “NIH requires that all trainees, fellows, participants, and scholars receiving support through any NIH training, career development award (individual or institutional), research education grant, and dissertation research grant must receive instruction in responsible conduct of research. This policy will take effect with all new and renewal applications submitted on or after January 25, 2010, and for all continuation (Type 5) applications with deadlines on or after January 1, This Notice applies to the following programs: D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R. This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.” *CSU includes R01s

Identifying the Trainees Criteria Research Account DataTrainees NSF research accounts created since January 1, 2010 NIH research accounts – new and additional dollars added since January 1, 2010 Job titles (graduate research assistant, student hourly, work study, post doc, etc.) Paid from research account (pay period >= January 1, 2010) Identify/Exclude individuals who have already been reported

Identifying the Trainees Sponsored Programs Award Database Human Resources Employee Data

Identifying the Trainees Pulling the Data Research Account Data HRS Data

Identifying the Trainees Detail Report Trainees Research Account Data

Identifying the Trainees Detail Report - Research Data Funding Mechanism

Identifying the Trainees Detail Report - Trainee Data

Identifying the Trainees Summary Report

Identifying the Trainees Sponsored Programs Award Data HRS Data Trainee Report Hard Copy Report Electronic Excel File RCR Office for Review

Department Notification

Grassroots Approach to Communication Bottom Up: Communicate to Trainees through the PIs and GECs Top Down: Buy-In and Support

Training Opportunities Online TrainingFace to Face Training

Back to the Pyramid….. RCR Online Training is expected for anyone that does research or scholarly activity at CSU 70% to pass Not dependent upon funding mechanism Assume Compliance/Information not tracked Mentoring is expected

Back to the Pyramid…. Standard being met by some departments Departments don’t have discipline specific RCR courses Active Compliance/Tracking RCR activities are evaluated

We Aim for the Gold Some departments have achieved this level Create ethical based research culture/less of a compliance mentality Discipline specific RCR training Increase number of departments to Gold level

Online Training

Online Training

Case Study Conflict of Interest Dr. Ashanti Quick is an internationally renowned author and an established authority in Creative Writing. In addition to teaching and advising at CSU, Dr. Quick is very much in demand across the country and works with her publisher to promote her books and present lectures at various writing workshops. She also supplements her income by serving as a panel member at the Iowa Writer’s Workshop (one month in the summer and during spring and fall breaks), consulting with a state literacy advisory panel (two evenings/month), and serving as an ad hoc consultant to a board of a private foundation (approximately 2 hours/week).

Dr. Quick Does a Financial COI appear to exist? A. Yes B. No C. Don’t Know

Dr. Quick should…. A.Resign from CSU if she is not willing to give up her outside professional development, as conflict of interest should be eliminated. B.Work with her department head to disclose her outside activities in a management plan C.Not do anything. Professional development and outreach is encouraged by the University.

Face to Face Training

Does your organization have…. RCR A. Online RCR Training B. F2F RCR Training C. Both D. RCR Training in Development E. Don’t know

Ethics Infusion Program

Science & Communication Workshops

RCR Training Costs 1 x cost – Online Training Huron Consulting Group/$60, – Ethics Infusion Program/$30, – I-clickers/$40.00 each Ongoing Costs – Adobe Licensing/$ – Staff support 25% FTE Director 50% FTE Coordinator IT Work Study Student $10,000/year – Workshops/2-3 year/$ each

Future Plans Revise the RCR training web site  Automate!  Authenticate login  Identify online trainees completing the master quiz  Identify face to face trainees via registration process

Future Plans Modify the existing database to identify and track trainees Oracle

Future Plans Develop an automated department notification process

Questions? ~ Thank You ~