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. Colorado B. East Coast

C. West Coast D. No Coast

E. Undecided

What Do You Do?

A. Pre-Award B. 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 Requirement NIH 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

Research@CSU• 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

RCRSponsored Programs

Research Services

RICRO

Provost

OVPR

Graduate School

Researchers

RCR Organization Chart

RCR DirectorDr. Kathy Partin

RCR CoordinatorMarty 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 TraineesNIH 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, 2011. 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 TraineesCriteria

Research Account Data Trainees

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 TraineesPulling the Data

Research Account Data

HRS Data

Identifying the TraineesDetail Report

Trainees

Research Account Data

Identifying the TraineesDetail Report - Research Data

Funding Mechanism

Identifying the TraineesDetail Report - Trainee Data

Identifying the TraineesSummary Report

Identifying the Trainees

Sponsored Programs

Award DataHRS Data Trainee Report

Hard Copy ReportElectronic 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 Training Face 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 Traininghttp://rcr.colostate.edu

Online Training

Online Training

Online Training

Case StudyConflict 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. YesB. NoC. 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….

RCRA. 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/$60,000.00 – Ethics Infusion Program/$30,000.00– I-clickers/$40.00 each

• Ongoing Costs– Adobe Licensing/$3000.00– Staff support

• 25% FTE Director• 50% FTE Coordinator• IT Work Study Student $10,000/year

– Workshops/2-3 year/$2000.00 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 ~