Compliance Training Programs

2. Today�s Agenda Why Faculty Need Compliance Education A Glimpse at Innovative Approaches at 2 Institutions How to Engage and Involve Faculty

3. Moderator Vivian Holmes Director, Finance & Administration, Division of Medical Sciences Harvard Panelists Louise Griffin Vice Chancellor, Administration & Finance, University of Massachusetts � Lowell Melinda Cotten Director, Office of Grants & Contracts Management, Vanderbilt Univ Medical Center

4. Compliance Sets the Stage What Faculty Should Know

5. Compliance In order to achieve faculty compliance on federal projects, you must engage them. Faculty educational programs should focus on their roles as principal investigators They can and will be held accountable. Research Administrators must have support for this at top levels of the institution

6. Huge Settlements for Top InstitutionsDue to Non-Compliance Costing or Misuse of Funds Issues University of Minnesota - $32 million New York University � $15.5 million Mayo Foundation - $6.5 million Harvard/Beth Israel - $3.25 million Effort Issues Florida International University - $11.5 million Northwestern University - $5 million University of Alabama at Birmingham - $3.4 million Johns Hopkins University - $2.7 million

7. Steps Taken ByVanderbilt University Medical Center FOTO � Faculty Orientation and Training Office Mandatory Online Effort Certification Training RCEs � Research Compliance Experts New Faculty Orientation

8. FOTO Faculty Orientation and Training Office (N=1830 SOM Faculty) All faculty training must be coordinated thru FOTO. Vanderbilt faculty have as many as 38 Compliance Training requirements. 17 are 1x only requirements.  21 require annual re-training. All are mandated through VU policies, federal regulations, or for accreditation (e.g. JCAHO, AAHRP). Faculty members involved in clinical care, biomedical research and education are subject to increasing and changing regulatory requirements that often require additional training. The Vanderbilt School of Medicine and the Vanderbilt Medical Center combined efforts to address the need for a centralized process for faculty to access training.Faculty members involved in clinical care, biomedical research and education are subject to increasing and changing regulatory requirements that often require additional training. The Vanderbilt School of Medicine and the Vanderbilt Medical Center combined efforts to address the need for a centralized process for faculty to access training.

9. FOTO

10. Mandatory Effort Training Short On Line Module (8 minutes) Tracked by Pre-Award Office Federal awards are restricted internally until training is completed

11. RCE Research Compliance ExpertsGuidelines Significant research effort Willing to work with peers and central administration RCE is allocated $5000 in unrestricted funds to support his/her own program (can use as salary or bonus Allocated 1% effort for this endeavor Attend Orientation by central administration Meet with faculty with =85% funded effort 1st Issue for RCEs was Effort Certification and federal and institutional guidelines 2nd Issue for RCEs was Direct Charge Guidelines 3rd Issue is now currently underway and is the electronic PAF and effort certifcation1st Issue for RCEs was Effort Certification and federal and institutional guidelines 2nd Issue for RCEs was Direct Charge Guidelines 3rd Issue is now currently underway and is the electronic PAF and effort certifcation

12. New Faculty Orientation Includes a Module on Research A representative from each research central admin office weighs-in on case study Grants & Contracts IRB IACUC Biosafety & Environmental Health and Safety GCRC Tech Transfer

13. University of Mass Lowell Background History Faculty maintained animal facilities USDA inspections Closure of facility Centrally managed facility

14. Getting Serious 2005 hires institutional director Official policy and procedures developed Embedded in the policies & procedures are the training requirements Training requirement implemented in May 2006 Adopted use of the Collaborative Institutional Training Initiative (CITI): IRB, IACUC & RCR www.citiprogram.org at a cost of $1,000 per year

15. Ensuring Compliance Protocols must include training certification information Coordinates with Pre and Post Award Managers Continuous education and outreach activities Brown Bag Series USDA presentation Newsletter Website (well received by faculty) www.uml.edu/ora/institutionalcompliance

16. Faculty Acceptance Skeptical at first as previous training format was not user friendly New training is accepted Surprise - Faculty report that they have learned new information

17. Lessons Learned Interview faculty about compliance issues Incorporate their comments into policies and procedures Build trust and improve communication for better relationships Faculty now raise concerns constructively, not critically Provided 3 month lead time before implementing the requirement Continuous communication

18. QUESTIONS???

19. Questions After video - �Thank you for allowing us to share information with you today. We hope you enjoyed our presentation and may be you can use some of these tips in the future.� Any Questions?After video - �Thank you for allowing us to share information with you today. We hope you enjoyed our presentation and may be you can use some of these tips in the future.� Any Questions?