HUMAN SUBJECT INCENTIVES PROGRAM Presentation to the Research Unit Liaisons September 15, 2009

1. HUMAN SUBJECT INCENTIVES PROGRAMPresentation to the Research Unit LiaisonsSeptember 15, 2009

2. Human Subject Incentives Project:Background and History • A number of issues existed with current subject fee processes. • August 2005 – SPA Team Recommendations • October 2007 – Charge to group from Marvin Parnes and Peggy Norgren • December 2007 – 3-day LEAN workshop • October 2008 – Proposed concept to Leadership Team; received approval to proceed with pilot

3. Human Subject Incentives Project:Background and History • October 2008-May 2009 – Developed system to automate requests, info. capture and reporting • May 2009 – Began pilot implementations to test the process and system • June 2009 – Began conducting focus groups with units not participating in pilot • August 2009 - Presented results of pilot / focus groups to Leadership Team; received approval to proceed with full implementation

4. Human Subject Incentive Project:Current Team Members • Yvonne Barber (Public Health) • Judy Birk (IRB) • Sherry Cogswell (Audit) • Chris De Vries (Medical School) • Doreen Graden (Dental) • Brent Haase (Internal Controls) • Jan Hewett (IRBMED) • Jennifer Ptak (FinOps) • Kurt Rigg (ISR) • Kathy Crawford (Treasury) • James Gorman (Treasury • Joann Marcoux (Social Work) • Sherry Mason (LSA Psychology) • Sally Sivrais (Ross School) • Deb Tatchin (Medical School) • Bryan Van Sickle (FinOps / Sponsored Programs) • Nancy Hobbs (Procurement) • Nancy Stock (Kinesiology) • Pam Fons (ITS / MAIS) • Jim Middlemas (Central Campus Teller Services) • Craig Peterson (Hospital Cashier)

5. Human Subject Incentive Project:Past Team Members • Tasha Allan (FinOps) • Jackie Creager (ITS / MAIS) • Tammy Gay (Medical School) • Eve Bernos (Nursing) • Ed Jennings (Tax) • Lois Brako (OVPR) • Cathy Thibault (ISR) • Carolyn Batts (ISR) • Ann Verhey-Henke (School of Information) • Various individuals from Dearborn, Flint Campuses

6. Human Subject Incentive Project:Leadership Team • Steven Heeringa (ISR) • Ray Hutchinson (Medical School) • Judith Nowack (AVP Research) • Marvin Parnes (AVP Research, DRDA) • Jeanne Strickland (UMHS) • Robert Joseph Taylor (School of Social Work) • Greg Tewksbury (Finance) • Pat Ward (Medical School) • Peggy Westrick (LSA Research)

7. Human Subject Incentive Project:Stakeholder GroupsFY2008, $7M in Incentives

8. Human Subject Incentive Project:Pilot Participants • Medical School • Behavioral & Decision Sciences (1 PI) • Internal Medicine (9 PI’s) • Psychiatry (10 PI’s) • School of Public Health – Epidemiology (2 PI’s) • Ross School of Business (2 PI’s) • School of Social Work (2 PI’s) • School of Dentistry (1 PI) • School of Nursing (2 PI’s) • School of Information (2 PI’s) • LS&A Psychology (2 PI’s)

9. Human Subject Incentive Project:Pilot User Feedback • “[Checks] were easy to get. Checks were sent out the day after I requested them. This was amazing.” • “This system has saved me time in every way possible. I LOVE IT!” • “It is fantastic not to have to complete paperwork for imprest cash funds. It's great not to have to complete a non-PO voucher. I didn't have to complete paperwork for an SLA. I didn't have to wait days/weeks for an imprest cash number or SLA.” • “An electronic process was definitely needed. this system has been well thought out, easy to use, flexible and staff easy to work with.” • “Being able to take all aspects of human subject payment OUT of the Pcard process has been helpful.” • “The system is now very transparent; in particular the individual control number assigned to each disbursement helps to clarify (on our end) which of our funds are to be paid to which of our subjects.”

10. Human Subject Incentive Project:Key Goals – “Three C’s” • Customer Service: Provide a central point of subject incentive management that facilitates efficient distribution, data collection, and reconciliation. • Compliance: Provide appropriate thresholds for capturing human subject information for tax reporting purposes while also ensuring compliance with IRB regulations. Integrate appropriate cash handling controls and accountability. • Confidentiality: Protect human subjects’ personal information by centralizing storage of, restricting access to confidential records. Enhance trust of the University from the subject population.

11. Human Subject Incentive Project:Quick Highlights • Customer Service • Central Hub • Single point of contact for incentive-related questions, issues • Quick Turnaround • Online management of incentive requests • Incentives are available within 2 business days of request approval • Multiple payment methods • Cash, Checks, Subject Payment Coupons, Visa Gift Cards • Compliance • Better accounting controls, manage risk • Reasonable Tax Compliance • Multiple Tiers / Reporting thresholds • Employee subjects treated as independent contractors • Confidentiality: Central repository for subject information (highly secure)

12. Human Subject Incentive Project:Process Overview

13. Human Subject Incentives Project:Current Activities • Finalizing Campus Implementation Plan • Prioritizing units who utilize Pcard, Imprest, SLA’s • Complete full implementation by December 2010 • Writing new SPG’s (an interim for the implementation phase and a final version, planned for post-implementation). • Working to ensure continued participation of various units – ISR, Dearborn, Flint, etc. • Working with MAIS on Phase 2 system development • Integration of HSIP with eResearch • Automated accounting • Imaging / data capture

14. Human Subject Incentives Project:Future Considerations • Internal Controls Certification for Human Subject Incentives (late 2010) • Evaluating Staffing Model • Funding Model • Currently using one-time money to fund HSIP through the implementation phase • We will track costs and evaluate options for funding this program long-term

15. Human Subject Incentives Project:Resources • Website - http://www.treasury.umich.edu/hsipabout.htm • Email – subject-incentives@umich.edu • Kathy Crawford – Program Manager klcrawfo@umich.edu • James Gorman – Project Manager jamesgor@umich.edu

16. THANK YOU!