HUMAN SUBJECT INCENTIVES PROGRAM

Presentation to the Research Unit Liaisons

September 15, 2009

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

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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 3

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)

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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

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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)

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HUMAN SUBJECT INCENTIVE PROJECT:STAKEHOLDER GROUPS

FY2008, $7M IN INCENTIVES

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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)

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HUMAN SUBJECT INCENTIVE PROJECT:PILOT PARTICIPANTS

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“[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.”

HUMAN SUBJECT INCENTIVE PROJECT:PILOT USER FEEDBACK

HUMAN SUBJECT INCENTIVE PROJECT:KEY GOALS – “THREE C’S”1. Customer Service: Provide a central point of subject

incentive management that facilitates efficient distribution, data collection, and reconciliation.

2. 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.

3. Confidentiality: Protect human subjects’ personal information by centralizing storage of, restricting access to confidential records. Enhance trust of the University from the subject population. 10

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)11

HUMAN SUBJECT INCENTIVE PROJECT:PROCESS OVERVIEW

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HUMAN SUBJECT INCENTIVES PROJECT:CURRENT ACTIVITIES

1. Finalizing Campus Implementation Plano Prioritizing units who utilize Pcard, Imprest, SLA’so Complete full implementation by December 2010

2. Writing new SPG’s (an interim for the implementation phase and a final version, planned for post-implementation).

3. Working to ensure continued participation of various units – ISR, Dearborn, Flint, etc.

4. Working with MAIS on Phase 2 system development Integration of HSIP with eResearch Automated accounting Imaging / data capture

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HUMAN SUBJECT INCENTIVES PROJECT:FUTURE CONSIDERATIONS

1. Internal Controls Certification for Human Subject Incentives (late 2010)

2. Evaluating Staffing Model

3. Funding ModelCurrently using one-time money to fund

HSIP through the implementation phaseWe will track costs and evaluate options

for funding this program long-term

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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

HUMAN SUBJECT INCENTIVES PROJECT:RESOURCES

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THANK YOU!