1. Neighborhood Watch: University Compliance Developments related to Research Susan Rafferty, Interim Director Office of Institutional Compliance

2. University Compliance Risk Profile: All Compliance Risk Issues IMPACT High Moderate Low ModerateHigh Low RISK Environmental Health/Safety Clinical Services (Boynton, CUHCHH, Dental) AthleticsGrants Administration Clinical Research Bio Hazards/Security Technology Transfer Fiscal (purchasing & disbursement) Youth camp/programs Privacy HIPAA Housing IT security Animal Research EOAA Immigration OSHA Asset Management Foundations Disability accommodations Student Finance Dining Services Copyrights Trademarks Tax HR Conflict of interest Campus Safety

3. University Compliance Risk Profile: Research-related Risk Issues IMPACT High Moderate Low ModerateHigh Low RISK Environmental Health/Safety Grants Administration Clinical Research Bio Hazards/Security Technology Transfer Fiscal (purchasing & disbursement) Privacy HIPAA IT security Animal Research OSHA Copyrights Conflict of interest

4. Factors Impacting Local U of M Compliance Picture University strategic direction Discovery of systemic issues University organizational or system changes New federal or state laws and regulations Heightened external scrutiny Inherent risks History

5. University Compliance Risk Profile: Emerging Research-related Issues IMPACT High Moderate Low ModerateHigh Low RISK Environmental Health/Safety Chemical Security Grants Administration Internal Service Organizations International Program Growth Code of Ethics Clinical Research Bio Hazards/Security BSL 3 Labs Technology Transfer Privacy HIPAA IT security Animal Research OSHA OHS Office Copyrights Conflict of interest National focus

6. Conflicts of Interest Recently scrutinized areas in higher education arena: financial aid and study abroad NIH oversight of financial conflicts of interest challenged by Office of Inspector General Growing national awareness of institutional conflicts of interest U of M has system for disclosing, reviewing, and addressing these matters

7. Biosafety Level 3 Labs U of M investment in high-quality biomedical research space Second highest of four safety levels; labs accommodate work performed with indigenous or exotic agents that may cause serious or potentially lethal disease through inhalation route exposure Special personnel training and lab engineering and design required

8. Growth in International Activities University’s level of engagement in international arena, including range and scope of research activities, will increase significantly Important to assess application of U.S. and foreign laws and regulations for each project and in each country

9. Chemical Security U.S. Department of Homeland Security new regulation: Chemical Facilities Anti- Terrorism Standards U of M Environmental Health and Safety is conducting system-wide top screen for chemicals of interest with cooperation of labs and departments Future Homeland Security focus on site security assessments and plans

10. Occupational Health and Safety Shared goal of protecting and promoting the health of the University community as a whole Opportunity to better integrate distributed occupational health program components Creation of new office in July 2007 reporting to Senior Vice President for Health Sciences

11. Internal Service Organizations Accounts providing goods and services at approved rates on a regular basis to predominantly U of M departments Costs must be allowable under OMB Circular A-21 to support charge to federally sponsored project Opportunity for improvements: - More guidance on establishing ISOs - Clearer message on expectations of management of ISOs, including rate setting - Stronger monitoring and follow-up New U of M policy and emphasis on compliance oversight effective July 2008

12. Code of Ethics New regulations for federal contractors where value of contract exceeds $5M and performance period longer than 120 days: -To have written codes of business ethics and conduct -To have employee training programs -To have internal control systems -To facilitate timely discovery and disclosure of improper conduct -To ensure corrective measures are promptly instituted and carried out

13. U of M Standards of Conduct Act ethically and with integrity Be fair and respectful to others Manage responsibly Protect and preserve University resources Promote a culture of compliance Preserve academic freedom and meet academic responsibilities Ethically conduct teaching and research Avoid conflicts of interest and commitment Carefully manage public, private, and confidential information Promote health and safety in the workplace

14. U of M System to Address Compliance Concerns Local reporting and resolution Key central offices UReport confidential reporting service: 1-866-294-8680 www.UReport.ethicspoint.com