neighborhood watch: university compliance developments related to research susan rafferty, interim...
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Neighborhood Watch:University Compliance Developments
related to Research
Susan Rafferty, Interim DirectorOffice of Institutional Compliance
University Compliance Risk Profile:All Compliance Risk Issues
IMPACT
Hig
h
Mod
erat
e
Low
Moderate High
Low
RIS
K
Environmental Health/Safety
Clinical Services (Boynton, CUHCHH, Dental)
Athletics Grants Administration
Clinical Research
Bio Hazards/Security
Technology Transfer
Fiscal (purchasing & disbursement)
Youth camp/programs
PrivacyHIPAA
HousingIT security
Animal Research
EOAA
Immigration
OSHA
Asset Management
Foundations
Disability accommodations
Student Finance
Dining Services
Copyrights
Trademarks
Tax
HR
Conflict of interest
Campus Safety
University Compliance Risk Profile:Research-related Risk Issues
IMPACT
Hig
h
Mod
erat
e
Low
Moderate High
Low
RIS
K
Environmental Health/Safety
Grants Administration
Clinical Research
Bio Hazards/Security
Technology Transfer
Fiscal (purchasing & disbursement)
PrivacyHIPAA
IT security
Animal Research
OSHA
Copyrights
Conflict of interest
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
University Compliance Risk Profile:Emerging Research-related Issues
IMPACT
Hig
h
Mod
erat
e
Low
Moderate High
Low
RIS
K
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
PrivacyHIPAA
IT security
Animal Research
OSHA• OHS Office
Copyrights
Conflict of interest•National focus
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
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
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
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
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
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
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
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
U of M System to Address Compliance Concerns
• Local reporting and resolution• Key central offices• UReport confidential reporting
service:1-866-294-8680www.UReport.ethicspoint.com
