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Evaluation of Research and Compliance Plans

Christine C. Boesz, Dr.P.H. Inspector General National Science Foundation, USA INORMS Brisbane, Australia August 24, 2006

Accountability: Who Cares?????
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Taxpayers Appropriators $$$$
(e.g., US Congress)

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Funding Agencies Scientific Community Partners Society

Perspective As a stakeholder where do you Different sit? levels of interest
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Different understandings of science Different views on costbenefits Different responsibilities in management Different responsibilities in research Different self-interests

One Question

Accountability: How well does the research community comply with “funding requirements”?
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Is the $ expended correctly? Are necessary precautions, permits and other issues handled correctly?

Two Frameworks to Consider in Addressing the Question

Compliance Plans
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Why are they important? How are they used? What are they?

Research Evaluations
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Research Institutions Research Findings Research Investments Research Requirements Researchers

Compliance Plan Advantages Why Important?

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Avoids improper expenditures and improves grant administration Signals importance of compliance to faculty and staff Avoids filing of legal actions May be considered as a mitigating circumstance when wrong-doing is discovered

How are Compliance Plans Used?
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Support research enterprise Demonstrate commitment to do the right thing Communicate facts and expectations Educate and train Systematic monitoring (technical assistance) Early detection of problems and prevention of regulatory action/penalty

What is a Compliance Plan?

An effective compliance program has 8 elements:
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1. Written policies and procedures 2. Designation of compliance officer and compliance committee 3.Education and training 4. Hotline or other reporting mechanism 5.Internal monitoring and audits

Eight elements (continued)
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6.Enforcing standards 7. Responding promptly to detected violations 8. Defining roles and responsibilities and assigning oversight responsibility

Reference OIG compliance materials at http://oig.hhs.gov/fraud/complianceguidance.html

Compliance Programs on the Rise

In the United States, a steady increase in the number of private companies with compliance programs (Sarbanes-Oxley) Also, increase in the number of compliance programs at colleges and universities

Evaluation of Research
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Qualitative Quantitative Multi-dimensional Measurement focus :
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Inputs Outputs

Financial Compliance Possible Areas to Measure
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Cost Sharing Conflicts of Interests Time & Effort Improper Expenditures Sub-Recipient Monitoring

Research Compliance Possible Areas to Measure
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Human Subjects Animal Welfare Radiation Safety Biosafety Collection Permits Environmental Permits PI Change/Absence Progress/Final Reports Export Controls

Steps in Evaluating

Do a risk assessment

Focus on high risk areas
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Compliance failure impedes research Compliance failure results in penalty Valid measures Reliable measures

Determine compliance measurement
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Establish baseline

Gather data Gather data over time

Track and Analyze Trends

Concluding Comments: Evaluation & Compliance

Compliance Measurements assess how well research practices comply, how compliance requirements are managed, how well institutions support the research enterprise, how well the structure of research is handled Compliance plans give structure to compliance efforts over time Structure is important to the research enterprise

Challenge

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Operationalize a compliance plan Establish measurements Collect data Analyze results as contributions to the research enterprise Result: Evaluating research accountability