Managing the Migration of Compliance Mandates

1
Managing the Migration of Compliance Mandates

• NCURA Region IV
• May 6, 2008

• Presenters
• Kathy Taggart, Creighton University
• Deborah Vetter, University of Nebraska Medical
  Center
• Joe Taylor, Huron Consulting Group
• Jim Maus, Washington University

2
Panel

• Moderator/Speaker
• Kathy Taggart, Assistant Vice President
• Research and Compliance
• Creighton University
• Speakers
• Deborah Vetter, Director
• Sponsored Programs Administration
• University of Nebraska Medical Center
• Joe Taylor, Managing Director
• Huron Consulting Group
• Jim Maus, Administrative Director
• Genome Sequencing Center
• Washington University

3
Compliance Officer

• Kathy Taggart
• Creighton University
• Assistant Vice President for Research and
  Compliance
• Responsible for directing research compliance
  including to implement and oversee
• research regulatory policies and procedures
• education and training for research regulatory
  areas
• key compliance units

• Compliance Units of Direct Report
• Pre Award Office
• IRB
• IACUC
• IBC
• COI-Financial
• Research Misconduct
• Legal Counsel for Regulatory Affairs
• Partners on compliance
• Post Award Offices
• Environmental Health and Safety
• Radiation Safety
• Billing Compliance Officer
• Risk Management
• Legal Counsel

4
Central Office

• Deborah Vetter
• Director
• Sponsored Programs Administration
• Responsible for
• Pre-award
• Submit grants
• Negotiate contracts
• Supervise Clinical Research Billing and
  Compliance Specialist
• Nonfinancial post-award
• Policy development, risk management
• . . . and more

• Partner with compliance units, including
• IRB
• IACUC
• IBC
• COI
• Physician Practice Plan
• Hospital
• Compliance Officer
• Legal Counsel
• Risk Management
• Post Award
• Financial Compliance Office

5
Departmental Administrator

• Jim Maus
• Administrative Director
• The Genome Center at Washington University
• Responsible for
• Pre-award
• Post-award
• Compliance
• Non-Research Administration
• Human Resources
• Facilities
• Space
• Strategic Planning
• Payroll
• And on and on

• Client of and Partner with compliance units,
  including
• IRB
• COI
• Compliance Office
• Legal Counsel
• Grants Contracts
• (Pre-Award)
• Sponsored Projects
• (Post-Award)
• HIPAA Privacy Office
• HIPAA Security Office
• Environmental Health Safety
• Radiation Safety

6
Post Award/Risk Management

• Joe Taylor
• Managing Director
• Huron Consulting Group, Health and Education
  Practice
• Experience
• 12 years consulting experience in and with
• Higher Education
• Health Care
• 25 premier research universities and hospitals
• Speciality
• Assisting research institutions in and with
• Operational, process, and compliance issues
• Preparing responses to federal audits/investigatio
  ns regarding compliance with federal research
  requirements

• Speciality, continued
• Conducting university compliance assessment with
  federal research requirements, focusing on
• direct charging practices
• cost accounting standards
• effort reporting
• cost sharing
• conflict of interest
• recharge centers
• financial reporting
• cash management
• unallowable costs
• period of performance
• cost transfers
• program income
• sub recipient monitoring

7
Interactive Session

• Panel of experts
• Have different responsibilities
• May differ on their approach to compliance
• Have guidance and resources to share
• Encourage creating an interactive session (i.e.,
  audience interaction)
• Audience
• May have varying responsibilities
• May differ on their approach and interpretations
• May have guidance and resources to share
• May offer stimulating questions or points for
  discussion

8
Session Approach

• Review comprehensive list of compliance risks for
  universities
• Introduce 1-3 relevant topics
• Present from perspective of
• compliance officer
• director of central office
• departmental administrator
• postaward/risk management expert
• Engage audience
• Summarize

9
Compliance Management

• Animal subject protections (IACUC)
• Award monitoring
• Clinical trial billing
• Conflict of interest
• Cost accounting standards
• Cost sharing
• Cost transfers
• Direct charging practices
• Effort reporting
• Environmental health safety
• Faculty owned start-ups
• Genomics
• Grants.gov
• Human subject protections (IRB)
• Interdisciplinary Research

• International collaborations
• Invention disclosure reporting
• NIH salary cap
• OMB Circular A-21
• Other support
• Pre-authorized spending authority
• Program income
• Recharge centers
• Scientific misconduct
• Scientific overlap
• Subcontracts
• Stem cell research
• Technology transfer
• Unallowable costs
• University equity interests

10
Topics

• Conflict of Interest
• Financial Compliance
• NIH Public Access
• . . . And More

11
Conflict of Interest

• Institutional, Financial, Individual
• Resources
• NIH?COI FAQs (revised 4/8/2008)
• http//grants.nih.gov/grants/policy/coi/index.htm
• http//grants.nih.gov/grants/policy/coifaq.htm
• AAMC?Protecting Patients, Preserving Integrity,
  Advancing Health Accelerating the
  Implementation of COI Policies in Human Subjects
  Research (02/2008)
• http//www.aau.edu/research/Rpt_AAU-AAMC_COI_208.p
  df
• Creighton Table of Comparison

12
Financial Compliance

• Effort Reporting/Other Support
• OMB Circular A-21, section J.10
• 45 CFR Part 74, Appendix E
• DHHS OIG Workplan
• Cost Transfers
• NIH Grants Policy Statement
• DHHS OIG Workplan
• Clinical Trial Billing
• The Centers for Medicare Medicaid Services
  (CMS) Clinical Trial Policy

13
NIH Public Access

• Resources
• NIH
• http//publicaccess.nih.gov/
• http//grants.nih.gov/grants/guide/notice-files/NO
  T-OD-08-033.html
• COGR Letter, 3/20/2008
• http//206.151.87.67/docs/PublicAccessComment.doc
• Model of Institutional Policy
• Creighton University

14
Strategies for Managing Risk

• Develop compliance program that meets the
  criteria for effective compliance programs as
  defined by the Federal government
• Policies and procedures
• Roles and responsibilities
• Compliance leadership
• Training and education
• Communication
• Monitoring
• Enforcement
• Corrective response
• Conduct compliance risk assessment
• Determine focus areas
• Review OIG workplans
• Conduct risk assessment
• Interview faculty and staff
• Review of policies and procedures
• Limited transaction reviews
• Assign risk priority
• Manage risk
• Remember - Some level of risk is acceptable