Research Compliance in The University of Texas System Charles G' Chaffin Systemwide Compliance Offic

1
Research Compliance in The University of Texas
SystemCharles G. ChaffinSystem-wide Compliance
OfficerThe University of Texas System

• HCCA
• Research Compliance Conference
• November 1, 2007

2
AGENDA

• History of Research Compliance prior to 1998
• Impact of Institutional Compliance Program on
  Research Compliance
• Common Infrastructure
• Collaboration
• Pro-active monitoring of the external research
  compliance environment
• Challenges Encountered
• Secrets of Success
• Benefits to Research from UT System Compliance
  Approach

3
Research Compliance in the University of Texas
System Prior to 1998

• Weak organizational structures with no Vice
  Chancellor and few Vice Presidents for Research
• Little sharing or coordination between
  institutions
• Limited internal monitoring, except for
  appropriate expenditures
• Limited auditing, except federal A-133

4
Research Compliance in the University of Texas
System Prior to 1998

• UTMB Human Subject Research suspended for one
  month
• Complaint regarding use of prisoners in research

5
Common Infrastructure

• Required Components
• Standard Risk Management Model
• Common Risk Areas
• Acceptable Assurance Activities

6
Required Components to Manage Research Risks

• Single Responsible Party for Research Compliance
• Risk Assessment Methodology
• Continuous Monitoring Plan
• Training Plan
• Reporting Plan

7
Responsible Party

• Financial Reporting
• Including Time Effort
• Human Subjects
• Including IRB
• Animals
• Including IACUC
• Environmental Health Safety
• Including Select Agents

8
Standard Risk Management Model

• Use facilitated workshops with brainstorming to
  gather information
• Determine major activity areas performed to
  achieve goals and objectives
• Identify the risks associated with each major
  activity area
• Prioritize risks based on (1) impact on
  achievement of goals and objectives and (2)
  likelihood of occurrence using subjective values
• Optimize the portfolio of controls chosen to
  manage the prioritized risks
• Develop a plan to continuously monitor the
  application of the optimized controls

9
Risks

• Tropical Storm Allison
• Floods Houston Medical School

10
Risks

• IT Security
• Release of 200,000 Social Security Numbers

11
Common Risk Areas

• Time Effort Reporting
• Allowable Costs (including indirect cost
  recovery)
• Animal Research
• Human Subjects Research (IRB)
• Institutional Oversight (Office of Sponsored
  Research)
• Conflict of Interest Integrity
• Technology Licensing (including Export Control)
• Environmental Health Safety (Labs)
• Biosafety National Security
• Medical Billing on Research Grants
• Information Technology Security

12
Acceptable Quality Assurance Activities

• Supervisory Review (Operating Management)
• Continuous Monitoring (Institutional Oversight)
• Internal line management monitoring
• Compliance Office monitoring
• External vendor monitoring
• Peer Reviews
• Accreditation teams
• External experts in area to be reviewed
• Audits
• Internal Audit
• OIG or other External Auditors

13
Quality Assurance Examples

• Time Effort
• Discussions with PI
• Human Research
• Protocol Inspections
• IT Security
• Encryption and Scans

14
Collaboration

• High Risk Area Working Groups
• University Compliance Group
• Conferences Materials

15
High Risk Working Groups

• Basic Research
• Clinical Research
• Time Effort Reporting
• Medical Billing
• Conflict of Interest

16
University Compliance Group

• Formed after 2nd Annual Conference on Effective
  Compliance Systems in Higher Education in 2002
• Research Universities
• Electronic Mailing List Teleconferences

17
Conferences Materials

• Five National Conferences on Effective Compliance
  Systems in Higher Education
• Book Effective Compliance Systems A Practical
  Guide for Educational Institutions, Institute of
  Internal Auditors, 2001
• Websites
• UT System-wide Compliance
• Individual Institutions UT Austin Research
• Presentations
• HCCA, NCURA, IIA, ACUA, NACUBO, COGR
• Regional Local Organizations

18
Pro-active Monitoring of External Compliance
Environment

• Higher Education Community
• Daily news
• Trade Organization National Conferences
• Higher Education Trade Organizations (HCCA,
  NCURA, ACUA, NACUBO)
• Federal Government OIG Activities
• Annual Audit Plans
• Hot Issues
• Actions with other higher education and hospital
  entities

19
Challenges Encountered

• No System Vice Chancellor for Research
• Institutional Vice President for Research has no
  dedicated research compliance resources or
  compliance authority
• No single responsible individual for research
  compliance
• Research compliance activities distributed
  throughout the organizational structure of the
  institution

20
Secrets of Success

• Simple, systematic repeatable methodology for
  assessing and managing risks
• Utilize the collective knowledge of your
  colleagues
• Monitor the research compliance environment
  because it changes constantly
• Recognize that the change may not be in the
  what but in the what is important today

21
Secrets of Success

• System-wide Working Groups
• Time Effort
• IRB
• IACUC
• EHS
• Accountability to Institutional Compliance
• Quarterly Reports
• Inspections Audits

22
Benefits to Research from The UT System
Institutional Compliance Program

• Represented a cultural shift from directives
  edicts to risk management by the right
  individuals
• Identified a risk management model in which
  assignment of responsibilities became obvious
• Delineated a universal process that could be
  adapted and applied in research administrative
  units, research centers, colleges, academic
  departments, research groups, and principal
  investigators
• Provided cross-training for key research
  administrators
• Provided road map for training future
  administrators
• Identified several oversights in research
  compliance
• Source U.T. Basic Research High Risk Advisory
  Committee Final Report, pg. 8

23
The University of Texas System-wide Compliance
Program Websites

• System-wide Compliance Program
• www.utsystem.edu/compliance
• 5th Conference for Effective Compliance Systems
  in Higher Education
• www.utsystem.edu/compliance/conference2007.htm
• Basic Research High Risk Working Group
• www.utexas.edu/administration/oic/research

24
Thank you

• cchaffin_at_utsystem.edu