Research Compliance in The University of Texas System Charles G. Chaffin System-wide Compliance Officer The University of Texas System

Transcription

1 Research Compliance in The University of Texas System Charles G. Chaffin System-wide Compliance Officer The 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 2

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 3

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 4

5 Common Infrastructure Required Components Standard Risk Management Model Common Risk Areas Acceptable Assurance Activities 5

6 Required Components to Manage Research Risks Single Responsible Party for Research Compliance Risk Assessment Methodology Continuous Monitoring Plan Training Plan Reporting Plan 6

7 Responsible Party Financial Reporting Including Time & Effort Human Subjects Including IRB Animals Including IACUC Environmental Health & Safety Including Select Agents 7

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 8

9 Risks Tropical Storm Allison Floods Houston Medical School 9

10 Risks IT Security Release of 200,000 Social Security Numbers 10

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 11

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 12

13 Time & Effort Discussions with PI Human Research Protocol Inspections IT Security Encryption and Scans Quality Assurance Examples 13

14 Collaboration High Risk Area Working Groups University Compliance Group Conferences & Materials 14

15 High Risk Working Groups Basic Research Clinical Research Time & Effort Reporting Medical Billing Conflict of Interest 15

16 University Compliance Group Formed after 2 nd Annual Conference on Effective Compliance Systems in Higher Education in 2002 Research Universities Electronic Mailing List & Teleconferences 16

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 17

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 18

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 19

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 20

21 Secrets of Success System-wide Working Groups Time & Effort IRB IACUC EH&S Accountability to Institutional Compliance Quarterly Reports Inspections & Audits 21

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 22

23 The University of Texas System-wide Compliance Program Websites System-wide Compliance Program 5 th Conference for Effective Compliance Systems in Higher Education Basic Research High Risk Working Group 23

24 Thank you 24