G1:The Value of Compliance in Today's Business Environment

Mr. Robert Estrada, The University of Texas System Board of Regents
Mr. William C. Powers, The University of Texas at Austin

G2: OCEG Compliance Standards

Outline to come. Mr. Scott Mitchell, OCEG

G3: Facilitated Enterprise-wide Risk Assessments: A Key to Involving Senior University Administrators in ERM

Faculty leaders of colleges and universities seem especially resistant to implementation of Enterprise-wide Risk Management (ERM) concepts. This stems from the natural aversion of senior administrators to anything that takes attention away from academic priorities, especially concepts that smack of management-consultant jargon. During 2005 and continuing into 2006, however, forward movement has occurred at Stanford University, based on a new approach which folded Internal Audit's long tradition of Enterprise-wide Risk Assessment (ERA) into ongoing high priority compliance and management improvement initiatives at the University.

This session will demonstrate facilitated ERA, using electronic polling technology, and then describe the steps taken by Stanford's internal audit and institutional compliance staff, in cooperation with the Director of Risk Management and the VP for Business Affairs, to ratchet ERM up a notch in the attention devoted by senior administration and the Board of Trustees. As a result, ERM is moving beyond jargon and becoming a value-added tool to the University. Come prepared to learn about practical ways in which barriers to implementing ERM might best be surmounted, including piggy-backing onto traditional audit risk assessment and newer compliance-related initiatives stemming from the current business climate. Dr. Steven Jung, Stanford University; Mr. Frank Topper, Stanford University.

 

 

A1: Hotlines/Helplines: Critical Success Factors

Hotlines have proven to be a valuable component of an institution’s governance program. Public and private institutions are experiencing increased pressure to implement more comprehensive governance programs including creating codes of ethics, formally educating employees on policies, opening new lines of communication, and allowing employees to anonymously report behavior of fiscal misconduct, conflicts of interest, fraud and more.

This interactive session will feature a panel of your peers discussing “do’s and don’ts” for scoping, creating and managing an effective anonymous hotline. Specific topics will include best hotline practices, options for outsourcing versus internally managed system, operational processes to consider, educating employees, and valuable insights to help you better manage an anonymous reporting system. The Q&A portion of this session will be your chance to resolve questions and benefit from the experience of others. Panel Discussion

A2: Institutional Compliance - Training - Education: A Symbiotic Relationship

This interactive session will provide you with insight into why training and education are key elements of a robust and effective Institutional Compliance Program.  Come listen to 75 years of University experience.  We will provide you with our secrets in these areas and hope you can share some of yours.  They will include training delivery and tracking, standards of conduct, ways to get management to embrace compliance, and obstacles and barriers to effective training. Ms. Laurel Harvey, Princeton Univeristy; Ms. Michelle Fortnam, Stanford University; Ms. Patti McCabe, Stanford University.

A3: Common Areas of Risk in Higher Education / The Risk Dictionary

Outline to come.
Mr. David Crawford, The University of Texas System

A4: Monitoring Plans & Assurance Actvities

This session will address monitoring plans and assurance activities utilized at the California Institute of Technology. Mr. Moyer will discuss their compliance risk matrix, compliance assessments, and corrective actions plans. In addition, he will describe compliance projects performed in partnership with key customers/subject matter experts in the following high risk areas:

• Grants and Contracts Management
• Environmental Management Integration
• Lab Safety
• Controlled Substances
• Animal Care
• Export Controls

Mr. Ricard Moyer, California Institute of Technology

A5: Centralizing Compliance Documentation Using "Off-the-Shelf" Solutions

Many universities and corporations are responding to emerging “best practices” for managing legal risk by establishing formal compliance and ethics programs. One of the challenges Brigham Young University (BYU) recognized immediately during the initial stages of building its program was the enormous amounts of documentation necessary to effectively implement and monitor compliance. This is mostly due to the fact that there are ten’s, even hundreds of diverse areas and departments where compliance is necessary and all of them should be monitored to one degree or another. This session will introduce a solution currently being implemented at BYU for centralizing compliance documentation in such a way that it is easily accessible by executives, auditors, compliance officers, and employees/end users. This solution can be used to capture compliance information and use it to create summary reports, policy statements, compliance guides, training materials, checklists, and other policy and procedural documents—all from one central document database. Participants will come away with a technique that can be used to identify the different components of compliance information as well as ideas for ways to store and access this information electronically using computerized document management tools. This session will include a question and answer period that will allow attendees to provide feedback and share ideas. Mr. David Galloway, Brigham Young University

 

 

 

B1: Export Controls

This session will cover compliance with U.S. trade controls in the university context, including the following issues:

• Why compliance with export controls is more important now than ever: emerging enforcement trends
• Brief overview of U.S. export controls, economic sanctions and embargoes, and other trade controls affecting universities
• What is the "fundamental research exemption," and how is the application of this exception changing?
• Other evolving issues that may have particular effects on universities and research labs
• How to manage compliance and spot issues before they turn into violations
• How new developments in export controls affect the open exchange of ideas: balancing academic freedom with compliance

Mr. J. Scott Maberry, Fulbright & Jaworski

B2: Top 10 Things I Learned from the IRB Accreditation Process

Human research studies at The University of Texas at Austin represent a wide variety of disciplines, e.g., nursing, pharmacy, social work, sociology, psychology, human ecology, kinesiology, biomedical engineering, and communication sciences. The number of human research studies is increasing as more emphasis is placed on health research and new health initiatives have been implemented. As a result of this past and anticipated future growth in health research, UT Austin embarked on a program for enhancing its human subjects protection program, with the ultimate aim of acquiring national accreditation status from the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). This session will describe the context and process of building towards attaining accreditation for the University's human research protection program. Discussion will focus on the lessons learned during the preparation for, participation in, and follow up after the AAHRPP peer review site visit that occurred in November 2005. Dr. Sharon Brown, The University of Texas at Austin

B3: Powerful Lessons Learned From a Successful Compliance Intervention

Steady growth in the research enterprise at the University of Texas Health Science Center at Houston resulted in severe pressures on limited research lab space, with equipment and supplies overflowing into the corridors and hallways. The situation shifted from being a perpetual debate about life safety code interpretation to an acute compliance concern when, in 2005, the Office of State Fire Marshall (OSFM) responded to a workplace safety complaint and issued 12 citations upon inspection. Given the seriousness of the matter, a series of definitive actions were taken to correct the situation, and upon re-inspection in January 2006, the OSFM documented the issues as resolved and remarked on the significant improvements that had been made. But the most interesting part of the story is that resolution was achieved without faculty and employee rancor. The lessons learned from the processes and mechanisms employed to resolve the matter have served as a model for how other compliance issues can be addressed in ways that serve to educate constituencies, establish dialog, and are service oriented. This presentation will describe the steps taken to achieve compliance and the underlying power lessons that can be applied to virtually all compliance efforts in an academic setting. Since one of the most powerful aspects to be discussed centers on performance metrics and data presentation, the session will include a specific focus on techniques that can be employed for the compelling display of data. Ample time will be allotted for questions and discussion. Dr. Robert Emery, The University of Texas Health Science Center Houston

B4: cGMP-cGLP-cGTP

This session will explain current Good Manufacturing Practices, current Good Laboratory Practices and current Good Tissue Practices and discuss compliance activities that are impacted by these regulatory requirements. The session will focus on the GMP, GLP and GTP requirements for clinical research studies with an emphasis on those cases where an institution holds the IND and manufactures materials to be used in a clinical trial. Compliance oversight issues to be discussed will include issues associated with GMP, GLP and GTP applications in academic and hospital environments, contract considerations involving GMP and GLP performance and special issues in auditing and inspections for the assessment of compliance. Dr. Richard Giles, MD Anderson Cancer Center

B5: Clinical Trials: Should You Audit or Should You Monitor?

This talk will discuss the various options and regulations for monitoring/auditing clinical trials research. Ms. Kirstin Bialobok, MD Anderson Cancer Center

 

 

 

C1: Federal Expectations of Effective Compliance Programs

Outline to come. Ms. Carol Blum, COGR

C2: OCEG Benchmarking Capabilities

Outline to come. Mr. Scott Mitchell, OCEG

C3: Compliance Self-Assessments

Ever wondered how your compliance program is doing or how to measure it? This session will offer an overview of several compliance self assessment tools, both qualitative and quantitative, designed to measure a compliance program against the elements in the model USSG program, monitor levels of oversight, and determine whether corrective action plans are in place. A gap analysis of compliance risks, implementation strategies, and what to do with the data will also be discussed. Mr. Tom Schumacher and Ms. Sophia Anema, The University of Minnesota

C4: Compliance Review Alternatives / Best Practices

Internal and external compliance reviews conducted by area experts are valuable assurance functions that offer a major source of objective appraisal of your program's effectiveness. They allow for the exchange of information between peers and content experts, while at the same time vastly expand the available resources for compliance assurance activities. In this panel discussion, compliance review experts will discuss items such as (1) what you should include in a compliance review (scope and objectives); (2) how and what to prepare for a review (such as source documentation); (3) the pros and cons of external reviews; and (4) reciprocal arrangements. In addition, this session will allow plenty of opportunity for Q&A. Panel Discussion

C5: Using Surveys to Measure the Effectiveness & Awareness of Your Compliance Program

All institutions are unique. Thus, all compliance programs will necessarily look different. Best practice means having a compliance program that is most effective for your institution. How do you ensure a proper fit? Embrace your individual culture. What does this mean? Know what others are doing, but make sure that your compliance program objectives, priorities and metrics are aligned with your institution’s values and beliefs, and operational strategies. Choose compliance program activities that serve as a catalyst for promoting those values and beliefs, and achieving those strategies. Mr. John Truslow, Ethics Resource Center and Mr. Paul Liebman, Temple Inland

 

 

 

The Pre-conference workshop will cover such areas as:

• The Essential Elements of an Effective Compliance System
• How to Start: An Action Plan to Enhance Compliance
• The First Six Months: Getting Organized
• The Standards of Conduct Guide & General Compliance Training
• Risk Assessment
• Assurance Strategies
• A Learning Organization: Measure & Renew

Mr. David Crawford, The University of Texas System