June 1 - 3, 2020
Virtual Research Compliance Conference
Virtual , Central Daylight Time (CDT)Agenda
The virtual conference times are listed in Central Daylight Time (CDT)
Monday, June 1
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09:00 AM - 10:00 AMGeneral Session: Research Year in Review F. Lisa Murtha, Senior Managing Director, Ankura Consulting, Inc.
- This session is designed to cover all new laws, regulations and guidance promulgated by the government in the area of research
- The session will outline new research related enforcement initiatives and settlements by the Department of Justice and the Office of Inspector General
- The speaker will describe the implications of these laws, regulations and guidance on research programs and will suggest affirmative actions to be considered to strengthen research compliance programs for universities, academic medical centers, hospitals, CROs and other research organizations
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10:15 AM - 11:15 AMBreakout Sessions#R02R02: OCR Audits: Past, Present, and Future Considerations for Privacy and Security Deanna Peterson, VP of Health Information Consulting, First Class Solutions, Inc. Edye Edens, Senior Research Compliance Consultant, First Class Solutions
- This session will provide an overview of the current state of audits performed by the Office of Civil Rights to enforce the requirements of HIPAA, especially as related to the current state of COVID.
- After capturing the current picture, session presenters will offer an informed discussion on predictions for future enforcement trends and audits based on progress by OCR thus far
- Finally, one of the most readily overlooked components of your privacy program in healthcare includes HIPAA implications and protections in human subject research. This session aims to close the gap between clinical and research considerations
Research Intermediate#R03R03: Stop! Or Else I’ll Say Stop Again! Institutional Responses to COI Noncompliance Craig Conway, Associate Vice President, Institutional Compliance, University of Texas Medical Branch- An interactive session designed to share ideas and best practices
- How do institutions respond when faculty members or employees intentionally or unintentionally fail to adhere to federal, state, or institutional COI requirements?
- This session will seek to identify common COI noncompliance areas x We will provide strategies and recommendations for handling COI noncompliance that participants may take back to their respective institutions
Research Intermediate -
11:30 AM - 12:30 PMBreakout Sessions#R04R04: The Civil Monetary Penalties Law and the Role of HHS-OIG: Self-Disclosure and Enforcement Michael Torrisi, Senior Counsel, Office of Counsel to the Insepctor General, U.S. D Geeta Taylor, Senior Counsel, Office of Counsel to the Inspector General, U.S. Dept Health and Human Services
- Have you identified potential fraud or non-compliance impacting your award? This presentation will help institutions and recipients of HHS awards understand their responsibilities to report potential misconduct
- Review BASICs of grant self-disclosures including mandatory disclosures of Federal criminal law violations, voluntary disclosures of conduct violating civil or administrative law, as well as the benefits of self-disclosure
- Overview of HHS-OIG sanctions for improper conduct related to federal awards under the Civil Monetary Penalties Law
Research Basic#R05R05: Managing Compliance as an NCI National Community Oncology Research Program NCORP Site? Sarah Duffy-Clinton, Research Compliance Officer, Providence Health & Services Stacey Medeiros, Research Support Svcs Mgr, Providence Health & Services- Examine the NCORP program’s structure from both a main site and a sub-site perspective
- Overview of the various research compliance items that need to be managed: grants, research billing, IRB review, data integrity, document management
- Provide tips on managing cooperative group research compliance from both a main site and sub-site perspective
Research Intermediate -
01:15 PM - 02:15 PMBreakout Sessions#R06R06: The Pathway of Part 2 Data in Research: Opioids, Covered Entities, and IRBs, Oh My! Marti Arvin, Executive Advisor, CynergisTek, Inc.
- Basic overview of Part 2 and the implications of recent proposed changes to the regulations
- The complexity of protecting Part 2 data and ensuring appropriate availability and use in research
- Educating the research team and the IRB on the requirements of Part 2
Research Advanced#R07R07: Responsible Conduct: Collaborating on RCR Training Sarah Archibald, Director, Office of Accountability & Compliance, Univ of Maryland-Baltimore Stephanie Suerth, Education & Outreach Program Director, University of Maryland, Baltimore- Tapping into institutional expertise to improve quality and encourage participation
- Customizing sessions so speakers and case studies are consistent and reinforce key concepts
- Keeping what works about the RCR training design while constantly improving to keep it fresh
Research Intermediate -
02:30 PM - 03:30 PMBreakout Sessions#R08R08: Compliance and Culture: How Design and Approach Can Help Support Clinical Trial Billing Kelly Willenberg, Manager, Kelly Willenberg and Associates Tracy Popp, Sr Director, Clinical Research, Tampa General Hosp
- Elevate your billing compliance program while building morale of stakeholders with ROI through research related billing reviews
- Describe how to gain buy-in for an understanding of the ADVANCED risks related to research billing such as payer issues, off-label drugs, CART-T, etc
- Discuss approach of self-monitoring and auditing of billing compliance that is authentic to the culture you have built
Research Advanced#R09R09: How to Overcome the Challenges of Effectively and Legally Implementing Research in a Skilled Nursing Facility Joseph Zielinski, Senior Counsel, Wooden McLaughlin llp- Discussion and analysis of the regulatory requirements of research in a skilled nursing facility and how a compliance program can effectively monitor them
- Attendees will learn about the unique challenges of doing research in a skilled nursing facility and how to assess and overcome those challenges, using a data driven approach, so research can be performed in a compliant manner
- Discussion of best practices for effectively implementing research in your organization and how to illustrate compliance with the regulatory requirements. Attendees will see and receive a tool they can use to apply a data driven approach to research
Research Basic -
03:45 PM - 04:45 PMGeneral Session: Preventing Grant Fraud, Waste and Abuse BARBARA ORLANDO, Grants Policy Manager, Department of Defense
- DoD Terms and Conditions
- Identifying possible grant fraud
- Sub-recipient monitoring
Tuesday, June 2
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09:00 AM - 10:00 AMGeneral Session: Difficult Case Scenarios in Clinical Research Billing Ryan Meade, Fellow, University of Oxford
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10:15 AM - 11:15 AMBreakout Sessions#R13R13: CRRC: Clinical Research Revenue Cycle Management: Avoiding the Pitfalls Erika Stevens, VP, Research Programs, Integrity, Northwell Health Mary Veazie, Exec Dir Clinical Research Finance, UT MD Anderson Cancer Center
- This session describes leading practices for establishing a clinical research revenue cycle CCRC, explores the regulatory landscape, identifies processes for implementing appropriate safeguards for risk mitigation, and applies methods for CCRC management
- Apply proven methods, such as data analytics and tracking trial performance trends, to improve CCRC program success and promote accountability
- Analyze lessons learned, leading practices, proven tools and implementation methods from a recent case study
Research Advanced#R14R14: The Benefit of Collaboration between Compliance and Business Units: Enhancing Compliance at Your Institution Kele Piper, Director, Research Compliance, Massachusetts General Hospital Eleanor Kuszmar, Associate Director for Research Complinace, Harvard Medical School- Define collaborative research compliance initiatives and discuss when they can be effective for your institution
- Evaluate the role research compliance can play in a collaborative initiative, including recognizing scope creep into operations
- Using case studies, work in small groups to discuss and map possible collaborative initiative scenarios from a compliance perspective
Research Intermediate -
11:30 AM - 12:30 PMBreakout Sessions#R15R15: A Compliance Officer’s Research Data Nightmare and How to Wake Up From It Ashley Huntington, Privacy Officer, Cook County Health Leyla Erkan, Global Healthcare Risk and Compliance Lead, Protiviti Melissa Mitchell, Healthcare Compliance Manager, Amazon Care
- Compliance officers in the research sphere play a significant role in protecting PHI and other forms of health data as it flows into from organizations to research and beyond, which often raises significant privacy issues
- We will discuss the privacy issues that arise in this cycle; including using data to recruit patients; communicating on and triaging issues when deviations in research occur and how, when, and why data is shared beyond the scope of research
- We will focus specifically on trends in how data are handled, potentially manipulated and shared, and how compliance can best partner with other departments across the organization to support this function while still safeguarding patient information
Research Intermediate#R16R16: Right to Try Laws vs. FDA Expanded Access: What You Need to Know and What You Need to Do Paul Papagni, Executive Director of Research, Holy Cross Hospital Trinity Health- Many states are passing laws allowing terminally ill patients access to experimental therapies that have not been approved by the Food and Drug Administration. The FDA already allows access to such drugs through Expanded Access Programs
- Do you your doctors, IRB, pharmacists, compliance staff know the differences in these laws/regulations and the different processes for seeking permission to use unapproved therapies?
- Know which is best for your patient, which is best for your institution, and which is more likely to be approved
Research Intermediate -
01:15 PM - 02:15 PMBreakout Sessions#R17R17: Protecting Research Participants Financially: Making SENSE of Patient-CENTric Research When Patients Lack CENTS Geoffrey Schick, Senior Consultant, PFS Clinical
- Explore challenges for participants in clinical trials when the patient is indigent or has high out-of-pocket expenses due to their commercial healthcare insurance policy. Explore effects from Medicare secondary payer, anti-kickback statutes, etc.
- Investigate the challenges of participating in sponsor-provided “Financial Hardship Programs” designed to help research participants with financial obligations
- Discuss opportunities to create a vehicle for the research entity to assist clinical trial participants through relationships with foundations. What are the benefits/risks of a program running side by side with existing charity care programs?
Research Intermediate#R18R18: In Unity Is Strength: Research Compliance Through Leadership David Staley, Research Compliance Officer, Children's Hospital Colorado- Identify your bundle of sticks as a leader in research compliance
- Frame a culture of research compliance by engaging with others, making commitments, and being present
- Construct tools that empower compliance leaders in bringing what matters to a collaborative space
Research Intermediate -
02:30 PM - 03:30 PMBreakout Sessions#R19R19: Dealing with Data: Non-technical Thoughts Concerning Data Security and Management John Baumann, Associate Vice President for Research Compliance, Indiana University
- Review and identify challenges and obstacles for data security and protection of confidentiality
- Identify best practices for the review of researchers’ plans for protection of data and confidentiality
- Identify strategies for institutions to work with researchers to develop and implement data management/security strategies
Research Intermediate#R20R20: When is it Research and When is it Not? The Special Cases of Quality Assurance Studies and Medical Device Improvement David Hoffman, Chief Compliance Officer, Carthage Area Hospital- When Johns Hopkins launched its quality assurance study of central line infection control practices, they exposed a fault line in the medical research community that continues to generate strong opinions about when IRB approval is appropriate
- In addition to the ongoing debate about whether their intervention required IRB approval due to human exposure to harm, the OHRP reaction to the Hopkins study triggered a debate about the need for IRB review as a condition of scholarly publication
- This presentation will explore the lingering impact of the OHRP-Johns Hopkins confrontation. We will discuss how to evaluate application of the common rule to non-patient focused research and medical device improvement efforts
Research Advanced -
03:45 PM - 04:45 PMR21: GENERAL SESSION: "Research Compliance During the Pandemic" - A Round Table
Wednesday, June 3
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09:00 AM - 10:30 AMBreakout Sessions#R22R22: Conflict of Interest 101: Identifying, Managing, and Preventing Research Risk Rebecca Scott, COI Specialist, HealthStream Andrew Hill, Compliance Analyst/Auditor, UK HealthCare Office of Corporate Compliance C.J. Wolf, Director, Conflict of Interest, Intermountain Healthcare
- Understanding the Sunshine Act, including recent changes and how they impact your research organization
- Gain useful insight and tools for managing COI research risk at your institution
- Learn to identify risks using the Open Payments database
Research Basic#R23R23: Supplementing Traditional Research Compliance Monitoring and Auditing with Anticipatory Surveillance Robert Bienkowski, Director, Office of Research Compliance, Central Michigan University Lynn Smith, Dir, Research Compliance Ofcr, Tampa General Hosp- Undetected research noncompliance presents risks to subjects, institutions, researchers, and entire fields of research
- Formal systems of monitoring and auditing have inherent blind spots to some types of research noncompliance
- Anticipatory surveillance is a proactive, predictive compliance activity that assists in the early detection of potential noncompliance and mitigation of noncompliance before it becomes serious
Research Advanced -
10:45 AM - 12:15 PMBreakout Sessions#R24R24: The Laws of the Jungle: An Introduction to the Regulation of Animal Research Kristin West, Council on Governmental Relations (COGR)
- Overview of the major federal agencies involved in the regulation of animal research and their roles and responsibilities
- Discussion of major laws and regulations in this area of research including the Animal Welfare Act, Public Health Service Policy on Human Care and Use of Laboratory Animals, and the Guide for the Care and Use of Laboratory Animals
- How to effectively work with Institutional Animal Care and Use Committees IACUCs and other institutional players to ensure a compliant research animal care and use program, including issue spotting and common program pitfalls
Research Basic#R25R25: Research Stepchildren: Humanitarian Use Devices and Expanded Access to Investigational Medical Products Deneice Kramer, HRPP Manager, Essentia Health Kim Wold, Compliance Specialist, Essentia Health Catherine Murray, Compliance Specialist, IRB, Essentia Health- Review related laws and regulations which help define HUDs and Expanded Access
- Describe IRB and institutional challenges when reviewing and monitoring HUDs and Expanded Access projects
- Essentia Health’s approach, lessons learned and yet to be learned
Research Intermediate -
01:00 PM - 02:30 PMBreakout Sessions#R26R26: "Wish I Had Known That a Year Ago": Lessons Learned in the Midst of Conducting a Research Misconduct Inquiry and Investigation Darri Scalzo, Research Compliance Officer, Univ of AR for Medical Science Nancy Rhea, Compliance Analyst, University of Arkansas for Medical Sciences
- This session will include a discussion of regulatory guidance on misconduct proceedings, as well as detailed information related to conducting inquiries and investigations of research misconduct
- Additional discussion points include mistakes to avoid and best practices to help the audience members become more prepared to take on a research misconduct inquiry and investigation
- Steps to help the audience members be prepared before getting the dreaded “I think we have a problem” call and tips for encouraging a culture of integrity and compliance at your institution
Research Intermediate#R27R27: Let’s Talk About It: The Reality of the Impact of the Changes from the Revised Human Subject Rules Mariette Marsh, Senior Director, Research Ethics & Quality, The University of Arizona- Identify gaps and problems areas after implementation of the new rule
- Learn various innovative methods for handling research activity revised under the rule
- Hear from peer organizations on best implementation practices to maintain compliance under the new rule
Research Intermediate -
02:45 PM - 04:15 PMBreakout Sessions#R28R28: Noncompliance in Animal Research Oversight Stacy Pritt, Assistant Vice President COI/IACUC, UT Southwestern Medical Center Elizabeth Trumpower, IACUC Manager, University of Texas Southwestern Medical Center
- Attendees will be given an overview of requirements relating to noncompliance in animal research, including federal laws and regulations along with accreditation guidelines, which the Institutional Animal Care and Use Committee is charged with managing
- Attendees will learn about options available in identifying, investigating, correcting, and documenting animal research noncompliance
- Attendees will be given different models for examining institutional risk when it comes to animal research oversight
Research Intermediate#R29R29: Demonstrating Good Clinical Practice (GCP) Compliance in Research through the maintenance of Regulatory Documents Christina Jackson, Director, Office of Research Integrity, AdventHealth-Orlando- Discussion of the 13 Principles of ICH GCP Guidelines x Identify Regulatory Documents to Maintain
- Recognizing the Most Common Deficiencies in Regulatory Documentation
- Moving from Paper to a Digital Environment
Research Basic
All breakout sessions have a knowledge level associated with them, these levels are just guidelines and you are free to attend sessions of any level.
Basic: Program knowledge level most beneficial to Compliance Professionals new to a skill or an attribute. These individuals are often at the staff or entry level in organizations, although such programs may also benefit a seasoned professional with limited exposure to the area.
Intermediate: Program knowledge level that builds on a basic program, most appropriate for Compliance Professionals with detailed knowledge in an area. Such persons are often at a mid-level within the organization, with operational or supervisory responsibilities, or both.
Advanced: This level focuses on the development of in-depth knowledge, a variety of skills, or a broader range of applications. Advanced level programs are often appropriate for seasoned professionals within organizations, and professionals with specialized knowledge in a subject area.