Agenda

Monday, June 14

  • 09:00 AM - 09:10 AM
    Welcome and Announcements
  • 09:10 AM - 10:10 AM
    Sites Beware: How to Prepare for the Upcoming Changes in Medicaid Kelly Willenberg, CEO, Kelly Willenberg and Associates Ryan Meade, Fellow, University of Oxford
    • Analyze potential impact to sites research billing process and coverage analysis
    • Discuss how the legislation fits into the federal and state Medicaid legal framework
    • Examine possible actions that state needs to take based on the language of the legislation
  • 10:10 AM - 10:30 AM
    Coffee Break
  • 10:30 AM - 11:30 AM
    Breakout Sessions
    #R1A
    If I Knew Then What I Knew Now: Lessons from the Trenches on Building a Physician Practice Clinical Research Compliance Program Jennifer Sartor, Vice President, Compliance, National Spine and Pain Centers
    • Challenges and obstacles to developing the research compliance program
    • Collaborative solutions that brought it all together
    • Continuous improvement: How we are continuing to grow and evolve the research compliance program
    Research Basic
    #R1B
    Electronic Systems in Clinical Research: How to Remain Compliant in the New "Virtual World" Candida Barlow, Clinical Research Informatics Specialist, Bio-Optronics, Inc. Christine Nelson, Director, Office of Clinical Trials, University of North Carolina at Chapel Hill
    Research Intermediate
  • 11:30 AM - 11:45 AM
    Coffee Break
  • 11:45 AM - 12:45 PM
    Breakout Sessions
    #R2A
    Bias and Structural Inequity in Research Mina Kini, System Director, Diversity and Inclusion, SSM Health Judith Burgan, Corporate Responsibility, SSM Health
    • Understand the history of bias and structural inequities in healthcare research. Most people know about the Tuskegee Syphilis Study. Explore other examples in the history of research where bias or structural inequity played a role
    • Using data, describe the effects of bias and structural inequity on healthcare research today. From basic laboratory research to clinical trials, bias and structural inequities continue to affect research and the healthcare individuals receive
    • List four strategies organizations can utilize to advance a culture of inclusion in research. Apply a strategy to improve diversity and inclusion in our workforces and engage with our communities
    Research Basic
    #R2B
    Clinical Trials Research Compliance: Auditing vs Monitoring Jana Dock, Director, Research Business Operations, Mercy Research Geoffrey Schick, Senior Consultant, PFS Clinical
    • Discuss the experience of Mercy's utilization of both auditing and monitoring in research compliance
    • Identify the key elements of (external) auditing methodology and discuss pros and cons
    • Identify the key elements of (internal) monitoring methodology and discuss pros and cons
    Research Intermediate
  • 12:45 PM - 01:45 PM
    Mid-Conference Break
  • 01:45 PM - 02:45 PM
    Breakout Sessions
    #R3A
    Complicated and Complex: Part C Medicare Advantage Billing for Clinical Trials Elizabeth Rodriguez, Associate Director, Johns Hopkins Medicine Scott Streibich, Director, Research Compliance Operations, Johns Hopkins Medicine
    • Design research workflows supporting charging to Medicare Advantage or conventional Medicare
    • Tackle complex research billing scenarios for clinical trials enrolling Medicare Advantage patients
    • Clarify regulations related to trial type to include INDs, IDEs, CEDs, and LCDs
    Research Intermediate
    #R3B
    Considerations in Building a Foreign Influence Compliance Program Janice Grace Kathleen McNaughton, Administrator, Mayo Clinic Will McIntire, Research Counsel, Boston Medical Center Callan Stein, Partner, Troutman Pepper Hamilton Sanders
    • Understand the Government’s (especially NIH, NSF, and DoD) recent focus on increased transparency concerning foreign elements and connections in applications for research grants
    • Identify and overcome operational challenges to maintaining foreign influence compliance
    • Mitigate legal exposure for investigators/ institutions by implementing an effective foreign influence compliance program
    Research Intermediate
  • 02:45 PM - 03:00 PM
    Coffee Break
  • 03:00 PM - 04:00 PM
    Breakout Sessions
    #R4A
    Legal Update: Developments in Clinical Research, EUAs, and IRBs Tracy Field, Partner, Parker Hudson Rainer & Dobbs LLP Sandra Miller, Partner, Womble Bond Dickinson (US) LLP
    • Spotting informed consent issues, EUA approvals, and other issues in a pandemic
    • Updated review of research subject disparities and practical ways to increase diversity in subjects
    • Review recent government enforcement actions for research misconduct with ways to mitigate risk
    Research Intermediate
    #R4B
    Privacy Considerations and AI in Medicine Mirena Taskova, Managing Director-Head of Privacy & Cybersecurity, Armanino Sarah Duffy-Clinton, Research Compliance Officer, Providence Health & Services
    • Learn about solutions that will enable the rise of the next generation of AI in medicine
    • Address privacy considerations if you use large amounts of data from healthcare machines
    • Learn about the role of the stringent global privacy laws GDPR (Europe) and HIPAA (USA) in medicine
    Research Intermediate
  • 04:00 PM - 04:15 PM
    Coffee Break
  • 04:15 PM - 05:15 PM
    Breakout Sessions
    #R5A
    Critical Elements of Animal Research Compliance: Semi-Annual Activities Elizabeth Trumpower, IACUC Manager, University of Texas Southwestern Medical Center Stacy Pritt, Assistant Vice President COI/IACUC, UT Southwestern Medical Center
    • Present the regulatory obligations for semi-annual program reviews, reports, and inspections
    • Examine various strategies and practices for conducting these semi-annual activities
    • Assess regulatory agency allowances for these activities during the COVID-19 pandemic and beyond
    Research Intermediate
    #R5B
    Responsible Conduct of Research (RCR): What It Is and Why It Matters Nancy Rhea, Compliance Analyst, University of Arkansas for Medical Sciences Darri Scalzo, Research Compliance Officer, Univ of AR for Medical Science
    • Discuss the definition of RCR, why it is important, and who should receive RCR training
    • Explore the role of the compliance officer in RCR training and best practices for providing training
    • Demonstrate how embedding RCR concepts in daily work can help avoid ethical issues in research
    Research Intermediate

Tuesday, June 15

  • 09:00 AM - 10:00 AM
    Breakout Sessions
    #R6A
    Patient Access, 21st Century Cures Act, and Information Blocking Debi Primeau, President, Primeau Consulting Group Jaime James, Sr. Consultant, Legislative Policy and Compliance, Midwest Medical Records Association
    • Explore the Cures Act as it relates to the Information Blocking Rule and the research environment
    • Discuss components of the Information Blocking Rule, including definitions, timelines, and exception
    • Examine key areas where research compliance professionals can focus efforts to prepare for change
    Research Intermediate
    #R6B
    What Your Research Investigators and IRB May Not Know: Regulatory and Ethical Implications for Human Subjects Research Barbara Vimont, Director, Compliance and Privacy , Akron Children's Hospital Patricia Blount MD, MSL, CIP, CHRC, Managing Director, ProtocolsByDesign, LLC
    • Understand the fundamental difference between the practice of medicine and clinical research: The confusing roles of physician and clinical investigator
    • Understand the FDA regulatory landscape of sponsor-investigator INDs, nutraceuticals, and devices
    • Understand the fundamental difference between an interventional and observational study: Misperceptions concerning research interventions considered "standard of care" procedures
    Research Intermediate
  • 10:00 AM - 10:15 AM
    Coffee Break
  • 10:15 AM - 11:15 AM
    Breakout Sessions
    #R7A
    It Takes a Village: Collaborative Solutions for Mitigating Clinical Research Revenue Cycle Risk Cynthie Lawson, Consultant, Self-Employed Katherine Cohen, Chief Compliance Officer, Southern Illinois University Medicine
    • Understanding clinical research revenue cycle basics and risks,
    • Common challenges in managing the Clinical Research Revenue Cycle
    • Best practices in efficient and compliant Clinical Research Revenue Cycle management
    Research Basic
    #R7B
    Grow Up! Maturing a Research Compliance Program Jordan Muhlestein, Compliance & Ethics Director, Intermountain Healthcare Neil Nokes, Compliance Partner, Intermountain Healthcare
    • Defining research compliance program maturity to obtain stakeholder buy-in
    • Applying compliance program maturity principles to a research compliance program
    • Measuring the research compliance program's maturity and effectiveness through KPIs
    Research Intermediate
  • 11:15 AM - 11:30 AM
    Coffee Break
  • 11:30 AM - 12:30 PM
    Research Year in Review 2020-2021 F. Lisa Murtha, Partner, Moses & Singer, LLP
    • Understand new research-related laws, regulations, agency guidance, enforcement cases, and other updates in research over the last year
    • Review OIG and DOJ cases as well as enforcement at the agency level: OHRP, ORI, FDA, ETC.
    • How should we shift our research compliance focus in light of the new laws, regs, and guidance?
  • 12:30 PM - 01:30 PM
    Mid-Conference Break
  • 01:30 PM - 02:30 PM
    Breakout Sessions
    #R8A
    Novel Conflict of Interest Collection Strategies for More Effective Oversight Catharine Fortney, Chief Compliance and Audit Officer, Denver Health and Hospital Authority Wendy Charles, Chief Scientific Officer, BurstIQ
    • Identify hidden gaps between conflicts of interest reported (and not reported) with other sources
    • Describe risks to institutions, individuals, and the public, of failure to identify and manage COI
    • Design an efficient COI collection process that promotes broader integrity and public trust
    Research Intermediate
    #R8B
    Compliance Reimagined: Making Compliance Intuitive and Accessible while Maximizing the Value Proposition Andrew Macan, BOWMA
    • Reimagining Compliance: Transitioning from rules to principles
    • Policy simplification and consolidation
    • Placing tools where they can be used
    • Making training memorable
    • Proving the value proposition
    Research Basic