June 8 - 10, 2022
Research Compliance Conference
Anaheim, CA, United StatesAgenda
Wednesday, June 8
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07:00 AM - 08:00 AMContinental Breakfast (provided)
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08:00 AM - 09:30 AMBreakout Sessions#RCP1P1 It's Not Research, It's Quality Improvement Thora Johnson, Partner, Orrick, Herrington Sutliffe LLP Mark Fox, Privacy and Research Compliance Officer, American College of Cardiology
- Discuss the differences between research and quality improvement activities
- Examine OHRP’s guidance on quality improvement and the revised Common Rule exemptions
- Explore case examples where organizations successfully navigated QI and research differences
Intermediate#RCP2P2 Oh My! The Unique Challenges of Monitoring Investigator Initiated Trials (IITs) Cynthia Dunn, Clinical Research Consultant, Crescent City Research Consulting, LLC Gabriella Neff, Research Compliance Officer, Moffitt Cancer Center- Identify the unique regulatory and operational challenges of monitoring IITs
- Learn the key components of monitoring IITs including remote risk-based monitoring
- Discuss the strategies to address operational challenges of monitoring IITs and share lessons learned from a designated cancer center
Intermediate -
09:00 AM - 09:45 AMNetworking Break
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09:45 AM - 11:15 AMBreakout Sessions#RCP3P3 Managing Conflict of Interest Risk in Academic Medical Centers: Beyond Regulations and Form Collections for Investigators Julia Campbell, Vice President - Compliance, Memorial Sloan Kettering Cancer Center James Sheehan, Chief, Charities Bureau, NY Attorney General
- Managing conflicts, compliance, and reputational risks: Governance and senior leadership issues
- Technology, data collaboration and transfer-startups, joint ventures, and faculty entrepreneurs
- Managing COI systems: Required disclosures, privacy and confidentiality, thinking about users, reporters, certifications, committees, regulators, grantors, and audits
Intermediate#RCP4P4 Sponsor Clinical Quality Assurance Audits of Investigator Sites- readiness, response and CAPAs- Understand authority, purpose and framework for sponsor CQA audit programs (including Investigator-Sponsors)
- Discuss Site audit readiness throughout study conduct and for the audit
- Discuss audit process, sponsor observations, site responses, quality CAPAs
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11:15 AM - 12:45 PMLunch (On Own)
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12:45 PM - 02:15 PMBreakout Sessions#RCP5P5 Building an Effective Export Control Program within an Evolving Research Environment Robyn Cunningham, Dir Research Compliance & Integrity, Nationwide Childrens Hospital Julia Leo, Chief Compliance Officer, Advocate Radiology Billing & Reimbursement Special
- Strategize and coordinate export control activities within a biomedical research institution
- Define key components of an effective export control program
- Communicating export control effectively with researchers
Basic#RCP6Best Practice Approaches to Building an Effective Research Billing Compliance Audit Program Dawn Pittinger, Research Financial Compliance Officer, Moffitt Cancer Center Joseph Fugitt, Director, Finance-Research, Spectrum Health- Identify the operational front-end and back-end processes necessary to set the foundation for successful research billing compliance audit outcomes
- Describe how collaboration is key to building an effective audit program
- Disscuss strategies to identify red flags and hot issues that could put your site at risk for research billing non-compliance before being discovered in an audit
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02:15 PM - 02:30 PMNetworking Break
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02:30 PM - 04:00 PMBreakout Sessions#RCP7P7 Clinical Trials in a Virtual World: A Case Study Analysis of Compliance Risks in Decentralized Clinical Trials Laura Podolsky, Senior Counsel, Nixon Gwilt Law
- Identify regulatory and legal hurdles for structuring and running virtual clinical trials
- Devise risk mitigation strategies to combat compliance challenges in decentralized clinical trials
- Implement best practices for protecting research subjects' data privacy and security
Intermediate#RCP8P8 Hot FDA Compliance Issues for 2022 Neil OFlaherty, Partner, Amin Talati Wasserman LLP- Learn what FDA is focused on this year in assessing and assuring compliance of medical device clinical investigations.
- What types of device clinical investigation violations are triggering compliance letters and enforcement actions?
- What should you do to meet FDA expectations and avoid regulatory problems in this area?
Intermediate -
04:00 PM - 05:30 PMWelcome Reception
Thursday, June 9
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07:00 AM - 08:00 AMContinental Breakfast (provided)
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08:00 AM - 08:15 AMWelcome and Opening Remarks
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08:15 AM - 09:15 AMGeneral Session: Research Year in Review F. Lisa Murtha, Partner, Moses & Singer LLP
- This session will present relevant new laws, regulations, and guidance from federal and state government agencies on the conduct of research; and
- We will review new OIG Workplan and it’s research initiatives as well as key enforcement initiatives and settlements related to research.
- We will discuss novel approaches to addressing these new government initiatives within research compliance programs.
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09:15 AM - 09:45 AMNetworking Break in Exhibit Hall
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09:45 AM - 10:45 AMBreakout Sessions#RC101101 Research Billing Compliance: A Case Study at Renown Health Using the Epic Research Module Diana Torres, Research Resource Analyst, Renown Regional Medical Center Amy Scott, Compliance Coordinator, Renown Health
- Making it work and work compliantly: Launching the Epic Research Module
- Collaborating and engaging multiple stakeholder: Who, when, where, how, and what
- After launching, the importance of continuous review and updating standards of work
Basic#RC102102 Use of Data from Non-Traditional Sources to Conduct Human Research: Emerging Ethical and Compliance Considerations Renee Pierre-Louis, Senior Compliance Officer, Human Subjects Research & Academic Affairs, Nuvance Health- Develop knowledge and understanding of emerging sources of data used in human subject research
- Understand ethical and regulatory issues in collection and use of data from non-traditional sources
- Equip Research Compliance Officers to apply the knowledge gained to strengthen compliance programs and train stakeholders in order to support growing strategic needs within organizations to adopt use of data-driven human research.
Advanced -
10:45 AM - 11:00 AMNetworking Break
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11:00 AM - 12:00 PMBreakout Sessions#RC103103 How to Get (More) Bang for Your Buck! Developing & Executing Good Clinical Practice (GCP) & Research Billing Audit Plans from Practical Risk Assessments Wendy Portier, Independent Consultant, Portier and Associates LLC
- Discuss strategies for developing risk-based audit plans using thoughtful and pragmatic risk assessments, sampling/testing techniques, and internal versus external auditors
- Examine nuances of "process audits" versus audits of individual studies, including phase one studies and investigator-initiated trials
- Share success stories and lessons learned conducting risk assessments, GCP, and billing audits
Intermediate#RC104104 Handling Multi-Faceted Investigations Related to Research Ana Andzic Tomlinson, Exec Dir Research Integrity & Compliance, Univ of New Mexico- How to conduct an effective internal investigation in research compliance despite slippery slopes
- How to deal with the phenomenon of "expecting the unexpected"
- What to do to help prepare your institution for public scrutiny caused by the investigation
Intermediate -
12:00 PM - 01:00 PMLunch (Provided)
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01:00 PM - 02:00 PMBreakout Sessions#RC105105 A Hidden Minefield? Navigating Legal and Compliance Risks in Research Budgeting and Compensation Andrea Ferrari, Partner, Jones Walker LLP
- In depth review of legal and regulatory risks in requesting, allocating, and paying research dollars
- Discussion of recent enforcement actions and litigation that illustrate risks related to improper budgeting and payments
- Ten tips for a compliance process that mitigates risk
Advanced#RC106106 Complexities of Data Sharing with External Researchers Kele Piper, Director, Research Compliance, Massachusetts General Hospital Fariba Houman, Research Compliance Officer, Boston Children's Hospital- Understand the background for undue influence concerns and the tension research security measures can create with open scientific collaborations
- Understand the regulatory and institutional reasons why data security measures are necessary.
- Learn about the complexity of implementing enterprise-wide changes and the intricacies of managing multiple stakeholders to enable a procedural change
Intermediate -
02:00 PM - 02:15 PMNetworking Break
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02:15 PM - 03:15 PMBreakout Sessions#RC107107 - Instituting Improvement and Quality Assurance in an Animal Care and Use Program in Transition Julia Doherty, Assistant Vice President, Research Compliance, University of Maryland Baltimore Sarah Archibald, Director, Auditing & Monitoring, Univ of Maryland-Baltimore
- Identifying program concerns through subject matter expert collaboration and coordination
- Standardizing practices and promoting education and training to create consistency
- Crafting a quality assurance program to embed improvements into the culture
Intermediate#RC108108 - Increasing Diversity in Clinical Research Jason Johnson, Partner, Lead Consultant, M/S Strategic Solutions- Identifying and understanding the importance and benefits of diversity in research
- Discuss recent FDA/NIH/state/industry guidance for addressing diversity in research
- Strategies for increasing diversity to meet laws, guidance and requirements
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03:15 PM - 03:45 PMNetworking Break
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03:45 PM - 04:45 PMBreakout Sessions#RC109109 CMS Open Payments Expansion: Impacts to Research Conflicts of Interest Catharine Fortney, VP, Chief Compliance and Privacy Officer, Cone Health Sandra Shumaker, Director Hospital Compliance, Denver Health and Hospital Authority
- Understand what has changed under the CMS Open Payments Expansion
- Explore how the HHS OIG identifies and investigates high-risk industry-provider relationships
- Discuss practical tips on incorporating CMS Open Payments review into research COI processes
Basic#RC110110 It’s Not You, It’s Me: Building and Maintaining Trust between Research Compliance/Administration Offices and the Research Community John Baumann, Associate Vice President for Research Compliance, Indiana University- Identify and discuss the importance of trust, respect, and legitimacy in the relationship between researchers and research compliance and administration offices
- Identify best practices for building trust, respect, and legitimacy between the researcher community and research compliance and administration offices
- Explore what participant offices can do to enhance trust/respect in their institution between the research community and research compliance and administration offices
Intermediate -
04:45 PM - 06:00 PMNetworking Reception
Friday, June 10
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08:00 AM - 09:00 AMGeneral Session: OHRP Compliance Update: Hot Topics Laura Odwazny, Senior Attorney, OGC US Dept of Health and Human Services
- What’s new with OHRP’s implementation of the revised Common Rule
- An overview of regulatory flexibilities pertinent to research conducted during the COVID-19 pandemic
- Update on OHRP’s compliance oversight activities
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09:00 AM - 09:30 AMNetworking Break in Exhibit Hall
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09:30 AM - 10:30 AMBreakout Sessions#RC111111 Managing COI Compliance: The Importance of Disclosures in Publications & Presentations Meredith Noto, COI Office Manager, UT Southwestern Medical Center Stacy Pritt, Associate Vice President, Research Support, UT Southwestern Medical Center
- Review compliance concerns with non-disclosure, including public opinion and backlash
- Understand current journal, association, and institutional requirements for COI disclosures
- Learn how to implement training and review processes to ensure compliance for COI disclosures
Intermediate#RC112112 Data Use in Research: Limitations, Obligations, Myths, and Mysteries Martha Arvin, VP, Chief Compliance Officer, Erlanger Health System- Discussion of continued myths around the use and disclosure of data for research
- Overview of the limitations and obligations on the use and disclosure of data for research
- Myths and mysteries regarding the impact of the ONC Information Blocking Rule on acquiring data for research.
Intermediate -
10:30 AM - 10:45 AMNetworking Break
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10:45 AM - 11:45 AMBreakout Sessions#RC113113 Expanding the Plan: Integrating Research Compliance Risk Assessments into Existing Monitoring Programs Marsha Wallace, Research Quality Assurance Monitor III, Children's Hospital of Philadelphia
- Integrating research compliance risk assessments into existing compliance monitoring programs
- Discuss considerations, priorities, and options with operationalizing a risk assessment plan
- Communicating results of work, developing targeting training, and education
Intermediate#RC114114 NIST Cybersecurity Framework = A Credible & Prescriptive Standard Uday Ali Pabrai, CEO, ecfirst- Establishing an evidence-based program based NIST standards
- Achieving CMMC Certification, a new DoD cyber standard based on NIST
- Managing the cyber supply chain to mitigate risk from business associates and third parties
Basic -
11:45 AM - 12:45 PMLunch (Provided)
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12:45 PM - 01:45 PMBreakout Sessions#RC115115 Point of Care Training for Research Coordinators Carole Klove, General Counsel and Chief Nursing Officer, Elemeno Health Kelly Willenberg, CEO, Kelly Willenberg and Associates
- Explore a point of care or pocket training for study coordinators
- Optimize efficiencies and increase patient safety
- Define new strategies for training
Basic#RC116116 Optimizing a Conflict of Interest, Conflict of Commitment, and External Activities for Pay Reporting Process Micki Jernigan, Consulting Manager, Huron Consulting Group- Understand the difference and similarities in COI, COC, and EAP
- Discuss common roadblocks that create inefficiencies
- Learn how to coordinate reporting for the end users and reviewers
Basic -
01:45 PM - 02:00 PMNetworking Break
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02:00 PM - 03:00 PMBreakout Sessions#RC117117 21st Century Cures Act: What Is It and How to Operationalize it Aurea Flores, Senior Director, Quality & Compliance, Aurea M. Flores
- Describe the 21st Century Cures Act
- Describe the 2020 amendment: Information blocking
- Describe how it affects clinical research operations
Basic#RC118118 Sponsor-Investigators of Medical Device Studies: Creating Front-Line Institutional Compliance Systems Christine Nelson, Director, Office of Clinical Trials, University of North Carolina at Chapel Hill- FDA regulations for clinical investigations with medical devices
- Elements to assess prior to study initiation for regulatory compliance
- An example of institutional level gate-keeping systems
Intermediate -
03:00 PM - 03:15 PMNetworking Break
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03:15 PM - 04:15 PMGeneral Compliance Session: Navigating the Research Fraud and Abuse and Billing Rules Tony Maida, Partner, McDermott Will & Emery
- Review Medicare research-related services and clinical trial billing rules and common challenges
- Explore anti-kickback, Stark Law, and patient inducement issues with provider and patient financial arrangements
- Discuss strategies for identifying and addressing potential non-compliance
Agenda subject to change.
Session Levels:
All 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.