Sunday, June 9
01:00 PM - 02:30 PMBreakout Sessions#P1P1 - Compliance within your HRPP Nathalia Henry, Executive Director, IRB Office, Northwestern University Leyla Erkan, Global Healthcare Risk and Compliance Lead, Protiviti
Research#P2P2 - Uniform Guidance 101 Matthew Staman, Managing Director, Huron Consulting Group Marisa Zuskar, Senior Director, Huron Consulting Group
- What is a HRPP and what do you have to comply with?
- Key HRPP components and structures.
- What mechanisms can you put in place to monitor compliance?
- Provide a (brief) background and introduction of the Uniform Guidance, including the purpose and impact of these federal sponsored project regulations.
- Review critical changes within the UG (from previous circulars) and cover major topical areas of the guidance, including: Cost Principles, Effort Reporting, Procurement, and Subrecipient Monitoring.
- Discuss the shift of the regulations towards Internal controls and institutional responsibility for ensuring compliance.
01:00 PM - 04:15 PMPre Conference - Sunday's Sessions100
02:45 PM - 04:15 PMBreakout Sessions#P3P3 - Sharpening Research Compliance: Heightened Awareness with a Self-Guided Risk Assessment David Staley, Research Compliance Officer, Children's Hospital Colorado Hannah Hyland, Research Compliance Analyst, Children's Hospital Colorado
Research#P4P4 - Identifying and Managing Physician Conflicts of Interest in the Research Context Amy Joseph, Partner, Hooper, Lundy & Bookman, PC Rebecca Ryan, Compliance Officer, Yale New Haven Hospital
- Employ risk assessment philosophies and principles to heighten awareness of risks in clinical research.
- Empower research teams to weigh and prioritize self-identified risks in order to create meaningful action plans.
- Form a self-guided risk assessment tool to encourage risk preparedness and sharpen research compliance.
- Review potential compliance issues related to physician relationships in the research context, including under anti-kickback and physician self-referral laws.
- Identify factors that could increase compliance risk for such relationships based on OIG guidance and recent enforcement actions.
- Discuss best practices for how a compliance program can effectively identify and address physician conflicts of interest, including approaches to policies and screening measures.
Monday, June 10
09:45 AM - 10:45 AMBreakout Sessions#101101 - Demystifying Human Subjects Research Versus Quality Improvement: A Compliance Case Study David Staley, Research Compliance Officer, Children's Hospital Colorado Hannah Hyland, Research Compliance Analyst, Children's Hospital Colorado
Research#102102 - Tricky Clinical Trial Budget and Research Billing Compliance Issues Inherited from Mergers & Acquisitions Geoffrey Schick, Senior Consultant, Site Strategy, WCG Ray Heller, Sr Dir Business Development, WCG PFS Clinical
- Review related laws and regulations which help define human subjects research.
- Examine real regulatory cases to distinguish quality improvement activities from human subjects research.
- Describe a governance structure that reviews quality improvement activities which aim to evaluate and enhance programs, processes, or systems.
Research#103103 - Navigating Federally Sponsored Projects Abroad: Common Compliance Challenges and Solutions Katherine Morga, Sr. Associate, Hogan Lovells Adilene Rosales, Associate, Hogan Lovells US LLP
- Session will use a "mock debate" format to present arguments on both sides of clinical trials research billing compliance challenges that arise from "inherited" studies.
- What happens when a Site "inherits" a Study - through merger, acquisition, PI relocation - that has questionable terms that have been in place from the start?
- Attendees will utilize real time voting tools to weigh in on the "winner" of each scenario.
- Identify key award terms and regulations that affect federally sponsored research abroad compliance.
- Discuss financial and administrative challenges, including engaging foreign personnel, managing foreign sub recipients, complying with U.S. and foreign human subjects research and ethical requirements, and applying cost accounting rules.
- Share practical experience and tips on how to manage risks and resolve challenges.
11:00 AM - 12:00 PMBreakout Sessions#201201 - The Intersection of Clinical Data Management and HIPAA: How to Assess Privacy and Information Security Compliance of Clinical Data Andrew Rodriguez, Corporate Privacy and Information Security Officer, Shriners Hospitals for Children
Research#202202 - Research Privacy and Security Considerations Beyond HIPAA: What are the Compliance Concerns? Marti Arvin, Executive Advisor, CynergisTek, Inc.
- Conducting a Privacy Assessment on Clinical Research Data
- Conducting a Security Assessment on Clinical Research Data
- "De-identification, you keep using that word. I do not think it means what you think it means."
Research#203203 - From Paper to Electronic: Evolution of an IACUC Protocol Management System Denise Ancharski-Stutler, IACUC Administrative Director, Children's Hospital of Philadelphia
- Privacy and security concerns that are unrelated to HIPAA such a GDPR, FERPA, GLBA, and contractual.
- What education may be necessary for the IRB and others to understand these obligations.
- Practical ways to incorporate this into the process for study preparation, approval and execution.
- Provide an overview of IACUC and protocols.
- Discuss methods to transition from paper to an electronic system.
- Identify opportunities within the electronic protocol form to reduce burden
01:00 PM - 02:00 PMBreakout Sessions#301301 - Clinical Trials Compliance Collaboration Builds Effectiveness Stephanie DeRijke, Director, Clinical Trials Audit and Compliance, Emory University Anne Adams, Chief Compliance Officer, Emory Healthcare, Inc
Research#302302 - Compliance through Collaboration: Partnering with Independent IRBs to Develop and Maintain a Strong Human Research Protection Program (HRPP) Cynthia Hahn, President, Integrated Research Strategy
- Outline steps to implement an independent clinical trial compliance program in a large academic medical center. Discuss reporting structure, function, responsibilities, and goals.
- Discuss strategies to connect researchers with the compliance team to develop proactive, collaborative, and reciprocal methods to achieve compliance through continuous quality assurance and improvement.
- Share Emory Clinical Trials Compliance tools: electronic audit tool in REDCap, data analytics tool to show trends, and clinical trial tools for researchers.