#R02

R02: 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 View Description

• 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

#R03

R03: 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 View Description

• 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

#R04

R04: 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 View Description

• 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

#R05

R05: Managing Compliance as an NCI National Community Oncology Research Program NCORP Site? Sarah Duffy-Clinton, Research Compliance Officer, Providence Stacey Medeiros, Research Support Svcs Mgr, Providence View Description

• 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

#R06

R06: The Pathway of Part 2 Data in Research: Opioids, Covered Entities, and IRBs, Oh My! Marti Arvin, Executive Advisor, CynergisTek, Inc. View Description

• 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

#R07

R07: 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 View Description

• 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

#R08

R08: Compliance and Culture: How Design and Approach Can Help Support Clinical Trial Billing Kelly Willenberg, CEO, Kelly Willenberg and Associates Tracy Popp, Advisor, A Clover Group View Description

• 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

#R09

R09: How to Overcome the Challenges of Effectively and Legally Implementing Research in a Skilled Nursing Facility Joseph Zielinski, Of Counsel, Dinsmore & Shohl View Description

• 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