2019 Research Compliance Conference

26. From Paper to Electronic: Evolution of an IACUC Protocol Management System

    2019 Research Compliance Conference  | Presenter(s): Denise Ancharski-Stutler  | June 10, 2019 

    • 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

27. Navigating Federally Sponsored Projects Abroad: Common Compliance Challenges and Solutions

    2019 Research Compliance Conference  | Presenter(s): Katherine Morga, Adilene Rosales  | June 10, 2019 

    • 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

28. Research Privacy and Security Considerations Beyond HIPAA: What are the Compliance Concerns?

    2019 Research Compliance Conference  | Presenter(s): Marti Arvin  | June 10, 2019 

    • 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

29. The Intersection of Clinical Data Management and HIPAA: How to Assess Privacy and Information Security Compliance of Clinical Data

    2019 Research Compliance Conference  | Presenter(s): Andrew Rodriguez  | June 10, 2019 

    • 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.”

30. Thorny Clinical Research Billing and Coverage Issues

    2019 Research Compliance Conference  | Presenter(s): Kelly Willenberg  | June 10, 2019 

    • Medicare Advantage issues

    • Sham Procedures

    • Contingency Budgets

31. Tricky Clinical Trial Budget and Research Billing Compliance Issues Inherited from Mergers & Acquisitions

    2019 Research Compliance Conference  | Presenter(s): Geoffrey Schick, Ray Heller, JoAnne Levy  | June 10, 2019 

    • 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

32. Compliance within Your HRPP

    2019 Research Compliance Conference  | Presenter(s): Nathalia Henry, Leyla Erkan  | June 09, 2019 

    • 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?

33. Uniform Guidance 101

    2019 Research Compliance Conference  | Presenter(s): Matthew Staman, Marisa Zuskar  | June 09, 2019 

    • Provide a (brief) background and introduction 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

34. Identifying and Managing Physician Conflicts of Interest in the Research Context

    2019 Research Compliance Conference  | Presenter(s): Amy Joseph, Rebecca Ryan  | June 09, 2019 

    • Review potential compliance issues related to physician relationships in the research context, including under antikickback 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

35. Sharpening Research Compliance: Heightened Awareness with a Self-Guided Risk Assessment

    2019 Research Compliance Conference  | Presenter(s): David Staley, Hannah Gilbert  | June 09, 2019 

    • 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