#R13

R13: CRRC: Clinical Research Revenue Cycle Management: Avoiding the Pitfalls Erika Stevens, VP, Research Programs, Integrity, Northwell Health Mary Veazie, Exec Dir Clinical Research Finance, UT MD Anderson Cancer Center View Description

• This session describes leading practices for establishing a clinical research revenue cycle CCRC, explores the regulatory landscape, identifies processes for implementing appropriate safeguards for risk mitigation, and applies methods for CCRC management
• Apply proven methods, such as data analytics and tracking trial performance trends, to improve CCRC program success and promote accountability
• Analyze lessons learned, leading practices, proven tools and implementation methods from a recent case study

Research Advanced

#R14

R14: The Benefit of Collaboration between Compliance and Business Units: Enhancing Compliance at Your Institution Kele Piper, Director, Research Compliance, Massachusetts General Hospital Eleanor Kuszmar, Associate Director for Research Complinace, Harvard Medical School View Description

• Define collaborative research compliance initiatives and discuss when they can be effective for your institution
• Evaluate the role research compliance can play in a collaborative initiative, including recognizing scope creep into operations
• Using case studies, work in small groups to discuss and map possible collaborative initiative scenarios from a compliance perspective

Research Intermediate

#R15

R15: A Compliance Officer’s Research Data Nightmare and How to Wake Up From It Ashley Huntington, Privacy Officer, Cook County Health Leyla Erkan, Global Healthcare Risk and Compliance Lead, Protiviti Melissa Mitchell, Healthcare Compliance Manager, Amazon Care View Description

• Compliance officers in the research sphere play a significant role in protecting PHI and other forms of health data as it flows into from organizations to research and beyond, which often raises significant privacy issues
• We will discuss the privacy issues that arise in this cycle; including using data to recruit patients; communicating on and triaging issues when deviations in research occur and how, when, and why data is shared beyond the scope of research
• We will focus specifically on trends in how data are handled, potentially manipulated and shared, and how compliance can best partner with other departments across the organization to support this function while still safeguarding patient information

Research Intermediate

#R16

R16: Right to Try Laws vs. FDA Expanded Access: What You Need to Know and What You Need to Do Paul Papagni, Executive Director of Research, Holy Cross Hospital Trinity Health View Description

• Many states are passing laws allowing terminally ill patients access to experimental therapies that have not been approved by the Food and Drug Administration. The FDA already allows access to such drugs through Expanded Access Programs
• Do you your doctors, IRB, pharmacists, compliance staff know the differences in these laws/regulations and the different processes for seeking permission to use unapproved therapies?
• Know which is best for your patient, which is best for your institution, and which is more likely to be approved

Research Intermediate

#R17

R17: Protecting Research Participants Financially: Making SENSE of Patient-CENTric Research When Patients Lack CENTS Geoffrey Schick, Senior Consultant, Site Strategy, WCG View Description

• Explore challenges for participants in clinical trials when the patient is indigent or has high out-of-pocket expenses due to their commercial healthcare insurance policy. Explore effects from Medicare secondary payer, anti-kickback statutes, etc.
• Investigate the challenges of participating in sponsor-provided “Financial Hardship Programs” designed to help research participants with financial obligations
• Discuss opportunities to create a vehicle for the research entity to assist clinical trial participants through relationships with foundations. What are the benefits/risks of a program running side by side with existing charity care programs?

Research Intermediate

#R18

R18: In Unity Is Strength: Research Compliance Through Leadership David Staley, Research Compliance Officer, Children's Hospital Colorado View Description

• Identify your bundle of sticks as a leader in research compliance
• Frame a culture of research compliance by engaging with others, making commitments, and being present
• Construct tools that empower compliance leaders in bringing what matters to a collaborative space

Research Intermediate

#R19

R19: Dealing with Data: Non-technical Thoughts Concerning Data Security and Management John Baumann, Associate Vice President for Research Compliance, Indiana University View Description

• Review and identify challenges and obstacles for data security and protection of confidentiality
• Identify best practices for the review of researchers’ plans for protection of data and confidentiality
• Identify strategies for institutions to work with researchers to develop and implement data management/security strategies

Research Intermediate

#R20

R20: When is it Research and When is it Not? The Special Cases of Quality Assurance Studies and Medical Device Improvement David Hoffman, Chief Compliance Officer, Carthage Area Hospital View Description

• When Johns Hopkins launched its quality assurance study of central line infection control practices, they exposed a fault line in the medical research community that continues to generate strong opinions about when IRB approval is appropriate
• In addition to the ongoing debate about whether their intervention required IRB approval due to human exposure to harm, the OHRP reaction to the Hopkins study triggered a debate about the need for IRB review as a condition of scholarly publication
• This presentation will explore the lingering impact of the OHRP-Johns Hopkins confrontation. We will discuss how to evaluate application of the common rule to non-patient focused research and medical device improvement efforts

Research Advanced

#R22

R22: Conflict of Interest 101: Identifying, Managing, and Preventing Research Risk Rebecca Scott, COI Specialist, HealthStream Andrew Hill, Compliance Analyst/Auditor, UK HealthCare Office of Corporate Compliance C.J. Wolf, Faculty, BYUI View Description

• Understanding the Sunshine Act, including recent changes and how they impact your research organization
• Gain useful insight and tools for managing COI research risk at your institution
• Learn to identify risks using the Open Payments database

Research Basic

#R23

R23: Supplementing Traditional Research Compliance Monitoring and Auditing with Anticipatory Surveillance Robert Bienkowski, Director, Office of Research Compliance, Central Michigan University Lynn Smith, Dir, Research Compliance Ofcr, Tampa General Hosp View Description

• Undetected research noncompliance presents risks to subjects, institutions, researchers, and entire fields of research
• Formal systems of monitoring and auditing have inherent blind spots to some types of research noncompliance
• Anticipatory surveillance is a proactive, predictive compliance activity that assists in the early detection of potential noncompliance and mitigation of noncompliance before it becomes serious

Research Advanced

#R24

R24: The Laws of the Jungle: An Introduction to the Regulation of Animal Research Kristin West, Council on Governmental Relations (COGR) View Description

• Overview of the major federal agencies involved in the regulation of animal research and their roles and responsibilities
• Discussion of major laws and regulations in this area of research including the Animal Welfare Act, Public Health Service Policy on Human Care and Use of Laboratory Animals, and the Guide for the Care and Use of Laboratory Animals
• How to effectively work with Institutional Animal Care and Use Committees IACUCs and other institutional players to ensure a compliant research animal care and use program, including issue spotting and common program pitfalls

Research Basic

#R25

R25: Research Stepchildren: Humanitarian Use Devices and Expanded Access to Investigational Medical Products Deneice Kramer, HRPP Manager, Essentia Health Kim Wold, Compliance Specialist, Essentia Health Catherine Murray, Compliance Specialist, IRB, Essentia Health View Description

• Review related laws and regulations which help define HUDs and Expanded Access
• Describe IRB and institutional challenges when reviewing and monitoring HUDs and Expanded Access projects
• Essentia Health’s approach, lessons learned and yet to be learned

Research Intermediate

#R26

R26: "Wish I Had Known That a Year Ago": Lessons Learned in the Midst of Conducting a Research Misconduct Inquiry and Investigation