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A unique conference experience

Get complimentary access to SCCE’s Higher Education Compliance Conference for free with your registration.

2020 hot topics:• Human subject protections

• Animal research regulation

• Clinical revenue cycle management

2020RESEARCHCOMPLIANCE CONFERENCE

LAKE BUENA VISTA, FL MAY 31 – JUNE 3

• FDA access programs

• Research misconduct inquiry and investigation

2 hcca-info.org/2020research

Certified in Healthcare Research Compliance (CHRC)®

Learn more about the CHRC certification at hcca-info.org/certification

EARN YOUR CERTIFICATION

Take the CHRC Certification Exam on-site after the conferenceWednesday, June 3 | 12:30 pm$275 HCCA MEMBERS OR $375 NON-MEMBERS

To apply, complete the CHRC exam application from hcca-info.org/2020research. Twenty CCB CEUs are required to sit for the exam. For Research Compliance Conference sessions, one clock hour equals 1.2 CCB CEUs.

Questions? Email [email protected]

About

Research compliance has garnered increased attention from government regulators and enforcers. Learn practical strategies to address regulations at this annual conference. Choose from a variety of sessions organized by knowledge level: Basic, Intermediate, and Advanced.

This conference provides you with the continuing education Units (CEUs) needed to sit for the optional CCEP certification exam offered on the last day of the conference.

Who Should Attend?This conference is ideal for any compliance professional or person in a related role who works in the clinical research setting. Past attendees have included:

- Compliance officers

- Audit professionals

- Scientists

- Research administrators

- Healthcare executives

- Attorneys

Why Should You Attend?This yearly conference offers ample opportunities for attendees to:

- Discover ways to increase the effectiveness of your organization’s compliance program.

- Discuss emerging risks and issues with your colleagues.

- Share best practices for research compliance.

- Build valuable relationships with other compliance professionals.

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.

AdvancedThis 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.

HCCA’s Mission The Health Care Compliance Association exists to champion ethical practice and compliance standards and provide resources for healthcare professionals and others who share these principles.

Our vision is to be the pre-eminent compliance and ethics association, promoting lasting success and integrity of organizations worldwide.

hcca-info.org/2020research 3

Sunday, May 31 / Pre-Conference12:00 – 5:30 pm Registration Open

1:00 – 2:30 pm BREAKOUT SESSIONS PRE-CONFERENCE

P1 Conflict of Interest 101: Identifying, Managing, and Preventing Research Risk – Rebecca Scott, Compliance/Privacy Manager, UK HealthCare Office of Corporate Compliance; Andrew Hill, Compliance Analyst/Auditor, UK HealthCare Office of Corporate Compliance, CJ Wolf, Director, Conflict of Interest Program, Intermountain Healthcare

P2 The Laws of the Jungle: An Introduction to the Regulation of Animal Research – Kristin West, Chief Compliance Officer, Emory University

2:30 – 2:45 pm Networking Break

2:45 – 4:15 pm BREAKOUT SESSIONS PRE-CONFERENCE

P3 Navigating Research Compliance and Privacy at a University – Jamie Parker, HIPAA/Medical Privacy Officer, University of Alabama

P4 Research Stepchildren: Humanitarian Use Devices and Expanded Access to Investigational Medical Products – Deneice Kramer, Compliance Manager, Essentia Health, MA, MBA, CCRP; Cathy Murray, Compliance Specialist, Essentia Health, MBA, CHC, CHRC; Kim Wold, Compliance Specialist, Essentia Health, MSPH, CCRC

4:15 – 5:30 pm Welcome Reception

Monday, June 1 / Conference7:00 am – 6:00 pm Registration Open

7:00 – 8:00 am Breakfast

8:00 – 8:15 am Opening Remarks

8:15 – 9:15 am General Compliance Session 1: Research Year in Review – Lisa Murtha, Senior Managing Director, Ankura Consulting Group

9:15 – 9:45 am Networking Break with Exhibitors

9:45 – 10:45 am BREAKOUT SESSIONS

101 OCR Audits: Past, Present, and Future Considerations for Privacy and Security – Deanna Peterson, Vice President, Health Consulting Services, First Class Solutions; Edye Edens, Senior Research Compliance Consultant, First Class Solutions

102 Rethink, Reduce, or Recycle Your Privacy Board in the Single IRB Era – Jason Cerman, Staff Attorney, Franciscan Alliance, Inc; Danielle Giltner, Associate Director, Human Research Protection Program, Indiana University

103 Stop! Or Else I’ll Say Stop Again! Institutional Responses to COI Noncompliance – Craig Conway, JD, LLM, Associate Vice President, Office of Institutional Compliance, University of Texas Medical Branch (UTMB)

10:45 – 11:00 am Networking Break

11:00 am – 12:00 pm BREAKOUT SESSIONS

201 The Civil Monetary Penalties Law and the Role of HHS-OIG: Self-Disclosure and Enforcement – Michael Torrisi, Senior Counsel, Office of Counsel to the Inspector General, U.S. Department of Health and Human Services; Geeta Taylor, Senior Counsel, Office of Counsel to the Inspector General, U.S. Department of Health and Human Services

202 Managing Compliance as an NCI National Community Oncology Research Program NCORP Site – Sarah Duffy-Clinton, Research Compliance Officer, Providence St. Joseph Health System; Stacey Medeiros, Research Director, Providence Anchorage Medical Center

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

12:00 – 1:00 pm Lunch

1:00 – 2:00 pm BREAKOUT SESSIONS

301 Late Breaking Research Hot Topics 302 Clinicaltrials.gov Oversite: Insights and Strategies for Tracking and Monitoring Compliance within an Academic Medical Center – Kaycie Craib, Clinical Research Compliance Analyst, Cedars-Sinai Health System; Hannah Coleman, Senior Clinical Research Compliance Analyst, Cedars-Sinai Health System

303 Compliance and Culture: How Design and Approach Can Help Support Clinical Trial Billing – Kelly Willenberg, Manager, Kelly Willenberg and Associates; Tracy Popp, Senior Director, Clinical Research, Tampa General Hospital

2:00 – 2:30 pm Networking Break with Exhibitors


401 Face Time vs. Screen Time: The Benefits of an In-Person Conference to Promote a Culture of Research Integrity through a Grant from the HHS Office of Research Integrity – Lynn Bartholow, Executive Director of Research Compliance, Avera Health, Avera McKennan Hospital

402 Using an IRB Online System for Documenting and Tracking Post-Approval Monitoring Activities: Audits, Complaints, and Allegations of Non-Compliance at an Academic Medical Center – Leah Silbert, Manager, Research Compliance & Post-Approval Monitoring, Cedars-Sinai Medical Center; Ambereen Burhanuddin, Senior Research Compliance Analyst, Cedars-Sinai Medical Center

403 CRRC: Clinical Research Revenue Cycle Management: Avoiding the Pitfalls – Mary Veazie, Exec Dir Clinical Research Finance, UT MD Anderson Cancer Center; Erika Stevens, Principal, Recherche Transformation Rapide; Mori Hall, JD, LLM, CHC, Senior Associate, Duggan Bertsch LLC


Program at a Glance


Program at a Glance

* Discussion Groups are limited to 50 attendees and open on a first-come, first-served basis. No pre-registration is available.

3:45 – 4:45 pm General Compliance Session 2: Medicare Coverage During Clinical Research Studies – Senior CMS Leadership (Invited)

4:45 – 6:00 pm Networking Reception

Tuesday, June 2 / Conference7:00 am – 4:30 pm Registration Open

7:00 – 8:00 am Breakfast

8:00 – 8:15 am Opening Remarks

8:15 – 9:15 am General Compliance Session 3: Difficult Case Scenarios in Clinical Research Billing – Ryan Meade, University of Oxford

9:15 – 9:45 am Networking Break with Exhibitors

9:45 – 10:45 am BREAKOUT SESSIONS

501 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 Compliance, Harvard Medical School

502 Responsible Conduct: Collaborating on RCR Training – Sarah Archibald, Research Integrity Officer, University of Maryland, Baltimore; Stephanie Suerth, Education & Outreach Program Director, University of Maryland, Baltimore

503 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 Compliance Lead, Protiviti; Melissa Mitchell, Chief Compliance Officer, Shirley Ryan Ability Lab


11:00 am – 12:00 pm 601 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

602 Protecting Research Participants Financially: Making SENSE of Patient-CENTric Research When Patients Lack CENTS – Geoffrey Schick, Senior Consultant, Site Strategy, WCG-PFS Clinical

603 In Unity Is Strength: Research Compliance Through Leadership – David Staley, Research Compliance Officer, Children’s Hospital Colorado

12:00 – 1:00 pm Lunch


701 How to Overcome the Challenges of Effectively and Legally Implementing Research in a Skilled Nursing Facility – Joseph Zielinski, Senior Counsel, Wooden McLaughlin LLP

702 Dealing with Data: Non-Technical Thoughts Concerning Data Security and Management – John Baumann, PhD, Associate Vice President for Research Compliance, Indiana University

703 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



801 Noncompliance in Animal Research Oversight – Stacy Pritt, Assistant Vice President COI/IACUC, UT Southwestern Medical Center; Elizabeth Trumpower, IACUC Manager, University of Texas Southwestern Medical Center

802 Research Compliance in Artificial Intelligence – Smitha Gopakumar, Sr. Research Director, University of Maryland Capital Regions Health

803 Supplementing Traditional Research Compliance Monitoring and Auditing with Anticipatory Surveillance – Robert Bienkowski, Director, Office of Research Compliance, Central Michigan University; Lynn Smith, Director, Research Compliance, Tampa General Hospital


3:30 – 4:30 pm General Compliance Session 4: TBA

Wednesday, June 3 / Post-Conference8:00 – 11:45 am Registration Open

8:30 – 10:00 am BREAKOUT SESSIONSPOST-CONFERENCE

W1 “Wish I Had Known That a Year Ago”: Lessons Learned in the Midst of Conducting a Research Misconduct Inquiry and Investigation – Darri Scalzo, Research Compliance Officer, University of Arkansas for Medical Sciences; Nancy Rhea, Compliance Analyst, University of Arkansas for Medical Sciences

W2 Let’s Talk About It: The Reality of the Impact of the Changes from the Revised Human Subject Rules – Mariette Marsh, Director, Human Subjects Protection & Privacy Program, University of Arizona


10:15 – 11:45 am BREAKOUT SESSIONSPOST-CONFERENCE

W3 Danger Zones: Avoid Common Pitfalls and Hazards in Building and Maintaining Your Coverage Analysis – Denise Quint, Research Compliance Analyst, University of Vermont Medical Center

W4 Demonstrating Good Clinical Practice (GCP) Compliance in Research through the maintenance of Regulatory Documents – Christina Jackson, Director, Research Integrity, AdventHealth Research Institute

12:30 pm CHRC Exam Check-in

12:45 – 3:15 pm Certified in Healthcare Research Compliance (CHRC)® exam (optional)


Agenda

Sunday, May 31Pre-Conference

12:00 – 5:30 pmRegistration Open

1:00 – 2:30 pmBreakout Sessions

P1 Conflict of Interest 101: Identifying, Managing, and Preventing Research RiskLEVEL: BASICRebecca Scott, Compliance/Privacy Manager, UK HealthCare Office of Corporate Compliance

Andrew Hill, Compliance Analyst/Auditor, UK HealthCare Office of Corporate Compliance

CJ Wolf, Director, Conflict of Interest Program, Intermountain Healthcare

x Understanding the Sunshine Act, including recent changes and how they impact your research organization

x Gain useful insight and tools for managing COI research risk at your institution

x Learn to identify risks using the Open Payments database

P2 The Laws of the Jungle: An Introduction to the Regulation of Animal ResearchLEVEL: BASICKristin West, Chief Compliance Officer, Emory University

x Overview of the major federal agencies involved in the regulation of animal research and their roles and responsibilities

x 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

x 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

2:30 – 2:45 pmNetworking Break


P3 Navigating Research Compliance and Privacy at a UniversityLEVEL: BASICJamie Parker, HIPAA/Medical Privacy Officer, University of Alabama

x Comparing and contrasting the HIPAA, FDA, and HHS rules regarding human subjects research

x Discussion on waivers of consent and waivers of authorization

x Discussing the requirements to permit reviews preparatory to research

P4 Research Stepchildren: Humanitarian Use Devices and Expanded Access to Investigational Medical ProductsLEVEL: INTERMEDIATEDeneice Kramer, Compliance Manager, Essentia Health, MA, MBA, CCRP

Cathy Murray, Compliance Specialist, Essentia Health, MBA, CHC, CHRC

Kim Wold, Compliance Specialist, Essentia Health, MSPH, CCRC

x Review related laws and regulations which help define HUDs and Expanded Access

x Describe IRB and institutional challenges when reviewing and monitoring HUDs and Expanded Access projects

x Essentia Health’s approach, lessons learned and yet to be learned

4:15 – 5:30 pmWelcome Reception

Monday, June 1Conference

7:00 am – 6:00 pmRegistration Open

7:00 – 8:00 amBreakfast

8:00 – 8:15 amOpening Remarks

8:15 – 9:15 amGeneral Compliance Session 1: Research Year in ReviewLisa Murtha, Senior Managing Director, Ankura Consulting Group

x This session is designed to cover all new laws, regulations and guidance promulgated by the government in the area of research

x The session will outline new research related enforcement initiatives and settlements by the Department of Justice and the Office of Inspector General

x The speaker will describe the implications of these laws, regulations and guidance on research programs and will suggest affirmative actions to be considered to strengthen research compliance programs for universities, academic medical centers, hospitals, CROs and other research organizations

9:15 – 9:45 amNetworking Break with Exhibitors

9:45 – 10:45 am Breakout Sessions

101 OCR Audits: Past, Present, and Future Considerations for Privacy and SecurityLEVEL: INTERMEDIATEDeanna Peterson, Vice President, Health Consulting Services, First Class Solutions

Edye Edens, Senior Research Compliance Consultant, First Class Solutions

x 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 as related to clinical research entities

x 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

x 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


Agenda

102 Rethink, Reduce, or Recycle Your Privacy Board in the Single IRB EraLEVEL: INTERMEDIATEJason Cerman, Staff Attorney, Franciscan Alliance, Inc.

Danielle Giltner, Associate Director, Human Research Protection Program, Indiana University

x Understand the roles and responsibilities of privacy boards

x Considerations as to why an organization may elect to retain HIPAA-related responsibilities when relying on an external IRB

x Learn how to establish a standalone privacy board and integrate this into reliance/single IRB processes

103 Stop! Or Else I’ll Say Stop Again! Institutional Responses to COI NoncomplianceLEVEL: INTERMEDIATECraig Conway, JD, LLM, Associate Vice President, Office of Institutional Compliance, University of Texas Medical Branch (UTMB)

x An interactive session designed to share ideas and best practices

x How do institutions respond when faculty members or employees intentionally or unintentionally fail to adhere to federal, state, or institutional COI requirements?

x 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

10:45 – 11:00 amNetworking Break

11:00 am – 12:00 pmBreakout Sessions

201 The Civil Monetary Penalties Law and the Role of HHS-OIG: Self-Disclosure and EnforcementLEVEL: BASICMichael Torrisi, Senior Counsel, Office of Counsel to the Inspector General, U.S. Department of Health and Human Services

Geeta Taylor, Senior Counsel, Office of Counsel to the Inspector General, U.S. Department of Health and Human Services

x 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

x 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

x Overview of HHS-OIG sanctions for improper conduct related to federal awards under the Civil Monetary Penalties Law and recent HHS-OIG enforcement actions

202 Managing Compliance as an NCI National Community Oncology Research Program NCORP SiteLEVEL: INTERMEDIATESarah Duffy-Clinton, Research Compliance Officer, Providence St. Joseph Health System

Stacey Medeiros, Research Director, Providence Anchorage Medical Center

x Examine the NCORP program’s structure from both a main site and a sub-site perspective

x Overview of the various research compliance items that need to be managed: grants, research billing, IRB review, data integrity, document management

x Provide tips on managing cooperative group research compliance from both a main site and sub-site perspective

203 The Pathway of Part 2 Data in Research: Opioids, Covered Entities, and IRBs, Oh My!LEVEL: ADVANCEDMarti Arvin, Executive Advisor, CynergisTek, Inc.

x Basic overview of Part 2 and the implications of recent proposed changes to the regulations

x The complexity of protecting Part 2 data and ensuring appropriate availability and use in research

x Educating the research team and the IRB on the requirements of Part 2

12:00 – 1:00 pmLunch

1:00- 2:00 pmBreakout Sessions

301 Late Breaking Research Hot TopicsLEVEL: INTERMEDIATE

302 Clinicaltrials.gov Oversite: Insights and Strategies for Tracking and Monitoring Compliance within an Academic Medical CenterLEVEL: INTERMEDIATEKaycie Craib, Clinical Research Compliance Analyst, Cedars-Sinai Health System

Hannah Coleman, Senior Clinical Research Compliance Analyst, Cedars-Sinai Health System

x Introduce the history, scope, and limitations of local compliance-based clincialtrials.gov oversite: resources, responsibilities, and communication efforts

x Present institutional experiences with proactive tracking, routine monitoring, and initial assessment of requirements related to clincialtrials.gov maintenance, registration, and results reporting using the IRB Application/system

x Discuss institutional challenges with clinicaltrials.gov registration, results reporting, and maintaining compliance in an ever-evolving regulatory landscape


Agenda

303 Compliance and Culture: How Design and Approach Can Help Support Clinical Trial BillingLEVEL: ADVANCEDKelly Willenberg, Manager, Kelly Willenberg and Associates

Tracy Popp, Senior Director, Clinical Research, Tampa General Hospital

x Elevate your billing compliance program while building morale of stakeholders with ROI through research related billing reviews

x 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

x Discuss approach of self-monitoring and auditing of billing compliance that is authentic to the culture you have built

2:00 – 2:30 pmNetworking Break with Exhibitors

2:30 – 3:30 pm Breakout Sessions

401 Face Time vs. Screen Time: The Benefits of an In-Person Conference to Promote a Culture of Research Integrity through a Grant from the HHS Office of Research IntegrityLEVEL: BASICLynn Bartholow, Executive Director of Research Compliance, Avera Health, Avera McKennan Hospital

x Self-paced online training is commonly used for Responsible Conduct of Research Training. Opportunities are limited for face-to-face training in a rural, non-academic setting. This training method can be more effective than self-paced online training

x Avera, a non-profit healthcare system based in South Dakota, was awarded a grant to host a conference in Spring 2020 in collaboration with other local institutions to create and cultivate a culture of research integrity and prevention of research misconduct

x Attendees will learn about the planning and execution of this event, the benefits of in-person training, and the activities involved to prevent research misconduct including a mentor match event and adult interactive learning methods

402 Using an IRB Online System for Documenting and Tracking Post-Approval Monitoring Activities: Audits, Complaints, and Allegations of Non-Compliance at an Academic Medical CenterLEVEL: INTERMEDIATELeah Silbert, Manager, Research Compliance & Post-Approval Monitoring, Cedars-Sinai Medical Center

Ambereen Burhanuddin, Senior Research Compliance Analyst, Cedars-Sinai Medical Center

x Provide an overview of the Post-Approval Monitoring program at Cedars-Sinai Medical Center

x Describe our recent implementation of a new IRB system, and how we utilize the system to manage post-approval activities e.g., audits, complaints, and allegations of non-compliance

x Review utilization of new processes and tools for facilitating the conduct of routine and for-cause audits, and discuss our experience and lessons learned using new systems

403 CRRC: Clinical Research Revenue Cycle Management: Avoiding the PitfallsLEVEL: ADVANCEDMary Veazie, Exec Dir Clinical Research Finance, UT MD Anderson Cancer Center

Erika Stevens, Principal, Recherche Transformation Rapide

Mori Hall, JD, LLM, CHC, Senior Associate, Duggan Bertsch LLC

x 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

x Apply proven methods, such as data analytics and tracking trial performance trends, to improve CCRC program success and promote accountability

x Analyze lessons learned, leading practices, proven tools and implementation methods from a recent case study


3:45 – 4:45 pmGeneral Compliance Session 2: Medicare Coverage During Clinical Research StudiesSenior CMS Leadership (Invited)

4:45 – 6:00 pmNetworking Reception

Tuesday, June 2Conference

7:00 am – 4:30 pmRegistration Open

7:00 – 8:00 amBreakfast

8:00 – 8:15 amOpening Remarks

8:15 – 9:15 amGeneral Session: Difficult Case Scenarios in Clinical Research BillingRyan Meade, University of Oxford

9:15 – 9:45 amNetworking Break with Exhibitors


Agenda

9:45 – 10:45 amBreakout Sessions

501 The Benefit of Collaboration between Compliance and Business Units: Enhancing Compliance at Your InstitutionLEVEL: INTERMEDIATEKele Piper, Director, Research Compliance, Massachusetts General Hospital

Eleanor Kuszmar, Associate Director for Research Compliance, Harvard Medical School

x Define collaborative research compliance initiatives and discuss when they can be effective for your institution

x Evaluate the role research compliance can play in a collaborative initiative, including recognizing scope creep into operations

x Using case studies, work in small groups to discuss and map possible collaborative initiative scenarios from a compliance perspective

502 Responsible Conduct: Collaborating on RCR TrainingLEVEL: INTERMEDIATESarah Archibald, Research Integrity Officer, University of Maryland, Baltimore

Stephanie Suerth, Education & Outreach Program Director, University of Maryland, Baltimore

x Tapping into institutional expertise to improve quality and encourage participation

x Customizing sessions so speakers and case studies are consistent and reinforce key concepts

x Keeping what works about the RCR training design while constantly improving to keep it fresh

503 A Compliance Officer’s Research Data Nightmare and How to Wake Up From ItLEVEL: INTERMEDIATEAshley Huntington, Privacy Officer, Cook County Health

Leyla Erkan, Global Healthcare Compliance Lead, Protiviti

Melissa Mitchell, Chief Compliance Officer, Shirley Ryan Ability Lab

x 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

x 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 occu; and how, when, and why data is shared beyond the scope of research

x 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


11:00 am – 12:00 pmBreakout Sessions

601 Right to Try Laws vs. FDA Expanded Access: What You Need to Know and What You Need to DoLEVEL: INTERMEDIATEPaul Papagni, Executive Director of Research, Holy Cross Hospital Trinity Health

x 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

x 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?

x Know which is best for your patient, which is best for your institution, and which is more likely to be approved

602 Protecting Research Participants Financially: Making SENSE of Patient-CENTric Research When Patients Lack CENTSLEVEL: INTERMEDIATEGeoffrey Schick, Senior Consultant, Site Strategy, WCG-PFS Clinical

x 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.

x Investigate the challenges of participating in sponsor-provided “Financial Hardship Programs” designed to help research participants with financial obligations

x 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?

603 In Unity Is Strength: Research Compliance Through LeadershipLEVEL: INTERMEDIATEDavid Staley, Research Compliance Officer, Children’s Hospital Colorado

x Identify your bundle of sticks as a leader in research compliance

x Frame a culture of research compliance by engaging with others, making commitments, and being present

x Construct tools that empower compliance leaders in bringing what matters to a collaborative space

12:00 – 1:00 pmLunch



Agenda

701 How to Overcome the Challenges of Effectively and Legally Implementing Research in a Skilled Nursing FacilityLEVEL: BASICJoseph Zielinski, Senior Counsel, Wooden McLaughlin LLP

x Discussion and analysis of the regulatory requirements of research in a skilled nursing facility and how a compliance program can effectively monitor them

x 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

x 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

702 Dealing with Data: Non-Technical Thoughts Concerning Data Security and ManagementLEVEL: INTERMEDIATEJohn Baumann, PhD, Associate Vice President for Research Compliance, Indiana University

x Review and identify challenges and obstacles for data security and protection of confidentiality

x Identify best practices for the review of researchers’ plans for protection of data and confidentiality

x Identify strategies for institutions to work with researchers to develop and implement data management/security strategies

703 When is it Research and When is it Not? The Special Cases of Quality Assurance Studies and Medical Device ImprovementLEVEL: ADVANCEDDavid Hoffman, Chief Compliance Officer, Carthage Area Hospital

x 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

x 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

x 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


2:15 – 3:15 pm Breakout Sessions

801 Noncompliance in Animal Research OversightLEVEL: INTERMEDIATEStacy Pritt, Assistant Vice President COI/IACUC, UT Southwestern Medical Center

Elizabeth Trumpower, IACUC Manager, University of Texas Southwestern Medical Center

x Attendees will be given an overview of requirements relating to noncompliance in animal research, including federal laws and regulations along with accreditation guidelines, which the Institutional Animal Care and Use Committee is charged with managing

x Attendees will learn about options available in identifying, investigating, correcting, and documenting animal research noncompliance

x Attendees will be given different models for examining institutional risk when it comes to animal research oversight

802 Research Compliance in Artificial IntelligenceLEVEL: INTERMEDIATESmitha Gopakumar, Sr. Research Director, University of Maryland Capital Regions Health

x Understanding AI

x Application of AI in clinical research

x Ensuring compliance in research while applying AI

803 Supplementing Traditional Research Compliance Monitoring and Auditing with Anticipatory Surveillance LEVEL: ADVANCEDRobert Bienkowski, Director, Office of Research Compliance, Central Michigan University

Lynn Smith, Director, Research Compliance, Tampa General Hospital

x Undetected research noncompliance presents risks to subjects, institutions, researchers, and entire fields of research

x Formal systems of monitoring and auditing have inherent blind spots to some types of research noncompliance

x 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


3:30 – 4:30 pmGeneral Session: TBA


Agenda

Wednesday, June 3Post-Conference

8:00 – 11:45 amRegistration Open


W1 “Wish I Had Known That a Year Ago”: Lessons Learned in the Midst of Conducting a Research Misconduct Inquiry and InvestigationLEVEL: INTERMEDIATEDarri Scalzo, Research Compliance Officer, University of Arkansas for Medical Sciences

Nancy Rhea, Compliance Analyst, University of Arkansas for Medical Sciences

x This session will include a discussion of regulatory guidance on misconduct proceedings, as well as detailed information related to conducting inquiries and investigations of research misconduct

x Additional discussion points include mistakes to avoid and best practices to help the audience members become more prepared to take on a research misconduct inquiry and investigation

x Steps to help the audience members be prepared before getting the dreaded “I think we have a problem” call and tips for encouraging a culture of integrity and compliance at your institution

W2 Let’s Talk About It: The Reality of the Impact of the Changes from the Revised Human Subject RulesLEVEL: INTERMEDIATEMariette Marsh, Director, Human Subjects Protection & Privacy Program, University of Arizona

x Identify gaps and problems areas after implementation of the new rule

x Learn various innovative methods for handling research activity revised under the rule

x Hear from peer organizations on best implementation practices to maintain compliance under the new rule

10:00 – 10:15 amNetworking Break


W3 Danger Zones: Avoid Common Pitfalls and Hazards in Building and Maintaining Your Coverage AnalysisLEVEL: INTERMEDIATEDenise Quint, Research Compliance Analyst, University of Vermont Medical Center

x Understand medical necessity, denials, and write-offs, and why they are so important to your coverage analysis

x Coding updates: How CPT, HCPCS, and ICD-10 code updates impact your coverage analysis and how you can stay abreast of the changes

x Coverage updates: How to stay up to date on national and local coverage determinations and implement them in your analysis process

W4 Demonstrating Good Clinical Practice (GCP) Compliance in Research through the maintenance of Regulatory DocumentsLEVEL: BASICChristina Jackson, Director, Research Integrity, AdventHealth Research Institute

x Discussion of the 13 Principles of ICH GCP Guidelines

x Identify Regulatory Documents to Maintain

x Recognizing the Most Common Deficiencies in Regulatory Documentation

x Moving from Paper to a Digital Environment

12:30 pmCHRC Exam Check-in

12:45 – 3:15 pmCertified in Healthcare Research Compliance (CHRC)® exam (optional)

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Research Compliance ConferenceMay 31–June 3, 2020 • Lake Buena Vista, FL

Contact Information Mr Mrs Ms Dr

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First Name MI Last Name

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AcknowledgementsBy submitting this registration, you agree to the full Terms and Conditions, including the use of your information, viewable at hcca-info.org/2020research.

Your information (postal address) may be shared with conference exhibitors, attendees, speakers, affiliates, and partners for marketing and/or networking purposes. To see the full use or if you wish to opt-out, visit hcca-info.org/privacy.

By participating in an HCCA conference, you grant HCCA, or anyone authorized by HCCA, the right to use or publish in print or electronic medium any photograph or video containing your image or likeness for educational, news, or promotional purposes without compensation.

Registration Fees

Member (Monday & Tuesday) $875Non-Member (Monday & Tuesday) $ 1045Registration + First-Time Membership* $ 1095Pre-Conference (Sunday) $ 140Post-Conference (Wednesday) $140Group Discount for 5–9 Attendees $ 50Group Discount for 10 or More $ 100

*Save by joining today (first-time members only). Dues renew at $325.TOTAL $

Session SelectionsVisit hcca-info.org/2020research to choose your sessions, update your conference badge, and see our on-site attendee networking opportunities. If you do not select your sessions online, please write them in the form below. Your selections will be used to assist us in planning. You are not obligated to attend the sessions you select. Session selection is not available for discussion groups.

SUNDAY MONDAY TUESDAY WEDNESDAY1:00 pm 9:45 am 9:45 am 8:30 am2:45 pm 11:00 am 11:00 am 10:15 am

1:00 pm 1:00 pm2:30 pm 2:15 pm

PaymentOnline registration at hcca-info.org/2020research

Mail this form to HCCA, 6500 Barrie Road, Suite 250, Minneapolis, MN 55435-2358

Fax this form to +1 952.988.0146

Email this form to [email protected] — Due to PCI compliance, do not provide credit card information via email. You may email this form (without credit card information), then call HCCA at 888.580.8373 with payment information.

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Questions? Call 888.580.8373 or +1 952.988.0141 or email [email protected]


Hotel & conference locationHilton Orlando Lake Buena Vista 1751 Hotel Plaza Blvd, Lake Buena Vista, FL 32830Online reservations: book.passkey.com/go/2020SCCEandHCCA

A reduced rate of $189 per night for single/double occupancy plus taxes currently 12.5% and fees, have been arranged for this program. To make reservations, call +1 407-827-4000 and ask for the SCCE/HCCA group rate.

To confirm a sleeping room within the Room Block, the sleeping room must be secured with a valid credit card. This card will be used to prepay a deposit for the first night and will be charged immediately. This deposit is refundable up to five days in advance of your arrival date.

The cutoff date for the group rate is May 9, 2020 or once the group room block is full, whichever comes first. Confirmation of rooms after the cut-off date will only be accepted based on availability and at the Hotel’s prevailing rates.

For those who wish to extend their stay, sleeping room rates are available three days before and three days after the conference based on availability.

PLEASE NOTE: Neither HCCA nor any hotel it is affiliated with will ever contact you to make a hotel reservation. If you receive a call soliciting reservations on behalf of HCCA or the event, it is likely from a room poacher and may be fraudulent. We recommend you make reservations directly with the hotel using the phone number or web link in this brochure. If you have concerns or questions, please call HCCA at 888.580.8373.

Continuing EducationHCCA will be applying for external continuing education units (CEUs). If you would like to make a request, please email [email protected]. Only requests from registered attendees will be considered. Visit HCCA’s website, hcca-info.org, for up-to-date information.

Details Research Compliance Conference • May 31–June 3, 2020 • Lake Buena Vista, FL