2020 Virtual Research Compliance Conference

1. Conflict of Interest 101: Identifying, Managing, and Preventing Research Risk

   2020 Virtual Research Compliance Conference  | Presenter(s): Rebecca Scott, Andrew Hill, CJ Wolf  | June 03, 2020 

   • 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

2. Supplementing Traditional Research Compliance Monitoring and Auditing with Anticipatory Surveillance

   2020 Virtual Research Compliance Conference  | Presenter(s): Robert Bienkowski, Lynn Smith  | June 03, 2020 

   • 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

3. Demonstrating Good Clinical Practice (GCP) Compliance in Research Through the Maintenance of Regulatory Documents

   2020 Virtual Research Compliance Conference  | Presenter(s): Christina Jackson  | June 03, 2020 

   • Discussion of the 13 Principles of ICH GCP Guidelines Identify Regulatory Documents to Maintain

   • Recognizing the Most Common Deficiencies in Regulatory Documentation

   • Moving from Paper to a Digital Environment

4. Let's Talk About It: The Reality of the Impact of the Changes from the Revised Human Subject Rules

   2020 Virtual Research Compliance Conference  | Presenter(s): Mariette Marsh  | June 03, 2020 

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

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

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

5. Noncompliance in Animal Research Oversight

   2020 Virtual Research Compliance Conference  | Presenter(s): Stacy Pritt, Elizabeth Trumpower  | June 03, 2020 

   • 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

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

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

6. The Laws of the Jungle: An Introduction to the Regulation of Animal Research

   2020 Virtual Research Compliance Conference  | Presenter(s): Kristin West  | June 03, 2020 

7. Research Stepchildren: Humanitarian Use Devices and Expanded Access to Investigational Medical Products

   2020 Virtual Research Compliance Conference  | Presenter(s): Deneice Kramer, Cathy Murray, Kim Wold  | June 03, 2020 

   • 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

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

   2020 Virtual Research Compliance Conference  | Presenter(s): Darri Scalzo, Nancy Rhea  | June 03, 2020 

   • 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

   • 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

   • 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

9. CRRC: Clinical Research Revenue Cycle Management: Avoiding the Pitfalls

   2020 Virtual Research Compliance Conference  | Presenter(s): Mary Veazie, Erika Stevens  | June 02, 2020 

   • 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

10. Compliance Officer's Research Data Nightmare and How to Wake Up From It

    2020 Virtual Research Compliance Conference  | Presenter(s): Ashley Huntington, Leyla Erkan, Melissa Mitchell  | June 02, 2020 

    • 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

11. Right to Try Laws vs. FDA Expanded Access: What You Need to Know and What You Need to Do

    2020 Virtual Research Compliance Conference  | Presenter(s): Paul Papagni  | June 02, 2020 

    • 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

12. Dealing with Data: Non-technical Thoughts Concerning Data Security and Management

    2020 Virtual Research Compliance Conference  | Presenter(s): John Baumann  | June 02, 2020 

    • 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

13. GENERAL SESSION: Difficult Case Scenarios in Clinical Research Billing

    2020 Virtual Research Compliance Conference  | Presenter(s): Ryan Meade  | June 02, 2020 

    • Case Study 1: Confusing Language

    • Case Study 2: Screening Labs

    • Case Study 3: Variable Billing

14. Unity is Strength: Research Compliance Through Leadership

    2020 Virtual Research Compliance Conference  | Presenter(s): David Staley  | June 02, 2020 

    • 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

15. RESEARCH COMPLIANCE GENERAL SESSION: "Research Compliance During the Pandemic" - A Round Table

    2020 Virtual Research Compliance Conference  | Presenter(s): Lisa Murtha, Ryan Meade, Lynn Batholow, Sarah Duffy-Clinton  | June 02, 2020 

    • Examine rapid study start-up

    • Discuss human subject protection safeguards during a crisis

    • Review emergency use FDA rules

16. Protecting Research Participants Financially: Making SENSE of Patient-CENTric Research When Patients Lack CENTS

    2020 Virtual Research Compliance Conference  | Presenter(s): Geoffrey Schick  | June 02, 2020 

    • 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?

17. The Benefit of Collaboration between Compliance and Business Units: Enhancing Compliance at Your Institution

    2020 Virtual Research Compliance Conference  | Presenter(s): Kelé Piper  | June 02, 2020 

    • 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

18. When is it Research and When is it Not? The Special Cases of Quality Assurance Studies and Medical Device Improvement

    2020 Virtual Research Compliance Conference  | Presenter(s): David Hoffman  | June 02, 2020 

    • 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

19. OCR Audits: Past, Present, and Future Considerations for Privacy and Security

    2020 Virtual Research Compliance Conference  | Presenter(s): Deanna Peterson, Edye Edens  | June 01, 2020 

    • 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

20. The Pathway of Part 2 Data in Research: Opioids, Covered Entities, and IRBs, Oh My!

    2020 Virtual Research Compliance Conference  | Presenter(s): Marti Arvin  | June 01, 2020 

    • 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

21. Responsible Conduct: Collaborating on RCR Training

    2020 Virtual Research Compliance Conference  | Presenter(s): Sarah Archibald, Stephanie Suerth  | June 01, 2020 

    • 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

22. Compliance and Culture: How Design and Approach Can Help Support Clinical Trial Billing

    2020 Virtual Research Compliance Conference  | Presenter(s): Kelly Willenberg, Tracy Popp  | June 01, 2020 

    • 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

23. GENERAL SESSION: Preventing Grant Fraud, Waste and Abuse

    2020 Virtual Research Compliance Conference  | Presenter(s): Barbara Orlando  | June 01, 2020 

    • DoD Terms and Conditions

    • Identifying possible grant fraud

    • Sub-recipient monitoring

24. GENERAL SESSION: Research Year in Review

    2020 Virtual Research Compliance Conference  | Presenter(s): Lisa Murtha  | June 01, 2020 

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

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

    • 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

25. How to Overcome the Challenges of Effectively and Legally Implementing Research in a Skilled Nursing Facility

    2020 Virtual Research Compliance Conference  | Presenter(s): Joseph Zielinski  | June 01, 2020 

    • 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 requirement. Attendees will see and receive a tool they can use to apply a data driven approach to research