2021 Research Conference

1. AI and Research: Trends to Tackle Bias, Data, and Compliance when Using Artificial Intelligence in Clinical Research

   2021 Research Conference  | Presenter(s): Namandje Bumpus, Richard Korman, Sarah Swank  | June 16, 2021 

   • Defining AI and current trends in clinical research

   • AI FDA regulations, virtual and home trials, data security, intellectual property, and COVID guidance

   • Addressing AI ethics, bias, and compliance

2. Building a New Research Compliance Program: Where Do I Begin?

   2021 Research Conference  | Presenter(s): Lynn Smith, Tracy Popp  | June 16, 2021 

   • Understanding the importance of a research compliance program

   • Define the elements of a research compliance program and what should be implemented first

   • Address the impact of research compliance on research operations

3. Clinical Research Privacy: Challenges from Technology, Public Health, and Law Require Both Innovative Solutions and Basic Fundamentals

   2021 Research Conference  | Presenter(s): Mary Alexander, Nicholas Weil  | June 16, 2021 

   • See how industry and public demands clash with data laws and risks, catching researchers in between

   • Respond with an innovative compliance program to engage colleagues and show commitment to ethics

   • Review the basics of a research privacy investigation: How to assess, respond, and mitigate breaches

4. Compliance Aftermath of COVID Research

   2021 Research Conference  | Presenter(s): Andrea Wever, Gerry Zack, Quincy Byrdsong  | June 16, 2021 

   • Compliance lessons learned and dealing with subsequently-discovered noncompliance

   • Consideration of inequities in health care as a compliance issue

   • The effects of the pandemic on future uses of emergency use authorization

5. General Session: FDA Clinical Research Compliance for Medical Devices: A Primer

   2021 Research Conference  | Presenter(s): Neil O'Flaharty  | June 16, 2021 

   • When does research of a medical device become subject to FDA oversight?

   • What are the key considerations for running a medical device clinical study in compliance with FDA requirements?

   • Strategies for avoiding non-compliant clinical research and running FDA-compliant studies

6. Data Governance: Unlocking Data to Advance Research While Safeguarding Human Subjects

   2021 Research Conference  | Presenter(s): Mark Fox, Thora Johnson, Deborah Marko Koeberer  | June 16, 2021 

   • Review the commentary from the Office of Human Subjects on Reasonable and Appropriate Safeguards.

   • Discuss the balance between protecting patient privacy and driving research discoveries.

   • Explore practical examples of effective data governance that promotes successful research while safeguarding data.

7. Incorporating Research Compliance into Privacy and Security Risk Management for Healthcare Organizations

   2021 Research Conference  | Presenter(s): Emmelyn Kim, Hamangi Patel  | June 16, 2021 

   • Implement effective ways to integrate research compliance into the healthcare compliance framework

   • Identify and manage unique areas locally and globally in research pertaining to privacy and security

   • Work with other stakeholders in research to better monitor and manage risk at healthcare organizations

8. Managing Undue Influence in University Research

   2021 Research Conference  | Presenter(s): Daniel Shapiro, Kenneth Liddle, Robert Roach  | June 16, 2021 

   • Understand the Biden Administration's approach to "undesirable" foreign influence in university research

   • Learn 5 steps universities can take to manage effective international research collaborations

   • Develop monitoring techniques to meet ongoing federal expectations and avoid federal agency review

9. Research Compliance Work Plans: Creating a Blueprint for a Successful Research Compliance Program

   2021 Research Conference  | Presenter(s): Eleanor Kuszmar, Kele Piper  | June 16, 2021 

   • Discuss how to use research compliance work plans to transform your program from reactive to proactive

   • Use the work plan to motivate and incentivize your research compliance staff and build confidence with your research community

   • Learn to build a flexible work plan that maximizes resources while adapting to a changing compliance environment

10. The Vital Role of Whistleblower Scientists in Exposing Fraudulent Research During the Pandemic

    2021 Research Conference  | Presenter(s): Elisabeth Bik, Mary Inman  | June 16, 2021 

    • Understand the compliance risks posed by scientists’ ability to bypass the peer-review process and expedite publishing of COVID-19-related research

    • Identify types of COVID-19 research fraud from real-world examples presented by whistleblower and scientific sleuth, Dr. Bik.

    • Learn techniques for how to handle internal whistleblower complaints of research fraud and obviate need for WB employee to proceed externally by contacting government authorities

11. Why Are Organizations Still So Confused about HIPAA and Research?

    2021 Research Conference  | Presenter(s): Marti Arvin, Linda Malek  | June 16, 2021 

    • Overview of the ways in which PHI can be used and disclosed for research

    • Why the structure and nature of the organization can result in different obligations under the rules

    • Common errors and implications of information blocking for research

12. Grow Up! Maturing a Research Compliance Program

    2021 Research Conference  | Presenter(s): Jordan Muhlestein, Neil Nokes  | June 15, 2021 

    • Defining research compliance program maturity to obtain stakeholder buy-in

    • Applying compliance program maturity principles to a research compliance program

    • Measuring the research compliance program's maturity and effectiveness through KPIs

13. General Session: Research Year in Review 2020-2021

    2021 Research Conference  | Presenter(s): F. Lisa Murtha  | June 15, 2021 

    • Understand new research-related laws, regulations, agency guidance, enforcement cases, and other updates in research over the last year

    • Review OIG and DOJ cases as well as enforcement at the agency level: OHRP, ORI, FDA, ETC.

    • How should we shift our research compliance focus in light of the new laws, regs, and guidance?

14. Building and Leading a Successful Research Organization: Insights and Tips for Commercial and NonProfit Organizations from Someone Who's Done It

    2021 Research Conference  | Presenter(s): Suzanne Page  | June 15, 2021 

    • Getting Started: What needs to be in place and how do you accomplish it?

    • Setting Goals: Where do you want to be and how do you plan to get there?

    • Continuous Execution and Improvement: How do you measure, maintain and celebrate success?

15. FDA Inspections: Always Be Ready and What to Do When They Actually Come Knocking on Your Door!

    2021 Research Conference  | Presenter(s): Paul Papagni  | June 15, 2021 

    • Learn from other people's mistakes: Common findings from 483s, FDA warning letters, and trends

    • Learn from the Compliance Program Guidance Manual: Instructions for conducting FDA inspections

    • Before, during and after inspection: What you need to know and what you need to do to prepare

16. It Takes a Village: Collaborative Solutions for Mitigating Clinical Research Revenue Cycle Risk

    2021 Research Conference  | Presenter(s): Cynthie Lawson, Katherine Cohen  | June 15, 2021 

    • Understanding clinical research revenue cycle basics and risks,

    • Common challenges in managing the Clinical Research Revenue Cycle

    • Best practices in efficient and compliant Clinical Research Revenue Cycle management

17. Novel Conflict of Interest Collection Strategies for More Effective Oversight

    2021 Research Conference  | Presenter(s): Catharine Fortney, Wendy Charles  | June 15, 2021 

    • Identify hidden gaps between conflicts of interest reported (and not reported) with other sources

    • Describe risks to institutions, individuals, and the public, of failure to identify and manage COI

    • Design an efficient COI collection process that promotes broader integrity and public trust

18. Oops the PI's Gone: What to Do Next!

    2021 Research Conference  | Presenter(s): Cynthia Dunn, Wendy Portier, Associate Vice President for Research Compliance  | June 15, 2021 

    • Discuss common oversight gaps that occur when the PI changes or leaves an organization

    • Outline areas to consider when a PI changes, including: IRB review/approval, contract changes, sponsor notification, the Form FDA 1572, delegation of authority, training, and more

    • Review key processes to address when a PI changes

19. Patient Access, 21st Century Cures Act, and Information Blocking

    2021 Research Conference  | Presenter(s): Debi Primeau, Jaime James  | June 15, 2021 

    • Explore the Cures Act as it relates to the Information Blocking Rule and the research environment

    • Discuss components of the Information Blocking Rule, including definitions, timelines, and exception

    • Examine key areas where research compliance professionals can focus efforts to prepare for change

20. What Your Research Investigators and IRB May Not Know: Regulatory and Ethical Implications for Human Subjects Research

    2021 Research Conference  | Presenter(s): Barbara Vimont, Patricia Blount MD, MSL, CIP, CHRC  | June 15, 2021 

    • Understand the fundamental difference between the practice of medicine and clinical research: The confusing roles of physician and clinical investigator

    • Understand the FDA regulatory landscape of sponsor-investigator INDs, nutraceuticals, and devices

    • Understand the fundamental difference between an interventional and observational study: Misperceptions concerning research interventions considered "standard of care" procedures

21. Considerations in Building a Foreign Influence Compliance Program

    2021 Research Conference  | Presenter(s): Janice Grace, Kathleen McNaughton, Will McIntire, Callan Stein  | June 14, 2021 

    • Understand the Government’s (especially NIH, NSF, and DoD) recent focus on increased transparency concerning foreign elements and connections in applications for research grants

    • Identify and overcome operational challenges to maintaining foreign influence compliance

    • Mitigate legal exposure for investigators/ institutions by implementing an effective foreign influence compliance program

22. Bias and Structural Inequity in Research

    2021 Research Conference  | Presenter(s): Mina Kini, Judith Burgan  | June 14, 2021 

    • Understand the history of bias and structural inequities in healthcare research. Most people know about the Tuskegee Syphilis Study. Explore other examples in the history of research where bias or structural inequity played a role

    • Using data, describe the effects of bias and structural inequity on healthcare research today. From basic laboratory research to clinical trials, bias and structural inequities continue to affect research and the healthcare individuals receive

    • List four strategies organizations can utilize to advance a culture of inclusion in research. Apply a strategy to improve diversity and inclusion in our workforces and engage with our communities

23. Electronic Systems in Clinical Research: How to Remain Compliant in the New Virtual World""

    2021 Research Conference  | Presenter(s): Candida Barlow, Christine Nelson, Laura Fluharty  | June 14, 2021 

    • Educate compliance professionals on FDA guidance for electronic systems

    • Explain FDA guidance as it relates to electronic systems used to collect data in clinical research

    • Describe steps an organization can take to remain compliant when leveraging technology

24. Clinical Trials Research Compliance: Auditing vs Monitoring

    2021 Research Conference  | Presenter(s): Jana Dock,, Geoffrey Schick  | June 14, 2021 

    • Discuss the experience of Mercy's utilization of both auditing and monitoring in research compliance

    • Identify the key elements of (external) auditing methodology and discuss pros and cons

    • Identify the key elements of (internal) monitoring methodology and discuss pros and cons

25. General Session: Sites Beware: How to Prepare for the Upcoming Changes in Medicaid

    2021 Research Conference  | Presenter(s): Kelly Willenberg, Ryan Meade  | June 14, 2021 

    • Analyze potential impact to sites research billing process and coverage analysis

    • Discuss how the legislation fits into the federal and state Medicaid legal framework

    • Examine possible actions that state needs to take based on the language of the legislation