2021 Research Conference

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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?

  19. 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?

  20. 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

  21. Privacy Considerations and AI in Medicine

    2021 Research Conference  | Presenter(s): Mirena Taskova, Sarah Duffy-Clinton  | June 14, 2021 

    • Learn about solutions that will enable the rise of the next generation of AI in medicine

    • Address privacy considerations if you use large amounts of data from healthcare machines

    • Learn about the role of the stringent global privacy laws GDPR (Europe) and HIPAA (USA) in medicine

  22. If I Knew Then What I Knew Now: Lessons from the Trenches on Building a Physician Practice Clinical Research Compliance Program

    2021 Research Conference  | Presenter(s): Jennifer Sartor  | June 14, 2021 

    • Challenges and obstacles to developing the research compliance program

    • Collaborative solutions that brought it all together

    • Continuous improvement: How we are continuing to grow and evolve the research compliance program

  23. Legal Update: Developments in Clinical Research, EUAs, and IRBs

    2021 Research Conference  | Presenter(s): Tracy Field, Sandra Miller  | June 14, 2021 

    • Spotting informed consent issues, EUA approvals, and other issues in a pandemic

    • Updated review of research subject disparities and practical ways to increase diversity in subjects

    • Review recent government enforcement actions for research misconduct with ways to mitigate risk

  24. Responsible Conduct of Research (RCR): What It Is and Why It Matters

    2021 Research Conference  | Presenter(s): Nancy Rhea, Darri Scalzo  | June 14, 2021 

    • Discuss the definition of RCR, why it is important, and who should receive RCR training

    • Explore the role of the compliance officer in RCR training and best practices for providing training

    • Demonstrate how embedding RCR concepts in daily work can help avoid ethical issues in research

  25. 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