Three I’s Conference 2020

11:00 a.m.

Welcome & Introduction

Suzanne Wilkison President North Carolina Association for Biomedical Research (NCABR)

SSA Gregory Kline ASAC Charlotte Field Office Federal Bureau of Investigation

11:10 a.m.

for All audiences

What Is Bioethics and Why Is It So Important?

Robert Klitzman, M.D. Professor of Psychiatry Director and Online and In-Person Masters of Bioethics Program Columbia University

12:15 p.m.

Break

12:30 p.m.

Breakout Sessions

for IACUC audiences  OLAW Update 

Neera Gopee, D.V.M., Ph.D. Director Division of Policy and Education OLAW

for IBC audiences  Best Practices for Institutions Adapting to a Boom in Gene Therapy

Daniel Eisenman, Ph.D., RBP Director of Biosafety Services ADVARRA

for IRB audiences Looking Back and Looking Ahead: Reflections on 25 Years in the IRB Business

Daniel Nelson Adjunct Professor of Social Medicine and Pediatrics Faculty Associate, Center for Bioethics University of North Carolina at Chapel Hill

1:30 p.m.

Breakout Sessions

for IACUC audiences  Implementation of the New USDA Rule Change to AWR Part 3. Subpart A. Dogs

Tonya Hadjis, D.V.M. Supervisor for Animal Care, NorthEast USDA

for IACUC audiences for IBC audiences Risk Assessment for Different Animal Models: The Ever-Changing Puzzle

Angela C. Birnbaum Director of Biosafety Tulane University

for RI audiences  The False Claims Act’s Application to Research Integrity

Derek M. Adams Partner Potomac Law Group, PLLC

for IRB audiences  Bringing Your IRB Up to Speed on Social Media Research Contexts and Dilemmas

Montana Miller, Ph.D. Research Compliance Officer & Associate Professor Bowling Green State University

2:30 p.m.

for all audiences

Cyber Threats to the Bioengineering Supply Chain

SA Scott Nawrocki Cyber Squad (CY-1) Biotechnology Threat Focus Cell Federal Bureau of Investigation

3:15 p.m.

End of Day 1

11:00 a.m.

for All audiences

The Synchrony and Synergy of Brain Rhythms

Flavio Frohlich, Ph.D. Associate Professor Department of Psychiatry University of North Carolina at Chapel Hill

12:00 p.m.

Break

12:15 p.m.

Breakout Sessions

for IACUC audiences  IACUC Tools of the Trade to Engage and Promote Compliance for Controlled Substances in Non-Human Research

Kelé Piper, MS, CIP, CHRC Director Research Compliance Office Massachusetts General Hospital

for IACUC audiences for IBC audiences  Standardizing Practices Between IACUC and IBC to Improve/Maintain Quality Programs

Victor Cuevas Regulatory Compliance Manager The Jackson Laboratory

for RI audiences  Outside Influences on Research and Academic Integrity

Chris Mangelli, J.D. Director, Office of Research Integrity (ORI) Ball State University

for Biosecurity audiences  Risk Assessment/TCE

SA Joshua Canter Weapons of Mass Destruction Coordinator Federal Bureau of Investigation

SA Matthew Perkins Weapons of Mass Destruction Coordinator Federal Bureau of Investigation

1:00 p.m.

Break

1:15 p.m.

Breakout Sessions

for IRB audiences  Establishing a High Quality Human Research Protection Program (HRPP): The AAHRPP Model

Elyse I. Summers, J.D. President and CEO AAHRPP

Michelle Feige, MSW, LCSW-C Executive Vice President AAHRPP

for IACUC audiences At the Intersection of Conflict of Interest & the IACUC: Re-Examining Conflicts in Animal Research Oversight

Stacy Pritt, D.V.M., M.S., M.B.A., CPIA, CHRC, DACAW Assistant Vice President, COI & IACUC University of Texas Southwestern Medical Center

for RI audiences  Lying, Cheating and Stealing: A Primer on Research Misconduct

Julie Simpson, Ph.D. Director, Affiliate Assistant Professor of College Teaching & of Education University of New Hampshire

for Biosecurity audiences  for IACUC audiences  for IBC audiences  Primer on Biosecurity Requirements for Select Agent Research

Angela C. Birnbaum Director of Biosafety Tulane University

2:00 p.m.

Break

2:15 p.m.

for IACUC audiences for IBC audiences for IRB audiences for Biosecurity audiences  Biosecurity Three I’s

SA Joshua Canter Weapons of Mass Destruction Coordinator Federal Bureau of Investigation

3:15 p.m.

End of Day 2

11:00 a.m.

for Biosecurity audiences

Challenges of Foreign Interest, Due Diligence, Inter and Conflict Interest

We will address foreign influence and cyber threats to universities, its research and the intellectual property rights from a North Carolina perspective.

SA Matthew Perkins Weapons of Mass Destruction Coordinator Federal Bureau of Investigation

SSA Gregory Kline Charlotte Division Weapons of Mass Destruction Directorate Federal Bureau of Investigation

TBA U.S. Attorney’s Office Representative

12:00 p.m.

Break

12:15 p.m.

Breakout Sessions

for IACUC audiences  Integrating and Managing Start-Ups in an Academic Institution

Rebecca D. Armstrong, D.V.M., Ph.D. Director, Research Subject Protection University of California Berkeley

for IRB audiences  Data Security and Privacy: A Practical Approach to Protect Confidentiality

Lisa DeSantes Research Review Specialist University of Pittsburgh

for Compliance audiences  Research Risk Assessments: A Tool to Identify Risk, Develop a Workplan and Effectively Allocate Resources

Kelé Piper, MS, CIP, CHRC Director, Research Compliance Office Massachusetts General Hospital

for RI audiences  Navigating Norms

Anne M. Corbin, J.D., Ph.D. Justice Policy Manager State of Vermont

Ross Hickey, J.D., CIP, CPIA Assistant Provost for Research Integrity Director Maine Regulatory Training and Ethics Center

1:00 p.m.

Break

1:10 p.m.

for All audiences

Research Integrity, Bioethics and You™… 

(a hands-on/interactive session)

Marley J. Thrasher Duke University

Ross Hickey, J.D., CIP, CPIA Assistant Provost for Research Integrity Director Maine Regulatory Training and Ethics Center (MeRTEC)

Amy Kilpatrick, BA, CVT, RLATg, CPIA Manager, Animal Welfare Compliance Novartis Institutes for Biomedical Research

Angelica N. Martins, Ph.D., RBP Interim Director of Research Compliance Research and Economic Development University of North Carolina at Charlotte

Cassandra Myers IRB Director Office of Human Research Ethics University of North Carolina at Chapel Hill

Jennie Ofstein IRB Director Sponsored Programs and Regulatory Compliance North Carolina State University

SA Matthew Perkins Weapons of Mass Destruction Coordinator Charlotte/Boston Field Offices Federal Bureau of Investigation

SA Joshua Canter Weapons of Mass Destruction Coordinator Charlotte/Boston Field Offices Federal Bureau of Investigation

3:00 p.m.

End of Day 3

11:00 a.m.

for All audiences Protecting United States Scientific Innovation From Inappropriate Foreign Influence Scientific integrity and scientists who are being investigated for failing to report their financial ties to foreign entities,  with a look at the economic and legal consequences of their actions.

Susan Cropp, Ph.D.  Chemical Biological Countermeasures Unit Weapons of Mass Destruction Directorate FBI Headquarters

 

12:00 p.m.

Break

12:15 pm

Breakout Sessions

for IACUC audiences  IACUC Challenges: Case Studies from Real Life

Marcy Brown, BS, MA, CMAR, CPIA Animal Welfare and IACUC Program Specialist

Deb Frolicher Director, IACUC Office Scripps Research Institute

Neera Gopee, D.V.M., Ph.D. Director, Division of Policy and Education OLAW

Tonya Hadjis, D.V.M. Supervisor for Animal Care, NorthEast USDA

for IRB audiences  An IRB Divided By the Common Rule Cannot Only Stand, It Can Thrive

Cassandra Myers, CIP Director Office of Human Research Ethics University of North Carolina at Chapel Hill

Mike Matamoros, MS, CIP Associate Director Operations and Education Office of Human Research Ethics University of North Carolina at Chapel Hill

John Roberts, CIP Associate Director Regulatory Affairs and Compliance Office of Human Research Ethics University of North Carolina at Chapel Hill

for Compliance audiences  RCR as Ethics, Not Compliance

Robin Tyndall Director of Research Compliance Clemson University

1:15 pm

for IACUC audiences for IBC audiences for IRB audiences for Biosecurity audiences  IACUC IBC IRB & Biosecurity: Spot the Issues©

Ted Myatt, Sc.D. Director of Research Integrity University of Rhode Island

Kathryn A. Holthaus, MS, MA  Director of Research Subjects Protection and Laboratory Safety Compliance Research Operations Brigham Health l Brigham & Womens Hospital

Elizabeth Kipp Campbell, Ph.D., CIP Director of Research Compliance MaineHealth

Chris Mangelli, J.D. Director, Office of Research Integrity (ORI) Ball State University

Matthew Mellini Senior IACUC Protocol Administrator Brigham and Women’s Hospital

2:45 p.m.

End of Day 4

11:00 a.m.

for IACUC audiences for IBC audiences for IRB audiences How Increased Communications and Transparency Translate Into Improved Security and Reduced Risk

Jim Newman Director and Online of Strategic Communications Americans for Medical Progress (AMP)

for Biosecurity audiences  DIY Covid19 Vaccines: What Happens When the Development and Testing of Vaccines Are Democratized?

Todd Kuiken, Ph.D. Senior Research Scholar Genetic Engineering and Society Center North Carolina State University

Susan Cropp, Ph.D..  Chemical Biological Countermeasures Unit Weapons of Mass Destruction Directorate Federal Bureau of Investigation

11:50 a.m.

Break

12:00 p.m.

Breakout Sessions

for RI audiences  Navigating Foreign Influence in the Lab What institutions should know about disclosures, the “China Initiative” and protecting US-based research.

Elizabeth McEvoy, Esq. Partner Barrett & Singal

for IACUC audiences Virtual Improvements to the PAM/SAPR Process

Christina Nascimento IACUC Manager Brigham Health l Brigham & Women’s Hospital

for IACUC audiences  for IBC audiences for IRB audiences The Four Corners of Stem Cell Research What should be considered when your institution conducts stem cell research?

Panel: Daniel Eisenman, Ph.D., RBP Director of Biosafety Services ADVARRA

Joseph Andrews, Ph.D., CIP, CCRP Assistant Dean, Regulatory Affairs & Research Integrity Wake Forest School of Medicine

David Lyons, Ph.D. Director, Animal Welfare Program & IACUC Wake Forest School of Medicine

John D. Jackson, Ph.D., MS Associate Professor Wake Forest Institute for Regenerative Medicine

Facilitators: Deb Frolicher Director, IACUC Office Scripps Research Institute

Marcy Brown, BS, MA, CMAR, CPIA Animal Welfare and IACUC Program Specialist

for IACUC audiences for IBC audiences for IRB audiences  Ethical Concerns of Foreign Influence

Mary Beth Koza Treasurer Division of Clinical Health & Safety The American Chemical Society

1:00 p.m.

Break

1:15 p.m.

for IACUC audiences  Going Virtual and What the Pandemic Has Taught Us About the IACUC in Cyberspace  

Barbara Garibaldi, D.V.M., DACLAM Director, Animal Research Facility Beth Israel Deaconess Medical Center

CeCe Brotchie-Fine, MA, CPIA Associate Director & Head, AWC Cambridge NIBR CA IACUC Chair & Animal Welfare Officer Novartis Institutes for Biomedical Research

for Compliance audiences for RI audiences Good Fences Make Good Neighbors: Building a Relationship Between Sponsored Programs and Research Compliance

Sherrie Settle Director of Sponsored Programs Sponsored Programs and Regulatory Compliance Services North Carolina State University

Jennie Ofstein IRB Director Sponsored Programs and Regulatory Compliance North Carolina State University

for IRB audiences  COVID-19 and the Learning IRB: A New Approach in a Challenging Time

Stephen Rosenfeld, M.D., MBA Consultant

2:00 p.m.

End of Day 5