Three I’s & Biosecurity Conference 2018

3Is 2018

 

There are dozens of webinars, online workshops, symposiums and conferences out there, but the Massachusetts Society for Medical Research’s Three I’s and Biosecurity™ conference is the first and only event designed to address the needs and concerns of security professionals, IACUCs, IBCs and IRBs.

The Three I’s & Biosecurity™: Promoting the Responsible Conduct of Research, Partnership, Ethics, Best Practices and the Exploration of Current Trends conference will address the complex challenges that touch the IACUC, IBC and IRB communities — issues relating to research integrity, ethics, communications and social media, importing/exporting and much, much more. It’s essential for the collaboration that drives the research community forward, enabling attendees to work smarter, not harder.

What’s more, attendees consistently rank the quality and ease of networking at the intimate Three I’s conference as a primary reason for selecting it over other national conferences each year.

Conference highlights will include:

  • Timely Topics: Dual use, Common Rule revisions, research misconduct, best practices for assessing biothreats, and more
  • Extensive preconference workshop options:
    • ABCs for IACUCs & IBCs: Frameworks for Compliance™ (Half-day workshop)
    • Understanding the Compliance Intersection: A Guide to Understanding Areas of Compliance Beyond the IACUC, IBC and IRB™ (Half-day workshop)
    • IACUC = Implementing Assurance Compliance Understanding and Confidence: A Nuts and Bolts Approach to IACUCS and Animal Care and Use Programs© (Full-day workshop)

MSMR, the North Carolina Association for Biomedical Research, the FBI Weapons of Mass Destruction Directorate, and the Maine Regulatory Training and Ethics Center, together with recognized industry experts and compliance professionals, will impart concrete strategies that will allow you to stay ahead of challenging regulatory and security issues. Panels and interactive discussion groups promise to offer a multifaceted learning experience.

The main conference will be held March 15-16. Half-day and full-day preconference workshops will be held March 14.

Each registrant may attend either one half-day workshop, which is included in the price of the main conference registration, or the full-day preconference workshop, which is not included in the price of the main conference and is open to those not attending the main conference. The two preconference half-day workshops are open only to main conference attendees.

This conference is eligible for contact hours through the Research Administrators Certification Council. This conference is eligible for professional CEUs and contact hours for CPIA and CIP.

Presenting Sponsor

UNC logo

Supporting Sponsors

atune

Boston University logo

 

 

NCBC logo

Speakers from...

Download speaker bios here

  • Beth Israel Deaconess Medical Center
  • Brigham and Women’s Hospital
  • Boston Children’s Hospital
  • Drug Enforcement Administration
  • Duke University/ Duke University Health System
  • Emory University
  • East Carolina University
  • Environmental Health & Engineering, Inc.
  • FASEB
  • FBI Weapons of Mass Destruction Division
  • Harvard Medical School
  • Maine Regulatory Training and Ethics Center (MeRTEC)
  • Michigan State University
  • NIH Office of Laboratory Animal Welfare (OLAW)
  • North Carolina State University
  • Northeastern University
  • Novartis Institute for BioMedical Research, Inc.
  • Tulane University
  • Scripps Research Institute
  • U.S. Department of Agriculture (USDA)
  • U.S. Department of Commerce
  • U.S. Environmental Protection Agency (EPA)
  • University of New Hampshire
  • University of North Carolina at Chapel Hill
  • University of North Carolina at Charlotte
  • University of Wisconsin-Stout
  • Wake Forest Baptist Health
  • Yerkes National Primate Research Center

Preconference Workshops (Wednesday, March 14, 2018)

ABCs for IACUCs & IBCs: Frameworks for Compliance™

ABC’s for IACUCs & IBCs: FRAMEWORKS FOR COMPLIANCE™ gives a detailed overview of the laws, regulations and policies that govern the work of these two important oversight committees. Presentations are intermingled with pertinent team exercises and sample protocols. This program is designed to help meet the requirement stated in the Guide for the Care and Use of Laboratory Animals 8th edition, 2011, that states: “All personnel involved with the care and use of animals must be adequately educated, trained, and/or qualified in basic principles of laboratory animal science to help ensure high-quality science and animal well-being.” It also will address USDA/APHIS/AC Policy 15.

Those completing the program will:

  • Have a clear overview of the laws, regulations, and policies that govern the human care and use of laboratory animals;
  • Learn about the NIH OBA, the contents of the NIH Guidelines for Research Involving Recombinant DNA Molecules, and the history of IBCs and develop an understanding of the range of responsibilities that IBCs have under the NIH Guidelines;
  • Examine the relationship of IBC and IACUCs in terms of their respective roles and responsibilities;
  • Discuss obstacles and other issues that both committees experience in meeting their ongoing research efforts and objectives;
  • Review the key components of an integrated program through case studies and protocol review; and
  • Engage in discussion with colleagues to share ideas about best practices, resources, innovative approaches, and collaborations.

Barbara Garibaldi, DVM, DACLAM
Director of the Animal Research Facility
Beth Israel Deaconess Medical Center
Instructor, Department of Medicine
Harvard Medical School

Karen Krueger, DVM, DACLAM
Director, Animal Resources
Boston Children’s Hospital
Chair, MSMR Program Committee

Christina Nascimento, MS, CPIA
IACUC Manager
Brigham and Women’s Hospital

Ted Myatt, Sc.D., RBP
Practice Director, Life Sciences
Environmental Health & Engineering, Inc.

Understanding the Compliance Intersection: A Guide to Understanding Areas of Compliance Beyond the IACUC, IBC and IRB™

  • Understand the major regulations and guidance governing research involving human subjects, animals and biological safety. Understand when review are required by multiple committees.
  • Identify strategies to effectively manage committees and best practices for coordination of review and oversight for research requires review from multiple committees.
  • Develop an understanding of federal grants management policy, including requirements for review and oversight of research involving recombinant DNA (rDNA), human subjects, and animal subjects.
  • Discuss other compliance issues, such as export controls, financial conflicts of interest, and research misconduct and their potential relation to research reviewed by the three I’s (e.g., IRB, IACUC, IBC).

An understanding of the range of research compliance areas and the regulations and guidance that underpin these areas can be beneficial to compliance professionals. For example, research typically encountered by animal welfare professionals and IACUCs may also require Institutional Biosafety Committee (IBC) or Institutional Review Board (IRB) review and oversight. In order to develop strategies on dealing with these areas of overlap, it is helpful to have a solid understanding of IRB, IACUC and IBC regulations and guidance. This knowledge can be used to develop best practices at your institution and in turn, reduce the regulatory burden on investigators. Additionally, comprehension of the regulations and guidance governing research involving human subjects and animal subjects, export controls, financial conflicts of interest will expand a course participant’s area of expertise, potentially leading to new opportunities within an institution’s overall research compliance structure.

The course will be taught with a mixture of didactic lecture, case studies and interactive exercises.

Kathryn Mellouk
Associate Vice President
Research Compliance
Boston University

Eric Everett, Ph.D.
Professor, Department of Pediatric Dentistry
Associate Dean for Research, School of Dentistry
Institutional Research Integrity Officer
University of North Carolina at Chapel Hill

IACUC = Implementing Assurance Compliance Understanding and Confidence: A Nuts and Bolts Approach to IACUCS and Animal Care and Use Programs©

IACUC Nuts and Bolts© is a full-day course that provides attendees with knowledge and information of the key elements of the IACUC relationship to an institution’s animal care and use program. After attending this course, attendees will understand: the key elements of an effective IACUC program, the primary functions of the IACUC, including protocol review, how to conduct semiannual inspections and program review, how to review animal welfare concerns, and the reporting responsibilities of the IACUC. In addition, faculty will describe the IACUC’s role in overseeing post approval monitoring and the institution’s training program for animal users.

This program is designed for IACUC members, IACUC administrators and support staff, institutional officials, and training and compliance personnel.

Agenda available here.

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

Deb Frolicher, BS, CPIA
Director, IACUC Office
The Scripps Research Institute

Day 1 Agenda (Thursday, March 15, 2018)

Registration & Breakfast

Welcome & Introduction

James O’Reilly
President
Massachusetts Society for Medical Research (MSMR)

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

Will So, Ph.D.
Policy & Program Specialist
Biological Countermeasures Unit
Weapons of Mass Destruction Directorate
Federal Bureau of Investigation

for All audiences

Translational Research
Bench-To-Bedside

Linda C. Cendales, MD
Associate Professor of Surgery
Duke Health Scholar
Director, Vascularized Composite Allotransplantation
Duke University Medical Center

for All audiences

Biosecurity and Effectively Communicating via Social Media

Lisa Newbern
Chief, Public Affairs
Emory University, Yerkes National Primate Research Center

Amanda Dettmer, Ph.D.
Speaking of Research

Shelley Lynch
Public Information Officer
Federal Bureau of Investigation

Break

Regulatory Breakout Sessions

for IACUC audiences
OLAW Update

Eileen Morgan
Director, Division of Assurances
Office of Laboratory Animal Welfare (OLAW)
National Institutes of Health (NIH)

for IBC audiences
Promoting Biosafety and Biosecurity Through Good Governance

Kathryn Harris, Ph.D., RBP
Contractor
Senior Outreach and Education Specialist Program
Office of Science Policy
National Institutes of Health (NIH)

for IRB audiences
Common Rule Revisions: The Saga Continues!

Daniel Nelson
Director, Human Research Protocol Office (HRPO)
National Health and Environmental Effects Research Laboratory (NHEERL)
U.S. Environmental Protection Agency (EPA)

Session description

for All audiences

Misconduct for NON-RIOs…(process, concepts, confidentiality, etc.)

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

Lunch

Breakout Sessions

for IBC audiences for IACUC audiences
When Committees Collaborate – Finding Balance and Optimizing IACUC/IBC Communications

Tonya R. Hargett, Ph.D.
Director of Research Compliance and Ethics
North Carolina A&T State University

F. Claire Hankenson, DVM. MS, DACLAM
Director and Attending Veterinarian, Campus Animal Resources
Professor, Pathobiology and Diagnostic Investigation, CVM
Michigan State University

for IBC audiences for IACUC audiences
Biosafety Program Building/Project Management

Angela C. Birnbaum
Director of Biosafety
Tulane University

Session description

for IRB audiences
IRB Considerations in De- and Re-Identification of Data

Elizabeth A. Buchanan, Ph.D.
Endowed Chair and Director, Center for Applied Ethics
Acting Director, Office of Research and Sponsored Programs
University of Wisconsin – Stout
Wisconsin’s Polytechnic University

for All audiences

Research Integrity, Ethics and You… Using Training and Communication to Advance Your Team Research Integrity Program

(a hands-on/interactive session)

Marley J. Thrasher
Assistant Director, Education and Communications
Office of Research, Innovation and Economic Development
Contracts and Grants
North Carolina State University

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


Ross Hickey, J.D., CIP, CPIA 

Assistant Provost for Research Integrity
Director, Maine Regulatory Training and Ethics Center


Will So, Ph.D.

Policy & Program Specialist
Biological Countermeasures Unit
Weapons of Mass Destruction Directorate
Federal Bureau of Investigation

Angelica N. Martins, Ph.D., RBP
Biosafety Officer
Office of Research Compliance
Research and Economic Development
University of North Carolina at Charlotte

Session description

Refreshment Break

for All audiences

Research Integrity, Ethics and You… Using Training and Communication to Advance Your Team Research Integrity Program

(a hands-on/interactive session)

continued

Adjourn

Day 2 Agenda (Friday, March 16, 2018)

Registration & Breakfast

Special Topics Breakout Sessions

for IBC audiences for IACUC audiences
Controlled Substances

Terrence L. Boos, Ph.D.
Section Chief
Drug & Chemical Evaluation Section
Diversion Control Division
Drug Enforcement Administration

Colleen Bennett, MS
Assistant Director, Oversight and Outreach
Clinical and Translational Science Institute
Wake Forest School of Medicine

Dorcas P. O’Rourke, DVM
Professor & Chair
Department of Comparative Medicine
Brody School of Medicine
Attending Veterinarian
East Carolina University

for IBC audiences for IACUC audiences
How to Balance Open Science and Security

Sonia Hunt
Biological Countermeasures Unit
Weapons of Mass Destruction Directorate
Federal Bureau of Investigation

 for IRB audiences
Confessions of a Research Compliance Officer: Lessons Learned, The Hard Way

Jeff M. Seo, J.D.
Assistant Vice Provost for Research Compliance
Northeastern University

Session description

Break

Morning 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, BS, CPIA
Director, IACUC Office
The Scripps Research Institute

Eileen Morgan
Director, Division of Assurances
Office of Laboratory Animal Welfare (OLAW)
National Institutes of Health (NIH)

William Stokes, DVW, DACLAM, DACAW, BCES, FATS
Assistant Director, Animal Welfare Operations
USDA, APHIS, Animal Care
Session description

for all audiences
Importing and Exporting Biological Materials, Equipment and Technology

Daniel Vick, MBA
Director, Export Controls
Duke University

Deborah L. Dufficy, DVM, MPH, DACVPM
Senior Staff Officer, Organisms and Vectors Permitting
Agricultural Select Agent Services (AgSAS)
National Import Services
USDA, APHIS, Veterinary Services

Jodi L. Kouts
Senior Export Policy Analyst
Office of Nonproliferation and Treaty Compliance
Chemical and Biological Controls Division
U.S. Department of Commerce

Session description

for IRB audiences
Does The Thought of International Research Keep You Up At Night?

Kelé Piper, MS, CIP,CHRC
Director, Research Compliance
Beth Israel Deaconess Medical Center

Session description

Breakout Sessions

for IACUC audiences
Responsible Conduct in Research Data Management

Patricia Condon, Ph.D.
Research Data Services Librarian
University of New Hampshire

Session description

for all audiences
Spot the Issues!

Christina Nascimento, MS, CPIA
IACUC Manager
Brigham and Women’s Hospital

Kathryn Harris, Ph.D., RBP
Contractor
Senior Outreach and Education Specialist Program
Office of Science Policy
National Institutes of Health (NIH)

Ted Myatt, Sc.D., RBP
Practice Director, Life Sciences
Environmental Health & Engineering, Inc.

Jeff M. Seo, J.D.
Assistant Vice Provost for Research Compliance
Northeastern University

FBI speaker (TBA)

Lunch

Afternoon Sessions

for IACUC audiences
Responsible Conduct in Research Data Management
(continued)

for IBC audiences for IRB audiences
Considerations for Institutional Oversight of Human Gene Transfer Studies

Ted Myatt, Sc.D., RBP
Practice Director, Life Sciences
Environmental Health & Engineering, Inc.

Daniel Eisenman, Ph.D., RBP, SM (NRCM), CBSP
Biological Safety Officer
Schulman IRB/IBC

Session description

for IRB audiences
Precision Medicine: Balancing the Benefits of Big Data with Individual Rights

Elizabeth Kipp Campbell, Ph.D., CIP
Director
Office of Human Research Ethics
University of North Carolina at Chapel Hill

for All audiences

Biosecurity…Assessing Biothreats

F. Claire Hankenson, DVM
Director and Attending Veterinarian Campus Animal Resources
Professor, Pathobiology and Diagnostic Investigation, CVM
Michigan State University

Angela C. Birnbaum
Directory of Biosafety
Tulane University

Lynell Dupree, BS, RLATG, CMAR
Associate Director
Department of Comparative Medicine
Tulane University

Elizabeth Kipp Campbell, Ph.D., CIP
Director
Office of Human Research Ethics
University of North Carolina at Chapel Hill

Moderators:
CeCe Brotchie-Fine, MA, CPIA
Associate Director, Global AWC Due Diligence
NIBR CA IACUC Chair & Animal Welfare Officer
Novartis Institutes for BioMedical Research, Inc.

Sonia Hunt
Biological Countermeasures Unit
Weapons of Mass Destruction Directorate
Federal Bureau of Investigation

Will So, Ph.D.
Policy & Program Specialist
Biological Countermeasures Unit
Weapons of Mass Destruction Directorate
Federal Bureau of Investigation

Refreshment Break

for All audiences

Biosecurity…Assessing Biothreats

 (continued)

Closing Remarks

Adjourn

Registration
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Sponsorship Fact Sheet

Event Details
  • March 14, 2018
    Preconference Workshops

     

    March 15-16, 2018
    Main Conference

  • Conference Location
    The Carolina Inn
    211 Pittsboro St.
    Chapel Hill, N.C.

     

    Click here to book at the discounted block rate of $189+ tax before February 19, 2018. Government Rate $115.

  • Who It’s For
    • Compliance officers and specialists
    • Research oversight officials
    • General and legal counsel
    • Government relations professionals
    • Policy directors
    • Security professionals

  • Deadline to register online is
    Monday, March 5, 2018

Format & Pricing
  • March 14, 2018:
    Preconference Workshops (3 Options)

     

    1.  ABCs for IACUCs & IBCs: Frameworks for Compliance™

    11:00 a.m. – 5:00 p.m.
    This half-day workshop is included in the cost of the main conference. Main conference registration is required to attend. A mid-day snack will be available for the half-day workshops.


    2.  
    Understanding the Compliance Intersection: A Guide to Understanding Areas of Compliance Beyond the IACUC, IBC and IRB™

    11:00 a.m. – 5:00 p.m.
    This half-day workshop is included in the cost of the main conference. Main conference registration is required to attend. A mid-day snack will be available for the half-day workshops.


    3.  
    IACUC = Implementing Assurance Compliance Understanding and Confidence: A Nuts and Bolts Approach to IACUCS and Animal Care and Use Programs©

    8:00 a.m. – 5:00 p.m.

    A separate registration fee is required for this full-day workshop. Main conference registration is not required to attend. Full breakfast, lunch, breaks, conference materials and parking are included in the fee.

     


    March 15-16, 2018
    :
    Main Conference
    7:00 a.m. – 5:00 p.m

    Full breakfast, lunch, breaks, conference materials and parking are included in the fee for the main conference registration package.

  • Prices Through January 5, 2018
    (includes half-day Preconference Workshop Options 1 & 2)

    • $495 for employees of MSMR, NCABR or SUBR member organizations
    • $525 for government/state employees
    • $625 for others


    Preconference Workshop Option 3 (full-day):

    • $250 plus conference fee – for those attending the conference

    • $375 for those not attending the conference

     

    Prices Starting January 6, 2018

    (includes Preconference Workshop Options 1 & 2)
    • $595 for employees of MSMR, NCABR or SUBR member organizations
    • $625 for government/state employees
    • $725 for others


    Preconference Workshop Option 3 (full-day):

    • $300 for those attending the conference

    • $425 for those not attending the conference

  • Payments by Check
    Please make your check out to “Massachusetts Society for Medical Research” and mail it to:
    MSMR
    Attn: Three I’s Conference
    73 Princeton Street
    Suite 311
    North Chelmsford, MA 01863

     

    Your check must be received no later than March 5 for your registration to be valid. If your check has not been received by that date, your registration will be canceled.

  • Cancellation Policy
    Orders canceled on or before January 5, 2018, are eligible for a full refund, less a $100 administrative fee.

    Orders canceled after January 5, 2018, are not eligible for a refund.

    To cancel, please notify Regina Williams at the contact info below.

  • Substitution Policy
    A substitution from the registrant’s organization is permitted. Please notify Regina Williams at the contact info below at least seven days in advance of the conference.

  • Questions About Registration?
    Contact Regina Williams, North Carolina Association for Biomedical Research, at rwilliams@ncabr.org or 919-785-1304 x 202

  • Other Questions?
    Contact Lynne Walsh, Massachusetts Society for Medical Research, at msmr@att.net or 978-251-1556