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.

 

 

Preconference Workshops (Wednesday, March 14, 2018)

ABCs for IACUCs & IBCs: Frameworks for Compliance™

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.

 

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.

Animal Care Programs and the IACUC – An Overview

* Key Elements of an Effective Program
* Key Players: Their Roles & Responsibilities
* Functions of an IACUC:  Protocol Processing
* Requirements for Review
* FCR, DMR, and VVC
* Functions of an IACUC:  Semiannual Program Evaluation and Facility Inspections
* Staying on top of semiannual inspections
* Review methods
* Review documentation
* Functions of an IACUC: Role in Overseeing the Training Program
* Functions of an IACUC: Role in Post approval Monitoring
* PAM Methods
* Making the most of what you already do!
* Functions of an IACUC:  Investigating Concerns  and Noncompliance
* Sources of Concerns
* Approaches to Investigations
* Suspensions
* Functions of an IACUC:  Reporting Responsibilities
* Reports to the Institutional Official
* Reports to External Agencies
* Q & A

Marcy Brown, BS, MA, CMAR, CPIA
Animal Welfare and IACUC Program Specialist
AAALAC, International ad hoc 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)

Edward H. You
Supervisory Special Agent
Biological Countermeasures Unit
Weapons of Mass Destruction Directorate
Federal Bureau of Investigation (FBI)

for All audiences

Translational Research
Bench-To-Bedside

TBA

for All audiences

Biosecurity and Effectively Communicating via Social Media

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

Debra Speert, Ph.D.
Director of Communications
FASEB

Amanda Dettmer, Ph.D.
Speaking of Research

Break

Regulatory Breakout Sessions

for IACUC audiences
OLAW Update, PHS Policy and Assurance Expectations

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

for IBC audiences
NIH-OBA

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

for IRB audiences
Common Rule Revisions

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

for All audiences

Misconduct for NON-ROIs…(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 Collide – Finding Balance

TBA

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

Angela C. Birnbaum
Director of Biosafety
Tulane University

for IRB audiences
DE Identify – Data IRB

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

Designing/Developing a Research Integrity & Ethics Training Program

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

Deb Paxton
North Carolina State University


Marcy Brown, BS, MA, CMAR, CPIA
Animal Welfare and IACUC Program Specialist
AAALAC, International ad hoc 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 HQ

Refreshment Break

for All audiences

Designing/Developing a Research Integrity & Ethics Training Program

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

Deb Paxton
North Carolina State University


Marcy Brown, BS, MA, CMAR, CPIA
Animal Welfare and IACUC Program Specialist
AAALAC, International ad hoc 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 HQ

Day 2 Agenda (Friday, March 16, 2018)

Registration & Breakfast

Special Topics Breakout Sessions

for IRB audiences for IACUC audiences
Controlled Substances

Colleen Bennett
Oversight and Outreach Manager Office of Research
School of Medicine
Wake Forest Baptist Health

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
FBI – Dual Use

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

 for IRB audiences
IRB

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

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
AAALAC, International ad hoc 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

for all audiences
Import/Export

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

for IRB audiences
International Research

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

Breakout Sessions

for IACUC audiences
Responsible Conduct in Research Data Management

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

for all audiences
Spot the Issues!

Kathryn A. Holthaus, MS, MA
Director of Research Subjects Protection and Laboratory Safety Compliance
Research Administration and Compliance
Brigham and Women’s Hospital

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

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

Lunch

Afternoon Sessions

TBA

for All audiences

Biosecurity…Assessing Biothreats

What You Should Know to Help Mitigate the Threat of Bioterrorism

F. Claire Hankenson, DVM
Director, Campus Animal Resources
Michigan State University

Angela C. Birnbaum
Directory of Biosafety
Tulane University

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

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 HQ

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

Refreshment Break

for All audiences

Biosecurity…Assessing Biothreats

What You Should Know to Help Mitigate the Threat of Bioterrorism

F. Claire Hankenson, DVM
Director, Campus Animal Resources
Michigan State University

Angela C. Birnbaum
Directory of Biosafety
Tulane University

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

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 HQ

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

Closing Remarks

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™

    11:00AM – 5:00PM
    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™

    11:00AM – 5:00PM
    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©

    8:00AM – 5:00PM

    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
    7:00AM – 5:00PM

    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