Three I’s & Biosecurity Conference

Presented by

3i-presenters

There are dozens of webinars, online workshops, symposiums and conferences for the IACUC, IBC and IRB communities — but there’s only one Three I’s conference.

The Three I’s & Biosecurity: Creating Connections, Sharing Solutions, Building Strategies will address the emerging and complex challenges that touch the IACUC, IBC and IRB communities — issues relating to nanotechnology, CRISPR technology, 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.

Highlights will include:

  • Action vs. Reaction: Disaster planning for the 21st century
  • Collaboration & Compliance: The ABCs for IACUCs & IBCs
  • PRIM&R IRB Course
  • Timely Topics: Dual use, Common Rule revisions, conflict of interest, research integrity
  • Dozens of other presentations that will engage and provide hands-on materials and experiences to take home

The Massachusetts Society for Medical Research, the North Carolina Association for Biomedical Research and the FBI Weapons of Mass Destruction Directorate, 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 April 14–15. Half-day workshops will be held Wednesday, April 13, on disaster planning, the ABCs for IACUCs & IBCs, and specialized training for IRBs led by PRIM&R.

Each attendee may attend only one half-day workshop, which is included in the price of a main conference registration. There is a separate fee to attend the half-day workshop without attending the main conference.

Presenting Sponsor

Supporting Sponsors

Speakers From...

  • Beth Israel Deaconess Medical Center
  • Boston Children’s Hospital
  • Brigham and Women’s Hospital
  • Centers for Disease Control and Prevention (CDC)
  • Copernicus Group
  • Duke University/ Duke University Health System
  • Emory University
  • FBI Weapons of Mass Destruction Division
  • Harvard University/ Harvard Medical School
  • National Institute of Environmental Health Sciences
  • NIH Office of Biotechnology Activities (OBA)
  • NIH Office of Laboratory Animal Welfare (OLAW)
  • North Carolina State University
  • Novartis
  • Pfizer
  • PRIM&R
  • Tulane University
  • U.S. Department of Agriculture (USDA)
  • U.S. Department of Commerce
  • U.S. Environmental Protection Agency (EPA)
  • University of Connecticut
  • University of North Carolina at Chapel Hill
  • University of Rhode Island
  • University of Wisconsin-Stout
  • Yerkes National Primate Research Center

Half-Day Workshop Agenda (Wednesday, April 13)

PRIM&R’s Specimens, Servers and Situations: Ethical Considerations in Protocol Design, Conduct and Review

Sponsored and conducted by PRIM&R

This intensive half-day program is designed for research professionals who understand the basic principles governing human subjects research but want to deepen their knowledge of core regulatory and ethical issues and learn practical strategies for effective design, conduct and review of research with human subjects. The program begins with a brief overview of the criteria for review applicable to federally funded human subjects research, including an examination of the recently proposed changes to the Common Rule. Three interactive modules on research with biological specimens, unanticipated problems and adverse events, and Internet research will round out the program. The course is designed for all members of an institution’s human research protections program, including institutional review board members and staff, investigators and research staff and institutional officials.

George Gasparis
President
The Peer Consulting Group, LLC

ABCs for IACUCs & IBCs: Frameworks for Compliance™

Conducted by MSMR

ABCs for IACUCs & IBCs: Frameworks for Compliance™ is an MSMR training program designed and developed for IACUCs and IBCs. Those who will profit most from this training program are IACUC and IBC administrators and staff, committee members (including non-affiliated members), research administrators, compliance staff, occupational health and safety staff, vivarium staff and attending veterinarians.

ABCs 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 will also address USDA/APHIS/AC Policy 15.

Both the IACUC and the IBC are committed to ensuring the protection of the research staff, the animal husbandry staff, veterinarians and all others involved in research or who may have contact with or exposure to biohazardous agents. Those participating in the program will:

  • Receive a clear overview of the laws, regulations and policies that govern the 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 they will 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
  • Engage in discussion with colleagues to share ideas about best practices, resources, innovative approaches and collaborations

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

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

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

David Goldberg, MS
Associate Director, Research Operations
Boston Children’s Hospital

Ted Myatt, ScD
Director of Research Integrity
University of Rhode Island

Disaster Planning for the 21st Century

This workshop will include lecture-style presentations from speakers representing each of the 3 I’s and the FBI, followed by a participatory scenario game. The initial presentations will provide the tools and information that participants will use to act out their roles in the interactive scenario game later in the session. Following the game activity, there will be a debriefing and a panel-style discussion between attendees and panelists.

Ron E. Banks, DVM, ACLAM, ACVPM, CPIA

Angie Birnbaum
Director of Biosafety
Tulane University

CeCe Brotchie-Fine, MA, CPIA
Manager, Animal Welfare Compliance
IACUC Chair & Animal Welfare Officer
Novartis Institutes for BioMedical Research, Inc.

Marcy Brown, B.S., M.A., CPIA
Regulatory Compliance
Comparative Medicine – La Jolla
Pfizer, Worldwide Research & Development
PRIM&R CPIA Council Vice-chair
AAALAC, International Ad Hoc Specialist

Charlotte H. Coley, MACT, CIP
Training Coordinator
Office of Human Research Ethics—IRB
University of North Carolina at Chapel Hill

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

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

Day 1 Agenda (Thursday, April 14)

Registration & Breakfast

Welcome & Introduction

Alan Dittrich, Ph.D.
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

Who’s Behind the Wheel? Gene Drives and Biosafety Challenges

Jennifer Kuzma, Ph.D.
Goodnight-NC GSK Foundation Distinguished Professor
Co-Director, Genetic Engineering and Society Program
School of Public and International Affairs
North Carolina State University

for All audiences

Biosecurity and CRISPR

Kathleen M. Vogel, Ph.D.
Director, Science, Technology and Society Program
Associate Professor, Department of Political Science
North Carolina State University

Regulatory Breakout Sessions

for IACUC audiences
OLAW Update, PHS Policy and Assurance Expectations
This session will describe the key elements of the PHS Policy and OLAW’s oversight responsibility, and will specify the details of the impact of the recent MOU between NIH/OLAW and the NSF to both PHS and NSF-funded institutions. It will depict recent updates to OLAW guidance regarding the definitions of the membership roles of the IACUC and also explain recent simplifications to the Vertebrate Animal Section in NIH grant applications and the impact for completion and review of the updated document.


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
Program on Biosecurity and Biosafety Policy
National Institutes of Health (NIH)

for IRB audiences
Common Rule Revisions
On September 8, 2015, the U.S. Department of Health and Human Services and fifteen other agencies issued a Notice of Proposed Rulemaking (NPRM) to revise the “Common Rule” regulations that govern research involving human subjects. If adopted, these would be the first substantive changes since 1981, altering requirements and procedures for informed consent, use of biospecimens, multisite trials and review of human subjects research. This session will preview proposed changes and discuss what they mean for researchers, IRBs and their institutions.


Daniel Nelson

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

for Security audiences
Closed Session for FBI only

Break

for All audiences

Trends in Research Misconduct Cases: Anticipating and Mitigating Risks

This session takes a look at current trends and environmental factors that contribute to questionable research practices and deceptive behavior, and attempts to provide attendees with practical strategies that can be applied to mitigate risk in this growing area of reputational, financial and institutional vulnerability.


Jeff M. Seo, J.D., LLM

Executive Director
Office for Academic and Research Integrity
Harvard Medical School

Lunch

Breakout Sessions

for IACUC audiences for IBC audiences
Animal Transport: The Grey Area

Angela C. Birnbaum
Director of Biosafety
Tulane University

for IBC audiences
The False Claims Act and the IBC

Jeff M. Seo, J.D., LLM
Executive Director
Office for Academic and Research Integrity
Harvard Medical School

for IBC audiences for IRB audiences
Conflicts of Interest in Research

Wesley G. Byerly, Pharm. D.
Associate Vice President
Office of the Vice President for Research
Research Compliance Services
UCONN Health

for Security audiences
Closed Session for FBI only

for All audiences

Best Practices among the Three I’s…Sharing, Integration and Overlapping…Streamlining the Processes and Reducing Burden…

While the responsibilities of IACUCs, IRBs and IBCs may vary by institution, these three oversight committees are key to a successful and collaborative compliance program. This session will begin with a brief overview of the composition, structure, functions and responsibilities of each of the committees and how they can work together to promote a culture of collaboration. Faculty will provide ideas for sharing, integration and overlap of the three committees in areas such as coordination of protocol review, shared practices and processes, reducing self-imposed regulatory burden and streamlining processes. The session will conclude with interactive case study scenarios.


Marcy Brown, B.S., M.A., CPIA

Regulatory Compliance
Comparative Medicine – La Jolla
Pfizer, Worldwide Research & Development
PRIM&R CPIA Council Vice-chair
AAALAC, International Ad Hoc Specialist

Debra L. Hunt, DRPH, CBSP
Director, Biological Safety Division
Occupational and Environmental Safety Office
Assistant Professor
Duke University

Jody Power, M.S., MBA, CIP
Executive Director
Institutional Review Board
Duke University Health System

Break

for All audiences

FBI Interactive Exercise

Case studies • Table-top exercises

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

End of Day 1

Day 2 Agenda (Friday, April 15)

Registration & Breakfast

Welcome to Day 2

for All audiences

Spot the Issues!

“A” is for “animal protocol”, “Z” is for “zebra fish“ and I” is for IRB, IACUC, IBC and FBI! If only spotting the contract and compliance issues were as easy as A, B, C! Issue-spotting skills are critical. Using a fact pattern, this session will be interactive and focus on 3 I’s obvious issues, while also identifying those underlying, less obvious issues. This session will help attendees recognize the legal, regulatory and contractual issues presented by the fact pattern. While identifying and scrutinizing the important facts, the session leader will help attendees efficiently choose the best course of action to facilitate, as well as promote, compliance with federal, state, enforcement and institutional guidelines, and to support investigators and institutional officials. Attendees will have fun spotting legal, regulatory and business issues, as well as discussing best practices for navigating them and determining what to watch out for, who to notify, how to get help, when to alert institutional authorities and so on.


Ted Myatt, Sc.D.

Director of Research Integrity
Division of Research and Economic Development
University of Rhode Island

Sabune Winkler, J.D.
Director of Regulatory Affairs Operations
Harvard Clinical and Translational Science Center

Kathryn A. Holthaus, M.S.
Director
Research Subjects Protection and Laboratory Safety Compliance
Research Administration and Compliance
Brigham and Women’s Hospital

Charles Cabral, Jr., M.Sc.
Special Agent
Weapons of Mass Destruction Coordinator
FBI, Boston

Break

Breakout Sessions

for IACUC audiences for IBC audiences

Details TBA

for IACUC audiences for IBC audiences for IRB audiences
The Magic of Engagement: Focus on the Learner and Build Effective Training Programs
How can you build a training program that not only meets organizational needs and ensures compliance, but also provides a compelling experience for your learners? What do learners need to truly engage in training and retain and apply content after they leave?
In this 90-minute “boot camp,” you’ll identify best practices for creating an effective training program that meets organizational and learner needs – and helps assure compliance. Learn how to assess training needs, identify and implement appropriate training methods, develop content with the learner in mind and evaluate outcomes. This interactive session will include case studies, small-group discussions, self-reflection and feedback on specific challenges participants face.


Marley Thrasher

Manager, Training and Communications
Office of Research, Innovation and Economic Development
Sponsored Programs and Regulatory Compliance Services
North Carolina State University

for IRB audiences
Social Media, Participant Recruitment and Behavioral Studies: Craigslist and Beyond
This session will describe various approaches to participant recruitment occurring through social media networks and tools. While many recruitment sites seem straightforward, for instance, Psychological Research on the Net, researchers engaging in behavioral studies can face various challenges when recruiting participants through spaces such as Facebook or Twitter. Beyond more oft-cited concerns with subject verifiability, other concerns are emerging, including the nature of recruitment and group harms, research bystanders, and data velocity and variability and their impact on participants.


Elizabeth A. Buchanan, Ph.D.

Interim Director
Research Services
University of Wisconsin-Stout

Breakout Sessions

for IACUC audiences for IBC audiences

Details TBA

for IACUC audiences for IBC audiences for IRB audiences
The Magic of Engagement: Focus on the Learner and Build Effective Training Programs (continued)

for IRB audiences
Ethical Review and Oversight of Nanotechnology Studies Involving Human Subjects
This session will describe some types of nanotechnology studies involving human subjects and the ethical and oversight issues related to this research, including: risk minimization, risk/benefit assessment, risks to third parties, informed consent, and potential interactions between IRBs, IACUCs, and IBCs.


David B. Resnik, J.D., Ph.D.

Bioethicist and IRB Chair
National Institute for Environmental Health Sciences
National Institutes of Health

Lunch

for All audiences

Importing/Exporting

DOT inspections • Permits • Tissue • Animals • Export control issues • Classify biologicalsThe presentation will include a review of the Organisms and Vectors permit application process, USDA VS Organisms and Vectors permitting authorities, which materials require permits, the types of permits issued, the differences between import permits and interstate transport permits, helpful hints toward a seamless application and permit approval, a review of new guidelines and policies, and web resources and contact information.


Kimberly Orr, DVM, Ph.D.

Microbiologist
Chemical Biological Controls Division
Bureau of Industry and Security
U.S. Department of Commerce

Deborah L. Dufficy, DVM, MPH, DACVPM
Senior Staff Officer, Organisms and Vectors
Agriculture Select Agent Services (AgSAS)
National Import Export Services
APHIS, Veterinary Services
U.S. Department of Agriculture

Von McClee, M.S.
Branch Chief
Import Permit Program
Division of Select Agents and Toxins
Centers for Disease Control and Prevention (CDC)

Deborah Howard, MPH, CBSP
Regional Biosafety Manager, North America
Bayer CropScience

Break

for All audiences

FBI General Session

Details TBA

Closing Remarks
Evaluations

End of Conference

Continuing Education Details

Some portions of this program may meet the requirements for CPIA continuing education. The CPIA Council accepts documentation of continuing education hours when the topics fall within the CPIA Body of Knowledge. If you are unsure about whether a specific session meets these requirements you should consult with PRIM&R. Some portions of this program may meet the requirements for CIP continuing education. CCIP accepts documentation of continuing education hours when the topics fall within the CIP Body of Knowledge and the education is intended to be beyond initial, basic or fundamental level education. If you are unsure about whether a specific session meets these requirements you should consult with PRIM&R.

Registration
Become a Sponsor

Sponsorship opportunities are available. For details and to become a sponsoring partner:

Sponsorship Fact Sheet

Event Details
  • April 13, 2016: Half-day workshop 12:00PM – 5:00PM
    April 14-15, 2016: Main conference 7:00AM – 5:00PM

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

    Click here to book at the discounted, block rate of $169+ tax before March 13, 2016. Use Group Code 476640.

  • Prices Through February 24
    (includes half-day workshop)

    • $495 for employees of MSMR, NCABR or SUBR member organizations, and members of PRIM&R
    • $525 for government/state employees
    • $625 for others

     

    Prices Starting February 25
    (includes half-day workshop)

    • $595 for employees of MSMR, NCABR or SUBR member organizations, and members of PRIM&R
    • $625 for government/state employees
    • $725 for others

     

    Price for Half-Day Workshop Only
    • $195 for all attendees

     

    Full breakfast, lunch, breaks, conference materials and parking are included in the fee for the main conference registration package. A mid-day snack will be available for the half-day workshop.

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

  • 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 April 8 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 26, 2016, are eligible for a full refund, less a $100 administrative fee. Orders canceled after January 26, 2016, 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 7 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