Stakeholder Engagement Workshop on Implementation of the USG Policy for Institutional Oversight of Life Sciences DURC

Location: 701 N Michigan Ave
Chicago, IL 60611
USA

On September 25-26, 2017, the U.S. Government hosted a public workshop to engage with stakeholders and facilitate information sharing among research institutions regarding their approaches to, and experiences with, implementing the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC).  The National Science Advisory Board for Biosecurity (Needs Link) helped to develop the agenda and plan the workshop.

Institutional oversight is a critical component of a comprehensive DURC oversight system because institutions are most familiar with the life sciences research conducted in their facilities and are in the best position to promote and strengthen the responsible conduct and communication of results.  This two-day workshop involved discussions with diverse institutional representatives and facilitated the sharing of experiences, strategies, best practices, challenges, and solutions regarding policy implementation and the identification and management of DURC.

Topics included:

  • Approaches taken to implement the policy
  • Experiences associated with policy implementation and steps taken to address any challenges encountered
  • Procedures established for reviewing research and identifying DURC
  • Experiences with developing and/or implementing risk mitigation plans
  • Best practices and novel strategies for managing DURC
  • Effective strategies for educating and training investigators and staff about DURC issues

Questions about the workshop may be sent to [email protected].

Agenda (Needs Link)

Slides

Welcome and Introduction
Carrie D. Wolinetz, Ph.D., National Institutes of Health (Needs Link)

SESSION I – Overview of the U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern
Carrie D. Wolinetz, Ph.D., National Institutes of Health

SESSION II – Establishing an Institutional Framework for Governance of Dual Use Research of Concern and an Institutional Review Entity
Cheryl Doerr, M.S., M.A., Kansas State University
Rebecca Moritz, M.S., CBSP, SM(NRCM), University of Wisconsin, Madison
Bruce Whitney, Ph.D., Texas A&M University System
Robert Ellis, Ph.D., CBSP, Colorado State University

SESSION III – Institutional Processes for Identifying and Reviewing Research Subject to the Policy
Andrew S. Pekosz, Ph.D., Johns Hopkins Bloomberg School of Public Health
David Pitrak, M.D., University of Chicago Medical Center
Philip M. Potter, Ph.D., St. Jude Children’s Research Hospital

SESSION IV – Risk Mitigation: Federal Agency Perspectives
Dennis M. Dixon, Ph.D., National Institute of Allergy and Infectious Diseases, National Institutes of Health
Steve Monroe, Ph.D., Centers for Disease Control and Prevention (discussion; no slides)

SESSION V – Institutional Approaches to Developing and Implementing Risk Mitigation Plans
Joseph Kanabrocki, Ph.D., SM(NRCM), University of Chicago
Rebecca Moritz, M.S., CBSP, SM(NRCM), University of Wisconsin-Madison
Adolfo Garcia-Sastre, Ph.D., Icahn School of Medicine at Mount Sinai

SESSION VI – Open Forum for Stakeholder Input (discussion; no slides)

SESSION VII – Institutional Approaches to Raising Awareness and Educating Personnel about DURC
Brandy Nelson, M.S., CBSP, SM(NRCM), University of Kentucky
Jennifer A. Perkins, M.A., CPIA, University of California, Los Angeles
Richard Frothingham, M.D., CBSP, Duke University School of Medicine

SESSION VIII – Research Investigator Perspectives on Implementation of the Institutional DURC Policy
Christopher J. Ehrhardt, Ph.D., Virginia Commonwealth University
Balaji Manicassamy, Ph.D., University of Chicago
Daniel R. Perez, Ph.D., University of Georgia College of Veterinary Medicine

SESSION IX – Open Forum for Stakeholder Input (discussion; no slides)

Webcasts

Day 1 – https://www.youtube.com/watch?v=mFBx4dEghIA

Day 2 – https://www.youtube.com/watch?v=tdeGOx5c6vY

NIH Guidelines: Honoring the Past, Charting the Future

On July 18-19, 2017, the NIH Office of Science Policy held a workshop on the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.  The goals of the workshop were to examine the current biosafety oversight framework, and discuss the future direction of biosafety oversight in light of the emergence of new technologies in the life sciences and the evolution in our understanding of risk and safety.

Questions about the workshop may be sent to [email protected].

Agenda

Asilomar ’75: The Beginning of the Future

A retrospective video from some of the participants of the landmark “International Congress on Recombinant DNA Molecules” (aka Asilomar Conference) regarding the legacy of that historical event.

Slides

Welcome and Introduction

Session I – David Baltimore, Ph.D.

Session II – Jessica Tucker, Ph.D.

Session II – Stephen J. Libby, Ph.D.

Session II – Hans-Peter Kiem, M.D., Ph.D.

Session III – Deborah E. Wilson, RADM, DrPH, CBSP

Session III – Samuel Edwin, Ph.D.

Session III – Thomas Nerad, MPH, Ph.D.

Session IV – Zach Adelman, Ph.D.

Webcasts

Attendees may view the meeting remotely by visiting www.videocast.nih.gov, or clicking on the links below:

Day 1: https://videocast.nih.gov/summary.asp?live=24762&bhcp=1

Day 2: https://videocast.nih.gov/summary.asp?live=24766&bhcp=1

National Science Advisory Board for Biosecurity (NSABB) Meeting

Webcasts

(teleconference meeting only)

Agenda

Meeting Minutes

Slides

Additional Files

For accessibility assistance with these files, please contact: [email protected].

National Science Advisory Board for Biosecurity (NSABB) Meeting 2017

Telephone conference call only (no in-person meeting)

Webcasts

(teleconference meeting only)

Agenda

Slides

Additional Files