Event Month: September

National Science Advisory Board for Biosecurity (NSABB) Meeting

Event Date: 09/21/2022

Time: 1pm to 5pm

Virtual Meeting

Federal Register Notice

Webcast

Agenda

Minutes

Additional Files

Public Comments

To sign up to make an oral public comment at the meeting, please send an email to SciencePolicy@od.nih.gov at least one business day prior to the meeting date. Once all time slots are filled, only written comments will be accepted. Any interested person may file written comments by forwarding the statement to SciencePolicy@od.nih.gov at least one business day prior to the meeting date. The statement should include the name, address, telephone number and, when applicable, the business or professional affiliation of the interested person. Other than name and contact information, please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your comments. Please note that any written comments NIH receives may be posted unredacted to the Office of Science Policy website.

Public Comments

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Novel and Exceptional Technology and Research Advisory Committee

Event Date: 07/14/2022 - 07/14/2022

Time: 1:00 PM to 2:30 PM ET

Federal Register Notice

NIH Videocast: 

The Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) will hold a virtual meeting to hear an update from the Working Group on Data Science and Emerging Technology on its work to address the charge the Committee received in June 2021.

Registration is not required to view the webcast.

Agenda

Minutes

Progress on Phase 1 of Current Charge

Additional Meeting Materials

Public Comments

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Single IRB Review for Multi-Site Research Resource and Infrastructure Development Workshop

Event Date: 09/12/2018

Time: 8:30 am – 3:45 pm

Location:

1750 Rockville Pike
Rockville, MD 20852

On September 12, 2018, NIH held a Workshop on Single IRB Resource and Infrastructure Development.  The workshop focused on successful strategies and lessons learned for modifying and enhancing institutional IRB infrastructure for single IRB review of multi-site studies.

Agenda
Biographies
Relevant Information and Resources
Presentations

SESSION I – Customizing eIRB Systems to Review Multisite Studies Using a Single IRB Model, Medical University of South Carolina

SESSION I – Models for Institutions Serving as sIRB of Record, Washington University

SESSION I – Single IRB Standard Best Practices, New York University

SESSION II – Models for Assisting Institution Relying on sIRB – Partnership and Innovation Exploring Single IRB Models to Support Clinical and Translational Research, Yale University

SESSION II – Models for Assisting Institutions Relying on sIRB – Incorporating sIRB Procedures into an Existing Research Network, University of Rochester

SESSION III – Facilitating Single IRB Review for Multi-site Research:The OneIRB IT Platform, University of Penslyvania

SESSION III – Administrative Supplements for CTSA Awardees: Development of Resources to Facilitate Single IRB Review for Multi-Site Research, University of Cincinnati

Webcast

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

Event Date: 09/25/2017 - 09/26/2017

Time: 8:00 AM to 5:00 PM

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 SciencePolicy@od.nih.gov.

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

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