Biosafety Oversight and Compliance: What do you Mean, I have to Fill Out Another Form?!

Brenda L. Petrella1

1 Environmental Health & Safety, Dartmouth College, Hanover, New Hampshire
Publication Name:  Current Protocols in Microbiology
Unit Number:  Unit 1A.5
DOI:  10.1002/9780471729259.mc01a05s39
Online Posting Date:  November, 2015
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Abstract

This unit is an overview of biosafety compliance and oversight in the United States. Specific attention is given to the oversight of the Institutional Biosafety Committee (IBC) and how the purview of the IBC may overlap with other local committees, such as the Institutional Animal Care and Use Committee (IACUC) for animal research and the Institutional Review Board (IRB) for research on human subjects. Requirements for the Federal Select Agent Program and Dual Use Research of Concern (DURC) are also briefly reviewed for those working with materials and experiments covered under these regulations. This unit serves as a guide for new and established investigators who are navigating the regulatory world and how regulatory oversight applies to their research. © 2015 by John Wiley & Sons, Inc.

Keywords: biosafety; biosafety compliance; biosafety oversight; biosafety regulations; Institutional Biosafety Committee; NIH guidelines

     
 
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Table of Contents

  • Introduction
  • NIH Guidelines
  • IBC Overlap with Other Institutional Oversight Committees (IACUC, IRB)
  • IBC Oversight and the Federal Select Agent Program
  • Figures
  • Tables
     
 
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Materials

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Figures

Videos

Literature Cited

Literature Cited
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   Smith, A.R. , Johnson, B. , Weaver, P.J. , and Fitch, J.P. 2014. New Entity CDC Select Agent Registration Process‐A Practical Guide to Lessons Learned. Appl. Biosaf. 19:56‐67.
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Internet Resources
   http://osp.od.nih.gov/office‐biotechnology‐activities/biosafety/institutional‐biosafety‐committees. Office of Biotechnology Activities Web site offers several resources regarding IBCs, the NIH Guidelines, biosafety and biosecurity.
   http://osp.od.nih.gov/office‐biotechnology‐activities/biosafety/nih‐guidelines. Link to the NIH Guidelines in html or PDF formats.
   http://osp.od.nih.gov/office‐biotechnology‐activities/biomedical‐technology‐assessment/hgt. Information regarding human gene transfer regulations.
   http://www.cdc.gov/biosafety/publications/bmbl5/. The Biosafety in Microbiological and Biomedical Laboratories is the lead reference for guidance on laboratory safety, practices and procedures, containment, etc.
   http://www.selectagents.gov/index.html. The Select Agent Web site has a wealth of information about the Federal Select Agent Program, including extensive FAQs.
   http://osp.od.nih.gov/office‐biotechnology‐activities/biosecurity/dual‐use‐research‐concern
   http://www.phe.gov/s3/Pages/about.aspx
   http://www.phe.gov/s3/dualuse/Documents/durc‐companion‐guide.pdf. Key Web sites and documents on Dual Use Research of Concern.
   http://www.fda.gov/default.htm. U.S. Food and Drug Administration Home Page.
   http://www.phe.gov/s3/dualuse/documents/durc‐policy.pdf. United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.
   http://www.phe.gov/s3/dualuse/Documents/us‐policy‐durc‐032812.pdf. United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern.
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