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Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review

In the United States, several regulations and federal policies govern the use of potentially biohazardous materials in research and industry. Part of this oversight is assigned by mandate to Institutional Biosafety Committees (IBCs). However, most research entities give additional responsibilities t...

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Detalles Bibliográficos
Autores principales: Rainer, David, Cook, Susan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7149535/
http://dx.doi.org/10.1016/B978-0-12-801885-9.00005-6
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author Rainer, David
Cook, Susan
author_facet Rainer, David
Cook, Susan
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description In the United States, several regulations and federal policies govern the use of potentially biohazardous materials in research and industry. Part of this oversight is assigned by mandate to Institutional Biosafety Committees (IBCs). However, most research entities give additional responsibilities to their IBC to take advantage of a standing body with significant expertise in review and oversight of biohazardous research. Two case studies are provided to highlight functions of the IBC which are not mandated, yet are critical for safe and responsible research. There are also types of biohazardous work that are currently unregulated and receive no review from an IBC or other group of subject matter experts, leaving a gap in safety oversight. To mitigate the hazard of working with potentially hazardous unregulated biological material, the necessity of performing a risk assessment and of performing a hazard review by subject matter experts, such as those on an IBC, is of paramount importance.
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spelling pubmed-71495352020-04-13 Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review Rainer, David Cook, Susan Ensuring National Biosecurity Article In the United States, several regulations and federal policies govern the use of potentially biohazardous materials in research and industry. Part of this oversight is assigned by mandate to Institutional Biosafety Committees (IBCs). However, most research entities give additional responsibilities to their IBC to take advantage of a standing body with significant expertise in review and oversight of biohazardous research. Two case studies are provided to highlight functions of the IBC which are not mandated, yet are critical for safe and responsible research. There are also types of biohazardous work that are currently unregulated and receive no review from an IBC or other group of subject matter experts, leaving a gap in safety oversight. To mitigate the hazard of working with potentially hazardous unregulated biological material, the necessity of performing a risk assessment and of performing a hazard review by subject matter experts, such as those on an IBC, is of paramount importance. 2016 2016-02-19 /pmc/articles/PMC7149535/ http://dx.doi.org/10.1016/B978-0-12-801885-9.00005-6 Text en Copyright © 2016 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Rainer, David
Cook, Susan
Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review
title Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review
title_full Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review
title_fullStr Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review
title_full_unstemmed Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review
title_short Overcoming regulatory gaps in biological materials oversight by enhancing IBC protocol review
title_sort overcoming regulatory gaps in biological materials oversight by enhancing ibc protocol review
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7149535/
http://dx.doi.org/10.1016/B978-0-12-801885-9.00005-6
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