Status Brief
History/Origins:
Developmental Milestones/Developments to Date:
Current Assessment/State of the Field:
Problems/Challenges:
Proposals:
2005
Concejo Superior de Investigaciones Scientíficas (Spain, Centre National de la Recherche Scientifique (France), Polish Academy of Sciences (Poland), The Royal Society (United Kingdom) “Implementing the ERC in Partnership with the European Institutions The Scientific Autonomy and the Self-governance of the European Research Council (ERC)” Sept. 19, 2005. http://www.mpg.de/pdf/brussels/politicalStatement050919.pdf
- “The European Commission has made commendable and rapid progress in working towards the establishment of a European Research Council. …The essential point being that the ERC should be able to promote basic research solely in accordance with its own scientific standards.”
Scientific Self-Governance, Europe
2013
Fouchier, Ron, García-Sastre, Adolfo, Kawaoka, Yoshihiro et al., “Transmission Studies Resume for Avian Flu,” Science Express – Letters, January 23, 2013 http://www.sciencemag.org/content/early/2013/01/22/science.1235140.full.pdf last checked January 24, 2013.
- ”In January 2012, influenza virus researchers from around the world announced a voluntary pause of 60 days on any research involving highly pathogenic avian influenza H5N1 viruses leading to the generation of viruses that are more transmissible in mammals. We declared a pause to this important research to provide time to explain the public-health benefits of this work, to describe the measures in place to minimize possible risks, and to enable organizations and governments around the world to review their policies (for example on biosafety, biosecurity, oversight, and communication) regarding these experiments.”
- ”The World Health Organization has released recommendations on laboratory biosafety for those conducting this research, and relevant authorities in several countries have reviewed the biosafety, biosecurity, and funding conditions under which further research would be conducted on the laboratory-modified H5N1 viruses. Thus, acknowledging that the aims of the voluntary moratorium have been met in some countries and are close to being met in others, we declare an end to the voluntary moratorium on avian flu transmission studies.”
- “The controversy surrounding H5N1 virus transmission research has high-lighted the need for a global approach to dealing with dual-use research of concern.”
- ”Because H5N1 virus transmission studies are essential for pandemic preparedness and understanding the adaptation of influenza viruses to mammals, re-searchers who have approval from their governments and institutions to conduct this research safely, under appropriate biosafety and biosecurity conditions, have a public-health responsibility to resume this important work.”
- ”Scientists should not restart their work in countries where, as yet, no decision has been reached on the conditions for H5N1 virus transmission research. At this time, this includes the United States and U.S.-funded research conducted in other countries.”
- ”Scientists should never conduct this type of research without the appropriate facilities, oversight, and all necessary approvals. We consider biosafety level 3 conditions with the considerable enhancements (BSL-3+) outlined in the referenced publications as appropriate for this type of work, but recognize that some countries may require BSL-4 conditions in accordance with applicable standards (such as Canada).”
- ”We fully acknowledge that this research—as with any work on infectious agents—is not without risks. However, because the risk exists in nature that an H5N1 virus capable of transmission in mammals may emerge, the benefits of this work outweigh the risks.”
Scientific Self-Governance, Dual Use, Flu, Biosafety, Biosecurity, WHO, Open Science, Oversight, Public Health, Canada, Risk, BSL, Pandemic
Roos, Robert, “NIH panel supports stronger safeguards for H5N1 research,” January 25, 2013, CIDRAP News, http://www.cidrap.umn.edu/cidrap/content/influenza/avianflu/news/jan2512biosafety.html
last checked Jan 26, 2013.
- ”A federal advisory committee yesterday recommended increased biosafety precautions for research involving H5N1 avian influenza viruses that can spread among mammals, a step that stems from the ongoing controversy over studies involving lab-modified H5N1 strains that show increased transmissibility in ferrets.”
- ”The Recombinant DNA Advisory Committee (RAC) of the National Institutes of Health (NIH) called for a number of additions to enhanced biosafety level 3 (BSL-3) precautions, which scientists have used in recent studies involving more-transmissible H5N1 viruses.
- ”… the committee rejected the option of advocating the highest level of biosafety, BSL-4, a standard that only a few labs around the world can meet. Just one member of the panel supported going to BSL-4.”
- ”The steps include things like more personal protective equipment, a “buddy system” for workers, taking baseline serum samples, giving a licensed H5N1 vaccine, if available, to all lab workers, and requiring personnel to avoid contact with susceptible bird species for 5 days after working with the viruses in question.”
- ”The recommendations come just a day after 40 leading flu researchers from around the world declared an end to a year-old moratorium on H5N1 “gain of function” research, meaning experiments leading to increased transmissibility or pathogenicity.”
- ”The stated aim of the RAC meeting was to look at biosafety in research on highly pathogenic avian influenza (HPAI) H5N1 viruses that can spread among mammals by respiratory droplets.”
- ” … higher containment than BSL-3 will be needed if an H5N1 virus isn’t sensitive to antivirals. Any experiment designed to increase the virus’s drug resistance would require approval from the NIH director or another federal agency, she added.”
- ”… Corrigan-Curay said existing BSL-3 specificiations include PAPRs, a protective suit, wrap-back disposable gowns, double gloving, shoe covers, and a shower before leaving the lab. The working group recommended adding the use of protective sleeves over gowns in a biosafety cabinet, spraying or wiping down PPE with disinfectant, and a buddy system, meaning a requirement to have two people in the lab at all times when work is going on.”
- ”The working group also recommended a personnel quarantine, meaning workers should avoid contact with susceptible birds for 5 days after working with mammal-transmissible H5N1 viruses. That recommendation imitates a US Department of Agriculture rule for those who work with HPAI viruses.”
Oversight, Public Health, Biosafety, BSL, Law, Flu, Scientific Self-Governance