Print ThisIn the coming weeks, research universities will know if they have a share in the C06 facility funding from the National Institutes of Health for construction and improvement of biomedical research facilities. G20 grant notifications will follow shortly thereafter. For funding proposals involving altering/modernizing/constructing space to create BSL-2/3 or ABSL-2/3 facilities -- or renovating existing facilities -- either a yes or no verdict will have serious project planning implications.
Biocontainment projects from the private sector, government, and universities all have a less-than-perfect track record. There are numerous cases of biocontainment spaces having been built that have never been able to muster certification, balancing, or validation criteria, and as a result, these costly facilities sit empty. If your biocontainment project proposal is approved for CO6 or G20 funding, the issue will be how to get a biocontainment facility built (or renovated) that will actually work.
Institutions will also face the additional challenge of conforming to the new NIH Design Requirements Manual for Biomedical and Animal Research Facilities (commonly referred to as the DRM). Universities have not previously had to conform to the DRM.
Increased Oversight
Furthermore, operating protocols for biocontainment facilities will be coming under increased oversight for safety and security. Careful attention to these evolving changes will be critical for your institution -- whether funded or not.
“Organizations will need to be prepared to integrate appropriate management practices, oversight, and training to maintain compliance with existing regulations as well as respond to any new policies or regulations that might emerge,” says Carol Linden, Principal Deputy Director of the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.
According to Linden, factors leading to the increased interest in biosecurity include the relatively recent expansion of the civilian biodefense program and the construction of a number of new high and maximum containment laboratories. In addition, there have been a few highly publicized, but isolated, incidents of either laboratory-acquired infections, or situations where individuals or institutions were not compliant with elements of the Select Agent regulations.
Linden points out that four reports pertaining to biosecurity and/or biosafety have been issued in the past year: two prepared by working groups of federal experts and another two prepared by groups of experts drawn from academia and industry.
“The reports are remarkably congruent in that they all recognize the inherent difficulties, within the framework of the Select Agent regulations, in regulating living organisms, and in regulating the behavior of individuals who have access to biological select agents and toxins,” says Linden. “The White House is reviewing these reports and other information to create and coordinate biosecurity policy among the relevant federal departments and agencies. The Senate has also proposed legislation containing provisions that would have serious impacts on implementation of biosecurity within the life sciences and biotechnology communities.”
Moving Forward Without Funding
If your biocontainment project proposal is NOT approved for this funding, the issue will be how to move biocontainment-based research programs forward on a more economical scale and qualify for other NIH research grants. This will mean searching out other avenues such as small-suite upgrades or modular-unit solutions.
All of this says that biocontainment projects, funded or not, are in need of new strategic thinking, attention to detail, and expert guidance.
Tradeline’s International Conference on Biocontainment Facilities in St. Petersburg (March 25 and 26) offers a host of solutions for getting up to speed:
- A fundamentals course for new people involved in delivering these construction grant funded projects – end user representatives, project managers, scientists, facility engineers – presented by specialists in the design, construction, and operation of successful BSL/ABSL facilities.
- New NIH DRM Workshop – presented by the NIH.
- New regulatory requirements and proposed changes – presented by the US Department of Health & Human Services.
- More than 20 different sessions on the successful planning, design, construction, operation, and maintenance of safe and secure biocontainment facilities.
For more information on the conference: http://www.TradelineInc.com/BIO2010
Much is at stake for research institutions, and time is short. Now is the time to make sure that your institution will be fully functioning and compliant for the next generation of funded research.
Steven L. Westfall, Ph.D.
President
Tradeline Inc.
We welcome your Questions and Comments
Copyright 2010 Tradeline Inc.
All Rights Reserved
ISSN: 1096-4894
