During the past two decades, UTMB has recruited an exceptionally talented cadre of experts in emerging infectious diseases. Now, as the federal government helps build the nation’s public health and security infrastructures, UTMB is playing a leading role in developing countermeasures against naturally emerging infectious diseases, some of which also might be employed by bioterrorists. Recognizing legitimate public concerns, UTMB will undertake this research with maximum feasible openness and transparency while maintaining a high level of security. The following questions and answers seek to share information about this involvement.
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- Why is the federal government funding expanded research into infectious diseases?
- After the anthrax attacks made via the U.S. postal system in late 2001, Congress funded a research agenda to protect America against those misusing anthrax and similar biological agents. To accomplish this agenda, the National Institute for Allergy and Infectious Disease (NIAID) and the National Institutes of Health (NIH), through a competitive peer-review process, awarded funds to construct two National Biocontainment Laboratories (NBLs) and established eight Regional Centers of Excellence (RCEs) to research biological agents.
- What is the Galveston National Laboratory?
- The Galveston National Laboratory, or National Biocontainment Laboratory, is a sophisticated biomedical research facility where scientists will safely study infectious agents that either pose threats as naturally emerging diseases or are potential bioweapons. Constructed primarily with NIH funds, the two National Biocontainment Laboratories will house scientific research projects to develop and assess countermeasures (including new vaccines or therapeutics) to diagnose, prevent or effectively treat the infections these agents cause. The Galveston National Laboratory will include research space designated at biosafety levels 2, 3 and 4.
Did Hurricane Ike affect the GNL?
- Hurricane Ike dealt a devastating blow to Galveston in mid-September 2008, but we are proud to report that the GNL stood strong, weathering the storm precisely as designed.
While Hurricane Ike registered as a Category 2 storm on the currently used Saffir-Simpson scale, according to a more accurate hurricane scale under development at the National Oceanic and Atmospheric Administration (NOAA) - the Integrated Kinetic Energy or IKE scale - Hurricane Ike received the highest rating assessed so far. The storm scored a 5.6 (on a scale from 1-6, with 6 being the most destructive possible storm) compared with a 5.1 score for Hurricane Katrina. A recent issue of industry publication Weatherwise, noted that Hurricane Ike's rating on the new IKE scale earns the storm the designation of the largest hurricane ever in the North Atlantic Basin.
From the perspective of safety and planning, it is important to note that the GNL survived the largest storm ever recorded using these modern measurement methods, without any significant damage.
Read more about the IKE scale here
- What are the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCEs)?
- These are regional entities supported by large research grants from the National Institutes of Health that involve consortia of institutions with complementary research expertise—mainly universities and medical schools, research foundations, national laboratories, and a few companies engaged in research related to the development of countermeasures for infectious agents. The NIH has provided RCE grants to ten centers until 2009. One such regional research collaboration is the Western RCE (WRCE), a consortium led by UTMB, that includes institutions in Texas, New Mexico, Louisiana, Oklahoma, and Arkansas. The WRCE has received over $60 million in federal support over six years, and has supported 72 research projects at 34 institutions. The development of vaccines, therapeutics, and diagnostics for Category A, B, and C Priority Pathogens remains at the forefront of WRCE research efforts.
- What experience does UTMB have operating a maximum containment laboratory?
- UTMB has long operated levels 2 and 3 labs. In 2004, UTMB began operating the Robert E. Shope, M.D., Laboratory, the only full-sized BSL4 lab on a university campus in the United States. It has been operating smoothly and safely for more than three years.
- Since the federal government largely paid for the Galveston National Laboratory, does the government own or run it?
- No. The facility is a university-owned and -operated building and a university program. The lab will pursue the research priorities that have been identified by the National Institutes of Health (with input from scientists from around the country, including some from UTMB). All research will be subject to review by the usual university review committees (including the Institutional Biosafety Committee).
- Why does the United States need high-containment labs?
- Because the dangers from infectious diseases demand them. Infectious diseases cause between a quarter and a third of the annual estimated 1 million deaths worldwide. Twenty well-known diseases—including tuberculosis (TB), malaria, and cholera—have reemerged or spread geographically since 1973, often in more virulent and drug-resistant forms. At least 30 previously unknown disease agents have been identified since 1973, including HIV, Ebola, hepatitis C and Nipah virus, for which no cures are available.
- Why did UTMB want one of these national laboratories?
- UTMB sought a National Biocontainment Laboratory because we have scientists with the necessary expertise to help the nation respond to the urgent problems dangerous infectious diseases pose. We have a societal obligation to contribute to this important effort.
- Will the Galveston National Laboratory also create biological weapons?
- Definitely not. UTMB’s research aims to protect people against the diseases caused by these infectious agents. UTMB has pledged to do neither classified research nor research to create offensive weapons. Summaries of all grants the university receives from the federal government are available for public inspection on the NIH “RePORT” web site — and similar public venues. All research protocols for work inside the BSL4 and other labs must be approved by the Institutional Biosafety Committee.
- How much will the Galveston National Laboratory cost?
- Building and equipping UTMB’s Galveston National Laboratory will cost an estimated $174 million. The NIH allocated $115 million to help design, construct and equip the Galveston National Laboratory. An additional $58.6 million came from university resources as well as from revenue bonds approved by the Texas Legislature.
- Where will ongoing operating funds come from?
- Both federal and university sources will fund operation of the GNL. An NIH-UTMB Operations Cooperative Agreement provides about $50 million to operate the facility from May 2006 through April 2011. This agreement will be supplemented as needed by university funds, including research grants and private philanthropy.
- Why is the U.S. government building two National Laboratories?
- The laboratories will have similar functions and capabilities, but each will have distinct research programs that complement one another rather than duplicating efforts.
- Will the GNL create jobs and attract business, or otherwise have a positive economic impact?
- Yes. Work done in this new facility will help to attract even more top researchers and research grants to UTMB. The existence of the Galveston National Laboratory is also expected to prompt a boom in biotech firms in Galveston and the surrounding region, and should help spark Galveston’s status as a leading center for biomedical research. For every dollar spent on research at UTMB, it is projected that three dollars will be returned to the local economy. The GNL is expected to add nearly $1.4 billion to the gross state product and almost 22,500 person-years of employment in the next 20 years. In addition, the GNL is expected to boost state revenues by more than $71 million and local government revenues by more than $6.6 million (See the economic impact report).
- How does UTMB ensure that researchers, employees and members of local communities are safe from microbes studied under high containment?
- A combination of rigorous training, meticulous procedures, tight security, carefully designed structures, and elaborate and redundant operating systems keeps everyone working in the high-containment labs safe. These measures also ensure the safety of those outside these labs. As the people most at risk in the event of an accident, the highly trained researchers working in such labs are carefully trained to rigorously follow safety procedures.
Biosafety Level 4 (BSL4) labs have been compared to “submarines inside bank vaults.” Heat, pressure, and chemical systems housed in the vault area process, or “cook,” all liquid and solid wastes completely, and high-efficiency filtration removes any airborne material, making all the liquid and air effluents sterile or safe before they leave the facility. Double and triple redundancies in equipment and systems help ensure that if an unexpected failure does occur, a backup is in place to maintain safety.
The laboratory studies tiny amounts of infectious agents and the diseases they cause in order to develop ways to mitigate their threat. As with all UTMB research involving infectious agents, work inside the BSL4 and BSL3 high containment labs is overseen by the Institutional Biosafety Committee. No experiment with such organisms can take place on campus without careful examination of all protocols to assess all risks.
- What are the dangers if a hurricane strikes the area?
- The GNL is among the strongest and most heavily reinforced of all structures in the region. It is designed to meet hurricane building codes. Despite its structural integrity, plans are in place to shut down and secure all laboratory operations if a hurricane landfall is predicted near Galveston. This shut-down and decontamination can be done quickly, with all work in the facility ceasing, the lab locked down, and all infectious agents and biological and chemical material placed into safe and secure storage.
- What happens when the power fails?
- As with all critical areas on the UTMB campus (which also is home to hospital facilities), the Galveston National Laboratory will have primary power plus independent backup power provided by multiple generators that are tested regularly.
- What happens if a researcher gets infected?
- In the unlikely event that a researcher becomes infected, he or she will be treated at a UTMB hospital with appropriate safeguards to ensure that neither staff nor visitors are exposed to the infection. UTMB is well-equipped and staff is well-prepared to care for individuals with serious and highly contagious infections.
- Have accidents in BSL4 labs ever occurred?
- Worldwide, very few accidents have occurred. Accidents such as needle sticks through the protective gloves that researchers wear have occurred, and on some occasions these events have led to tragic outcomes for the infected scientists. The scientists working within the BSL4 labs are those most at risk. None of these episodes to date, however, has resulted in the spread of an infectious disease to anyone outside the facility.
- What about security?
- As is now the case with UTMB’s existing BSL4 lab, strict security measures are planned for the GNL and include several card-entry and keypad checkpoints as well as checkpoints using unique biometric markers. All of this is required before scientists can approach and enter through the heavy metal doors sealing the facility. Under federal laws, security at and around the GNL facility will be regulated, and will include security checks of personnel, traffic checkpoints and a 200-foot vehicle-free safety zone. Campus and community law enforcement officers and other first responders receive special training on security and safety issues involving the laboratory. The state-of-the-art security systems will be reviewed and updated regularly. Rigorous procedures and practices will be consistent with federal guidelines. UTMB also has the benefit of the safety and security expertise of some of the world’s best-known and most knowledgeable BSL4 experts, recruited to the university during the development of the Robert E. Shope, M.D. Laboratory.
- What kinds of microbes will researchers be working with in the Galveston National Laboratory?
Researchers working in the Galveston National Laboratory will study what are known as NIAID Category A, B and C priority pathogens. Examples of Category A agents include anthrax and hemorrhagic fever viruses such as Lassa fever, dengue and Ebola; Category B agents include typhus fever and salmonella bacteria, and hepatitis A, Venezuelan equine encephalitis and West Nile viruses; Category C pathogens are agents such as Nipah, yellow fever and Crimean-Congo hemorrhagic fever viruses. (For a complete list of select agents and the category descriptions, visit the NIAID web site.)
It’s worth re-emphasizing that all of these agents are naturally occurring and, in many cases, emerging or re-emerging threats. Several occur naturally in Texas or have spread here in the past. All of these organisms are among the many already being studied at UTMB.
- Does this research involve the use of laboratory animals?
In many instances, yes. The continuum of medical research generally takes the development of new therapies from the research bench to animal models to human applications. Because UTMB is dedicated to developing actual vaccines and treatments for these agents, it is probable that we will need to study them in laboratory animals. Currently, there is no substitute for animal research to test the safety and effectiveness of most new drugs and vaccines. UTMB is committed to exploring alternate approaches such as computer modeling as they become available.
All research involving animals will be conducted with the highest ethical standards and with respect for the sacrifice required by this important work. The animals—most often rodents or other small mammals, but on some occasions, primates—will be housed, cared for and contained according to strict federal guidelines to maintain their comfort. As is the case with other research being conducted at UTMB, the use of animals is and will continue to be monitored by oversight committees that include community representatives who ensure the university’s adherence to federal and other guidelines for such research. One of the key points here is that the Institutional Review Board (IRB) process ensures that the protocol involves the fewest animals possible and the Institutional Animal Care and Use Committee (IACUC) ensures that those animals are provided humane care.
- Where can we get more information? What else is UTMB going to do to keep the community informed?
- University officials maintained communication throughout the proposal, planning, building and operations process of its containment facilities. A series of forums and meetings with community groups continues, including meetings with the Community Advisory Board and Community Liaison Committee, both of which were created to sustain channels of communication with the community about UTMB’s high-containment labs. If you are interested in additional information or you’d like to arrange for a speaker address your group, please call the Institute for Human Infections and Immunity at 409-266-6500.
UTMB welcomes input from the public and encourages those with questions or concerns to e-mail us at email@example.com. Or contact us via this web site.