Today the Federation of American Scientists (FAS) launched the Office of Technology Assessment Archive, http://www.fas.org/ota. The site allows the public to access over 720 reports and documents produced by OTA during its 23 year history, including many that have not been available to the public previously. OTA served as an independent branch of the U.S. Congress that provided nonpartisan science and technology advice from 1972 until it was defunded and forced to close in 1995. Continue Reading →
On Tuesday, July 15, 2008 the National Science Advisory Board for Biosecurity (NSABB) hosted a meeting to solicit public comment on the June 2007 report, “Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information”.
The meeting was broken into three panels that examined different aspects of the framework document, and each panel included several members of the public who shared their perspective on these issues. Continue Reading →
The Federation of American Scientists has joined 16 prominent scientific and engineering groups to ask all Congressional candidates seven questions on the science and technology policies that affect all of our lives.
The November election will be a critical moment for science and technology policy in the United States. Voters must know where the candidates stand on issues such as climate change, the environment, and soaring energy prices.
Innovation 2008 is a voter education initiative from Scientists and Engineers for America (SEA) to make science and technology a prominent part of the 2008 elections. Ask your candidates today!
For more information please visit: http://sharp.sefora.org/innovation2008/.
By Michael Stebbins, originally at Science Progress.
The principle is simple. The products, information and techniques of some life sciences research could be misused for nefarious purposes, such as bioterrorism, and the scientific community should do everything it can to prevent such misuse without impeding research progress. What is unclear is what steps scientists should take when they have concerns about such “dual-use” research.
The problem is that we (myself included) have not taken the long-view on this issue.
Dual-use research has been the subject of much discussion in the biosecurity community since the 2003 release of the National Research Council report, Biotechnology Research in the Age of Terrorism, which suggested that, “Adequately addressing the potential risks that research in advanced biotechnology could be misused by hostile parties will require educating the community of life scientists, both about the nature of these risks and about the responsibilities of scientists to address and manage them.” But convincing scientists that they should add dual-use research awareness and evaluations to their already long list of idiosyncratic worries turned out to be far harder than anyone imagined.
Enter the National Science Advisory Board for Biosecurity. In June of last year, the NSABB released their Proposed Framework for the Oversight of Dual Use Life Sciences Research, in which the board recommend that life scientists receive “mandatory education about dual-use research issues and policies,” with the goal of “ensure(ing) that all individuals engaged in life sciences research are aware of the concerns and issues regarding dual use research and their roles and responsibilities in the oversight of such research.”
In addition to mandatory training, both the National Research Council and the NSABB have advocated for the creation of codes of conduct for life sciences researchers that includes dual-use awareness. Now, research societies are preparing and implementing their codes of conduct, infusing another layer of awareness into the research community.
Indeed, it will not be long before it is mandatory that all federal grantees in the life sciences receive such training, and that all biologists sign codes of conduct. Awareness will spread like happy little dandelions. That is until someone points out that they are weeds.
Don’t get me wrong. I am an advocate of mandatory training and think codes of conduct are a good tool for increasing awareness. Not least of the reasons for my support being that the Federation of American Scientists arguably has the most extensive dual-use training materials available to date in the form of our multimedia Case Studies in Dual-Use Research. Wide distribution of these case studies and materials created by other groups has been a goal of ours from the time we started the project.
The problem is that we (myself included) have not taken the long-view on this issue. If we dramatically increase awareness, then we also increase the chances that scientists will have concerns about dual-use research or worse—suspicions that a colleague is up to no good. What the NSABB, National Research Council and the biosecurity community on the whole have failed to fully address is how those researchers should attend to their concerns. Government-issued guidelines for researchers will only get them so far.
Since part of the duty of a responsible researcher will certainly be reporting unsafe experiments or suspicious behavior, instituting codes of conduct and training all scientists makes potential whistleblowers out of every working biologist. This creates an immediate need for protocols and methods for scientists to get advice and report their concerns.
There is currently no reliable independent system in place for these researchers to report or receive advice on how to handle their concerns.
It is well recognized that a major barrier to reporting such incidents to law enforcement, supervisors, biosafety officers, or institutional review boards, is the fear of reprisal. This might also be compounded by some members of the scientific community not trusting government officials and law enforcement in particular. This extends from laboratory technicians and support staff to primary investigators. Even if there is no indication of foul play, scientists may feel that there are experiments being conducted at their institution that have serious dual-use implications, or that are dangerous to those conducting them and their colleagues.
There is currently no reliable independent system in place for these researchers to report or receive advice on how to handle their concerns. Such a system would be a valuable contribution to strengthening biosecurity awareness and participation within the biological research community. It should be pointed out that such a system is a good way to get across the idea that official whistle-blowing is not the first and only resort.
I and others have suggested that we need to build a secure Internet-based system where scientists will be able to report their concerns and receive advice and recommendations on the steps that they should or should not take. Concerns will naturally run the range of how to fill out dual-use reporting forms on grants to reporting potentially illegal situations in the lab. It is important that the government not operate the system to ensure buy in. Rather, an ombudsman network should be run by a non-government organization that will allow partial anonymity.
In the event that a clear cause of action is required, such as when a law is being broken, a non-government organization would be well-placed to help facilitate conversations with law enforcement, make queries on the behalf of the scientist to government, or alleviate concerns without endangering their status at the institute.
The system will have to be backed by a large group of advisors, including experts from multiple science disciplines, ethicists, legal and law enforcement representatives to ensure that users are receiving timely and accurate advice. The system administrator will have to be available at all times and have constant access to advisors in the case of a serious problem.
One major concern of scientists will be the preservation of anonymity. This issue can be simply handled by having staff farm out the query to advisors without revealing the identity of the scientist. Total anonymity, however, cannot be completely preserved in such a system.
In principle, users will turn to this system when they feel uncomfortable reporting concerns within their institution or when they are unsure of who to turn to. Responses will either ask for further information, clarification, or report back advice on the appropriate course of action.
Users must also feel comfortable that the information they divulge will not be released to anyone unless they approve it. This can be accomplished by making users agree to simple terms before sending their query. Those terms will detail operation standards and will inform users under which conditions the managers have a legal responsibility to inform appropriate authorities, and that they may be contacted by such authorities directly in the event that a law has been or is about to be broken.
Detailed records of responses and customizable electronic form letters will allow us to provide useful assistance and inform users of their rights and the laws that might apply to them in a timely manner. It should be stressed that in the event a user reports an imminent threat, they will automatically receive instructions on who they should contact. There are several important issues that will have to be addressed while developing a biosecurity reporting system, among them:
Whistleblower Laws. The United States has a well-established set of “whistleblower” laws that protect people from reprisals for reporting. There are several excellent non-profit groups that specialize in this area and it will be important to bring them in for legal advice and possibly to present a series of Frequently Asked Questions on the site for scientists to learn about their options.
Legal Advice. We will need legal advice on a broad range of issues, including the liability associated with giving advice, maintaining anonymity, the situations under which those with knowledge of possible crimes are legally obligated to contact law enforcement, and applicable laws for users.
Advisory Boards. An advisory board consisting of scientists, ethicists, biosecurity experts, and legal advisors will have to be brought in for the design and implementation. A second advisory board will have to be available for advice on individual cases. It will be important to have a wide array of expertise and knowledge on hand to address any reports that come in.
Law Enforcement Guidelines. A clear relationship with law enforcement will need to be established so that in the event that there is a user who is uncomfortable going to law enforcement themselves, we would be able to report an incident on their behalf.
Testing. It will be necessary to test the system through a series of table-top scenarios that provide challenges to our response times and content.
It is a virtual certainty that this type of system would eventually be abused maliciously against other scientists trying to slow down a competitor, or exact revenge. In that sense, the system itself would have dual-use potential and like science, safeguards and awareness will reduce, but might not eliminate, unfortunate incidences.
It is also hard to predict how often such a system would be used and what percentage of the time it would receive cranks. But it is equally unclear to what degree dual-use research is a threat to national security. If we are going to require scientists to learn about the potential for misuse, then it is essential that they have a place to turn if they recognize potential misuse or have questions about complying with legal and ethical requirements.
On July 15, 2008, the Federal government will be sponsoring a public consultation to engage the scientific community and research organizations in a discussion of a framework for the oversight of dual use research proposed by the National Science Advisory Board for Biosecurity (NSABB). The proposed framework, which has been formally submitted by the Board to the Federal government for its consideration, outlines key features of oversight of dual use research, including criterion for identifying dual use research of concern, local oversight, evaluation and risk assessment of research with dual use potential, responsible communication of research with dual use potential, considerations in developing codes of conduct, and the need for outreach and education. The proposed framework also outlines the roles and responsibilities of key individuals and institutions in managing dual use research, including researchers, research institutions, institutional review entities, the NSABB, and the Federal government.
The public consultation meeting will take place from 8:30 am – 4:00 pm at the Natcher Conference Center (Building 45) on the National Institutes of Health (NIH) Campus in Bethesda, Maryland (Natcher Center – NIH Visitor Information). The meeting will focus on a set of questions, included in Appendix 2 of the NSABB’s proposed oversight framework, on which the government would specifically like to solicit comment. These questions concern such matters as the clarity of the criterion proposed by the Board for identifying dual use research of concern; institutional oversight responsibilities, including how to balance appropriate controls with academic freedom and scientific exchange; and approaches to education to enhance awareness of the issue.
The meeting will be conducted as a series of panels where participants will be asked to discuss particular topics of interest to the government. Each panel will include ample time for in-depth discussion of the issues surrounding each topic.
The meeting is open to the public and free of charge. Due to limited space, pre-registration is encouraged. To register, please connect to: http://www.capconcorp.com/meeting/lifesciences2008/ . Notice of this meeting will also be published in the Federal Register. Any groups or individuals who cannot attend the meeting are encouraged to submit in advance of the meeting written comments on the questions found in Appendix 2 of the NSABB’s report to: email@example.com . Please note that this meeting will not be Web cast.
More information about the NSABB is available at http://www.biosecurityboard.gov/. Questions about this meeting can be addressed to Allan C. Shipp, Director of Outreach, NIH Office of Biotechnology Activities, 301-435-2152 or firstname.lastname@example.org.
Steven Aftergood at Secrecy News, just released a report produced for the intelligence community on pox virus research around the world. The report was written by Dr Alfred D. Steinberg, working for MITRE Corporation and published last January. While not classified, the report was also not approved for public release. From the report “It is widely feared that samples of variola virus may have been retained in several countries after a WHO directive to allow storage of such samples only in Russia and the United States.” It details the published pox virus research from around the world and provides a snapshot of the breadth of pox virus research happening today.
From Secrecy News:
Dozens of countries are conducting research involving animal pox viruses, according to a descriptive survey performed for the U.S. intelligence community’s Open Source Center.
There are various potential public health and security concerns associated with pox viruses (such as smallpox), the OSC report says in a background discussion.
“Naturally occurring smallpox disease was eliminated worldwide in 1977. Routine vaccination of US civilians against smallpox was discontinued in 1971, but allowed for travelers to endemic regions until the late 1970s. In most other countries, vaccination of the general population ended by 1982. As a result of this halt in vaccination, most of the US population could now become ill with smallpox disease should it be reintroduced by accident or intentionally.”
“In addition, humans are susceptible to several naturally occurring viruses related to smallpox, one of which could become a serious disease risk through natural evolution. Routine smallpox vaccination previously protected against these viruses. Finally, there is concern about the potential creation of a genetically engineered poxvirus that might be markedly pathogenic for humans.”
Like most finished intelligence products from the Open Source Center, the report on animal pox viruses has not been approved for public release. But a copy was obtained independently by Secrecy News.
Today in a hearing of the House Committee on Energy and Commerce it was revealed by the Government Accountability Office (GAO) that the Department of Homeland Security’s plan to move foot and mouth disease research to the mainland United States is based on faulty assumptions.
Foot and mouth disease is caused by the most infectious virus known to man. Nearly 100% of exposed animals become infected. Currently, the only place where foot and mouth disease (FMD) research can be done in the US is the Plum Island animal disease research facility, located off the tip of Long Island.
DHS had been planning to move that research to the mainland for sometime now, but that seems doubtful. The testimony given today by Nancy Kingsbury, the managing director of Applied Research and Methods at GAO indicates that DHS based its decision to move FMD research on a 2002 USDA study that simply addressed whether it was technically feasible to do so, ignoring the potential for human error.
We found that DHS has neither conducted nor commissioned any study to determine whether FMD work can be done safely on the U.S. mainland. Instead, DHS relied on a study that USDA commissioned and a contractor conducted in May 2002 that examined a different question: whether it is technically feasible to conduct exotic disease research and diagnostics, including FMD and rinderpest, on the U.S. mainland with adequate biosafety and biosecurity to protect U.S. agriculture. This approach fails to recognize the distinction between what is technically feasible and what is possible, given the potential for human error. DHS told us that this study has allowed it to conclude that it is safe to conduct FMD work on the U.S. mainland.
In addition to a number of other methodological problems with the study, we found that it was selective in what it considered in order to reach its findings. In particular, the study
1. did not assess the history of releases of FMD virus or other dangerous pathogens,
2. did not address in detail the issues related to large animal work in BSL-3 Ag facilities, and
3. was inaccurate in comparing other countries’ FMD work experience with that of the United States.
Subcommittee chairman Rep. John Dingell (D-MI) was particularly critical of DHS in his opening statement, noting the trend to move infectious animal disease research to islands, not off them.
“Equally troubling, it appears that DHS is out of step with the rest of the world. GAO investigators visited major labs across Europe and found that in other developed countries, the trend is to do just the opposite of what DHS has proposed: Germany built its new lab on an island; Denmark built its new lab on an island; and the U.K. Parliament is debating the relocation of its lab to an island.” Dingle continued, “Why then would DHS propose to move live virus of foot-and-mouth from Plum Island to the American heartland? GAO was unable to find a scientific reason for the move. They found apparent agreement that the current Plum Island lab needs substantial renovation, but they found no justification for moving the lab to the mainland.”
FAS just launched an online compilation of more than 500 documents on the US ratification of the Chemical Weapons Convention (CWC). The Archive (http://fas.org/blog/cw) includes a timeline of CWC negotiations, a history of its signing and ratification, and current news and commentary on the CWC.
In addition to the documents, Cheryl Vos, FAS Biology Research Associate, will report daily from The Hague during the Second Review Conference, 7 – 18 April 2008, on the proceedings, plenary sessions and open forum.
The online archive’s “Document of the Day” feature will kick off with a letter submitted by former Secretary of Defense and current Vice President Dick Cheney to the Senate Foreign Relations Committee. The letter expresses Cheney’s deep opposition to U.S. ratification of the Chemical Weapons Convention and was read into the record by former Secretary of Defense James Schlesinger who, along with fellow former Secretaries of Defense Donald Rumsfeld and Caspar Weinberger, was present at the Committee hearing to provide testimony against the CWC. http://fas.org/cw/cwc_archive/cheneyletter_4-8-97.pdf
The CWC entered into force on April 29, 1997. The archive highlights accomplishments over the past 11 years, and arguments made for and against US ratification in Congress.
Many of the letters, petitions and reports have not been previously available online.
Visit the Chemical Weapons Convention Archive at http://fas.org/blog/cw/.
To begin the day the NBSB listened to presentations from each of the members of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE). The Enterprise is coordinated within HHS by the Assistant Secretary for Preparedness and Response and includes the NIH, CDC, FDA and BARDA. PHEMCE’s role in HHS is to coordinate the research, development, acquisition and deployment of medical countermeasures to chemical, biological, radiological or nuclear (CBRN) threats. Many of the topics the NBSB will consider and provide recommendations on will fall within the PHEMC Enterprise, so the board heard a representative from each of the agencies describe their efforts and role in PHEMCE. The morning session ended with presentations from Bruce Gellin giving an overview of the HHS pandemic flu program and Robin Robinson detailing BARDA’s pandemic preparedness and response activities.
During the afternoon session the board got down to business. After being presented with information on the possible topics that they were considering, the NBSB voted for 4 specific topics and formed subcommittees for each.
First the NBSB wanted to address the issue of pandemic influenza preparedness. The subcommittee will evaluate current research, identify the gaps, and then report to the whole board to begin making recommendations.
The second subcommittee will review the US government research portfolio to determine whether efforts are as integrated as they could be. They too will return their findings to the whole board with the goal of making recommendations to increase collaboration and avoid duplication of efforts.
The third subcommittee was commissioned to look at disaster medicine. They will take HSPD-21 as a framework for evaluation and further development of a national disaster medicine plan. It will include the possibility of promoting ‘disaster medicine’ as a new discipline and setting up dedicated training courses and programs.
Finally, it was agreed that a subcommittee be set up to look at the gaps in the medical countermeasures marketplace. This subcommittee will focus on the private sector and look at ways to engage their involvement in countermeasures development.
It was also agreed that the issue of special and at-risk populations and the issue of communications and data interoperability not be stand alone topics. They will be integrated into each of the four subcommittees and a decision to exclude them would need to be explicitly justified.
Finally the members of the NBSB volunteered their placement on subcommittees within their areas of expertise and subcommittee chairs were appointed. Andrew Pavia will chair the pandemic influenza subcommittee, Patrick Scannon; the government research evaluation subcommittee, Jim James; the disaster medicine subcommittee and John Parker; the gaps in countermeasure marketplace subcommittee. The NBSB will meet again in 6 months to hear reports from the subcommittees and make recommendations.
Written with Cheryl Vos
The National Biodefense Science Board (NBSB) began their inaugural meeting yesterday in Washington DC. The board, made up of 13 voting members and 21 non-voting ex officio representatives, was created as part of the 2006 Pandemic and All-Hazards Preparedness Act. The NBSB was chartered with the task of providing expert advice to the Department of Health and Human Services (HHS) Secretary on science, technology, and other matters of special interest on chemical, biological, radiological, and nuclear issues, including both naturally occurring and deliberate events.
The members include Patricia Quinlisk (Iowa Dept. of Public Health, chair), James J. James (American Medical Association), Steve Cantrell (Denver Health Medical Center), Eric Rose (SIGA Technologies), Albert Di Rienzo (Welch Allyn), Ken Dretchen (Georgetown University Biosecurity Institute), John Grabenstein (Merck Vaccine Division), Ruth Berkelman (Emory University , Thomas MacVittie (University of Maryland School of Medicine), John Parker (SAIC), Andrew Pavia (University of Utah Medical Center) Roberta Carlin (American Association on Health and Disability), and Patrick Scannon (XOMA).
After the morning introductory session, the group listened to several talks presented by executive branch officials that discussed current US Government policies on preparedness and response. After this, the group heard another series of talks that outlined possible topics and issues that the NBSB could focus on initially. The broadly defined proposed topics, developed by officials at HHS, are as follows- an evaluation of research and development components of the HHS influenza preparedness strategy, innovation and medical countermeasure development, how to address gaps in the medical countermeasures marketplace, modeling and metrics to inform medical consequence assessment, and considerations for special and at-risk populations.
Today the group will make decisions about how to go forward as a board. The group will try to prioritize topics and determine how to fulfill their charge. Since the mandate to the NBSB is so broad, many members agreed that it is important to determine the group’s focus in a way that considers issues based on their timeliness and achievability.
Written by Nate Hafer