October 10, 2002 - Conducting Research During the War on Terrorism: Balancing Openness and Security

The American Society for Microbiology (ASM) is pleased to testify before the House Committee on Science hearing on "Conducting Research During the War on Terrorism: Balancing Openness and Security." The ASM is the largest life science society in the world with over 42,000 members. The ASM publishes eleven scientific journals focusing on distinct specialties within the microbiological sciences, including Infection and Immunity, Journal of Bacteriology, and Journal of Virology.The ASM also annually publishes numerousscientific books and sponsors many scientific meetings, conferences, and workshops to stimulate research and the dissemination of experimental data.

The Society's large and diverse membership of scientists unites in a common appreciation of science and a commitment to scientific integrity.The ASM recently affirmed the long-standing position of the Society that microbiologists will work for the proper and beneficent application of science and will call to the attention of the public or the appropriate authorities misuses of microbiology or of information derived from microbiology.ASM members are obligated to discourage any use of microbiology contrary to the welfare of human kind, including the use of microbes as biological weapons.Bioterrorism violates the fundamental principles expressed in the Code of Ethics of the Society and is abhorrent to the ASM and its members.

Prudent Balancing of Security Concerns with the Need to Conduct Research and Diagnostic Testing

Since September 11, 2001 and the ensuing anthrax attacks, there has been heightened fear and demands that we enhance our protection against such future attacks. Many worry that terrorists can subvert the normal scientific enterprise and hence there has been increasing public discussion about restricting access to materials and information that could be used by bioterrorists.Science holds enormous promise for improving health and protecting the public.Yet, it also represents opportunity for deliberate harm.

The microbiological community faces the challenge of protecting the public against the threat of infectious diseases and bioterrorism, while simultaneously facing heightened scrutiny over the misuse of science by terrorists.Expanded biodefense research on the most dangerous agents and toxins - select agents - has intensified questions about the secure conduct of scientific inquiry in areas related to biodefense and about the publication of research results in the life sciences.

The scientific community must confront issues of improving security in research and in the publication of research results.This must be done without compromising vital public health interests that are posed by unwarranted or unwise limitations of scientific inquiries or of the publication of research results.Crucial research related to prevention of bioterrorism or the cure of infectious diseases, for example, may require the utilization of pathogenic material and the consequent placement of signs warning of a biosafety risk to protect persons working in the area.At the same time, however, placement of warning signs may alert would be terrorists to the presence of materials that may have the potential for use in bioterrorist attacks.

The ASM recognizes the legitimacy of concerns about the publication and dissemination of scientific information and supports reasonable, balanced, and sensible restrictions on access to select agents that pose a high risk to public health and safety.The ASM agrees that we must deny scientific and technical information to terrorists and enhance laboratory security.At the same time, we must avoid restraining the exchange of scientific information in a manner that inhibits scientific research and medical progress thereby adversely affecting public health.If policy measures to prevent terrorists from acquiring pathogens, equipment, and technical information are not crafted with great care, they may have a significantly adverse effect upon critically important research activities.

The ASM urges a careful and prudent balancing of public concern about safety and security with the need to conduct legitimate research and diagnostic testing.Policies should not stifle research needed to develop countermeasures or it will become too difficult to pursue this research.Thus far, Congress has responded to the scientific community's concerns and has enacted legislation that, on the whole, represents a balanced approach. Until we see the regulations for select agents, we remain concerned that those regulations will be balanced and appropriate and will be implemented in a timely and workable manner consistent with the need to move forward with important research on select agents.

Scientific Publication Security Issues and Policies

In the past year, there has been a growing sense that scientists and their journals should restrict the release of "sensitive" scientific findings, exercise voluntary efforts to withhold experimental data, and heighten awareness of the potential destructive application of certain experiments.Some have suggested creating a new "regime" to prevent destructive applications of research that has potential for developing bioweapons.Ideas have included selective dissemination of "restricted" information only to "qualified" persons on a "need to know basis," or allowing sponsoring agencies to deny publication of work that could result in threatening applications.It has been discussed that those seeking access to genomic sequence data for dangerous pathogens might be required to provide evidence of their accreditation with a legitimate laboratory and that scientific articles should be edited to eliminate experimental details.Indeed, there are reports of researchers halting or abandoning research efforts for fear that results may fall into the wrong hands or may be misapplied.

The ASM is seriously concerned about proposals that may adversely impact research and publication.The ASM seeks to achieve a proper balance between necessary security and vital scientific research and publications.It urges a careful and reasoned public debate of such issues.For this reason, the ASM formally requested that the National Academy of Sciences convene a meeting of scientific publishers and encourages an examination and discussion to strike a balance that will enable the free flow of scientific information without providing information that would be useful to bioterrorists.Achieving consensus within the scientific community and among scientific publishers of biological journals worldwide on appropriate practices is critical at this time.The Academy has agreed to hold such a meeting early in 2003.The meeting will focus on developing common policies regarding review and publication of manuscripts dealing with research that could present public safety issues, and identifying "sensitive" information and policies to screen information in a manner that will not interfere with or jeopardize research.

In 1975, scientists met at Asilomar and voluntarily adopted guidelines for the conduct of research on the then new technology of recombinant DNA.Some have recommended that an "Asilomar" meeting be held to discuss and examine issues surrounding the withholding or classification of "dangerous" scientific information. We feel that a self-imposed code of responsible conduct and oversight is preferable to a mandated regime.However, the issue of preventing malicious application of research and the publication of research results is different from preventing accidental release of microorganisms which was the concern at Asilomar.The ASM believes that participants in the meeting sponsored by the Academy will understand these differences and will be well prepared to discuss procedures that will balance the need for aggressive, ongoing scientific research and protection against misuse of research results for the purposes of terrorism or biowarfare.

Because the ASM is committed to the responsible and ethical publication of science, it has adopted specific policies and procedures for its Journals to provide a degree of careful scrutiny in the peer review process of submitted manuscripts dealing with select agents.This review seeks to determine if an article contains details of methods or materials that might be misused or might pose a threat to public health and safety.ASM reviewers inform editors if a manuscript contains details that in their view may be subject to misuse.If a reviewer brings a manuscript to the attention of an editor, the editor considers whether in his or her view a risk of adverse use may exist.If in the opinion of the editor a risk exists or the editor is unsure, that editor brings the matter to the attention of the editor in chief of the journal and the chair of the Publications Board, and they confer about the issues raised.If warranted, the chair brings the manuscript to the Publications Board for further review and disposition.The ASM's Publications Board, in turn, has made it clear that the ASM will not publish papers that violate the ASM Code of Ethics or that violate other widely accepted guidelines for research such as the NIH Recombinant DNA guidelines for research involving recombinant DNA.Thus, the ASM is very sensitive to research reports that might impinge on national security or be used for illegitimate purposes.

At the same time, ASM does not support unwarranted restrictions on the free flow of legitimate scientific communications within microbiology that could lead to valuable advances in biomedical science.The best defense against anthrax or any other infectious disease is information; information in a form that can be used by scientists and public representatives to guide rational and effective actions to ensure public safety. Placing major barriers in the path of the flow of information ultimately may contribute to terrorism by interfering with our ability to prepare and respond to the threat of the misuse of science by bioterrorists.The free exchange of scientific information has contributed to the saving of human life, to increased quality of life, and to greater promise for yielding future benefits to health and the environment.Public health and safety depend on the advancement of biomedical science which could be harmed by undue restrictions on publication of research.

Thus, while ASM has modified its own procedures for publication of its Journals and increased its internal awareness of the need for careful review, ASM continues to require that research articles contain sufficient detail to permit the work to be repeated by others. Authors also must continue to agree to make materials available to the scientific community while, of course, adhering to all laws and regulations governing the shipment, transfer, possession, and use of biological materials.Omission of materials and methods from scientific literature would compromise the scientific process and could lead to abuses as well as the perpetuation of errors.Independent reproducibility is the heart of the scientific process.Even within the context of heightened scrutiny, research articles must be published intact. If scientists cannot assess and replicate the work of their colleagues, the very foundation of science is eroded.Open research is essential to discovery and building on past scientific discoveries.Indeed the risk to public health and safety may be greater from restricting research than from allowing the publication of research that could be read by a wrongdoer. Restricting research findings may in fact have no effect on deterring terrorists.

Integrity of the Scientific Process and Appropriate Communication of Research is Critical

The ASM is attempting to protect against misuse of science without undermining the integrity of the scientific process or appropriate communication of research results that is critical to sound science.Review for "sensitive" information is difficult and complicated.There is no common definition of what is dangerous or sensitive information and no individual is empowered to decide what is potentially dangerous knowledge.There is also the issue of dual application of scientific knowledge for beneficial and malicious purposes.Research to make new drugs sometimes might be used to develop bioweapons. Genomic data is valuable for identifying targets for therapeutic drugs and vaccines, but such information can be viewed as potentially valuable for identifying means to increase the virulence of microbial agents and to counter currently available therapies, vaccines and detection protocols.

This duality is real, and the potential for both good and evil is encoded within genomes. There has been concern that the complete genome sequence of many pathogens including the smallpox virus is publicly available, providing weapons designers with information that may enable them to increase pathogenicity. The same information, however, can be used to help develop new medical treatments or genetic fingerprinting to trace sources of bioweapons. Genome sequences are far more valuable to legitimate researchers and to the health and safety of the public than to bioterrorists.Transparency in science is also important to differentiate whether offensive or defensive research is being conducted in other countries.In addition, law enforcement and the judicial process depend on methods that must be published in the peer reviewed literature if they are to be used for prosecution of criminal cases.

The heightened concern about publishing "dangerous" research results and the conviction by some that particular lines of research should be banned, emanates in part from an earlier response to experiments conducted in Australia in which the interleukin -4 gene from a mouse was inserted into mousepox virus, enhancing its virulence. When the modified virus expresses the IL 4 gene, it effectively overcomes genetic resistance to mousepox virus and suppresses immune responses to the host to a greater extent than anyone had predicted. Virus encoded IL 4 not only suppresses primary antiviral cell mediated immune responses but also can inhibit immune memory responses.Such experiments may indicate that poxviruses can be engineered by widely available techniques and equipped with readily accessible genes to render immunization ineffective. The implications for the smallpox virus were it to be genetically engineered in the same way are horrific.With hindsight, some critics have asked whether this research should ever have been permitted. They also suggest that we should have known in advance how dangerous these results might be.Others were surprised by the result and argue that this study alerts us to the need for more research on immune responses to such viruses and the need to develop antiviral drugs.In short, this incident provides one example of the difficult issues in confronting the benefits and potential dangers resulting from research related to pathogenic organisms.

Responsible oversight and reasoned discussion is important at this critical juncture.National security may be best served by allowing the free flow of all scientific and technical information that is not directly connected to technology deemed critical to national security. Mechanisms exist to control findings that have clear implications for bioweapons. National Security Decision Directive 189, formulated in l985, and recently upheld by the Bush Administration as the current Administration's policy, states that to the maximum extent possible the products of fundamental research should remain unrestricted and that no restrictions may be placed on the conduct or reporting of federally funded fundamental research that has not received security classification. This Directive establishes two important policies: fundamental research should remain unrestricted and there is one official mechanism for the control of information, classification.

Finally, as the scientific community discusses the appropriate measures for security in undertaking and publishing research, it will also be important to have discussions with the national security community.Clearly, this community has legitimate objectives, and it may weigh the costs and benefits of proposed policies differently from the scientific community.Both communities must share a common goal of discouraging the development of biological weapons while taking into account the traditional and necessary openness of scientific research.Ultimately, open and collaborative research is key to US technological advances and to the protection of the citizenry against infectious diseases and bioterrorism.

Thank you for the opportunity to testify.