(via Kaiser-J 2007, Science 316:529 and discuss [AT] syntheticbiology.org)
The National Science Advisory Board for Biosecurity (NSABB) has released a Draft Report (available as pdf) providing recommendations on how to minimize misuse of biological research. This report was discussed publicly on April 19, 2007 (see webcast).
The 50-page draft makes it clear that there is a difficult dialectic between imposing restrictions on research that can be misused for harmful purposes on one hand, and, on the other hand, the necessity of facilitating open and rapid information exchange to accelerate scientific progress, for the benefit of society in general, but also to precisely counteract potential threats. The report insists on the prime importance of openness in scientific research and clearly states that unrestricted progress and communication should be the “default position”.
One major recommendation of the draft report is that Principal Investigators should carry the responsibility for the initial evaluation of the potential for misuse of their own research. Concrete implementations could be inclusion of check boxes in grant proposal forms and annual reports to the researchers institution to formally certify that risk assessment has been performed.
Dual Use Research of Concern is defined as follows:
Research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agriculture, plants, animals, the environment, or material.
To aid identification of research that might be qualified as “dual use research of concern”, seven categories are listed (inspired from the National Research Council “”http://books.nap.edu/openbook.php?record_id=10827&page=5">experiments of concerns“, in ”http://books.nap.edu/catalog.php?record_id=10827">Biotechnology Research in an Age of Terrorism):
- Enhance the harmful consequences of a biological agent or toxin.
- Disrupt immunity or the effectiveness of an immunization without clinical and/or agricultural justification
- Confer to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin, or facilitate their ability to evade detection methodologies.
- Increase the stability , transmissibility, or the ability to disseminate a biological agent or toxin.
- Alter the host range or tropism of a biological agent or toxin.
- Enhance the susceptibility of a host population.
- Generate a novel pathogenic agent or toxin, or reconstitute an eradicated or extinct biological agent.
The philosophy of self-regulation by researchers appears to be in line with the stated purposes of raising awareness on dual use research issues and promoting a culture of responsibility within the scientific community. The report recognizes however major difficulties in defining a threshold at which dual use research would be clearly “of concern”, which makes it difficult to come up with clearcut and concrete recommendations. In the report, NSABB provides “tools” to assist the formulation of an appropriately balanced response via a risk/benefit assessment in research management and communication. The final decision will influence content, timing and distribution of publications reporting “dual use” research. As such, scientific journals will play an important role in developing a “Code of Conduct for Dual Use Research in the Life Sciences”:
Those who play decision-making roles in the process of communicating scientific information have an ethical responsibility to consider whether the information being considered for publication could be used to endanger public health, agriculture, plants, animals, the environment, or materiel. Depending on their analysis of the risks and benefits of communications regarding information or technology that meet criteria for dual use research of concern, they may choose to proceed in a way that mitigates or manages the risks associated with communication – for example, by adding contextual information not found in the original article, or delaying communication until a time at which the risks would be reduced.
A series of questions for comments is included in the report:
- What entity should be in charge of reviewing research identified by PIs as dual use of concern?
- Is the definition of dual use research of concern appropriate in terms of its “specificity” and “sensitivity”?
- Are the listed seven categories of potentially dual use research appropriate?
- Should the PI be the sole and prime responsible to identify his own research as dual use of concern?
- What additional guidance is required?
- What burden does these recommendations (eg necessity to review research identified as dual use of concern) represent for your institution?
Proposed Biosecurity Review Plan Endorses Self-Regulation. Kaiser-J (2007), Science 316:529