HHS. NIH. DHS. ORI. NSABB. SOB. Washington, DC, is a town full of acronyms.
As ethical editors, there is another one we should be familiar with: DURC, or dual-use research of concern.
DURC is defined as research that, based on current understanding, can be reasonably expected to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, or materiel.1,2
On 13 January 2011, the National Science Advisory Board for Biosecurity (NSABB) convened a working group to review journal polices on handling the review process for DURC. The session was attended by journal editors broadly representing the STM fields; representatives of the US Office of the Director of National Intelligence, US Department of Health and Human Services, and National Institutes of Health (NIH); and representatives from the Council of Science Editors, the Committee on Publication Ethics, and the World Association of Medical Editors.
The meeting was divided into four main parts, beginning with an overview of NSABB’s activities related to guiding journal review policies on DURC.
The board was established in 2004, and three previous roundtables have been held.3 The roles of the board have been to raise awareness of DURC; address potential risks of publishing this research; establish a manuscript-review process used to evaluate DURC papers; minimize the misuse of data; and share best practices among editors for reviewing, managing, and publishing DURC papers.
Since its inception, the board has been building upon the ideas and principles noted in the National Research Council’s report Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma, the result of a committee chaired by Gerald Fink.4
The Fink report identified seven types of research to consider when evaluating experiments of concern:
- Would it demonstrate how to render a vaccine ineffective?
- Would it confer resistance to therapeutically useful antibiotics or antiviral agents?
- Would it enhance the virulence of a pathogen or render a nonpathogen virulent?
- Would it increase transmissibility of a pathogen?
- Would it alter the host range of a pathogen?
- Would it enable the evasion of diagnostic or detection modalities?
- Would it enable the weaponization of a biological agent or toxin?
Since 2007, guidance and tools have been available to the public on the NIH Web site to help identify potential DURC.5
The second session was a review of existing policies of various journals and discussion about how journals handled certain publications. The American Society for Microbiology uses checkboxes on its review forms; if a box is checked by a referee, the editor is alerted and involved in the decision process to ensure security concerns have been considered. NSABB recommends all journals have a policy clearly stated in their information for authors.
The Proceedings of the National Academy of Sciences (PNAS) and Science ask authors to identify their own research as possible DURC and state security experts may be consulted to comment on the work. Nature policies were also discussed.6
The various policies identified different courses of action editors need to consider the following:
- Do nothing and publish as is.
- Edit the work to remove potentially harmful details and publish.
- Publish with a commentary or editorial to place the work into context.
- Reject on the basis that the security risk is too high.
The publication of a PNAS paper7 that modeled inserting botulinum toxin into the milk supply and the corresponding editorial8 were noted as one possible outcome of a dual-use review.
The next session dealt with working as a community to identify and share information and practices. An interesting question was raised about what to do with a paper rejected for dual-use concerns. Where does the responsibility of a journal editor end? A discussion of whether it is appropriate to contact an author’s institution with concerns ensued, and many editors indicated that this was not advisable unless there was falsification, fabrication, or plagiarism.
Should editors of one journal contact another journal with concerns if they think a rejected paper will be resubmitted further down the line? This is the type of open question that is best dealt with on a caseby-case basis.
The role of NSABB, journal editors, and international editor organizations was discussed in relation to providing a unified policy and framework for all journals to use. The almost unanimous decision was that this would be problematic. The use of NSABB communication tools was discussed, as the board provides a risk/benefit tool for editors to use when evaluating a potential publication.6
The last session addressed best practices for dealing with dual-use submissions. Education and awareness should be emphasized at an early level such that authors, editors, and referees are all aware of the potential problems of misuse. At the journal level, training should be provided to ensure editors understand what to do when a concern is raised. Checkboxes on referee forms to aid the reporting and identification of DURC can be a useful tool for tracking and identifying problematic papers. Consulting outside security experts to review a paper when dual-use concerns have been raised was recommended.
Additionally, the role of editors’ groups and associations was discussed as a means to educate readers.
The need to followup with authors to help them understand dual-use concerns is a task that should not be overlooked. If you are going to publish DURC, contextualizing the research with editorials or commentaries or issuing a press release to put the research in the proper context is recommended.
As an ethical editor, you must have procedures in place for identifying, reviewing, and publishing DURC. A multitude of resources are available on the NSABB Web site (http://oba.od.nih.gov/biosecurity/about_nsabb.html), within the CSE White Paper, and noted below for further reading.
DANIEL SALSBURY is managing editor of the Proccedings of the National Academy of Sciences.
References
- Frequently asked questions [Internet]. Washington (DC): National Science Advisory Board for Biosecurity [cited 2011 May 25]. Available from: http://oba.od.nih.gov/biosecurity/nsabb_faq.html#NSABB_FAQ001.
- White paper on promoting integrity in scientific journal publications [Internet]. Wheat Ridge (CO): Council of Science Editors [cited 2011 May 25]. Available from: http://www.councilscienceeditors.org/i4a/pages/index.cfm?pageid=3354.
- Past meetings [Internet]. Washington (DC): National Science Advisory Board for Biosecurity [cited 2011 May 25]. Available from: http://oba.od.nih.gov/biosecurity/nsabb_past_meetings.html.
- Committee on Research Standards and Practices to Prevent the Destructive Action of Biotechnology, National Research Council. Biotechnology research in an age of terrorism: confronting the dual use dilemma. Washington (DC): The National Academies Press; 2004.
- Proposed framework for the oversight of dual use sciences research: strategies for minimizing the potential use of research information [Internet]. Washington (DC): National Science Advisory Board for Biosecurity [cited 2011 May 25]. Available from: http://oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_Sept07.pdf.
- Biosecurity policy [Internet]. London (UK): Nature Publishing Group [cited 2011 May 25]. Available from: http://www.nature.com/authors/policies/biosecurity.html.
- Wein LM, Liu Y. Analyzing a bioterror attack on the food supply: the case of botulinum toxin in milk. Proc Natl Acad Sci USA. 2005 July 12;102(28):9984–9989. [Internet] [cited 2011 Sept 28]. Available from: 10.1073/pnas.0408526102.
- Alberts B. Modeling attacks on the food supply. Proc Natl Acad Sci USA. 2005 June 28;102(28):9737–9738. [Internet] [cited 2011 Sept 28]. Available from: 10.1073/pnas.0504944102.
Further Reading
Committee on Genomics Databases for Bioterrorism Threat Agents, National Research Council. Seeking security: pathogens, open access, and genome databases. Available from: http://www.nap.edu/catalog.php?record_id=11087.
Committee on Scientific Milestones for the Development of a Gene-Sequence-Based Classification System for the Oversight of Select Agents, National Research Council. Sequence-based classification of select agents: a brighter line. Available from: http://www.nap.edu/catalog.php?record_id=12970.
Cozzarelli NC. PNAS policy on publication of sensitive material in the life sciences. Proc Natl Acad Sci USA. 2003;100(4):1463. Available from: www.pnas.org/content/100/4/1463.full?sid=203bc741-2080-4276-83f6-d36ce8d45227.
Falkow S. “Statement on scientific publication and security” fails to provide necessary guidelines. Proc Natl Acad Sci USA. 2003;100(10):5575. Available from: www.pnas.org/content/100/10/5575.full.
Journal Editors and Authors Group. statement on scientific publication and security. Science 2003;299(5610):1149. Available from: www.sciencemag.org/site/feature/data/security/statement.pdf.
National Science Advisory Board for Biosecurity. Responsible communication of life sciences research with dual use potential. Available from: http://oba.od.nih.gov/biosecurity/pdf/Communication_Tools%20_Dual_Use_Potential.pdf.