Unintended Use of Research Results
through Publication: Dual Use ofVirus Study
Masayuki Saijo, M.D.
Editor-in-Chief of JJID
Director of the Dept Virol 1NIID

NIID
The National Institute of Infectious Diseases (NIID)
is a research institute attached to the Ministry ofHealth and Welfare for conducting
 fundamental and applied research on infectious
diseases national test for lot release and development ofantibiotics and vaccines
 surveillance of infectious diseases in Japan andabroad Etc.

History of JJID
• As the official journal of NIID, JMJ wasestablished in 1948.
• The name of JMJ was changed to Japanese
Journal of Medical Science and Biology(JJMSB) in 1952.
• The name of JJMSB was changed to Japanese
Journal of Infectious Diseases (JJID) in 1999.

Dual Use Research in the field of virus study
Case 1: R.J. Jacobsonet al. “Expression of mouse interleukin-4 by a recombinant ectromelia virus suppresses cytolytic lymphocyte
responses and overcomes genetic resistance to mousepox.” J. Virol., Vol 75, pp. 1205-1210, 2001.

• Aim– The researchers in Australia inserted a mouse IL-4 gene into themousepox virus hoping to ultimately induce infertility in mice byusing the product as a pest control agent for the overpopulationof mice in Australia.

• Results– The altered virus was capable of killing both naturally resistantmice, and those that had been vaccinated against ordinary
mousepox.

• Concerns– The article was not only alerting potential terrorists to a possible
novel biological orthopox virus weapon (such as modified
smallpox), but also providing them with detailed instructions on
how to construct it.

Dual Use Research in the field of virus study
Case 2: M.M. Becker, et al. “Synthetic recombinant bat SARS-like coronavirus is infectious in cultured cells and in mice.”
Proc. Natl. Acad. Sci. USA, Vol 105(50), pp. 19944-9, 2008.

• Aim– U.S. scientists conducted research to synthetically generate a
non-cultivatable bat virus genetically related to a severe acuterespiratory syndrome coronavirus (Bat-SARS-like CoV).
– The overall goals of the research were to establish strategies forrecovery, testing, and attenuation of the potential pandemic
non-cultivatable viruses, and to determine pathways of Bat-CoV
host-species movement and adaptation.
– The research was considered highly significant since it could
enable more timely response to potential species jumps andmore rapid and effective public health intervention.

ResultBat-SARS-CoV with replacement of RBD of SARS-CoV
acquired replication capability in cell culture including
human epithelial cells.

DURC assessment in Virology• Study design – Scientist(s), Department and Institutional
consideration/regulation• Study application to funding agency – Funding agency’s
consideration/responsibility• Biosafety and biosecurity clearance – Institutional guidelines• Conducting researches – Department responsibility• Acquisition of research results - Department responsibility• Preparation of manuscript – Scientists/Department responsibility• Submission of the manuscript – Scientists/Department
responsibility• Editorial decision of the manuscript for publication – Editorial board
responsibility• Publication

DURC and Biosafety, biosecurity

DURC
DURC

Biosafety

Biosecurity
Biosafety

How high should the biosafety level
Bat-SCoV-SRBD be?

Biosecurity

Imagine to perform Ebolavirus-associated study

Interaction of DURC with ScientificInterest and Freedom

Scientific and social moral
Scientific Interest and freedom

Biosafety

DURCBiosecurity

DURC-definition/criteria
Proposed by NASBB
A.
B.

Enhance the harmful consequences of a biological agent or toxin
Disrupt immunity or the effectiveness of an immunization withoutclinical and/or agricultural justification
C. Confer to a biological agent or toxin, resistance to clinically and/oragriculturally useful prophylactic or therapeutic interventions
against that agent or toxin, or facilitate their ability to evadedetection methodologies
D. Increase the stability, transmissibility, or the ability to disseminate
a biological agent or toxin
E. Alter the host range or tropism of a biological agent or toxin
F. Enhance the susceptibility of a host population
G. Generate a novel pathogenic agent or toxin, or reconstitute aneradicated or extinct biological agent

Responsibility of the editorial
board of JJID in terms of DURC
• The formal assessment system for the submitted
manuscript on DUR/DURC has not yet been introduced.
• We have to discuss on the DUR/DURC issues in the JJID
editorial board members.
• In the case that DUR/DURC criteria was introduced for
publication decision making, how should the criteria
should be?
• Who should have responsibility for the decision
making? – Editor-in-Chief?
• Further discussion is needed not only in NIID, but also
in the scientific community.

DURC and NIID
• NIID should deal with the DURC issues in accordance withthe progress on DURC issues in the scientific communities
not only in Japan, but also in the world.

– Introduction of the education system for DURC in the training
course of biosafety and biosecurity– Evaluation system for the applied research projects as a funding
agency– Introduction of the prequalification system for the manuscripts
in preparation– JJID should consider DURC issues• NIID should acknowledge the value of scientific interest andfreedom under the scientific and social moral.
• Necessity to declare Code of Conduct associated with DURC
issuesDUR/DURC is the matter of• Regulation by the authorities?
• Moral issues for the scientist?

– Transparency is rather important to reduce therisk of DURC risks?
– Self censorship is enough?
– Education system is already implemented?

• Who is the specialists for DURC
• Who educate scientists the issue of DURC
• Code of conduct declared from the scientific societies?

Summary• NIID and JJID are introduced• Significant manuscripts
associated with DURC areintroduced.
• The DURC-associated matterswhich should be discussed in
the NIID and JJID editorial
board is presented.
• Personal consideration on theDURC issues are discussed.

Dual Use Research of Concern Issues
in the Field of M icrobiology Research in JapanR eview:

Dual Use Research of Concern I ssues
in the Field of M icrobiology Research in Japan
M asayuki Saij oDepartment of Virology 1, National Institute of Infectious Diseases
Toyama 1-23-1, Shinjuku-ku, Tokyo 162-8640, Japan
E-mail: msaijo@ nih.go.jp[Received M arch 31, 2013; accepted M ay 24, 2013]

M icrobiology researches and infectious disease researches have to contribute to the progress of science and contribute to m easures against infectious disease burdens. H owever, researches on infectious diseases and m icrobiology always have a potential risk
related to scientiﬁ c am biguity, i.e., so-called Dual Use
R esearch of Concern (DUR C). M ost of m icrobiologist, now trying to im prove the level of biosafety andbiosecur ity, will be required to also im prove their consciousness about DUR C and pay attention to trends ofdom estic and international DUR C issues in the ﬁ eldof m icrobiology and properly cope with them . W hen
m ak ing plans, applying for research funding, and publicizing research outcom es, researcher s are required toalso care about DUR C. To set up such system , discussions need to be m ade also at research institutes, including the National I nstitute of I nfectious Diseases,
over DUR C issues, such as how to educate the researchers and how to cope with DURC.
K eywords: dual use research, dual use research of concern, biosafety, biosecurity, JJID

1. I ntroduction
Recently, scientiﬁ c research outcomes are recognized
as they have both advantageous and disadvantageous inﬂuences on society. Researches that have advantageousinﬂuences but may have potential disadvantageous inﬂuences on society are called Dual Use Research (DUR) andDURs that have such concerns are called Dual Use Research of Concern (DURC). Even if a microbiology research is scientiﬁ cally interesting and contributes to theprogress of science, knowledge of the research can possibly be abused by a certain party or an organization andwhich may produce bioweapons by applying the knowledge, thereby causing danger in society. It has been longsince DURC issues were focused on and researches related to nuclear or DNA recombination technology havebeen publicized with deep discussions each time. M icrobiological DURC issues have also been discussed so
far by specialists in many international frames. The central role of the discussions has been played by the U.S.
[the U.S. Congress, recently, the U.S. Homeland SecuJournal of Disaster Research Vol.8 No.4, 2013

rity, the National Science Advisory Board for Biosecurity (NASBB), the National Institute of Health (NIH), andthe like], including discussions on how to deﬁ ne DURCrelated researches, how to regulate them, what sort of researches to be regulated in the ﬁ rst place, and what to do
to internationally penetrate DURC-related regulation.
W hen researches [1, 2] were publicized recently of thebird ﬂu virus A/H5N1, which acquired high transmission
capability among mammals, a concern was raised by persons involved (research funding agencies, journal editorial boards, and so on) that unlimited disclosure of suchinformation results in giving society negative inﬂuences(disadvantages), more speciﬁ cally, a concern of negative
inﬂuence caused by highly pathogenic, highly humantransmissible viruses artiﬁ cially generated by using suchinformation and spread in human society. A discussion
was made on how to publicize the research outcomes(W HO, 26 to 28 February 2013, Geneva1 ). Also in Japan,
discussions over DURC issues have been made by someresearchers and relevant institutes. However, it may be
no exaggeration to say that the issues have not penetrated
among and cared about by Japanese researchers. This article gives an explanation on the relation between microbiology and DURC from a point of view of researchersof microbiology. It is to be noted that opinions seen inthis article are not given on behalf the National Instituteof Infectious Diseases (NIID), where the author belongs,
but as the author’s personal opinions that are responsible
only for the author.

2. Researches with DURC
Representative literatures with DURC in the ﬁ eld ofmicrobiology research include one reporting that mouseIL-4 expression recombinant mousepox virus was synthesized by introducing genes that express mouse IL-4
to mousepox virus (ectromeria virus), resulting in notjust a pathogenicity increase but also acquiring resistance against a smallpox vaccine, which is effective for amousepox virus infections, losing its effect for the recombinant virus infectious disease [3]. This literature concerns about DURC due to a research outcome demonstrat1. http://w ww.who.int/mediacentre/events/meetings/2013/durc/en/[accessed July 29, 2013]693

Acknowledgement
All the contents in this presentation wereprepared based on the personal opinions of
this presenter, Masayuki Saijo, Departmentof Virology 1, National Institute of Infectious
Diseases. Please remind that the contents inthis presentation do not represent those of
the National Institute of Infectious Diseases,Tokyo, Japan.