Team:Bielefeld-CeBiTec/Practices/DualUse
Dual Use
More than biosafety and biosecurity: Ethics, Laws and Guidelines
Overview
We decided to do an analysis of biosecurity, specifically the dual use issue of our project. While we were scanning the literature for information about our biosensor for detection of date rape drugs, we encountered many sensitive information about the accessibility and (chemical) synthesis of date rape drugs. Those information are publicly availably. Especially the publication of a freely available ingredient raised our concern. In our opinion, this knowledge can create a threat to the health of people, if it is misused.
Because iGEM is an open source competition, we might ourselves provide knowledge that could be of dual use. Since iGEM asks us to be striving to be conscientious members of the synthetic biology community, we informed ourselves about existing biosafety, biosecurity and dual use regulations.
We found the legal situation in Germany, the European Union and the USA to be inconsistent. In addition to these laws, many proposals from various advisory boards and non governmental organizations exist. We provide an overview about the proposals of these organizations and summarize various aspects of the ongoing ethical discussion about the opposing needs freedom of science and regulation of research with possible biosecurity issues. Therefore we contacted several experts from ethics committees, members of the German ethics council, a constitutional lawyer and a law student from the USA, as well as the iGEM safety committee itself. In fruitful discussions we obtained various opinions from different fields of expertise/from different academically point of views/from different perspectives.
We wondered, why we did not find any biosafety, biosecurity and dual use definitions within the iGEM safety page. iGEM offers many regulations and risk assessments concerning biosafety and provides a great infrastructure with its interdisciplinary expert team, the biosafety commission. We want to complete this biosafety and security aspects by finding guidelines for the safe distribution of information and the dual use in research. We propose the implementation of definitions in the safety page and questions aiming for biosecurity and dual use risk assessment in the obligatory safety forms. iGEM has a unique potential in reaching out in education of young researchers to contribute to a responsible research community.
We performed the risk assessment for our project, which, in addition to our public outreach and several expert contacts, influenced our project significantly. It broadened our horizon in the context of interdisciplinary collaboration and communication with the public - to build up to the trust put into us.
We believe, that iGEM can be a role model in raising awareness of biosecurity and dual use risks - for a better international collaboration to create beneficial knowledge.
We briefly summarize our findings on these pages. The detailed report is available as PDF.
Definitions
Legal institutions in Germany, the European Union and the United States of America define the term dual use as the risk that chemicals, organisms or technologies can be misused for military purposes. This definition originates from the bioweapon convention in 1972. A point of view more adapted to recent developments in technology and the uprising discussion about research with biosecurity concern can be found in discussions and proposals of non governmental institutions and advisory boards, such as the World Health Organization (WHO), the National Science Advisory Board for Biosecurity (NSABB) and the Leopoldina (German Academy of Sciences). Some define dual use to the potential of research results to be used in benevolent and malevolent purposes as well. As a result of our analysis, we find the definitions to vary between the different states and organizations. While organizations within the USA use the term for research results as described, in Germany this dilemma is referred to as “research with security concern”. This topic was addressed by the FBI a Giant Jamboree in Boston. Nevertheless, we could not find a definition of dual use within the iGEM safety page. More surprisingly, we did not find definitions of biosafety and biosecurity either. To promote a better understanding of the underlying principles and raise the awareness of the dual use dilemma, we want to provide definitions of biosafety, biosecurity of dual use and dual use research of concern.
Biosafety
"Biosafety describes the containment principles, technologies and practices that are implemented to prevent the unintentional exposure to pathogens and toxins, or their accidental release.” (World Health Organization 2004)
Biosecurity
"Laboratory biosecurity describes the protection, control and accountability for valuable biological materials (…) within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release."(World Health Organization 2004)
Dual Use
Initially the term dual use used to be refered to the aspects of certain materials, information and technologies that are useful in both military and civilian spheres. The expression is increasingly being used to refer not only to military and civilian purposes, but also to harmful misuse and peaceful activities.” (World Health Organization 2006)
Dual Use Research of Concern (DURC)
The National Science advisory board refers the “generation and communication of information and new technologies from life sciences research that have the potential for both benevolent and malevolent application (…) along with the subset of dual use research with significant potential for generating information that could be misused (…) to as “dual use research of concern.” (NSABB 2007)
In view of these non consistent definitions in such an important field, we see the necessity of an international definition to establish a uniform basis for discussion and establishment of guidelines. Containing both definitions, namely the potential use of goods or technologies for military purposes as well as the potential misuse of information and knowledge, we find the definition of the WHO to fulfill those needs. We consider biosecurity to be not only the protection of material, but also the prevention of risks that arise by the knowledge provided in research.
Laws
Ethical questions
Biosafety and Biosecurity in iGEM
Proposals for the iGEM community
Integration in our project
Interviews
For our report about Dual Use we worked with various experts in ethics, laws and sociology. The complete interviews and statements are available in the report itself.
Prof. Kathryn Nixdorff (Microbiology)
The report (“Dual Use - A report by the Team iGEM Bielefeld-CeBiTec 2015”) the Team iGEM Bielefeld CeBiTec 2015 has submitted in the context of the iGEM competition, as an aspect of their synthetic biology project, is in my view an innovative contribution that will help promote the aim of the iGEM to foster conscientious members of the synthetic biology community. Several surveys over the past ten years have clearly documented that the majority of scientists involved in modern life sciences work do not devote a great deal of active consideration to questions of biosecurity, mainly because they have little awareness of possible dual-use implications of their work. In the iGEM competitions, a lot of emphasis is placed on working safely, with required questionnaires, which, however, mainly cover biosafety aspects of their work. This is an excellent procedure and imperative to working responsibly. While the efforts of the iGEM organizers to promote awareness of biosecurity issues are growing steadily, the same rigorous questioning about dual-use biosecurity risks in carrying out the iGEM projects has to my knowledge not yet been applied. The proposal of the Bielefeld-Team to assess possible dual-use biosecurity risks in the context of all iGEM competition projects is a step in the right direction to promote awareness of biosecurity concerns among competition teams and to allow them to demonstrate that they are acting responsibly not only with biosafety concerns, but also with those related to biosecurity. I consider this relevant and necessary in light of the steadily growing reports of work involving dual-use research of concern (DURC) in the scientific literature that have generated much controversy and debate in the scientific community and in the general public about the need for carrying out research in a responsible manner. In my opinion, the proposal of the Bielefeld CeBiTec Team is a needed step that can definitively complement the standing efforts of the iGEM organizers to foster conscientious members of the synthetic biology community."
Professor Alfons Bora (Sociology)
"The aspect of dual use deserves highest attention, both in science and politics. Therefore, national states as well as international organisations are obliged to monitor all relevant trends and to apply regulation, where necessary. Equally important, however, is the responsibility of scientists and their organisations. The training of young scholars, the implementation of clear and expedient rules and monitoring mechanisms, and the obligation to take dual use aspects into consideration at any step of the research process are important components of scientific self-regulation."
Constantin Teetzmann (Constitutional Lawyer)
"The iGEM competition could strengthen responsible decisions on the dual use research while respecting freedom of research if it provided the necessary resources. The competition offers already one resource by its very nature: iGEM is a good forum to discuss the issue. The second one needs to be developed: well-founded decisions about dual-use research need factual knowledge and normative considerations. Information about the facts and different normative perspectives on the problem could be published within iGEM and institutional points of contact might be established. It would be great if such point of contact could provide counseling and help to examine the issue on all relevant aspects. The decision would still stay with the team and ultimately with every individual researcher. Therefore, any advice shall not get judgmental or take over the decision by giving specific recommendations."
Joseph Ayar (J.D. candidate, Santa Clara School of Law)
"Different perspectives within iGEM, such as legal and ethical, not only help to ground scientific research within the current legal and ethical framework, they can even help drive the progression and evolution of the framework itself. Bielefeld-CeBiTec’s report on dual use research is a manifestation of such a collaboration as it provides the building blocks for a responsible approach to a field that is advancing at an ever-increasing pace."
Additional interviews
To analyse the current situation at our university, we further contacted and interviewed Prof. Bohner, head of the ethics commission of our university. He is professor in the department of psychology and provided us valuable insights on the current status and possible further implementation of council for researchers at our university. The analysis of applicable laws and responsibilities of the german legislation are complemented by an interview with the German Federal Office for Consumer Protection and Food Safety, Department 4: Genetic Engineering.
