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

In our analysis, we find the legal situation in the European Union, Germany and the USA to be inconsistent. Most laws only apply to the dual use items, such as chemicals. In some countries publications are dealt with as such dual use items and laws are applied, in others not. This inconsistency lead to a broad ethical debate.

Since it seems to be unclear, whether the existing laws apply, we see a definite need for an international regulation and a guideline. Such are proposed by various advisory boards, non governmental organizations and ethical committees. We further describe the laws in detail, possible guidelines, implications and proposals of those boards and committees and display various opinions in the broad field of ethical questions concerning dual use in our report.

Ethical questions

The discussion about moral and ethical questions of the dual use matter is of very broad range. The complete understanding of the ethical basis is far beyond the size of this record and requires a deep understanding of ethics. To display various points of view beyond the laboratory work and to complete our findings we contacted various experts and display a summary of different points of view.

Freedom and responsibility in science

The advances of communication technology create free access and communication. This is promoting the progress of science. Simultaneously, this freedom creates the possibility of access of this information for potential misuse (Deutsche Forschungsgesellschaft/Leopoldina, 2010). Freedom of science and the possible need for restriction of information for security purposes are hence controversial and need to be weighed carefully.

Self regulation vs. institutional oversight

A self regulation process needs responsible participation of everyone involved in the path of research and its publication: researchers, funding institutions, cooperators, coworkers, editors and reviewers of journals, ethics councils and legal institutions. While this responsibility is called for by various advisory boards and non governmental institutions (NSABB, 2007,European Commission, 2014), the need for institutional oversight is still stated. Different points of view from experts are discussed in detail in our report. Among them is the point of view of Constantin Teetzmann, constitutional lawyer. He promotesa self regulation process involving expert advisory. Prof. Kathryn Nixdorff points out the importance of oversight and education. Prof. Alfons Bora explains the idea of reaching out to everyone conducting research and education. In addition, several advisory boards promote institutional oversight and international regulation.

Responsibility of publishing institutions

Editors are the ones making final decisions about the publication of research result. They collaborate with reviewers in the process of publication. Therefore those persons in charge should be guided by further educational courses on dual use issues and the incorporation of their needs in biosecurity guidelines. Nevertheless, this establishment can only be a part of the progress of responsible oversight.

“To try to prevent misuse at the publication level serves no purpose, this is too late. By then, detailed knowledge about the contents of the publication is already known to collaborators, and the work has in most cases been presented at meetings. (…) The point of oversight and application of mitigating measures must begin at the planning stage and continue throughout the experimentation process until the work has been completed. This is why the risk assessment your Bielefeld-Team proposes is so important. Identify risks at the very beginning and find ways to mitigate those risks before any risk-laden methods become public knowledge.”

Prof. em. Kathryn Nixdorff (Department of Microbiology and Genetics, Darmstadt University of Technology)

Responsibility of the researchers

Because up to now no legal restrictions apply, the researcher himself is making the decision in collaboration with ethic councils, whether the benefits of the research outweigh the risks, whether there are ethical or moral reasons not to investigate the question of concern and whether the results can be (partly) published. The decision is made at the planning stage. This moral reasons need to consider the consequences of science – such as application in pharmacy, medicine and other fields (DFG/Leopoldina 2014).

Conclusions

In our opinion, the ethical dilemma points out the necessity for the implementation of the dual use issue in research at the very beginning: The education and advisory of young researchers is a key step towards this goal. To ensure these progresses, advisory institutions, such as ethical commissions, need to be established. While the optimal solution would be international applicable guidelines, which advisory boards are reaching out for, we believe iGEM to have the unique chance to be a role model in international collaboration and education of young researchers.

Biosafety and Biosecurity in iGEM

Every team is dealing with genetically modified organisms, methods of synthetic biology to analyze, combine and build those organisms and DNA parts, respectively. Therefore, the question of regulation is given in context of biosecurity and biosafety. It needs to be dealt with within each team and the competition itself as well.

Biosafety and Biosecurity in iGEM

However, we could not find definitions of biosafety, biosecurity, dual use and dual use research of concern (DURC) within the iGEM safety page. In terms of biosafety, obligational forms need to be filled and check-ins for certain organisms and proteins are required. A list of organizations publishing instructions and legal regulations for different countries is provided, since iGEM faces the challenge of teams from a broad range of countries. Regarding biosecurity on the other hand, we found questions to be asked in context of safe project design, such as “To whom will it be benefitial or harmful?” on the safety page. It is noticeable, that the questions asked try to cover a mixture of biosafety and biosecurity issues. The answers differ among the iGEM teams in a very broad spectrum. Interestingly, the questions aim to the designed product or the used methods/chassi, but not the information that are distributed among our society by the team´s homepages, wiki and other published materials, so does the question concerning security in the safety form: “What risks might your project pose, if it were fully developed into a real product that real people could use? What future work might you do to reduce those risks?” We think that biosecurity risks need to be defined and the question to be asked more precisely.

Dual Use Dilemma in iGEM

Nevertheless, iGEM members are supposed to live up to the trust that is put into them by society and “design, build and share biological devices safely” (iGEM Safety Page, 2015). Aspects of dual use have found focus in Terry Johnson´s call for awareness: iGEM participants, but also participants anywhere in the biotechnological environment, “should be aware of: the organization or organizations overseeing (ones) work, the appropriate Risk Group for the organisms that (one is) working with, and any select agents that might be involved. Further consider: any potentials for dual use, and especially if there are any biosafety or biosecurity concerns that are not addressed by current administrative controls”. (Terry Johnson, 2013). Interestingly, the security page of 2011 contains details about biosecurity risk assessment. The possible misuse of information is pointed out. At the time of this years project design and conduction neither on the main igem page nor on the 2015 page a security page was existent. Nevertheless, the iGEM competition established a safety committee that has members with very deep knowledge about the dual use concern.

Conclusions

Facing this dilemma in our own project, we have not found proper guidelines within the competitions to apply to our concerns. While iGEM provides expert council through its safety committee, we find this not to be sufficient to call for awareness of dual use in states of research. As proposed in our description of the ethical debate, this is critical for the planning of research. Therefore, we propose the implementation of biosecurity risk assessment in obligational forms. Since the iGEM competition asks us to be “striving to be conscientious members of the synthetic biology community” (iGEM Safety Page, 2015), we want to complete this safety and security aspects by finding guidelines for the safe distribution of knowledge and the question of dual use research of concern. As it is an international competition aiming to promote the communication between researchers as well as between them and the public, iGEM could be a role model in considering the dual use dilemma.

Proposals for the iGEM community

We propose the implementation of the definitions of biosafety, biosecurity and dual use in the iGEM safety page. This is suggested to increase awareness of biosecurity risks and especially the dual use issue from the very beginning of research progress in iGEM projects.

Further, on advice of Prof. Nixdorff and in hindsight of the proposals of several advisory boards, we propose a general biosecurity risk assessment by implementation of questions into obligatory safety forms:

General biosecurity risk assessment

• Do you work with any S3/4 organism’s sequences or toxins or does your work contain any sequences or proteins specifically produced/contained in these organisms? Do you provide any knowledge of constructing, manipulating or influencing these agents or toxins?
• Do your experiments meet any of these criteria or provide knowledge about the conduction of these experiments?
• “Enhances the harmful consequences of the agent or toxin
• Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical or agricultural justification
• Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
• Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
• Alters the host range or tropism of the agent or toxin
• Enhances the susceptibility of a host population to the agent or toxin
• Generates or reconstitutes an eradicated or extinct agent or toxin listed above”
(United States Government, 2014)

Dual use risk assessment

• Can you imagine any malevolent use of the knowledge and sequences published on your team’s wiki? Could the knowledge you provide in direct consequence be used for the creation of products or organisms that pose a danger to humans or the environment?
• In case of collaboration, does the sharing of devices or information create the potential of misuse?
• In case of potential risk, did you initiate oversight or seek ethical/legal council or advice?

Prospect

We favor the implementation of international applicable guidelines for biosecurity and dual use risk assessment. We found the importance of the establishment of oversight and assessment in every state of research progress, beginning at raising awareness of the risk up to the establishment of the risk assessment in hindsight of research: publication and collaboration. The detailed implementation and process is displayed in our report.

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.