Proceedings of the Dual Use Research of Concern Panel Discussion: challenges and perspectives

The rise of CRISPR-Cas has revolutionized the field of gene and genome editing. Design-Build-Test-Learn (DBTL) cycles, fueled by artificial intelligence and machine learning, are rapidly advancing opportunities for deliberate engineering of biological systems and are accelerating the development of products and applications. The COVID-19 pandemic has demonstrated the capacity of joint global research and development (R&D) efforts and information sharing, with tests and vaccines, including novel vaccines based on mRNA, being generated at an unprecedented speed. The multiple advantages of this development are clear; however, assessing the extent to which new risks will emerge and how they should be managed remains challenging. An important aspect of biological risk is Dual Use Research of Concern (DURC). DURC is defined as research that could be misappropriated to do harm and not used in the way intended by researchers. The identification of DURC aims to reduce the potential for research to be misused and cause harm to public health and safety, agricultural species and other plants, animals, and the environment (World Health Organization 2020).

Once research is published, it is not possible to put the genie back into the bottle; therefore, the assessment of research requires prior consideration. In academic research, both results and methodologies are published in broadly accessible scholarly journals. This is a key requirement for reproducibility and is in the spirit of open science. At the same time, this also means that malicious actors can easily reproduce research outputs. It is unclear and an object of ongoing debate whether academia pays sufficient attention to DURC. The rapid development of novel mRNA vaccines during the COVID-19 pandemic and the continued mistrust of these vaccines in certain segments of the population highlights that progress within the life sciences can often move quickly, creating challenges for public consultations and multistakeholder discourse. Another example is genome sequencing, in which current technologies provide the opportunity for personalized genome sequencing by private companies using data stored in cloud services. Academic research revealing new insights into the human genome in general could now be used directly by a company having access to a person’s genome to know about genetic predispositions. The person may neither be aware of new genomic research nor have provided consent to the company to apply new knowledge to their personal genome. Examples such as this indicate the broadening interface of open access science and society, an interface that will continue to increase in the future, along with an increase in the potential of misusing the results of academic research.

In response to this ongoing discourse, the DURC Panel Discussion was held online on June 23rd, 2021, to facilitate discussions on the current and future challenges regarding DURC. Here, we provide a short summary of the proceedings and outcomes of this panel discussion.

The panel was held online and included one moderator and six panelists, with the aim of bringing together different stakeholders connected to academic life sciences research. The stakeholders included researchers, publishers, and policymakers, many with a connection to the International Genetically Engineered Machine (iGEM) competition (https://2021.igem.org/), the international student competition in synthetic biology (SynBio), and a leading organization in the field of biosecurity (Table 1).

The event opened with a presentation by Svenja Vinke at the DURC Workshop, which was held online on June 9th, 2021. This workshop involved international participation and diverse academic backgrounds. Surveying the participants confirmed that graduate students in the life sciences are mostly unaware of the acronym DURC, and none have received formal training on DURC during their academic studies (Table 2).

The workshop presentation was followed by the opening statements of the remaining five panel participants. The statements offered general information on DURC and biosecurity, as well as personal experiences regarding DURC risks and regulations. Panelists also highlighted the most prominent treaties and initiatives involved in DURC regulations. Within the international context, the Biological Weapons Convention (BWC) (Conference of the Committee on Disarmament 1975) prohibits states from developing biological and chemical weapons. Connected to the BWC is the Australia Group (https://www.dfat.gov.au/publications/minisite/theaustraliagroupnet/site/en/index.html), an informal group of countries that seek to harmonize export controls to prevent the development of biological and chemical weapons. The Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies (Wassenaar Arrangement Secretariat 1996) promotes export controls for military dual-use technologies, including biotechnology. While these international frameworks are not specific to DURC within academic research and provide no direct guidance, they provide international fora to discuss DURC-related issues and share information. It was noted that BWC is not well known among life scientists. Contrary to previous editions, DURC is mentioned in the 4th edition of the WHO Laboratory Biosafety Manual (World Health Organization 2020). However, this is limited to two short paragraphs that explain the concept of DURC.

At the federal level in Canada, DURC falls within the responsibilities of the Centre for Biosecurity (https://www.canada.ca/en/public-health/services/laboratory-biosafety-biosecurity/about-centre-biosecurity.html) at the Public Health Agency of Canada (PHAC), where DURC is regulated under the Human Pathogens and Toxins Act (HPTA) (Health Canada 2015a), the Human Pathogens and Toxins Regulations (HPTR) (Health Canada 2015b), and certain sections of the Health of Animals Act (HAA) (Health Canada 1990) and its regulations. Detailed information and explanations can be found in the Canadian Biosafety Guideline on Dual-Use Research in the Life Sciences (Public Health Agency of Canada 2018). Additionally, implications for dual use arise from the following acts and agencies: The Transportation of Dangerous Goods Act (Transport Canada 1992), the Export and Import Permits Act (Global Affairs Canada 1985), and the Environmental Protection Act (Environment and Climate Change Canada 1990). It should be noted that synchronizing regulations arising from these different acts is a complicated and time-consuming process. However, this synchronization between different Canadian agencies is necessary to address dual use in its entire complexity and to avoid legal uncertainties.

In Canada and the USA, the evaluation to determine whether life science research falls under DURC is based on two lists. The first is a list of DURC agents and toxins that currently contain eight viruses and six bacteria, as well as botulinum neurotoxins. The second list summarizes seven different experimental effects of concern that could make an existing agent or toxin more dangerous. If research involves one of the 15 agents or toxins and includes one of the seven experimental effects, it falls under DURC and needs to be evaluated and oversighted. However, this is just the baseline criterion, and institutions can expand both lists to include further agents and experiments.

During the panel, the panelists unanimously agreed that DURC is not limited to lists of agents and experimental effects. Other bacteria and viruses can be modified to gain or increase their pathogenicity, and there are ways to misuse research, aside from producing deadly pathogens or toxins. For example, CRISPR-CAS is a powerful and versatile tool for modifying the genomes of humans, plants, animals, and microbes. Because of this versatility, CRISPR-CAS applications could be misused in many ways to cause harm that would not fall under the DURC list of agents and experiments. The implementation of DURC and the respective training of life science students need to be done in ways that go beyond the simple ticking of boxes on checklists. It is necessary to identify and mitigate true biosecurity risks, not perceived risks. Both the education and awareness of researchers are key to identifying matters of concern early and developing mitigation strategies (Fig. 1). Additionally, researchers may need to broaden their perspective, for example, by assuming the role of someone with nefarious intent, to better guide the identification of the potential misuse of their research. This change in perspective places researchers in conflicting positions. They are best suited for identifying matters of concern and are not captured by standardized lists. At the same time, the more researchers explore and communicate identified matters of concern, the more likely their research will be impeded or at least burdened with additional administrative hurdles. This paradox needs to be addressed by incentivizing researchers to care about the dual use aspects of their research.

The question of whether the research falls into the category of DURC is not a single yes or no question to be answered at the research proposal stage. Research projects are prone to changes in direction, which is an integral part of the research process. Therefore, DURC considerations should cover the full spectrum from proposal to publication, and integrate additional stakeholders, including funding agencies and publishers. Scientific journals are the main gatekeepers for the dissemination of research, and the move towards open access articles makes this information easily accessible to the public. To date, there has been no standardized way for publishers to address DURC concerns. The Committee on Publication Ethics (https://publicationethics.org/) provides guidelines and workflows for publishers but has no section on DURC. Establishing the governance of DURC within academic research and its structures is important. However, information is broadly available on the internet, and researchers are increasingly using social media to share their research findings. Together with the trends in citizen science and do-it-yourself biology (DIY biology), this suggests that the dissemination of DURC results cannot be contained in traditional institutions alone. DIY biolabs may not have a biosecurity officer and instead rely on publications within scientific journals to foster a culture of open and direct sharing of information.

For society to benefit from biotechnology advancements, the need to engage with the public about the ethical nature of research continues to be critical. The survey conducted during the panel discussion (Fig. 2) aligns with the opinions of panelists that public engagement should be more prominent within the field of biosecurity, especially within DURC. Inclusive public engagement is important, particularly within the younger demographic, to create scientific literacy that enables the public to meaningfully participate in discussions. Failure to communicate and engage the public can lead to the rejection of research solely based on perceived risks rather than actual risks. Engagement with the public contains an inherent contradiction with respect to information hazards: the more information and training on actual risks stemming from research is disseminated, the graver these risks might be perceived by the public, and malicious actors get informed of what type of research has the highest potential to cause harm. It is a balancing act to have an open dialog on biosecurity without generating fear or pointing malicious actors towards the biggest biosecurity risks. However, not having such a dialog at all will be the worst choice, as it creates suspicion and a lack of information that can easily be exploited with misinformation.

Addressing DURC in a meaningful discourse is challenging. The main challenge is to identify the appropriate balance between raising awareness and the precautionary principle, while avoiding unnecessary administrative burdens on research and creating public fear. The panel participants agreed that DURC guidelines and best practices should be established bottom-up from within the scientific community. Professional scientific associations are well-positioned for developing such guidelines specific to their field of research, as they contain the relevant expertise. Having such guidelines led by scientific associations would help create engagement and acceptance among the researchers. However, technology in the life sciences will likely continue to outpace governance. Therefore, resources should primarily be directed towards increasing awareness and risk assessments, instead of creating new rules and extending lists. Education on DURC should already happen at the student level and not be postponed until later stages of the scientific career. This will increase the chance of identifying concerning research and technology trends sooner and provide more time to establish governance.

Another challenge arises from the fact that only one laboratory in a single country is required to conduct and publish DURC research to make this research available to the rest of the world. Even though the guidelines should be bottom-up for specific research fields by national scientific associations, the ultimate goal is towards internationally synchronized standards regarding DURC. A path forward could be that national scientific associations create their own guidelines and subsequently work collaboratively to create international guidelines for their research fields. International scientific networks already exist, and they are well suited for the task, as trust and openness within the scientific community are generally very high. This will help overcome controversies and differing individual interests and create internationally accepted guidelines that can then be used by policymakers.

The final challenge regarding DURC is to determine the correct level of public engagement. As life science research is becoming more interconnected with daily life, the public has a higher interest in this research, and public acceptance of the research has become more important. At the same time, putting the public focus on DURC can create information hazards in the form of undue fear of life science research or motivate actors with bad intent to misuse research results. The panel concluded that awareness raising inside and outside academia is important and should be conducted in a thoughtful manner that minimizes the aforementioned threats of information hazard.

The authors declare no competing interests.

The DURC Panel Discussion and associated DURC workshop were made possible through the support of the Alberta RNA Research and Training Institute (ARRTI) at the University of Lethbridge and Synbio Canada, a community platform for synthetic biologists in Canada. Benjamin Scott from Synbio Canada provided administrative support for conference planning. We thank Daniel Feakes of the United Nations Office for Disarmament Affairs for their participation in the panel.