Aspiring scientists face a multitude of challenges that are directly connected or related to safety. There are countless issues waiting to be solved and problems deserving more attention than they are currently receiving. While there is certainly no shortage of challenges, we chose to focus on those which we believe to be the most pressing and to have a global impact in the coming decades.
Deliberating the lack of education in academic institutions on biosafety, biosecurity, and dual use research of concern (DURC) as well as risk assessment is essential. Additionally, the declining mental health due to the COVID-19 pandemic as well as current laws concerning biotechnology and responsible research need to be discussed. By addressing these issues, we intend to provide a concise overview of challenging topics for young researchers. We aim to provide the necessary information for further research and hope to elicit a deeper understanding of safety in the iGEM community and in the scientific community in general.
In 2018 the iGEM Team of the University Bielefeld conducted an international survey testing the knowledge of university students in the area of dual use research of concern. 249 participants from 39 countries took part in the survey. The results revealed a significant gap in the education concerning DURC in young scientists. 71 % did not know the definition of research of concern, 60 % did not know who they could turn to for questions and instructions and 63 % were dissatisfied with the education they received at their respective universities regarding this field (iGEM Team Bielefeld CeBiTec, 2018).
This lack of knowledge is the first major hurdle prospective researchers face, when being confronted with the multitude of safety aspects for the first time. To ease the way into the complex topic of DURC, we decided to compile a broad overview providing not only information about research of concern, but also biosafety, biosecurity, and risk assessment.
The terms “biosafety” and “biosecurity” are often mistaken for definitions of equivalent laboratory safety measures. However, a closer look into the meaning of the words quickly reveals an important distinction.
The World Health Organization released the following definitions for biosafety and biosecurity in their fourth Laboratory biosafety manual in 2020.
Biosafety:
“Containment principles, technologies and practices that are implemented to prevent unintentional exposure to biological agents or their inadvertent release.” (World Health Organization, 2020)
Biosecurity:
“Principles, technologies and practices that are implemented for the protection, control and accountability of biological materials and/or the equipment, skills and data related to their handling. Biosecurity aims to prevent their unauthorized access, loss, theft, misuse, diversion or release.” (World Health Organization, 2020)
While both focus on the protection of an important component to safe laboratory work, they differ in what they are supposed to protect. Biosafety is meant to minimize the risks to persons working within the laboratory and develop strategies to avert accidental release of biological agents. Biosecurity focuses on preventing the misuse of biological agents, materials, and equipment (World Health Organization, 2020).
An important aspect of biosecurity is the deliberation of dual use.
Biotechnology has been one of the fastest growing fields in the past decades. Milestones ranging from the sequencing of the entire human genome to the development of the CRISPR/Cas9 system have been shaping factors not only in the science community, but for society itself.
However, with every newly developed technology, there is the danger of misuse for hostile purposes. A quick look into history itself reveals that mankind has made a mastery out of misusing novel technologies to threaten or harm others. A well known example are nuclear technologies, which can be used in civil application or be implemented into weapons of mass destruction (WMD) for military purposes (Miller & Sagan, 2009).
This example can be broadly summed up in the term “dual use”. Dual use refers to research findings, methods and items that are intended for peaceful and beneficial purposes, but can be misused to do harm to people or the environment (World Health Organization, 2020). Therefore, dual use items can be used in civilian applications, such as the development of vaccines, but also for military, terrorist or criminal purposes (German National Academy of Sciences Leopoldina).
Dual use research of concern, short DURC, is a subpoint of dual use (Boston University, 2022).
“[...] DURC includes work in the life sciences that can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to cause damage to public health and safety, the environment or to other important legal interests.” (German Ethics Council, 2014)
While the term dual use includes material items besides knowledge and technology, DURC focuses on research and its potential. Furthermore, DURC is limited to life sciences, while dual use can be applied to any field of science.
The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) and the National Academy of Sciences Leopoldina are of the opinion that DURC does not efficiently cover the entirety of the dual use dilemma. They prefer the term “security-relevant research”, which does not exclude other fields of sciences from research in dual use (German National Academy of Sciences Leopoldina).
“Security-relevant risks arise, in particular, in research which produces knowledge, products or technologies that could be misused directly by third parties.” (German National Academy of Sciences Leopoldina and Deutsche Forschungsgemeinschaft, 2016)
The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) and the National Academy of Sciences Leopoldina have deliberated on how to deal with the dilemma of dual use.
Various ways have been proposed to deal with the problematic of dual use. They range from adapting publications over not publishing specific results to shutting down entire projects (German National Academy of Sciences Leopoldina and Deutsche Forschungsgemeinschaft, 2022).
However, taking these extreme measures to prevent dual use would lead to a significant decrease in novel inventions intended for beneficial purposes. The exchange of knowledge and publication of research findings is elemental to scientific research (German National Academy of Sciences Leopoldina and Deutsche Forschungsgemeinschaft, 2022). Stagnation in any field of science is unacceptable for all of the issues today's society is facing.
In Germany the freedom of research is guaranteed in Article 5 Paragraph 3 of the German Basic law.
“Arts and sciences, research and teaching shall be free. The freedom of teaching shall not release any person from allegiance to the constitution.” (German Federal Ministry of Justice, 2020)
Since research can almost never be qualified as fundamentally “good” or “bad”, finding a middle ground between transparent research and avoiding the risk of dual use is challenging.
There are a significant number of national laws dealing with security-relevant research in life sciences in Germany. To name but a few, the infectious disease protection laws, such as the Act on the Prevention and Control of Infectious Diseases in Man (Infektionsschutzgesetz, IfSG), the Epizootic Diseases Act (Tiergesundheitsgesetz, TierGesG), and the Plant Protection Act (Pflanzenschutzgesetz, PflSchG), aim to protect humans, animals and plants from transmissible diseases and prevent these illnesses from spreading. Another example is the Ordinance on Safety and Health Protection at Workplaces Involving Biological Agents (Biostoffverordnung, BioStoffV), which protects researchers handling biological agents. The Genetic Engineering Act (Gentechnikgesetz, GenTG) deals with safely handling genetically engineered items, the environment in relation to biotechnology as well as human protection (German Ethics Council, 2014).
Preventing the misuse of security-relevant research falls under the jurisdiction of the regular criminal law and the export regulations of the Federal Office of Economics and Export Control (Bundesamt für Wirtschaft und Ausfuhrkontrolle, BAFA) (German National Academy of Sciences Leopoldina). The BAFA contributes to minimizing the abuse of dual-use goods by implementing the EU regulation (EU) 2021/821 dealing with the export of dual use items (German National Academy of Sciences Leopoldina). By controlling the export and transit of dual-use items, the EU aims to secure international peace and prevent the proliferation of weapons of mass destruction (European Commission, 2021). Furthermore, targeted human rights violations and threats of international terrorism are hindered by export control regulations (German Federal Office of Economics and Export Control, 2019). The EU's export control regime also includes a common EU list of dual-use items (European Commission, 2021).
The Biological and Chemical Weapons Conventions (BWC and CWC) aim to eliminate biological and chemical weapons by prohibiting their development, production, storage, distribution, and use (German Federal Foreign Office, 2020). Both conventions have been ratified by the majority of countries worldwide with 193 states commiting to the CWC and 182 states to the BWC (Organization for the Prohibition of Chemical Weapons, 2022, and United Nations Office for Disarmament Affairs, 2022). According to the Organization for the Prohibition of Chemical Weapons (OPCW) 99 % of chemical weapons declared by members have been verifiably destroyed (Organization for the Prohibition of Chemical Weapons, 2022).
On the 26th of September 2022, the International Day for the Total Elimination of Nuclear Weapons, UN secretary-general António Guterres said:
“Eliminating nuclear weapons would be the greatest gift we could bestow on future generations. On this important day, let us commit to forging a new consensus around defusing the nuclear threat for good and achieving our shared goal of peace.” (United Nations, 2022)
Not only laws can contribute to this vision of peace António Guterres painted, but also scientists who critically examine their work leading to self-regulation of science. According to the DFG and Leopoldina researchers should not content themselves with following legal regulations but also be mindful of ethical issues regarding their projects. They should weigh the risks against the opportunities their research offers. By doing so, they will be able to evaluate their project critically in regard to responsibility (German National Academy of Sciences Leopoldina and Deutsche Forschungsgemeinschaft, 2014).
One of the most important ways to reduce said risks is by an early and thorough education about DURC. In 2014 the DFG in cooperation with Leopoldina published recommendations to deal with security-relevant research. One of those recommendations was the establishment of interdisciplinary committees at each institution. Their task is to provide consultation in security-relevant research as well as assess risks and ethical aspects (German National Academy of Sciences Leopoldina and Deutsche Forschungsgemeinschaft, 2014).
According to the recommendations of the DFG and Leopoldina, the University Heidelberg established a commission named “Responsibility in science” (German: “Kommission Verantwortung in der Wissenschaft”) in 2017 (Ruprecht Karls University of Heidelberg, 2021).
Assessing risks is an essential component of conducting novel research in the field of synthetic biology. The WHO defined risk assessment as such:
“A systematic process of gathering information and evaluating the likelihood and consequences of exposure to or release of workplace hazard(s) and determining the appropriate risk control measures to reduce the risk to an acceptable risk.” (World Health Organization, 2020)
The likelihood of a hazard causing harm combined with the severity of the consequences in the event of an incident is known as risk. (World Health Organization, 2020)
Trying to understand the definitions and implications of the entire risk management process is certainly a daunting task. A lot has to be considered along the way to a successful - and more importantly - safe project. Therefore, we provided a concise overview of the complicated process of managing risks. We based our risk assessment process on the fourth Laboratory Biosafety Manual of the WHO and tried to implement our own ideas.
A detailed illustration of our developed risk management process can be seen in Figure 1.
Following the guide of Figure 1, each step in the risk management process will be carefully explained and examples provided of what needs to be considered.
After the evaluation whether the risk reduction was successful, the process begins anew with new procedures to minimize dangerous situations and reduce potential harm to personnel.
The fourth leading cause of death in adolescents between the ages of 15 and 29 years is suicide (World Health Organization, 2022). This number plainly states why education on mental health is fundamental for young people and should under no circumstances be underestimated.
Mental illnesses can affect anyone. One in eight people worldwide lives with a mental disorder. Despite this high prevalence across the world, mental health systems are underfunded. Averagely, only 2 % of countries' health care budgets are dedicated to mental health (World Health Organization, 2022).
Additionally, in the first year of the COVID-19 pandemic common mental illnesses such as depression and anxiety increased by more than 25 % (World Health Organization, 2022).
During researching the topic of mental health, our iGEM team came to the conclusion that we had to raise awareness of mental health not only on our Wiki, but reach out to university students themselves. To do that, we conducted a survey dealing with mental health of university students and specifically asked further questions about those studying STEM courses. We provided a detailed overview on mental health on our inclusivity page.
If you are not feeling well, please turn to your family and friends. Alternatively, most universities and countries have mental health hotlines, websites addressing any questions you might have or programs you can sign up for to improve your mental health. Remember that you are not alone.