Ethics, Biosafety and Biosecurity


Team Equality and Diversity Policy

Diversity is found in any social identity such as gender or identifying as non-binary, age, nationality, ethnicity, culture, political belief, religion or the lack of religion, sexual orientation, and other attributes. At iDEC we aim to create a community for directed evolution researchers where everyone is welcome and feels free to be themselves. We want to involve, accept, and value everyone regardless of their social identity. We strongly believe that creating an open and diverse (research) community is the only way to solve the problems of both the present and the future. We expect all teams to foster a team culture where every voice is welcome, respected, and heard.

We from iDEC HQ want to encourage everyone with an interest in directed evolution to join our community and/or competition. If you feel like any structures in your home institution, country or team are holding you back to do so, please contact us!

How Can You Help Us Reach This Goal?

When you recruit your team, make sure the team reflects the diverse background of your area. If you only receive applications from a non-diverse group (e.g., gender), seek contact with potential candidates and ask them what the barriers are that prevent them from wanting to join your team. Try to remove these barriers together!

Words matter! And graphics, too! Have you ever thought about gender-neutral language? Or if your standard representation in pictures and graphics of a scientist is diverse? Language and representation have a huge influence on how (and if) people feel approached. Would you answer a job application you think is only searching for people of another gender? Always try to write with gender-neutral language and highlight that you and your team support building a project that is beneficial for the whole society.

Get in contact and discuss. As scientists, we rarely learn how to build a diverse and inclusive community, definitely less than people studying other subjects, but this does not mean that it is less important in our community. If you feel like you do not understand why someone feels offended, ask this person. Only an open dialogue can change our community to become better when it comes to diversity and inclusion. This is true for the iDEC HQ as well: if you feel like something is wrong or missing on this page, please contact us!


Responsible Research

"Responsible research" – Have you and your team ever thought was this term means for you?

At iDEC, we have thought a lot about how we could responsibly conduct our research.

The first (and most important) remark is: You are responsible for designing a research project that is beneficial for our society and the environment.

To participate in iDEC, you and your team must fill out a responsible research form. This will address your research's biosafety, biosecurity, and ethical implications. This webpage will give you some guidance on how to do so.

Commission for Responsible Research (CRR)

We have a Commission for Responsible Research (CRR) to help you regarding related questions and approve your responsible research forms. Please feel free to contact us with any questions or concerns.

Please keep in mind that this step is not to forbid you from following your project idea. Thinking about making your project safe and conducting your research with responsibilities will make your project better and is the only way to design directed evolution projects that can influence our world beyond your lab bench.You should always evaluate your project individually with the question in mind: Can my project cause harm?

In your responsible research form, you will need to answer some questions regarding biosafety, biosecurity, and the ethical implications of your research. You will find definitions of what these aspects mean for us on this page.

To ensure your safety, we have set up a few policies regarding responsible research. Please review them carefully. Ignoring these policies can lead to your team being disqualified from the competition.

The iDEC Commission for Responsible Research (CRR) will have the right of final explanation on all relevant provisions.


About Biosafety and Biosecurity

The definition of biosecurity can be confusing sometimes, and biosafety and biosecurity are often mistaken to refer to the same concept.

Don't worry. First, we should understand that biosafety is not the same as biosecurity.

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, 2006 [1]

Biosafety measures include the categorization of laboratories into safety categories, safety equipment and waste management in the laboratory.

In contrast to biosafety, biosecurity is defined as follows:

The term “biosecurity” refers to the “institutional and personal security measures designed to prevent the loss, theft, misuse, diversion or intentional release of pathogens and toxins.
World Health Organization, 2006 [1]

Aspects of biosecurity are information security, access control, and inventory control.

Biosafety and biosecurity measures are often closely related. For example, efforts to prevent unintentional release of biological material (an aspect of biosafety) often prevent intentional release (biosecurity) as well. Thus, biosecurity countermeasures are usually covered by biosafety laws. However, additional regulations related to biosecurity with hazardous organisms have been implemented to prevent their misuse.

To illustrate the difference between biosafety and biosecurity, the Biosecurity Office of the Dutch National Institute for Public Health and the Environment (RIVM) made the following distinction: "With biosafety, people are protected against dangerous pathogens, while with biosecurity, the pathogens are protected against malicious people"[2].

For iDEC, we want to talk specifically about two kinds of biosafety and biosecurity issues: Gain-of-Function experiments and Dual Use Research of Concern. It is important that you and your team consider if your project falls in one of these categories and if so, what countermeasures you can establish to make your project as safe as possible.

Gain-of-function (GOF) research involves experimentation that aims or is expected to (and/or, perhaps, actually does) increase the transmissibility and/or virulence of pathogens.

In some experiments, the biosafety level of the organism we use can be changed by engineering traits of this organism. These experiments are called “Gain-of-Function” (GOF) experiments.

If you identify a risk of GOF of your experiments, please contact the Commission for Responsible Research. Keep in mind that this does not only include expected increase in virulens; even engineering of e. g. abilities to form biofilms, might make your organism more difficult to inactivate, thus, increasing the transmissibility.

Biosecurity issues mainly arise from the possibility of misusing scientific findings to cause harm. Research with the potential to be used in both a benevolent and a malevolent way is called "Dual Use Research of Concern (DURC)."

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

Dual Use Research of Concern (DURC) is a part of biosecurity. When thinking about Dual Use Research of Concern, research on pathogens is probably the first thing that comes to mind. Some organisms which are known to be a threat to human health and security are listed as “selected agents”[5]. These include, for example, pathogens like the ebola virus[6].

But even research based on non-selected agent organism can have a potential of misuse. An example would be viruses to engineer traits of agricultural plants on the field. Designing a vector that can engineer a whole field to become e.g. drought resistant, might be misused to introduce traits that destroy entire crops or introduce toxin production.

This webpage is not meant to spread panic or evoke the image that directed evolution research is too dangerous. Most projects have a very low potential of causing harm, but even if the potential to harm is low for most projects, identification of risks is crucial to establish precautions. Right now, we rely on the self-regulatory approach when it comes to some biosecurity issues (e.g. DURC), meaning all researcher are responsible to screen for risks and establish precautions themselves. Regulations by an external body would restrict the right of free research, but to make this approach work, we need to ensure that every researcher has the skills to determine biosafety and biosecurity risks and the best way to do so is a good education on these issues.

We are aware that many educational institutions still did not include such teaching programs in their curricula globally.

iDEC is committed to establishing an awareness of biosafety and biosecurity matters.


Ethical Implications

Identifying ethical issues of scientific research projects is a big part of responsible research. To identify possible unethical practices, teams need to evaluate who is impacted by their project and what this influence means to the person, group, or society as a whole. If you have any questions regarding your project's ethical implications, we would recommend contacting your university's or institutional ethics council or contacting our Commission for Responsible Research (CRR).

It is important to get clearance through your ethics council if you want to conduct any research on humans or human samples, including surveys.

It is also helpful to get in touch with people affected by your research and ask them how they would envision a solution for their problem. Designing projects hand in hand with the people who will use them later will help you develop a beneficial product.

To analyze a project's societal and environmental context is often referred to as "Human Practices". The term "Human Practices" was first coined by the Synthetic Biology Engineering Research Center (Synberc) as a defining part of its policy and practices thrust. [7]

iDEC is committed to communicating the importance of considering ethical implications.


  1. All iDEC teams must fill out the responsible research form.
  2. We recommend conducting experiments after the CRR has approved the responsible research form.
  3. Projects using gene drives are forbidden in iDEC.
  4. GMOs and products produced by GMOs are not allowed to be taken outside of the lab.
  5. Animal testing is forbidden.
  6. All teams must follow not only the iDEC safety policies but also the local and institutional regulations.
  7. Self-experimentation, including testing samples of team members (e.g., blood, urine, salvia), is not allowed.
  8. All iDEC entries must be research projects completed by registered team members. Plagiarism and falsified contributions of any nature are strictly prohibited.
  9. The data and graphs displayed by the participating teams must be reliable and meet academic standards. Fabrication and/or falsification is never allowed.
  10. The contents of the experiment records must be true. Falsification of the experimental record is never allowed.
  11. The participating teams should cite the work of predecessors or others in a standardized manner. It is unacceptable to infringe on the intellectual property rights of others.
  12. Participants need to comply with other academic ethics requirements of the local country, research institution, or school.

The Responsible Research Form

The responsible research form aims to check that your team considers possible risks and establishs suitable countermeasures.

Please submit your form before Jul 1.

For the responsible research form, all teams must answer questions in the following categories: Laboratory biosafety, used chassis and genes, biosecurity and ethical concerns (including research on humans).

The responsible research form can be submitted on a rolling basis but must be submitted by each team before they start with their wetlab work and latest July 1. The responsible research forms will be reviewed and approved by the commission for responsible research. If a team wants to use additional genes, chemicals, methods or chassis that have not yet been mentioned in the responsible research form, they can send a request to get these genes approved by the commission for responsible research.

Your team will get a link to fill out the Responsible Research Form online. If you want to have a look at the questions, you can download the Responsible Research Form as .pdf document here:

A Responsible Research Form will be available for download on Mar 20.

To give you some guidance on how to fill out the form, we designed an example project:

An example Project Responsible Research Form will be available for download from Mar 20.

If you have any questions regarding the Responsible Research Form, please contact the Commission for Responsible Research (vinke@idechq.org).

Biosafety

Biosafety describes the personal protection and protection from unintentional release of biological agents with the potential to cause harm to plants, animals, humans or the environment. Within the biosecurity section of the responsible research form, the teams need to answer questions regarding safety equipment in their laboratory as well as safety countermeasures to ensure the prevention of unintentional release of GMOs. Possible fields of the form could be:

  • Mention the PI of your team and the relevant qualifications of your PI to function as your team's person responsible for safety.
  • List all topics mentioned in your safety introduction.
  • Consider the biosafety level of your laboratory.
  • Describe the safety measures in your laboratory (e.g. eye shower, emergency shower, etc).
  • Describe how GMOs are prevented from being unintentionally released into the environment, including waste management.

Genes and Chassis

Genes and chassis of each team have to be biosafety level 1 or 2. All genes and chassis of organisms falling into the category biosafety level 3 or 4 are forbidden to be used in iDEC. There will be a white list of chassis which are allowed to be used within the competition. All genes and chassis used in addition to these need to be listed in the responsible research form. Possible fields of the form could be:

  • Please provide an abstract of your project.
  • List all chassis you plan to use that are not listed in the iDEC white list, as well as their biosafety level (with reference) and a short explanation how you plan to use these.
  • List all genes you plan to use, as well as their original host/lab and their biosafety level (with references) and a short explanation on how you plan to use these.

Biosecurity

Biosecurity describes the prevention of biological agents from unauthorized access, theft, misuse or loss. In the biosecurity section of the responsible research form, teams are required to evaluate potential biosecurity risks and their countermeasures. Possible fields of the form could be:

  • Describe the access control measures of your laboratory.
  • Evaluate if your project has Dual Use Research of Concern potential.
  • If yes, indicate what measures your team takes to minimize the risk of misuse.

Ethical Issues

Identifying ethical issues of scientific research projects is a big part of responsible research. To be able to identify possible unethical practices, teams need to evaluate who is impacted by their project and what this influence means to the person, group or society as a whole.

  • List all people/groups that are potentially influenced by your research or outcomes of your research and describe the impact of your project on these people/groups.
  • Do you see any ethical issues arising from your project? If so, indicate why.
  • Do you plan to conduct research on humans or human samples (this includes questionnaires)?
  • If yes, does your experiment fulfil all requirements to be categorized as research with low potential of ethical issues?

References

[1] Definition by the World Health Organisation (2006). Available online: https://www.who.int/influenza/pip/BiosecurityandBiosafety_EN_20Mar2018.pdf?ua=1[06/11/20].

[2] Website of the Biosecurity bureau from the RIVM. https://www.bureaubiosecurity.nl/en/about-biosecurity-office [06/11/20]

[3] Selgelid, M. J. Gain-of-Function Research: Ethical Analysis. Sci Eng Ethics. 2016; 22(4): 923–964. Published online 2016 Aug 8

[4] Definition adapted from the definition by the National Institute of Health. Available online: https://osp.od.nih.gov/biotechnology/dual-use-research-of-concern/ [06/11/20].

[5] Website of the Center for Disease Control and Prevention (CDC). https://www.cdc.gov/cpr/dsat/what-is-select-agents.htm#:~:text=Select%20agents%20are%20biological%20agents,to%20animal%20or%20plant%20products [06/11/20]

[6] List of selected agents from the Federal Selected Agents Program. https://www.selectagents.gov/sat/list.html [06/11/20]

[7] Website of the Synthetic Biology Engineering Research Center. https://ebrc.org/synberc/ [25/01/2021]