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Safety forms were approved on September 29, 2013 by the iGEM Safety Committee.
iGEM Safety Questions
1. Would our project raise any safety issues in terms of:
Researcher safety- Certain chemicals used in our research may be harmful ie. ethidium bromide when running agar gels. The safety issues are covered in COSHH assessments and safety protocols will be followed. Bunsen burners are used when making agar plates for sterility need to follow safe working practices for bunsens. Need to use aseptic techniques to avoid contamination with bacteria from us and to us. Also we will be handling hot agar so care should be taken not to burn ourselves by using oven gloves. Throughout our research we will follow health and safety regulations required by law. To add to this university health and safety policies will be enforced to ensure researcher safety.
Public safety- If our Biosystems were to be used as a commercial device, the effects that it would be have on the environment and wildlife would have to be considered; as well as possibly contamination it could cause. This is a concern as the plasmid we are using to carry our genes contains an antibiotic resistance gene which could be transferred to other virulent bacteria. Therefore a kill switch will be inserted into our plasmid with will allow us to kill bacteria easily if a containment issue occurred. Therefore this would will stop the creation of any dangerous, resistant bacterial strains hence keeping the public safe from our product.
Environment- Once again we need to make sure our genes will not be transferred to wild virulent strains of bacteria so not to cause antibiotic resistance. Hence the insertion of a kill switch into the bacterial plasmid should make killing a harmful or contaminated strain easy and safe to do. To add to this, any bacteria we use and have used and no longer any use of, as well as those that may have become contaminated, will have to be disposed of appropriately using an autoclave. This will make sure all the cells are killed and are of no harm to the environment, lab researchers or the public.
2. Do any of the new biobricks raise any safety issues?
We believe that our new biobricks will be safe as they do not produce any harmful chemicals. However there is the consideration that they could be harmful if a person became infected with the bacteria we are working with. But this will be because of the adverse effects of the bacteria itself, not from the biobricks we have inserted into the bacteria. To avoid this situation, health and safety measures will be put in place and keep to by the researchers working in the labs at all times. To avoid the public being affected by the bacteria we are working with, they will be disposed of in the proper way, for example autoclave (as previously mentioned), so that all bacteria is killed and disposed of correctly and safely.
3. Is there a local biosafety group at your institution?
There is specialised health and safety department at the university and it has a specific biosafety section. The people that work in this area are fully aware of our research and have seen no additional safety issues than those addressed so far. All the members of the team have undergone health and safety training before working in the labs and this was given by a member of the faculty of biological science health and safety team.
4. Any other ideas on safety issues for future iGEM competitions? How can any parts be made safer through biosafety engineering?
The parts we are engineering have been made safer by introducing the kill switch, mentioned earlier, so that if the bacteria became virulent ect. they can quickly be disposed of safely. We hope that our biobricks are safe and don’t impose any risk to the environment or the public but as we go along with our work we will be sure to keep assessing the risks involved with our biobricks and synthetic biology in general to make sure that our work is as safe as possible!
Biosafety
The chassiss we are using are E.coli BL21 gold strain which are in risk group 1, Our lab has a bio-safety rating of 2. Therefore it is ok to work with this strain in our lab. When handling bacteria sterile techniques were used and anything that comes into contact with the bacteria is autoclave sterilized.
Lab Safety
For safety in the Labs we have undergone compulsory health and safety training run by the Faulty of Biological Sciences. We will also be following UK Health and safety legislation in our work. For every new Chemical or reagent used we will follow the risk assessments put in place, and the COSHH assessments. When handeling bacterial cultures we will use sterile techniques and employ the use of PPE to prevent contamination.
Ethics
Ethics is a big consideration when doing biology, especially synthetic biology as we are making new systems and engineering bacteria to have new and desired properties.
A primary concern is the accidental release of these redesigned organisms. Current policies are alreadt prepared to deal with this situation if it were to occur.
An even more daunting possibility is the fact that terrorist organizations could use engineered microorganisms to harm others. This is a new concern called Bioterrorism and it is fast becoming a growing concern. Bioterrorism is defined as terrorism involving the international release or dissemination of biological agents.
Questions are also raised over the unpredictable nature of these pathogens. Biosecurity measures within the field of synthetic biology must be finalized to reduce the sense of fear that accompanies its advances.
Even if no immediate danger exists, ethical issues remain as synthetic biology can be deemed as "playing God". Redesigning organisms opens the possibility for redesigning humans
To gain an insite into what the public think of synthetic biology we sent out an initial survey about what synthetic biology is. One of the questions on this survey included "do you think synthetic biology is unethical?" Surprisingly all but one answered this question "no". We then asked them to expand further; here are some of the responses:
"[...]if the end justifies the means. But it would be unethical if there was animal testing involved."
"Knowledge is basically neutral, but I can see situations where it can be misused, so ethics should never be ignored."
To further address ethics we have also included an ethics video in our series of synthetic biology videos for young people at school/in sixth form. To do this we undertook some research and discovered that Synthetic biologists have already taken a proactive attitude by collaborating with social scientists and engaging with the public from the outset to help further the publics understanding and help diminish controversy. For example, the four Research Councils in the UK (BBSRC, EPSRC, ESRC and AHRC) have created and jointly funded seven research networks that include researchers interested in the ‘ethical, legal and social implications' (ELSI) of synthetic biology. These networks encourage regular meetings of synthetic biologists and ELSI researchers, informing both sides about technological and ELSI progress. Moreover, public engagement meetings that should ensure the correct interpretation of the biotechnological achievements, and future public acceptance, are strongly encouraged. The European Commission initiated the SYNBIOSAFE consortium (http://www.synbiosafe.eu/) focusing on the discussion of biosafety and ethical concerns, and facilitating a socially acceptable development in all related fields.
As part of our outreach activities we will also be doing a synthetic biology presentation in a sixth form class at the beginning of September. During this presentation we will be undertaking an exercise in order to make the pupils understand the importance of considering ethics in the world of science and it will hopefully give us more of an idea of what the public think about synthetic biology and what ethical concerns they have around the subject area.
We are currently working on a survey based purely on the ethics of synthetic biology and will be posting the comments and feedback we received as we get it so be on the look out!
Ethics Assessment Form
Click to download our proposed Ethics Assessment Form
This form is designed to encourage the contemplation and assessment of all ethical issues involved within your iGEM project. The form is split into five sections addressing various aspects of ethical implications a synthetic biology project could have. The concept of this is similar to a risk assessment form and adopts a pseudo-quantitative analytical approach. The main assessment component is in tabular form, below are instructions for completing these tables with each column explained.
- Identify - State here the ethical hazards in question and the target audience that it could potentially affect and elaborate in as much detail as possible what implications they could result in
- Control - State here the controls e.g. elimination, substitution, engineering controls and personal protective equipment which will be used to minimise the risks from the ethical hazards. Continue on a separate sheet if necessary.
- Inform - State here the information (relevant policy/code of practice/local rules or local, local rules), instruction & training that will be provided to the researchers and if necessary the public on the hazards and control measures.
- Review - State whether this ethical hazard needs review after a certain time. Remember to review this assessment at least annually and more often if there is a material change to the work which may affect this risk assessment.
- Risk – Scale of 1-5
- Ethical impact – Scale of 1-5
- Severity - The product of impact and risk - i.e. Risk (1-5) x Ethical Impact (1-5). Depending on this score, review whether action is needed for the ethical concern in question. Use the table below to determine this.
1) Economic implications
Synthetic biology has the potential to create an abundance of new industries and jobs, however in the process of doing so can cause current industries, companies and/or jobs to become redundant. This can result in a sharp increase in unemployment which can be made worse by the fact that these people may have a very specific skill set and thus need retraining.
- Identify – Could your research cause job loss? Could it cause a current industry to be made redundant? Is the funding source kosher?
- Control - Not particularly that relevant for this section; however consider possible solutions or preventative procedures that one could implement
- Inform – Not normally relevant for this section
- Review - This could be quite important, could need to review after the research has been conducted to check on the economic impact
2) Legal implications
Patent law is an extremely crucial part of scientific research and development. It is important to assess whether you are illegally using other people’s work/products and consider when it is appropriate to ask for permission. It is also important to consider the implications of potentially patenting your final research, for example patenting a vaccine could result in it saving a lot less lives. This section can also be used to consider dealing with illegal substances such as drugs as part of one’s research.
- Identify – Are you defying current patent laws? Have you carried out research into the legality of your product? Could your research result in a need for new laws/regulation? Are you using any illegal substances as part of your research?
- Control – Do you need special permissions? How can you be careful with illegal substances?
- Inform – Do you need to inform someone who owns the intellectual property
- Review - This could be quite important, could need to review after the research has been conducted to check if a patent is needed
3) Bioterrorism risks
Bioterrorism is a relatively new concern that could become a big problem if Synthetic Biology and other Biological Science research is used in the wrong way. Your device may have the potential to be made weaponizable and this is something that worries the public. This section deals with the potential of your device being harmful and what would happen if it were to be used for something other than its original purpose.
- Identify – Could your device be weaponizable? Could your device have harmful effects? Can you identify any way that your device could be used in a negative way?
- Control - How will you make sure that your device can't be used in a harmful manner? What precautions could you put in place to make sure that it can’t be used in that way?
- Inform – How will you protect your device to make sure that it will not become weaponizable?
- Review - This could be quite important, could need to review after the research has been conducted to think about whether the device could be used for other, harmful, purposes. What is the plan to make sure the device does not fall into the wrong hands?
4) Accidental release
A major worry of the public is that harmful bacteria, with modified genes, may be accidentally released into the environment if lab procedures are careless. However accidental release of genetically modified organisms is more likely to occur during their use in the field. The worry is that GMO’s could pass on their modified genes to wildtype organisms and create new lines of that particular species.
- Identify - What problems could occur from your device being accidentally released?
- Control - What measures need to be put in place to make sure that accidental release is minimised? What measures can you take to make accidental release doesn’t cause harm if it does occur?
- Inform - How will you publicize that the organism is safe to use?
- Review - After the project has been undertaken, did accidental release occur? When using the device in its field, what aspects have you considered to make it safe in case it is accidently released?
5) Testing
Some people share the view that testing on animals and humans is unethical and wrong. Your biodevice has to be tested in some way, but what experiments could you do that don’t involve testing on animals or humans. Some people believe that testing on humans is a little less unethical than testing on animals as humans have to give their consent to be tested upon, whereas animals have no choice and are often breed for that sole purpose.
- Identify - Identify any issues there is with testing the device. Is there any stage in your project that it will be necessary to test your device using animals or humans?
- Control- Is there any other ways that it is possible to do such experiments and gaining the data not using either animals or humans? What other experiments could you run that are more ethical?
- Inform - How will you reassure the public that your testing method is safe and ethical?
- Review - Review the implications of all the methods used during the project. Were any experiments unethical? What could you have done better in terms of the ethics during the experimental stages of the project?
6) Damage to the environment/ecosystem
Many Synthetic Biology research projects plan to introduce genetically modified organisms into the environment. Some devices aim to improve the quality of the environment but in doing so is there some risk that they could change the balance in an essential ecosystem? Another aspect that falls into this category is that during the research stages of the project, a lot of lab equipment is used and there is a possibility of wastage of reagents and equipment if they are not used in a proper manner. This could cause environmental damage in the form of; unnecessary use of plastics or unsafe disposure of reagents. This section is intended to make you consider any wider environmental implications your device could cause when it is used in its intended field.
- Identify - Will your device or research cause any damage to the environment? If so, specify e.g. which species, which ecosystem, what environment?
- Control - How can you minimise the damage caused to the environment during your research? How can you minimise the amount of damage your device causes to the environment?
- Inform - How can you inform people that you have considered the impact you are causing to the environment whilst carrying out your environment? How can you reassure the public that your device will cause minimum damage to the environment and ecosystems?
- Review - After you have undertaken the research project, review the methods you undertook to make sure the impact on the environment was minimal. Review the methods you undertook to make sure the impact your device has on ecosystems when it is used in the field.
Explanation of the ethics assessment form
Whilst considering the ethics and safety aspects of our iGEM project we got to thinking that the way that ethics is approached within the iGEM competition isn’t very standardised. Consequently the Leeds iGEM team decided to think of ways we could improve this. In the end the idea created was, The Ethics Assessment Form.
The Ethics Assessment Form is based on Safety assessment form which are commonly used everyday in workplaces and labs. The basic idea behind the form is to identify any ethical problems there may be with the research your iGEM team is undertaking and then to see how severe the ethical impact would be if nothing were to change. This is done by using a score table where the severity of the ethical consideration and the risk of the ethical consideration in question are rated on a scale of 1-5 and then the ratings multiplied to get a final score of the severity of the ethical consideration. The chart incorporates a colour scheme, which tells you for each score given whether action needs to be taken against the ethical consideration. Green means that the ethical impact is low, yellow means that small changes could be made in order to make the project more ethical and red means that action should be taken as the consideration is very unethical and will cause problems.
The form is split into sections that, after research and through doing outreach activities, are what we think the main areas of concern when it comes ethics in Synthetic Biology. These sections are; Economical Implications, Legal Implications, Bioterrorism Risks, Accidental Release, Testing and Damage to the Environment.
For each of the sections there are four intersections to consider when dealing with the ethical implications of each point raised. These sections are; Identify, Control, Inform and Review. As a brief explanation of the sections; Identify involves finding the ethical considerations within your project to do with the section in question, e.g. Damage to the Environment, then taking the consideration that has been identified, the Control section allows you to think about ways to minimise the ethical impact and how you will control it. The Inform section is for showing how you will ensure the public that there implications of the project are nothing to worry about; this is an important section as the public play a huge role in ethics within Synthetic Biology and scientific research in general. Then after the project has been finished the Review section allows the team to go back over ethical considerations they had at the beginning of the project and see if they have addressed them all or if anything has changed, as most projects do not stay the same as they were at the beginning of the research. By considering each of the sections, it allows the concern in question to be fully explored and understood.
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