Safety Form

1. Your Training

a) Have your team members received any safety training yet?

-Yes, we have already received safety training.

b) Please briefly describe the topics that you learned about (or will learn about) in your safety training.

-All the members were trained for safety regulations of the laboratory as well as toxicity of the chemicals we use in our lab. The basic lab safety training including instructions of safe wearing such as gloves, lab coats and goggles is given. Additionally, the general lab safety attitude such as use of benson burners, electrophoresis procedure, sterilization and disinfection for environment safety is also shared. Lastly, we raised the awareness about the public and environment safety that the materials of synthetic biology labs must be taken care of extensively in order not to contaminate outside of labs.

c) Please give a link to the laboratory safety training requirements of your institution (college, university, community lab, etc). Or, if you cannot give a link, briefly describe the requirements.

Click Here

2. Your Local Rules and Regulations

a) Who is responsible for biological safety at your institution? (You might have an Institutional Biosafety Committee, an Office of Environmental Health and Safety, a single Biosafety Officer, or some other arrangement.) Have you discussed your project with them? Describe any concerns they raised, and any changes you made in your project based on your discussion.

-In Turgut Ozal University Medical School, Laboratory and Research Biosafety Committee is responsible for control as well as the biosafety of laboratories and the biosafety regulations on the ongoing projects. This committee works under the Dean of Health Sciences and the director of Research Project Committee of Turgut Ozal University Hospital, Prof. Dr. Mehmet Gunduz. Form on the safety rules of Turgut Ozal University Medical School Laboratory was filled in as required. We discussed our project with Prof. Dr. Mehmet Gunduz. Safety and security issues are found sufficient enough that no change is considered as necessary. (Further questions can be directed to Prof. Gunduz, tel: +90-312-203 5103, mgunduz@tugutozal.edu.tr)

b) What are the biosafety guidelines of your institution? Please give a link to these guidelines, or briefly describe them if you cannot give a link.

-The Biosafety guidelines are here

c) In your country, what are the regulations that govern biosafety in research laboratories? Please give a link to these regulations, or briefly describe them if you cannot give a link.

Turkey has national biosafety regulations and the link is given as

3. The Organisms and Parts that You Use

4. Risks of Your Project Now

Please describe risks of working with the biological materials (cells, organisms, DNA, etc.) that you are using in your project. If you are taking any safety precautions (even basic ones, like rubber gloves), that is because your work has some risks, however small. Therefore, please discuss possible risks and what you have done (or might do) to minimize them, instead of simply saying that there are no risks at all.

a) Risks to the safety and health of team members, or other people working in the lab:

-Few hazardous chemicals and solutions such as EtBr are used in some lab procedures. However, these chemicals and solutions are used according to the safety rules of the laboratory with care and caution. We work with low Risk Group laboratory strains of Escherichia coli; thus, there is no actual risk against our team members during lab work. We also apply the basic safety precautions strictly such as wearing gloves, lab coats and goggles when we are working in the lab.

b) Risks to the safety and health of the general public (if any biological materials escaped from your lab):

-When released by accident, our parts and materials actually cause no negative damage to the general public; because our parts or plasmids do not produce toxic chemicals or proteins. E.coli K12 strains is known not to be associated with disease process in humans in regular conditions, and thus, is supposed to be benign by nature and present no danger to anyone. However, all of our team members are trained about the safety of our laboratory rules and using mask and gloves when dealing with bacteria. Besides all experiments are performed in synthetic laboratory designated by Turgut Ozal University Medical School and no material is carried out of the laboratory.

c) Risks to the environment (from waste disposal, or from materials escaping from your lab):

In the event of any material escape such as plasmids, vectors, insert genes etc from our lab, these material will not have enough time to transmute the ecological environment because of their fragil structure. And also our plasmids do not enter into the chromosomal DNA, they are just be degraded by the natural ways quickly, that's why if one of our parts will enter into a cell type, it will be degraded and destructed by the cell's natural pathways. Besides that our parts do not produce unhealthy and toxic materials.

d) Risks to security through malicious mis-use by individuals, groups, or countries:

- As our project does not require any additional measurement method or extra lab equipment to test our parts efficiency and documentation, there are no risks besides the basic lab risk possibilities. We dispose our biologic waste carefully and according to Safety Guidelines in order to prevent their possible harmful effects on environment or misuse. Since we use only the lowest risk group chassis, there is no additional risk due to this.

e) What measures are you taking to reduce these risks? (For example: safe lab practices, choices of which organisms to use.)

-In the lab, the toxis chemicals and solutions are used according to the safety rules of the laboratory with care and caution. We work with low Risk Group laboratory strains of Escherichia coli; thus, there is no actual risk against our team members during lab work. We also apply the basic safety precautions strictly such as wearing gloves, lab coats and goggles when we are working in the lab.

5. Risks of Your Project in the Future

What would happen if all your dreams came true, and your project grew from a small lab study into a commercial/industrial/medical product that was used by many people? We invite you to speculate broadly and discuss possibilities, rather than providing definite answers. Even if the product is "safe", please discuss possible risks and how they could be addressed, rather than simply saying that there are no risks at all.

a) What new risks might arise from your project's growth? (Consider the categories of risk listed in parts a-d of the previous question: lab workers, the general public, the environment, and malicious mis-uses.) Also, what risks might arise if the knowledge you generate or the methods you develop became widely available?

-Our project depends on the implementation of synthetic biologic designed constructs on human body to reduce ischemic tissue damages. That means we need to make sure that in the future, this kind of therapy option should not pose any risks for the patient in the view of causing new diseases or contaminate natural environment of inside of the body. If we could not regulate the beneficial effect we assume, it may also cause harmful conditions. As we continue our in vitro measurement on the efficiency of our construct and as the literature encourages us for that kind of approach on the body, it is necessary to think of reducing these risks in order to propose new treatment alternatives.

b) Does your project currently include any design features to reduce risks? Or, if you did all the future work to make your project grow into a popular product, would you plan to design any new features to minimize risks? (For example: auxotrophic chassis, physical containment, etc.) Such features are not required for an iGEM project, but many teams choose to explore them.

-To prevent unwilling reactions from the body to our constructs, we intent to use autologous stem cells of the treatment receiving patient. To control the release of our therapy parts in order to treat the disease conditions in the body without disturbing and causing harmful effects, we added additional regulator systems at the transcriptional level by using inducible promoters and at the translational level by using regulator proteins. In the future, by the development of gene therapy and cell therapy industries, we hope to implement our systems to the current treatment options in an easier and safer way.

6. Further Comments

If you are completing a Preliminary Version of your Safety Form, use this space to describe how far you have progressed in your project, and give some comments about any questions that you left blank. You can also use this space for any other comments or additional material.

-So far, we have finished our literature search and began our lab work. Cloning of our parts has been succeeded and now, we want to test our parts in our real chassis which are eukaryotic cells. The production efficiency and the effects of our planned parts at the disease conditions will be measured, hopefully. Meanwhile, we are working on additional safety and future plan projects to contribute iGEM community and scientific background about project.