INTEGRATED HUMAN PRACTICE
Highlight of UI Human Practice projects and how it builds an integrated human practice
Ethical Review
Our project, Finding Diphthy, is expected to be implemented among the society in the future. But in the other hand, there is a potential controversy within this project by using HB-EGF genes (which comes from human genes) as one of the materials. Thus, we need to ensure the society reaction and acceptance due to its ethical aspect including the legal and religion view. This ethical review is also being held to direct our project according to the society’s view so that our project can optimally affect the society.
Legal Perspective of Finding Diphthy Project
The legal perspective of our project is being discussed with Mr. Wahyu Andrianto, S.H., M. H., one of lecturers in Faculty of Law, Universitas Indonesia, who is an expert in Health Law aspect. The discussion was held in 26th July 2018 in the Faculty of Law, Universitas Indonesia. Here, we are discussing about genetic engineering in general and our project through the national law perspective.
According to Mr. Adrianto, in general, genetic engineering technology has not been strongly regulated by the Indonesian law. Mostly, the law only regulating about genetic engineering in food product, therapeutic, and a few of stem cell development, while our project tends to be included as medical research. Despite of that, inform consent of its project has to be held and has to be operated by health professionals according to Permenkes No. 585 Tahun 1989 renewed in Permenkes No. 290 Tahun 2008 and also supported by the special rules (lex specialis) in Undang-undang Kesehatan No. 36 Tahun 2009.
Discussion session with Mr. Wahyu Andrianto, S.H., M. H. in the Faculty of Law, Universitas Indonesia
Although the Indonesian National Law have not strongly regulating about this issue yet, but we can us the legal aspect corridor from Helsinsky Declaration that regulating about medical research that involving human which containing some regulation according to clinical test, research, and etc.
Concerning about the using of HB-EGF gen, as long as the gen is obtained from a legal method and institution everything is acceptable. In addition, the fact that the gen supplier has its own legal perspective in which country it is located (which is different to Indonesia) is need to be concerned. But, for Indonesia itself, as long as the supplier has a legal permission from Indonesia Ministry of Health, it can be stated as legal and acceptable. In addition, concerning about its implementation, it is still possible to apply the operator independency of Finding Diphthy tool that makes the society able to use it by themselves as long as we have a clear boundaries and procedure, safety instruction, and accounted validity.
Overall, the implementation of Finding Diphthy project is considered legal and acceptable for the law aspect. The implementation is allowed with some terms applied, which are: not against the ethic and norms, the used medium is qualified, all parties working hand in hand with law corridor, and is not for commercial matters.
Religion Perspective of Finding Diphty Project
Biotechnology as an applied biological science has proven to have helped overcome many problems in human life such as food, agriculture, health and industry, as well as remediation of environmental damage. However, it should also be recognized that the use of biotechnology by humanity can have an unexpected impact. Concerns about the negative impact of using genetically engineered products on social and religious impacts, occur in the application of biotechnology such as cloned misuse.
The most prominent scientist of this century Albert Enstein states "Religion without science is blind. Science without religion is paralyzed." Enstein's statement is advice to scientists, and for all of us, that the development of science needs to pay attention to religious values. Indonesia is an archipelago country full of wealth and diversity of natural resources, culture, race, regional languages, and religion. In Indonesia there are several religions such as Islam, Christianity, Catholicism, Hinduism and Buddhism. We conducted a study on the views of religious leaders on our project so that our project does not cross social and religious boundaries and is expected to be accepted by the community, especially the Indonesian people.
Religion View Discussion session with Ps. Raditya Oloan
We have conducted interviews with leaders of Islam, Christianity, Catholicism, Hinduism and Buddhism. From the results of the interview, it can be concluded that genetic engineering is allowed as long as it does not endanger the existence of a living creature and has benefits for many people. These are the two conditions needs to be fulfilled in order to be accepted from religion’s perspective. For this project, it is necessary to use human genes because diphtheria bacteria attack human body cells and then put them into bacteria so that they can be reproduced, this project is acceptable as long as it can fulfill both conditions. Moreover, the human gene that we used is not obtained by taking itself from humans, but through the services of suppliers by creating synthetic genes. Information regarding the supplier’s raw material is still classified, but it is ensured the method does not harm any living being.
Religion View Discussion session with Ir. Soelyono, M.M.
The product of the igem UI 2019 project is categorized as a biology-based medical device. This means that the product produced is not consumed by the user. This is acceptable; especially the final product that will be produced can bring benefits to humanity. In its implementation, the use of this tool is done by throat swab technique. This technique can be done provided that the retrieval is only in the level of need / according to the needs only and has received approval from the patient.
Religion View Discussion session with Father Swasono
Ethical Review Result
From this discussion, we direct our project work to make some terms and biosafety appliance according to the result of our ethical review. This shows us how our human practice is integrated and works in two directions (our project affecting the society and society directing our project work).
Follow Up of Ethical Review Result: Biosafety Appliance
Below is the discussion result with Prof. Dr. dr. I Made Djaja, SKM, M.Sc. from Faculty of Public Health Universitas Indonesia according to biosafety appliance of Finding Diphty project:
- Although it is operator independence, the product should be applied only by the health professional in order to avoid any potential risk.
- The using of personal protective equipment is must during the process of the making and during the operation of appliance.
- Please make sure the type of E. coli that will be used in and be genetically engineered is not pathogen. Since then, the biosafety of the product can be easier.
- The management of this product’s waste has to be organized by health professionals (such as hospital) and not recommended to use incinerator or do the disposal before putting it in autoclave.
Prof. Dr. dr. I Made Djaja, SKM, M.Sc.helps us to discuss about the biosafety as the follow up of the ethical review result
Religion View Discussion session with Father Swasono
Ethical Review Result
From this discussion, we direct our project work to make some terms and biosafety appliance according to the result of our ethical review. This shows us how our human practice is integrated and works in two directions (our project affecting the society and society directing our project work).
Follow Up of Ethical Review Result: Biosafety Appliance
Below is the discussion result with Prof. Dr. dr. I Made Djaja, SKM, M.Sc. from Faculty of Public Health Universitas Indonesia according to biosafety appliance of Finding Diphty project:
- Although it is operator independence, the product should be applied only by the health professional in order to avoid any potential risk.
- The using of personal protective equipment is must during the process of the making and during the operation of appliance.
- Please make sure the type of E. coli that will be used in and be genetically engineered is not pathogen. Since then, the biosafety of the product can be easier.
- The management of this product’s waste has to be organized by health professionals (such as hospital) and not recommended to use incinerator or do the disposal before putting it in autoclave.
Prof. Dr. dr. I Made Djaja, SKM, M.Sc.helps us to discuss about the biosafety as the follow up of the ethical review result
Below is the discussion result with Prof. Dr. dr. I Made Djaja, SKM, M.Sc. from Faculty of Public Health Universitas Indonesia according to biosafety appliance of Finding Diphty project:
- Although it is operator independence, the product should be applied only by the health professional in order to avoid any potential risk.
- The using of personal protective equipment is must during the process of the making and during the operation of appliance.
- Please make sure the type of E. coli that will be used in and be genetically engineered is not pathogen. Since then, the biosafety of the product can be easier.
- The management of this product’s waste has to be organized by health professionals (such as hospital) and not recommended to use incinerator or do the disposal before putting it in autoclave.
Prof. Dr. dr. I Made Djaja, SKM, M.Sc.helps us to discuss about the biosafety as the follow up of the ethical review result
CAMPUS CAMPAIGN
The news of diphtheria outbreak that lately happened in Indonesia, especially in West Java, is widely spread over the country. Our team considers that the solution of it—which is our project, Finding Diphthy—has to work the same, widely spread. Campus campaign as a start of our public engagement is aiming to raise public awareness about our project and also gaining public opinion about Finding Diphthy.
Campus campaign was held in Faculty of Public Health, Universitas Indonesia in February 2018 and was attended by the faculty students. This target is considered suitable for our project since they are located in the exact place where the outbreak happened, which is Depok City. Meanwhile, the age of the students are still considered as a risk population of this outbreak.
In this campaign, our team brings up the diphtheria outbreak case and also our project: how it works, how we make it, how it would impact the outbreak and society, and also the comparison to previous diagnostic method. We purposely give a deep explanation about Finding Diphthy to the students so that they—as public and a risk population—can understand the solution and criticize our project. In the end of the session, we held a mini survey by giving them a questionnaire according to our project and their opinion and advice about it. This campaign and mini survey is used to direct our project based on the society needs and views, for our project will also impact the society too.
CAMPUS CAMPAIGN QUESTIONNAIRE RESULT
The respondents of the survey about our project are second year students of Environmental Health Department, Faculty of Public Health, Universitas Indonesia (in total 40 students). Respondents were interviewed about their opinion and knowledge towards genetic engineering, diphtheria, and our project Finding Diphty after socialization was given.
Below are the results of our survey about Finding Diphty:
Society opinion about Finding Diphty Diagnostic Tool
How effective is Finding Diphthy diagnostic tool?
According to the result 63% of respondents stating that our diagnostic tool is an effective tool, with 20% within stating that this tool is a very effective. In addition, only 2% of the respondents have an objection about its effectiveness. In conclusion, according to the society’s view, the effectiveness of Finding Diphty tool is considered high (88%).
How difficult is the work mechanism of Finding Diphthy?
According to the society, the work mechanism of Finding Diphty (throat swab), is considered as a friendly user tool with positive response as much as 83% in total. Only 7% of the respondents stating that the work mechanism of Finding Diphty considered difficult.
Do you think how urgent is Finding Diphthy to answer the society needs?
According to the result, most of the society thinks that our project needs to be implemented in real life. Moreover, 46% of it stating that this tool is urgently needed and 36% stating that it is needed. Only 3% have an objection according its urgency.
Compare to the previous tool, which one is more beneficial?
Comparing to the previous diagnostic tools, 95% of the society finds it more beneficial to use Finding Diphty rather than other diagnostic tool to help diphtheria diagnosis.
In future implementation, will you use Finding Diphthy?
In future implementation, 90% of the society is interested to use Finding Diphty as a diagnostic tool rather than the previous diagnostic tools.
How much do you think is the suitable cost for Finding Diphthy?
According to the society opinion, 95% stating that IDR 50.000-150.000 is a suitable cost of Finding Diphty, 5% stating for IDR 200.000-500.000, and none stating for higher cost. It means that the society sees it as a reachable tool.
CONCLUSION
The society has a positive response of Finding Diphthy project according to its effectiveness, urgency, and simplicity. Most of the society find that Finding Diphthy is more beneficial compare to the previous diagnostic tool and interested to use this product in future implementation.
The respondents of the survey about our project are second year students of Environmental Health Department, Faculty of Public Health, Universitas Indonesia (in total 40 students). Respondents were interviewed about their opinion and knowledge towards genetic engineering, diphtheria, and our project Finding Diphty after socialization was given. Below are the results of our survey about Finding Diphty:
Society opinion about Finding Diphty Diagnostic Tool
How effective is Finding Diphthy diagnostic tool?
According to the result 63% of respondents stating that our diagnostic tool is an effective tool, with 20% within stating that this tool is a very effective. In addition, only 2% of the respondents have an objection about its effectiveness. In conclusion, according to the society’s view, the effectiveness of Finding Diphty tool is considered high (88%).
How difficult is the work mechanism of Finding Diphthy?
According to the society, the work mechanism of Finding Diphty (throat swab), is considered as a friendly user tool with positive response as much as 83% in total. Only 7% of the respondents stating that the work mechanism of Finding Diphty considered difficult.
Do you think how urgent is Finding Diphthy to answer the society needs?
According to the result, most of the society thinks that our project needs to be implemented in real life. Moreover, 46% of it stating that this tool is urgently needed and 36% stating that it is needed. Only 3% have an objection according its urgency.
Compare to the previous tool, which one is more beneficial?
Comparing to the previous diagnostic tools, 95% of the society finds it more beneficial to use Finding Diphty rather than other diagnostic tool to help diphtheria diagnosis.
In future implementation, will you use Finding Diphthy?
In future implementation, 90% of the society is interested to use Finding Diphty as a diagnostic tool rather than the previous diagnostic tools.
How much do you think is the suitable cost for Finding Diphthy?
According to the society opinion, 95% stating that IDR 50.000-150.000 is a suitable cost of Finding Diphty, 5% stating for IDR 200.000-500.000, and none stating for higher cost. It means that the society sees it as a reachable tool.
CONCLUSION
The society has a positive response of Finding Diphthy project according to its effectiveness, urgency, and simplicity. Most of the society find that Finding Diphthy is more beneficial compare to the previous diagnostic tool and interested to use this product in future implementation.
SOCIAL WORK / KERJA SOSIAL (KERSOS)
Our team understands that the future implementation of Finding Diphthy project will need a real foundation from any society levels. Through KERSOS, we are aiming to reach the grass-root level. Not only focusing on educating the people about diphtheria outbreak and our project, moreover we want to know about their health needs. From the insights, we understand how our project would affect the society’s life.
KERSOS was held in collaboration with the Faculty of Engineering, Universitas Indonesia. It was held in 4-8 June 2018 and took place at Cikidang Village, Sukabumi,West Java. In here, our team took part in training the volunteers of KERSOS to give a talk to the villagers about health issue related to diphtheria and also about Finding Diphthy project in brief. The volunteers then came door to door toward the houses to explain all the issues and approach the villagers. This method was purposely applied so that our team can engage more people (the volunteers and also the villagers) in our project.
In the end of the socialization, our team did some follow ups to the villagers directly to make sure they got the right information and to measure how far their understanding about the issues. In the follow up, we got the insights from their testimonies about how important our project and how it would beneficially affected their health. Moreover, they consider it as a “friendly-user” diagnostic tool since it can be used by everyone without really depending to the health officer. They also consider it as a relevant solution, for it would be accessible for them who are still hard to reach nearest PUSKESMAS (health center) or hospital.
Besides the socialization, in collaboration with KERSOS FTUI Committee, we build some lavatories and any sanitary facilitation for the villagers. We also patched stickers of the right steps to wash hands in every house to remind the villagers in keeping their hands free from bad-bacteria. Those was aimed to prevent and minimize the risk of diphtheria outbreak to happen in that location since diphtheria can caused by the bad quality of sanitation and health habits.
BIOSAFETY & BIOSECURITY TRAINING AT IHVCB UI
Institute of Human Virology and Cancer Biology (IHVCB), Faculty of Medicine, University of Indonesia is one of the best research centers in Indonesia. IHVCB accommodates research activities focused on the agents that cause diseases such as virus and cancer in humans. In addition, IHVCB also train and provide opportunities for students to conduct research. Other activities that are also conducted by IHVCB, which supports research and education purposes, is training, seminars and others.
iGEM University of Indonesia 2018 attend a series of Biosafety & Biosecurity training at IHVCB to enhance our knowledge in biomedical laboratory techniques, including basic safety and safety requirements to prepare. Such knowledge will surely produce accurate and non-harmful results for the surrounding environment in our researches at the laboratory. Researches with biological agents, proper use of chemicals, as well as good laboratory techniques require studies in the safety aspects of biological materials.
On the first day of the training, iGEM UI 2018 team obtained lessons on Biosafety, Biosecurity, Code of Conduct and Dual Use Research. This will deepen our knowledge of techniques and equipment to protect ourselves, also the environment from exposure to biological agents; potentially causes illness, mitigation action, and misuse of a pathogen or toxin into the environment. In addition, iGEM UI 2018 also study microbiology techniques including biological hazards.
On the second day, we received material on bio-risk management, risk assessment and good laboratory practice. Through this lesson, the team correctly following the steps in doing research at the laboratory; reducing the risk of accidents that may occur. Such steps are, but not limited to, using the right clothes in the laboratory, the correct way of sampling and the proper procedure of sharps and harmful substances disposal.
On the third day, iGEM UI 2018 studied a variety of techniques that could support research such as polymerase chain reaction (PCR); it is a method to multiply or replicate large amounts of DNA in a short time. The DNA recombinant technique is a technique for combining or recombining two or more strands of DNA thread that in normal circumstances not pairing or occurring together. In addition, iGEM UI 2018 also study the techniques of serology, cell culture, etc.
On the last day, iGEM UI 2018 received a lesson on emergency response, which is useful to know the effective response to emergency situations; minimizing the effects of emergency situations. In the last day, the team also conducted a lab practice to simulate directly the lesson that have been learnt in the last 4 day. iGEM UI 2018 are very excited in participating the training.
HUMAN PRACTICE CATALOGUE