Team:CSMU Taiwan/Safety

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Introduction


The ultimate aim of technology is to create a better world for human beings. However, risks arise during the development of these techniques, varying from physical harm to privacy invasion. The advantages of technology can never be fully demonstrated if these potential hazards presents, therefore, safety should be of the top priority no matter for researchers or users.

Our team aims to develop a more essential influenza rapid test tool. Meanwhile, creation of a new diagnostic tool takes more than research and development. Implementation of such a device means it will be brought into direct contact with society. To ensure that our work is safe for the end user and to prevent miscommunication about the purpose of the technology, it is also essential to consider the social aspects that our tool will bring.

To sum up, in the safety section, we are going to explore four different aspects of our project, respectively Biosafety, Lab Safety, Regulations, and Ethics.

Biosafety

Labsafety

Regulations

Ethics

Biosafety

Our team complies with the third edition of Laboratory Biosafety Manual released by World Health Organization.

Moreover, according to Taiwan Centers for Disease Control(Taiwan CDC), some of the current status for Biosafety are stated as bellow:


1.Legislative and Regulatory Changes

In 2018, Taiwan CDC completed editing, revision, and announcement of the “Guideline for Governing Management of Select Agents and Toxins”, “Guidance on the Inventory of Select Agents and Toxins”, “Security Guidance for Select Agent or Toxin Facilities”, “Guidance for Suitability Assessments”, “Drills and Exercise Guidance”, and “Select Agents or Toxins Biosafety/ Biocontainment Plan Guidance”. We also accomplished the amendment of the “Regulations Governing Management of Infectious Biological Materials” on January 31, 2019, categorizing select agents and toxins as a special section.

What our team did to comply with it

Although no select agents or toxins on the list are involved in our experiment, we still looked through the guidance carefully.

Nucleoprotein and hemagglutinin of Influenza A and Influenza B virus are our target protein for SELEX, meanwhile whole influenza viruses are used to test the inhibition ability of our selected aptamers. In addition, in the Charactization and Improvement section, we improved the water solubility of HA1(Hemagglutinin for H1N1). The subtypes we chose are classified as seasonal influenza, which are surprisingly potential select agents too.

Apart from complying to the Biosafety manual for Level 2 labs, we also took some effort looking through Dual Use Research of Concern, DURC. After discussing with our instructor, we drafted a Risk mitigation plan.

Risk mitigation plan

2. Biosafety Mechanism Registration

By December 2018, 502 entities reported biosafety management units to Taiwan CDC, of which 496 entities established biosafety committees and 6 entities designated a biosafety specialist staff. These included 20 government agencies, 153 medical institutions, 54 academic research institutions and 275 other groups.

What our team did to comply with it

We are proud to announce that our institution, Chung-Shan Medical University, is one of the registered entity! We have applied for agreement to use virus in our experiment at the safety committee of CSMU, and the safety committee checked our facility, gave us a quiz regarding associated operations before permitting us. In addition, CDC tracks our usage regarding all contagious agents including influenza virus.


3. Biosafety Inspections of High-Containment Laboratories

Since 2006, Taiwan CDC has routinely inspected BSL-3 and above laboratories to monitor operations and ensure safety. In 2009, TB-containment laboratories, which process culture manipulation for identification and drug-susceptibility tests, were added to inspections. In 2019, Taiwan CDC completed the annual routine laboratory biosafety and biosecurity inspecting of 22 high-containment laboratories (refers to Level 3 and Level 4 biosafety and animal biosafety laboratories.) and RG3 pathogens storage facilities.

In addition, Taiwan CDC supervised the local government health bureaus to complete the laboratory inspecting of 75 BSL-2 microbiology laboratories of biotechnology industries. In order to strengthen biosafety and biosecurity of the entities that possess or use select agents and toxins, Taiwan CDC has counselled and visited the facilities of 7 entities in 2018.

What our team did to comply with it

All of our experiments regarding virus were conducted in the Biosafety Level-2 laboratories. Under the supervision of CDC, our instructor manages the lab strictly and obeys to all guidance written in the manual. For example, we were never allowed to enter the lab before putting on gloves, masks and lab coats. The wastes were always carefully collected and dispensed. Most importantly, our instructor seldom leaves us alone when performing experiments that could infect disease accidentally.


4. Laboratory Biosafety Education and Training

In 2018, 4 e-learning courses on laboratory biosafety were recorded. Taiwan CDC also organized 3 biorisk management and 3 select agents and toxins training course sessions, with a total attendance of 429 laboratory workers. Taiwan CDC developed “Laboratory biosafety management information system” (ver. 2.0) which helps to conduct and oversee the condition of management of storage and transformation of infectious biological material. We held 10 operation training and 2 systematic data maintenance symposiums to help all entities getting familiar with the system, and 508 laboratory workers attended.

What our team did to comply with it

We have organized to watch these videos when facing the same situations the videos focused on.


5. Laboratory Biorisk Management

In 2018, the bio-risk management system using CWA 15793 standard was introduced to 17 biotechnology-relatived microbiology laboratories. By focusing on continuous improvement and the Plan-Do-Check-Act (PDCA) cycle, this system will identify and monitor all aspects of laboratory biosafety and biosecurity.


6. Future Prospects

Taiwan CDC has participated in the Global Health Security Agenda (GHSA) for several years and realized the international concern of Biological Select Agents and Toxins (BSAT). In 2016, we applied JEE Tool (Joint External Evaluation Tool) published by WHO to assess the epidemic prevention system of our nation which includes reviewing the level of BSAT management. For the JEE Tool, the highest score for each indicator is score 5-sustaninable. Taiwan was scored 3-developed capacity in BSAT management. As a result, by 2018, Taiwan CDC has improved the insufficiency of BSAT management and has made a great progress on it. We believe by the time of 2020, we will reach a higher score on BSAT management on JEE tool, to prove the nation’s ability of managing BSAT can be as well as other advanced countries.

What our team did to comply with it

Not only did our team complied with the rules, we aimed to contribute to elevate the biosafety of lab and public health. In the section of design, we developed an AI system that is able to predict the spread of influenza.


To sum up, since our experiment involves in virus experiments, we paid special attention towards this issue to secure the safety for both the researchers and public.

Ethics

Ethics plays a crucial role in scientific research. All products our team developed and designed aims to give human beings a better and healthier life, hence the physically and mentally health, and the privacy of users should be of prior.

The diagnostic tool (rapid test paper), therapeutic vaccine, air purifier, and AI system involves different aspects of ethical issues, and we discussed these problems with Doctor of the Laws Huei-Chih Niu, specializes in Health Care Law and Bioethics and Legal Policy for Gene Technology.

Responsibilities

As mentioned in the Regulation section, even after the product is successfully launched, long-term follow-up is still required because most adverse drug reaction are unpredictable, so some questions came to our mind:

Q. Since our products composes of gene, and the affection of gene is unpredictable maybe it’ll take three to five years to see its side effect. When this happens, is it the manufacturer, the product designer, or the government who should be responsible for the problem?
In other words, after all, the government had made an endorsement of the product, and the manufacturer sells it to the market with the endorsement. If a sudden problem occurs in the future, who should be responsible for it?

A. There are two different logics here:

1. Consumer Protection Law and Products Liability

If the products has met the technology and standards of the time when launched to the market, and the government also approved the launch according to that standard. But then a problem which was unpredictable at that time arises after several years, we could not be blame the manufacturer.

2. Opposite view of the logic above

Since the consumers trusted the government, the product itself, and the company. But when accident happens, it is unreasonable to say that no one should be responsible for it. Therefore either the government or manufacturer should be responsible for it.

Public Promotion

Q. How do people feel commonly towards GMP products? How can we promote our product?

A. This is a complicated question. The main problem is how consumers feel

For example, if an epidemic becomes very serious one day, nothing else except the vaccine cures disease, people will use it no matter what risk it composes.

But if we have other choices, as long as any other competing company deliberately sets a rumor, the vaccine will not be accepted by the public.

The feelings towards this kind of technology products of Taiwanese people are bipolar,

  • Sometimes they are superstitious. As long as it‘s high-tech, everyone rushes to buy it.

  • Sometimes they are very sensitive, considering high-tech as high-risk and not even willing to try


Hence, it depends on public education and commercial means.


Dr. Niu thought that because the sensitivity of this issue(DNA) is a bit higher than food, it is harder to predict how consumers will feel. The main concern for consumers should be safety, whether the aptamer(DNA) will cause mutation or not.

  • As long as it isn’t injected into germ cells, rarely will it cause any harm. Therefore we will have to explain it to the public.

To sum up, the feeling of consumers should also be taken into consideration, which is also a part of ethical issues that most people forget!