HUMAN PRACTICES

Human Practices are a fundamental aspect to take into account in order to develop a successful project. SPYKE aims to gather, analyze and assess the criteria necessary to design a device that has meaning for society and takes into account other aspects of relevance for further implementation in society. For this reason, it is essential to take a step beyond the foundational scientific research behind the sensor and analyze how our solution can have the beneficial impact we envision. Therefore, we have cooperated with stakeholders, groups, and individuals that are directly and indirectly affected by our project, and asked for their input and opinions on the design of SPYKE. Read more on how consulting a broad range of stakeholders has affected our project on the integrated human practices page.

When defining the initial configuration of our product, we conducted a value-sensitive design analysis. The aim of value-sensitive design is to make design choices that suit values of associated stakeholders, with the intention of technologies or applications being more 'fitting' to particular needs [1] . Said process is, in general, composed of three steps: a literature research, stakeholder identification, and value analysis. For our project, initially, the problem in itself and its implications were extensively evaluated. The second step consisted of identifying the relevant stakeholders and the values these stakeholders deemed important. The identification of all the key stakeholders is essential, as it provides opportunities to improve the overall project by developing the technology in a value-sensitive and responsible manner. During the last step we identified the most relevant values from the stakeholders. These values were used to create design norms and subsequently design requirements. By combining these design requirements we came to an initial design of SPYKE.

Finally, as part of our Human Practices analysis of the project, we evaluated the potential risks that our project may carry and how we can take action to minimize or mitigate said risks. Safety was identified as one of our core values, which was deeper analyzed through a safe-by-design approach . By incorporating these measures together with value-sensitive design and the feedback provided by the stakeholders, we managed to create an optimal design for SPYKE.

Responsible Innovation

Our team, following the iGEM philosophy, highly regards the use of synthetic biology to contribute to solving health and environmental problems. To have a significant influence, technologies should shift from a "science in society" to a "science for society" approach. After all, new technologies can only have an impact if they are societal and ethically acceptable while taking into account the context and demands of their users. To become a useful weapon in the fight against GHB spiking, our detection approach must be developed responsibly. This implies that many stakeholders need to be involved in the advancement of technology, as well as the values associated with them. It is frequently discovered during the creation of a new technology that values are unconsciously embedded in the product design. As previously stated, we used a value-sensitive design strategy for systematically approaching the intentional integration of desirable values into our new technology [2] [3] .

Drink spiking is a recurrent practice worldwide, however, with a higher incidence recorded in Western Europe [4] , namely the United Kingdom [5] , Belgium, France, and the Netherlands [6] . For this reason, we have decided to further explore these regions, especially the Netherlands, our home country. Furthermore, we focused our attention on one specific drug: GHB. In the context, we have investigated, GHB has been reported as the most common rape drug [7] . Due to the rapid breakdown of GHB molecules in the body, it is unlikely to identify this drug in the body six hours after consumption [8] . As a result, hospitals cannot confirm most cases of drugging, leading to a lack of data [9] and victims are left with no evidence which prevents them from filing an official complaint. Currently, there are no passive (i.e. continuous testing) detection methods available on the market as they all require active testing on behalf of the user, as described in the Market Analysis. Moreover, in hospitals, the standard protocol foresees a urine test, which detects only cocaine, cannabis, amphetamine, and opioids, but not GHB. Tests for this drug need a trained pharmacist to be performed as we discovered thanks to Amber van Beest Schaafsma , a first aid doctor.

Unfortunately, it is relatively simple these days to acquire information online about how to make GHB [10] and, the accessibility of this substance is increased by the cheap prices of GBL, the precursor to GHB, which is also easily acquired online. Furthermore, at the start of our project we also learned about a “possible antidote for club drug GHB overdose” called diclofenac [11] . If this antidote would indeed work, making a quick GHB biosensor could prevent overdosis. For example, if a club-goer passes out and the sensor indicates their drink was spiked with GHB, diclofenac could be administered to lower the risk of severe consequences. Much more research should be done to make sure diclofenac works well in this scenario. This is further explained in the proposed implementation .

Stakeholder Identification

Within our region of interest, Western Europe, we identified relevant stakeholders by literature reviews and brainstorming sessions. An overview of the stakeholders can be seen in Figure 1 .

The stakeholders were ranked on their concern and their responsibility based on literature. Figure 2 displays their ranking based on responsibility and concern.

We selected the stakeholders with the greatest concern and responsibility and got in contact with them. As our understanding of the problem increased during our engagement with the stakeholders, the number of relevant stakeholders increased also.

Description of stakeholders

The identified stakeholders and their connection to SPYKE are elaborated on in this section. Based on the functions that each of the primary characters relevant to our project performs, we determined and established the values for each of them.

Target audience

The Western European population is the most significant stakeholder as they represent our primary client. We initially focused on the Netherlands, but later in the process, we expanded our scope to other countries as well. The general public has a great concern [6] about the problem and very low responsibility as they have little power to solve the problem. To start, we conducted a focus group to evaluate the sentiment of a more condensed audience. We then gathered information from end users and distributed a survey amongst a larger audience to collect feedback. We also spoke with GHB spiking victims since their perspectives are essential to our investigation.

Healthcare

Healthcare facilities in the Netherlands are important stakeholders in our study. Their goal is to ensure that people have the best possible health and thereby, reducing GHB spiking is one of their concerns [12] . We spoke with hospital staff members, the Trimbos institute—which promotes drug use monitoring, prevention, and harm reduction—as well as Event Medical Services. The latter offers first aid at events and places a high priority on safety—in order to gather the broadest possible perspective of healthcare institutions.

Currently, there is no effective rapid test on the market that these organizations can use to detect GHB. For further details, see the Timeline and the Market Analysis . This lack of testing leads to inaccurate emergency response and an overall scarcity of data regarding the problem. Healthcare organizations could profit from SPYKE to enable more precise interventions given their objective. By filling the current gaps in the data on GHB spiking with exact information on its incidence, SPYKE has the potential to increase the cost-effectiveness and coverage of particular requirements for these tactics. Therefore, it is anticipated that these stakeholders will hold a position of great interest. Furthermore, it is essential to build a cooperative relationship with them, for the duration of the project development and implementation.

Dutch government

The government of the Netherlands is also an important stakeholder. Several institutions are involved in our project, namely:

• Police

The police are involved as they safeguard the public and collect data on the incidence of GHB spiking. They have a high responsibility for reducing spiking. A positive test result serves as evidence of the accident, which is necessary for the reporting procedure. Since it cannot guarantee public safety without verifying cases through testing, this stakeholder has a very high concern. This institution's objective of maintaining public safety would be aided by a trustworthy, quick, and affordable detection technology granted thanks to SPYKE [13] .

• National institute for public health and the environment in the Netherlands (in Dutch: RIVM)

The RIVM is the national institute for public health and the environment in the Netherlands. By conducting research and gathering information nationally, RIVM carries out research in order to ensure public health and a safe environment. Also, the institute has a signaling function in terms of new trends in the fields of biotechnology and synthetic biology, which are used to provide recommendations to the Dutch Ministry of Infrastructure and Water Management - which is responsible for Biotech regulation. Due to their tasks and assigned responsibility, they are interested in the overall safety of our product and any possible emerging risks to society [14] .

• Department of Justice

The Ministry of Justice is engaged in creating regulations for governing GHB spiking and the requirements for reporting. They are an important stakeholder in our project since filing an official report calls for a trustworthy detection tool. For this reason, they are responsible and have a high level of concern [15] .

Hospitality businesses

The hospitality industry is a significant stakeholder in our research since GHB spiking incidents occur at their venues. We spoke with Koninklijke Horeca Nederland (Dutch Royal Hospitality Business), an organization that includes a lot of hospitality-related companies. Its goal is to support business owners of hospitality enterprises in keeping their customers safe. [16] We also spoke with bouncers and managers from bars. The hospitality industry is very concerned since the issue of GHB spiking is affecting their establishments. Given that they are not the perpetrators, but spiking does happen under their watch they have a medium level of responsibility.

Scientific community

Regarding the technical aspects, safety, security, and ethical considerations, numerous scientists provided us with significant assistance. They provided us with information about the feasibility of our project when taking time and resource constraints into account, as well as their expertise in biology and electronics, which helped us create a better operating product. Additionally, through recommendations and accurate criticism, they assisted us in making our product safer. Overall, they have lower responsibility and concern but are interested in helping us.

Values, norms and design requirements

From these stakeholders, associated values to our project were divided into four sectors with the core value being safety. As for all of the stakeholders, the value safety was identified and all the other values contribute to the safety of our product. This safety can be related to the user of SPYKE, the public, or the environment.

For all the values, norms were derived from which necessary design requirements were identified:

Our device aims at protecting the user from drink spiking, therefore the user’s safety was a core value throughout the designing process. Our sensor should be safe for the user to use in the first place as well as accurate and reliable when testing for the drug. Therefore, we opted for food-safe materials to protect the user’s health and a bio-electronic detection method to obtain accurate and reliable results.

Our sensor can be effective only if it is socially accepted, hence people trust the device and use it in their nightlife experience. To accomplish this, we decided to rely on a clear and secure readout, thanks to purified biological parts. Acceptability is a value important for hospitality businesses as well as hospitals and law enforcement.

It is very important for the device not to be easily recognizable as this would make those without the sensor an easy target for spiking. Therefore, a design that minimizes said risk is necessary and can be achieved by positioning the sensor in a well-hidden spot and by choosing a design that is not flashy. This value is important to users as well as healthcare facilities and juridical organizations as they all have at heart the well-being of society. This value is also important for nightlife establishments as the use of GHB sensors might result in bad publicity.

Talking to users made us realize that creating a device that is user-friendly is necessary in order to have a product that is unbiased and that can reach the broadest possible audience. Therefore we thought about an easy interface for the user and an easily recognizable output signal so that everyone is able to access the sensor easily.

Bias around our sensor can also be reduced by making it easily accessible to everyone. Making the device affordable is necessary so that people from different economic backgrounds can be protected. This is a very important value for healthcare facilities. To make the biosensor affordable, the components can be mass-produced and re-utilized multiple times. Furthermore, collaborating with nightlife establishments can help distribute the sensor, allowing a larger number of people to be protected.

Health institutes and the police made us realize that there is a profound lack of data on GHB spiking. Therefore, our device must be able to provide credible data about the problem at hand. To do so, we incorporated an easy and readable output. Furthermore, a legally binding output can help not only with filing an official report by the user but also by providing credible statistics.

While developing our sensor, we also thought about the sustainability of the product. This value is mainly important for users, however, it is important for the RIVM as well. We chose materials that are recyclable and can be reused multiple times, to maximally reduce the waste produced.

Using these design requirements, we could start developing an initial, optimal product. We came to a first design of the biosensor consisting of a small electrode with immobilized DNA attached to a molar tooth. The electrode would be encased in a membrane, inside which purified proteins would be present. When GHB is present, a simple electronic circuit would send a Bluetooth signal to an app on your phone. Your phone would warn you by producing sounds and vibrating. The components of the sensor should be safe to consume and most of the parts should be recyclable. Figure 12 shows the initial design of our sensor.

The value-sensitive design was the first step toward designing an impactful solution to GHB spiking. The interaction with the stakeholders which is discussed in the integrated human practices together with our safe-by-design approach changed the desired design drastically.

Secondary effects of SPYKE

We determined all the characteristics our product has to offer by utilizing a value-sensitive design integrated into our sensor. Following upon, we needed to consider all of the secondary implications of the existence of our product. As the scientists behind SPYKE, it is our duty to consider the impact of these consequences and work to reduce the likelihood of unfavorable effects. We had a brainstorming session with our team to explore the most likely secondary effects of SPYKE.

We started by trying to imagine what unintended consequences developing a GHB biosensor would have. After that, we determined both the advantages and disadvantages of these effects. We adopted a strategy similar to that used by team TU Delft 2019 to identify the negative side effects that could result from our project. The GHB biosensor has already been subject to an ethical analysis by the Bielefeld 2015 team . Building upon this team’s analysis, we included more effects related to the present and our own goods, as well as their favorable and unfavorable effects. We identified three additional secondary effects, together with potential benefits and drawbacks, that the implementation of a GHB biosensor could have.

After that, we began examining the likelihood and significance of the discovered secondary negative effects. We made use of a safe-by-design approach and talked to stakeholders during our integrated human practices to find out the probability of these consequences and other aspects of our project.

Increased fear of GHB spiking

The increased knowledge of GHB spikes may promote an increased awareness of GHB spiking, which could lead to increased fear and possibly panic. To establish whether this might be the case, we spoke with Steven Biemans of the Trimbos institute. He warned us that although the fear of GHB spiking could indeed increase due to the promotion of our product, this has already been the result of media attention. Thus, the creation of a GHB biosensor would probably not add to this anxiety, but would rather decrease it because people would feel safer with our product.

Increase in GHB production

We hypothesized that disclosing the simplicity of GHB manufacturing could lead to an increase in GHB production. The Bielefeld 2015 team has already spoken with an iGEM safety officer, Kelly Drinkwater, about this worry. She assured them that the degree of information they provide on GHB is perfectly reasonable given that it is widely accessible. In order to prevent issues, we chose to not provide more information on GHB manufacturing than the Bielefeld iGEM team 2015.

Increase in use of other drugs for spiking

If a reliable GHB biosensor were to become available, alternative drugs might become common for spiking instead of GHB. We spoke with the Dutch Forensic Institute , which confirmed that alternative substances may be used for spiking. During our safe-by-design approach , we suggested more research that may be done to develop a combination biosensor for GHB and these drugs.

Increase in needle spiking

If a reliable GHB biosensor is made available, needle spiking may become the primary method of GHB administration. Drugs are put in needles used to spike people at nightlife establishments, a practice known as "needle spiking". The extent to which this is occurring is quite uncertain [17] . The first proven occurrence of needle spiking happened during our development stage [18] , however, this is the only instance. We made the decision to consult with authorities at the Trimbos Institute, Event Medical Services, a physician, and the police [TU Delft, integrated human practices ]. They informed us that they didn't think needle spiking would be a problem. We suggest that the proposed implementation of our GHB biosensor could be employed as a fast detection kit also in presumably needle-spiked individuals. This could determine whether needle spiking is actually an issue and whether more action is required to address it.

Conclusion

Using the value-sensitive design we came to an initial design of SPYKE consisting of a GHB biosensor attachable to a tooth. Then we identified and weighed possible positive and negative secondary effects of a GHB biosensor and concluded the positive effects outweighed the negatives. Combined with consulting the key stakeholders during the integrated human practices and using a safe-by-design approach, we came to the conclusion that SPYKE clearly would have more positive than negative effects on the world.