Team:TUDelft/Human Practices
Human Practices
To enable a responsible, impactful, and inclusive technology, we performed a value-sensitive design. Here, we show how this value-sensitive approach helped to promote the early inclusion of direct and indirect stakeholders into the development of our vitamin detection test.
Introduction
Human Practices are an essential aspect in the development of new technological advances to ensure the development of an impactful device. Within Human Practices, we wanted to ensure that our vitamin detection test, AptaVita, could make the real and meaningful impact we envisioned. Therefore, we took a step beyond the lab and engaged with stakeholders relevant to our project to get their input and perspectives on the design of AptaVita. To check how the engagement with stakeholders shaped our project, take a look at our Integrated Human Practices page.
As part of the responsible and realistic development of our project, a value-sensitive design approach was undertaken [1]. This approach is composed of three different steps: literature research, stakeholder identification, and value analysis. Through a literature review, the identified problem was thoroughly analyzed. Afterwards, stakeholder identification, as well as their roles, led to value derivation based on the information obtained for each stakeholder. Finally, design criteria were defined based on the stakeholder information, which guided our project's design and development. These efforts resulted in an initial design proposal that was further challenged and adapted as stakeholders were actively engaged, and their feedback and contributions were fused to our project.
This value-sensitive design promotes the early inclusion of direct and indirect stakeholders into the technology development. Therefore, the first step of the value-sensitive design was to perform a stakeholder identification. Stakeholders are individuals or groups who are involved and affected by the development of our project, either directly or indirectly. The stakeholders can be identified by the incentive they may have to influence the development of our proposal, through their position of power, interest, resources, etc. 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. Additionally, it identifies potential issues that may show up during the development by considering the stakeholder's values, derived norms, and design requirements.
Responsible innovation
Our team highly values, as does the iGEM competition itself, the importance and potential of science & technology in improving societies' needs. Technologies should move from "science in society" to "science for society" to achieve a real impact. After all, new technologies can only become impactful when the technology is acceptable from a societal and ethical point of view, taking into account the context and needs of their users.
For AptaVita to become a useful tool in the efforts against vitamin deficiency, our vitamin detection test needs to be developed as a responsible innovation. New technologies come with new challenges. For any developing technology, many stakeholders are involved who value and prioritize different aspects of the development. During the development of new technology, it is often found that values are unconsciously embedded into the design of the technology. To carefully decide on which design choices to implement in AptaVita, it is important to conduct an analysis on the different stakeholders, deduct their values and norms, and identify the possible conflicting values between these actors. As explained previously, the value-sensitive design provides a systematic method to approach the intentional embedding of these desired values into new technology [1, 2].
Contextualization:
Hidden hunger is a recurrent health concern occurring worldwide, with an estimated one in three people suffering from it [3]. However, a higher incidence of severe micronutrient deficiency has been predicted in the Sub-Saharan region and South Asia. To narrow the scope of the project, the Sub-Saharan region was explored further because of the higher number of recorded disability-adjusted life years (DALYs) due to micronutrient deficiencies [4].
To deepen our understanding of the context of the implementation of point-of-care diagnostics in Sub-Saharan Africa, we have chosen to focus our efforts on one country. We do not have the capacity to intervene in politically unstable countries, either due to corrupt governments and lack of clear governmental institutions or ongoing wars. Therefore, although citizens of politically unstable countries can benefit from our vitamin detection test and may even have a higher need for it, they were omitted in our decision [5, 6]. Furthermore, we focused on countries with a hierarchical and present healthcare system and the required infrastructure for tentative future production of our rapid diagnostic test (RDT) [7]. The former is important to implement a policy to target micronutrient deficiency, while the latter contributes to social sustainability through a circular economy. By means of a circular economy, we can achieve a broader and more realistic impact in the target society. Ultimately, we choose Uganda as our target country, because it meets all the previously stated requirements.
To get a better understanding of the context surrounding the problem AptaVita addresses and the solution we present, please review our Project description page.
Stakeholder identification
Within our region of interest, we identified sectors to which the most important stakeholders in our project belong and the overlapping interactions expected to be observed, depicted in the stakeholder map in Fig. 1. Subsequently, based on a literature review, the stakeholders were classified according to their power and interest regarding rapid diagnostic testing of vitamin deficiencies, resulting in a power-interest grid shown in Fig. 2. Following the Rathenau Institute’s iGEMers Guide to the Future, this grid is applied as a tool to decide which stakeholders to enter a conversation with about AptaVita during the initial stage of our Human Practices work. This way, we aim to make our synthetic biology application highly relevant to the involved stakeholders.
Description of the relevant stakeholders:
Through this section, the identified stakeholders and their relation to AptaVita are further explained. The values for each of the main actors relevant to our project were identified and established based on literature analysis and the purposes that each of the actors serves. Using the power-interest grid, the values of the actors with the highest interest and power and those that appeared recursively and shared the highest affinity towards the goal of our project were selected and highlighted in green.
Local government of Uganda:
The Ugandan government, especially the Ministry of Health, is committed and invested in reducing the magnitude of malnutrition for all Ugandans. The Ugandan government established a National Food and Nutrition Policy aiming for the reduction and eventual elimination of malnutrition and implemented the 5-year Uganda Nutrition Action Plan (UNAP) [8]. This action focuses on increasing coverage of micronutrient supplementation programs and improving feeding and nutrition habits by raising the populations' awareness. The government does this by identifying and implementing cost-effective nutrition program designs that are scalable at local and national levels. Recently, a second UNAP has been passed, which will cover 2020 to 2025 to further work on the goals of improved nutrition among the Ugandan population [9].
Considering this mission, local governments could benefit from AptaVita to enable better-targeted interventions. AptaVita has the potential to improve the cost-effectiveness and coverage of specific requirements for these strategies by filling the current gaps on vitamin deficiencies data with precise information on populations' needs. The government is therefore expected to have a high-interest position. As intervention programs are mostly arranged with the help of external and non-profit health organizations, the government may not have as high power as the WHO and the CDC. However, throughout the development of the project, it is important for the government of Uganda to be managed closely and to establish a cooperative relationship with them.
Local communities in Uganda:
The local Ugandan community is an important stakeholder in our project, particularly vulnerable groups [7, 10], since they will ultimately benefit from a rapid diagnostic test. To attain the desired outcome for the implementation of our proposed solution, the cooperation of local Ugandan communities is a key factor [10]. This cooperation will strongly depend on patients' beliefs and educational background on the importance of nutrition for healthy development.
We assume that there is a high interest in having a healthier life, thereby preventing diseases, and ensuring families' survival and higher quality of life. They have medium power in the use of RDT technology. On a high level, the government is likely to decide the utilization of the technology. However, the population could oppose their use, preventing a successful micronutrient survey. Therefore, the local community must be kept informed and satisfied throughout the introduction of the project.
Health Organizations:
Various health organizations are involved in tackling worldwide micronutrient deficiency. Therefore, our proposed RDT could be of interest to them and be used to shape their subsequent interventions accordingly. In this case, three major health organizations involved in micronutrient deficiency were identified: The World Health Organization (WHO), the Center for Disease Control and Prevention (CDC), and the Food and Agriculture Organization of the United Nations (FAO).
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CDC
The United States' CDC strives to improve vitamin and mineral malnutrition not only in the United States but throughout the world by the implementation of the International Micronutrient Malnutrition Prevention and Control (IMMPaCt) program. This program aims to achieve optimal health among vulnerable populations by improving micronutrient nutrition globally [11].
To reach its goal, IMMPaCt focuses on micronutrient surveillance and research to fill critical data gaps. A reliable rapid diagnostic test for micronutrient deficiencies can expand global micronutrient surveys in countries with insufficient laboratory resources. Therefore, the CDC has been assigned a high-interest position. However, there may be a limitation in authoritarian power over the intervention of this project in certain countries with a poor foreign relationship with the United States.
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FAO
The FAO is a specialized agency of the UN that strives to eradicate worldwide hunger. To achieve their goals, they prioritize food security and access by encouraging political commitment of local governments for sustainable healthy diets [12]. They offer guidance to nations to help develop their appropriate dietary guidelines to promote health and good nutrition and to prevent diseases [13].
The FAO is currently conducting semi-qualitative dietary intake surveys throughout vulnerable populations to obtain the data required to formulate successful nutritional projects, policies, and programs. However, this data is obtained through nutritional estimates rather than direct measurements through means of biological samples [14]. A detection kit capable of accurately measuring patients' micronutrient levels would provide higher quality data, adding to the quality and accuracy of such surveys. Lacking direct affinity with the implementation of our project, the FAO portraits a lower power compared with other health organizations. However, they could highly benefit from the data generated by our project to formulate better strategies for their nutrition-related projects. Therefore, it is expected that the FAO will have a high interest in introducing the detection kit.
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WHO
The WHO is a United Nations-derived agency focusing efforts on improving overall health around the world. The WHO has set a goal to eradicate micronutrient deficiencies from the world by the year 2026. To achieve this, it ensures a common vision, narrative, and plan on micronutrient deficiencies for its Member States [15], mainly working as a director and coordinator of international efforts to improve and assure the health of people around the world. However, besides planning, analyzing, reporting, disseminating, and applying nutrition-related data, the WHO also concentrates on conducting cross-sectional micronutrient surveys [16].
Due to its nature and its purpose as an international health organization, the WHO is given a high position in terms of interest towards our project. The benefits generated by our detection kit are likely to be channeled to partners that directly implement health-related activities. It is also considered that the WHO has relevant power due to its influential capability through their recommendations on the introduction of this detection kit in their surveying efforts.
Health facilities at the point of care:
Health workers play an important role in developing our project by being the ones who perform the tests with our RDT once it is introduced. To base the surveying within the local healthcare system, these point-of-care clinic workers must go through training for the accuracy and safety in detection [17].
The nature of point-of-care units is to provide primary health care for small, local communities. These units are often composed of one or a few medical specialists assisted in basic activities by locally trained personnel [18]. Because of the limited availability of their resources, point-of-care clinics must have a high interest in technology such as our RDT. Low-cost diagnostics methods are likely to improve the labor of health personnel, allowing for better diagnostics and more efficient use of resources. Unfortunately, these small organizations lack relevant power since they mainly operate as part of the national health systems and are limited and regulated by the national health systems. Therefore, there is a high dependency on central governments and international organizations. Regarding the implementation and promotion of rapid tests within their communities, clinics mainly play an informative role, educating and informing the local community on important health practices and considerations. Despite any possible influence power on the opinions and decisions of individuals, they are not capable of pushing any policies [10]. Therefore, this community should be kept informed and satisfied throughout the project.
Diagnostic companies:
Astel Diagnostics (U) LTD is a local Ugandan company that manufactures diagnostic products for use in hospitals, clinics, and laboratories with the approval of the National Drug Authority. Astel Diagnostics (U) LTD's mission is to contribute to the quality of healthcare in Uganda and surrounding countries and promote healthy lifestyles. Astel Diagnostics values innovation as can be seen from their close collaborations with research institutes and research groups from universities [19]. Astel Diagnostics produces detection kits for local, prevalent diseases such as malaria, syphilis, and HIV, as well as pregnancy tests [20]. A RDT like ours could be a valuable addition to their manufactured diagnostic products.
Given that there are no products within their catalog related to detecting micronutrients, it could be possible to establish a cooperative relationship for the implementation and production of our RDT. This relationship could result in an interesting opportunity for the company and further pushes their interest in our project. Based on a scenario of local production and commercialization of our project, Astel Diagnostics (U) LTD should be given a moderate interest for the reasons mentioned above. In terms of power, Astel Diagnostics (U) LTD is expected to have significant influence because of its status as a well-established company that dominates the market and owns the required infrastructure that the production and distribution of a test like ours could require.
iGEM:
The iGEM foundation is a non-profit organization dedicated to the advancement of synthetic biology, education, competition, and the development of an open and collaborative community. They emphasize the social, political, economic, and ethical aspects that should be considered throughout the competition [21]. The iGEM foundation has a strong human practices perspective embedded in its philosophy and is highly interested in generating a meaningful social impact through its platform, although their efforts don’t concentrate with high specificity on topics such as micronutrient deficiency.
The organization's involvement is limited time-wise to the time frame involving the competition. Unless further collaborations are sought, there is no direct involvement and could be primarily considered a diffusion platform, thus should be monitored. Given these reasons, the iGEM foundation is given a low interest and low power position, as a secondary actor that is involved only by the context in which this proposal was developed.
Values, norms, and design requirements
The previously identified values are condensed in Fig. 3 and used to derive the design norms and requirements that would guide the planning and development of our initial project proposal.
It can be seen in Fig. 4 that the value with the most relevance to our project is Health, becoming the core and most important norm from which all other values can be derived and related to. The value of health was identified by all of the main actors and is within the nature and scope of the development of diagnostic technology for the identification of vitamin deficiencies.
Health is defined by the WHO as a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity. This state of well-being is a right that must be attainable for all individuals despite identity, beliefs, origin, or socio-economic background [22].
The derived values ruling our design will be defined next along with the proposed design norms and design requirements based on them:
The detection and diagnosis of micronutrient deficiencies depend on the accuracy and reliability of the performed measurements [23]. This is, respectively, the degree to which the measurements conform to the correct value and the overall consistency of the measurement. Such quality characteristics are considered as minimum requirements within the desired ones for rapid diagnostic tests for health organizations such as the WHO and CDC [24].
Efficiency is a broadly used term that could be simplified as the system's resulting output to input ratio. In a healthcare context, efficiency is then interpreted as the cost of the resources (personnel, equipment, money, time, etc.) required per health-related output [25]. For the case of a rapid diagnostic test, we define such an output as the correct diagnosis of an individual subjected to the test. Under this definition, the design requirements for the value of efficiency were formulated in Fig. 6.
Accessibility to health refers to the capacity of a population to reach appropriate health services and a general state of health and well-being. Accessibility is dissected into three main branches by the WHO: physical accessibility, economic accessibility, and cultural accessibility [26]. All three of these characteristics should be taken into account to guarantee the accessibility to proper diagnostics and obtention of health to its full extent.
The principle of equality is an internationally recognized proposition stating that people in identical circumstances are treated equally under the law and in practice. According to the WHO, this principle should also apply to healthcare, food security, environmental safety, etc., and should be sought after by the global population. An important part of equality is established by inclusivity, which is defined as the inclusion of the disabled and minority groups in (mental) healthcare and providing accessibility to healthcare [27, 28].
Acceptability in healthcare refers to the extent to which medical services (and practices) meet the requirements of its users either at a personal or community level, affecting the utilization of such service [26]. On the other hand, trustworthiness relates to the confidence produced in individuals in regards to healthcare providers and services [29]. Trustworthiness and acceptability share specific design requirements. However, the slight difference between these two terms led us to identify a conflict between two opposing design requirements derived from these values. While acceptance is the action of consenting to receive or undertake something offered, trust is confidence in or reliance on some person or quality. This consideration impacts the sample of choice to perform the test.
With the current world population and its requirements, the current production and consumption rate of all resources cannot be maintained. Sustainable development is a new way to adjust the world's model of progress. For this purpose, the UN has devised the Sustainable Development Goals (SDGs) as a road map for future developments [30]. More about the SDGs that AptaVita will be contributing to can be found on our Sustainable Development Goals page.
The Ugandan health and safety institutions do not provide a clear definition of safety. However, according to the Center for Environmental Safety and Security at the National Institute for Public Health and the Environment in the Netherlands, safety is defined as the controlled use and disposal of chemical, biological, radiological, and nuclear (CBRN) agents. Therefore, this is the definition we will uphold when considering the value of Safety [31]. Furthermore, the preservation and improvement of the environment and especially climate change are highly valued by the United Nations and incorporated in the Sustainable Development Goals [32]. According to the WHO, health security, and more specifically global public health security, is defined as "the activities required, both proactive and reactive, to minimize the danger and impact of acute public health events that endanger people's health across geographical regions and international boundaries" [33].
The value-sensitive design provided design requirements for an initial approach in the planning of our project. These design requirements were formulated to comply with the principal values identified for what are believed to be the main stakeholders. However, these values, and most importantly the derived design requirements, do not necessarily align with each other, and prioritizations are required. Therefore, a clashing values analysis and an initial design proposal were performed. To further know how the values were prioritized and resulted in an initial project design visit our Integrated Human Practices page.
It is important to note that the conclusions obtained from our human practices analysis were not expected to remain unchangeable but are required to evolve and adapt along with the development of our work. In order to challenge our analysis and conclusions, experts and actors in the related sectors were contacted. Their input molded the design considerations and progressively transformed our project, and provided a clearer perspective of the involved sectors, actors, and their interactions. Fig. 12 shows the actors who participated in developing our project and provided insight and feedback to conduct our project towards a significant responsible innovation. Integrated Human Practices further explains who these actors are and how their involvement shaped our project to its final form.
Make sure to read how interactions with stakeholders has shaped our project on the Integrated Human Practices page!
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