Our Human Practices work began with two guiding questions:
These questions are inseparable. To create something that truly matters, we first had to understand the needs of those who would use an STI self test, listen to clinicians’ advice, and navigate regulatory and ethical landscapes. Human Practices became the framework that ensured we were solving the right problem - through stakeholder engagement, scenario planning, reflection, and an end-user-centered survey.
Over the past months, we connected with more than 20 stakeholders from diverse fields, surveyed 417 potential end-users, held team workshops, and carried out in-depth research. Each step shaped our design decisions, helping us refine our project along the way.
The urgency of our work stems from a troubling reality: while STI cases are on the rise, testing accessibility and options are still lagging far behind [1]. We soon realized that this challenge cannot be solved by technology alone. Financial, clinical, societal, regulatory, and ethical factors are deeply intertwined, demanding a global approach.
To capture this complexity, we organized our Human Practices work into six dimensions, each guided by central research questions/topics:
These six dimensions guided our reflections and actions throughout the project. Together, they helped us build something that is not only scientifically sound, but also ethical, clinically relevant, socially responsible, regulatory-aware, and entrepreneurial in vision.
We approached our Human Practices work using several complementary frameworks. These frameworks guided us in navigating the complexities of our project by helping us anticipate potential outcomes, reflect on our responsibilities, follow ethical standards such as informed consent, identify gaps in our work, and monitor the integration of stakeholder feedback.
For readers short on time, we recommend reading the AREA Framework if you’re not yet familiar with it, as well as the Human Practices Interview Framework, since they provide the foundation for how our Results are structured. Once you’ve read them, you can jump ahead to the Integrated Human Practices section.
The AREA framework - Anticipate, Reflect, Engage, Act - is designed to help researchers remain aware of the broader consequences of their work. It supports a systematic way of asking the right questions at the right time. [2]
In this framework, Anticipate means considering potential impacts and outcomes of research, Reflect involves examining the values and assumptions behind it, Engage refers to involving stakeholders and society in the discussion, and Act means responding responsibly to the insights gained.
At the beginning of our project, the Human Practices Team carried out the Anticipate step of the AREA framework by holding a brainstorming workshop. In this session, we explored different scenarios that could arise from our research. This helped us identify potential challenges early on and decide which aspects of our project would need closer attention.
To guide these discussions even more systematically, we drew on an expanded version of AREA: the AREA 4P framework [3]. This approach allowed us to organize our reflections into four guiding categories: Process, Product, People, and Purpose.
Building on our anticipation work, a follow-up workshop was dedicated to reflecting on the scenarios and questions we had identified. This was crucial for targeted stakeholder identification and for refining the questions we would ask during our engagements. Our anticipations and reflections are presented within the different dimensions outlined in the next section.
Following this, we moved into the Engage phase, where we sought input from a wide range of stakeholders based on the anticipations and reflections we had developed. Finally, the Act step was implemented across other frameworks to ensure we transformed insights into action.
Together, these tools ensured that the AREA framework was not just theoretical but visible across every dimension of our Human Practices work.
Stakeholder engagement was central to our project. To ensure that each conversation was purposeful and consistent, we created our own comprehensive Interview Planning Template. The template is divided into three sections, designed to guide the process before, during, and after the interview, and to support iterative, well-documented stakeholder engagement.
Planning the Interview (Pre-Interview)
Before each interview, we defined clear objectives to ensure the conversation is focused and productive:
By clarifying these elements in advance, we could approach each interview strategically and ensure that insights gathered are relevant and actionable.
Conducting the Interview (During)
The second part of the template provides a structured guide for the conversation itself:
This approach ensured that interviews were consistent and structured while remaining adaptable, giving interviewers the freedom to respond naturally to each stakeholder.
Reflection and Debriefing (Post-Interview)
After each interview, we used the final section of the template to synthesize insights and plan next steps:
Using this template allowed us to maintain extensive, transparent documentation of our design choices, directly supporting iGEM medal requirements for Human Practices. It also enabled iterative stakeholder engagement, where each round of interviews informed adjustments to our project and clarified next steps.
All of our stakeholder engagement pages are structured around this framework, ensuring that every interaction was well-documented, traceable, and actionable. By consistently applying this process, we could integrate stakeholder feedback systematically and demonstrate a clear link between input and project evolution.
This Interview Framework was invaluable in helping us structure and document stakeholder engagement, conduct consistent and insightful interviews, and systematically integrate feedback to shape our project’s development. We are sharing this framework as a resource to guide future iGEM teams in engaging stakeholders effectively and using their input to meaningfully improve their projects. Visit our Contributions Page for more information.
Managing input from dozens of stakeholders can be overwhelming without structure. To address this, we employed stakeholder mapping. While originally based on a simple power-interest matrix, we adapted the framework to better suit our needs. Our version included the following categories:
This system helped us in two important ways: first, it ensured that no opinion, value, or piece of advice was lost; and second, it revealed gaps in our engagement, alerting us to stakeholder groups we had not yet consulted.
Informed consent was a central principle in all our interactions. To make sure our engagements were ethically sound, we created a standardized document based on both local legal requirements (such as GDPR) and the guidance provided on the iGEM website. This document outlined the purpose of each interview, how data would be used, and the rights of participants, ensuring transparency and trust.
Rules and Guidelines on informed consent can be confusing for new teams. To make this easier, we are sharing our informed consent sheet as a resource that future teams can adapt and build upon. Visit our Contributions Page for more information.
The Integration Logbook is a structured tool that centralizes all stakeholder feedback and experimental insights in one place, ensuring every input is tracked, linked to project decisions, and preserved. By keeping everything together rather than spread across multiple documents, it prevents loss of information, supports traceability, and provides evidence of reflective, informed decision-making. For future iGEM Teams, the template can be found on our Contributions page.
The scientific dimension of our Human Practices work focused on identifying the key challenges in developing a paper-based STI test using RPA, CRISPR, and DNA hybridization. We examined the feasibility of combining RPA and CRISPR, addressing potential hurdles such as efficient lysis and the choice of detection method. This also involved considering practical aspects of performing RPA, optimizing Cas protein purification, and ensuring overall reagent stability. Insights gained through discussions with wet lab experts and these evaluations were critical in shaping and guiding the direction of our project.
To answer these questions, we reached out to various stakeholders. Click on the cards to learn more about these engagements and how the insights gained were implemented into the project.
PhD student at the Pelkman's Lab
Head of Diagnostics & Development at the Institute of Medical Virology, University of Zurich
Full Professor at the Department of Molecular Life Sciences at the University of Zurich
Professor of Biochemistry and Systems Biology at the University of Zurich
Head of Biosystems Science and Engineering Department at ETH
Senior Scientist at ETH DeMello Group
Full Professor of Biochemistry at the University of Zurich
Contact person at Milenia Biotec
A brief overview of what we learned in these engagements and how we implemented this into our project. Read the Interview pages for the full picture.
We learned that several diagnostic routes – RPA, RCA, gold-nanoparticle hybridization, and CRISPR-Cas – each offer valuable opportunities but differ in feasibility and complexity. RCA, while promising for signal amplification, requires multiple enzymes and complex buffers, making it less practical than alternatives like quencher-based or colorimetric detection. Gold-nanoparticle hybridization proved both feasible and adaptable, depending on probe design, melting temperature, and sequence specificity. CRISPR-Cas and DNA hybridization remain our most robust and flexible options, particularly when combined with RPA, as both can operate with high specificity.
These insights were integrated by refining our detection focus toward DNA hybridization and CRISPR-Cas. We implemented improved probe validation through BLAST, planned fluorescent and colorimetric visualizations, and optimized experimental design using HybriDetect strips. Input from experts also guided our shift to preparing test strips in-house, developing asymmetrical RPA assays, purifying Cas12a proteins locally, and consulting additional specialists. Check out our Engineering and Cylces Page as well as our Notebook Page.
The clinical dimension of our Human Practices work centered on understanding how an at-home STI test could fit into existing healthcare structures and clinical expectations. This included gathering clinicians’ perspectives on the potential role of self-testing, determining how test results should connect with professional medical care, and learning about relevant pathogens as well as sampling strategies. These insights were essential in grounding the project within real-world healthcare needs and ensuring that scientific design choices aligned with clinical realities.
Anticipation 1: The feasibility of self-sampling
Reflection: Successful at-home testing depends on whether individuals can reliably collect their own samples. Is self-sampling feasible and how does the accuracy of self-collected samples compare to clinician-collected ones?
Anticipation 2: Misunderstanding the consequences of test results by people with limited health knowledge
Reflection: Users may misinterpret positive or negative results, which could lead to unintended harm. Providing clear explanations, supporting materials, counseling options, and follow-up guidance is essential to help users make informed decisions. This also includes explicitly highlighting the possibility of false results, ensuring that (false) negative results do not encourage risky behavior.
Anticipation 3: Highly sensitive detection could lead to overdiagnosis and unnecessary treatment
Reflection: Detecting very low pathogen levels may not always indicate a clinically relevant infection. This risks unnecessary antibiotic use, which could contribute to antimicrobial resistance. Establishing clear clinical thresholds for meaningful detection would be critical if this is a problem.
Anticipation 4: Integration with professional medical care
Reflection: At-home diagnostics only create value if positive results are linked to follow-up care. Without clear referral pathways, individuals may be left without treatment or counseling, undermining both personal and public health outcomes.
Anticipation 5: The actual size and urgency of the need for at-home STI diagnostics may be uncertain
Reflection: While access to convenient testing appears valuable, the extent of unmet need is not always clear. Without evidence of demand or identification of target populations, it may be difficult to ensure that the test will be impactful and integrated into existing care structures.
Anticipation 6: The psychological impact of receiving a positive result at home
Reflection: Self-testing reduces barriers to diagnosis but may also isolate individuals at vulnerable moments. Without immediate access to counseling or medical advice, a positive result could cause distress or delay appropriate care-seeking.
To answer these questions, we reached out to various stakeholders. Click on the box to learn more about these engagements and how the insights gained were implemented into the project.
Specialist in Infectious Diseases, General Internal Medicine, and Pharmaceutical Medicine at Hirslanden Hospital
Senior Physician, Deputy Clinic Director, Department of Gynecology at the University Hospital Zurich (USZ)
Leading Physician at Checkpoint Zurich
Senior Assistant at the Department of Psychology, Applied Social and Health Psychology
From our medical consultations, we understood that certain pathogens, like Mycoplasma genitalium, are unsuitable for screening, while others, such as Syphilis, are essential despite requiring blood samples. Urine alone is insufficient for reliable detection, highlighting the need to include swab and, in some cases, blood-based sampling. Experts emphasized that self-tests can fill an existing gap in screening access but must include clear result interpretation, emotional support, and regulatory compliance.
We integrated these insights by refining our test panel to prioritize clinically relevant pathogens, focusing on Syphilis and HPV as key targets. Our sampling strategy expanded beyond urine to include swabs, improving diagnostic coverage. We consulted Swissmedic, the BAG, and Aids-Hilfe Schweiz to ensure alignment with regulations and existing initiatives. Following psychological guidance, we structured our communication materials using the HAPA and Common-Sense Models to build trust, reduce stigma, and promote routine testing behavior (see our Product Page, containing accessible instructions as well as pre- and post-test guidance). Together, these changes made our prototype more realistic, responsible, and user-centered.
The societal dimension of our Human Practices work focused on understanding how our at-home STI test could address unmet needs, values, and preferences of our potential end users. We explored how factors such as stigma, cultural attitudes, and accessibility barriers shape testing behavior and influence trust in self-diagnostics. This pillar focused on understanding what society expects from our test and how it could promote equitable access to sexual health resources. Through a stakeholder discussion, we also gained insights into how to communicate about sexual health appropriately and effectively, especially with teenagers – ensuring that our messaging is both informative and sensitive. These findings guided the development of a test that not only meets technical and clinical standards but also resonates with real users in their social contexts.
To make sure we are developing a product that puts the user’s needs in the middle
Sex Pedagogue from liebesexundsoweiter
A brief overview of what we learned in these engagements and how we implemented this into our project. Read the Interview and Survey page for the full picture.
The insights from these engagements were integrated across the project: user feedback informed our business planning and entrepreneurship strategy, refined epidemiological modeling based on demographic and testing behavior, improved product accessibility with video and audio instructions for diverse needs, and enhanced communication and usability through clearer guidance and illustrative visuals on the Product page.
The ethical dimension of this project goes beyond technical considerations, encompassing broader societal, social, and personal implications - ensuring our project is responsible and good for the world. Anticipating these challenges early allowed us to examine potential issues and design the project accordingly. The following section outlines key anticipations and concerns that guided later engagement and supported responsible project development.
Anticipation 1: Careful collection and handling of data
Reflection: Effective data management is essential to ensure that findings are transparent, reproducible, and trustworthy. At the same time, transparency can conflict with the need to protect sensitive personal information. Sharing detailed data or participant quotes may improve openness and scientific accountability, but it could also compromise privacy if participants have not given informed consent. This tension highlights a central ethical dilemma: how can transparency be maximized while fully safeguarding individual rights and confidentiality?
Anticipation 2: Ethical Human Practices
Reflection: Certain populations, such as sex workers or minors, may be directly affected by the project, but interacting with these groups raises ethical questions. Can we engage with them safely and respectfully? Should they be involved at all?
Anticipation 3: Public perception and ethical considerations of CRISPR in non-living systems
Reflection: Even when working with non-living systems, the use of CRISPR may prompt public concerns and ethical debate. What ethical considerations does this raise?
Anticipation 4: Shifting responsibility for sexual health onto individuals
Reflection: A self-administered test could be interpreted as placing the burden of sexual health solely on users—whether in terms of performing the test, interpreting results, managing follow-up care, or dealing with anxiety and potential costs—raising potential issues of fairness and stigma.
Anticipation 5: Exclusion of people with low literacy or disabilities
Reflection: Accessibility is a critical concern. The test and its instructions must be designed inclusively, using plain language, visual aids, or alternative formats to ensure that all potential users can participate safely and effectively.
To discuss these anticipations and reflections, we contacted Dr. Deplazes from the University of Zurich. Click on the card to learn more about this engagement and how the insights gained were implemented into the project.
Doctor of Ethics at the University of Zurich
We learned that self-tests can enhance autonomy and anonymity while aiding infection control, but they must be communicated responsibly and supported by easy follow-up to avoid false reassurance. Ethical and regulatory considerations are essential, especially around data handling and participant inclusion. Her input was integrated by embedding these principles into our design: we prioritized user autonomy (e.g. by providing clear and accessible instructions), clear result communication, and transparent information about CRISPR. We ensured follow-up options remain low-threshold and avoided collecting sensitive data or involving high-risk groups directly, aligning our project with responsible and ethical research practice.
The regulatory dimension of our Human Practices work centered on understanding the legal frameworks that govern the development and use of STI diagnostics in Switzerland. This involved clarifying how medical devices are classified and regulated, examining the roles of Swissmedic and the Federal Office of Public Health (BAG), and analyzing the restrictions placed on self-tests under the In Vitro Diagnostics Ordinance (IvDV) and the Epidemics Act (EpG). These insights were essential in grounding our project within the realities of national regulation and ensuring that our design choices aligned with the legal context in which our test could eventually be implemented.
Anticipation 1: Navigating the regulatory pathway for diagnostics
Reflection: Understanding the regulatory pathway for diagnostic devices is crucial We need to know which steps will be required, and whether there are hidden requirements that could slow development. Understanding this in advance is essential for planning resources and timelines effectively.
Anticipation 2: Differences in regulations between self-tests and point-of-care tests
Reflection:Are there legal restrictions that could prevent self-tests from being offered directly to users? This might affect our design choices, the intended use cases, and whether it will be possible to scale the product beyond clinical settings without running into compliance issues.
Anticipation 3: Local vs. International regulations
Reflection:Are regulations in Switzerland similar to those in other countries? We need to know which differences could affect classification, approval steps, or compliance, and whether differences in Swiss regulations compared to other countries could complicate expansion or compliance in other markets.
To answer these questions, we reached out to different national institutions. Click on the cards to learn more about these engagements and how the insights gained were implemented into the project.
Federal Office of Public Health
National authorisation and supervisory authority for drugs and medical products
We learned that current Swiss regulations prevent STI self-tests from being sold directly to the public, with HIV and SARS-CoV-2 tests as the only approved exceptions. While a potential revision of the Epidemics Act (EpG) could enable broader self-testing in the future, strong federal oversight will remain. The approval process for medical devices involves conformity assessments by notified bodies rather than direct Swissmedic approval, and additional legal requirements under the IvDV, MepV, and EpG restrict who can perform testing and how products are classified.
We integrated these insights by reframing our entrepreneurship strategy into a two-step pathway: initially developing a point-of-care Syphilis test for clinical settings, and planning to expand to direct-to-consumer self-testing once regulations allow.
The entrepreneurship dimension of our Human Practices work focused on exploring how our at-home STI test could evolve into a viable product and, ultimately, a company. We began by identifying unmet needs and analyzing potential customers, which provided the foundation for developing our solution through tools such as the Business Model Canvas, MVP design, SWOT mapping, and competition analysis. To understand the broader context, we examined market size and dynamics, situating our project within a rapidly growing self-testing industry. Building on this, we outlined a long-term vision that traced a path from our current prototype toward a scalable product and company development strategy, while assessing potential risks in the scientific, regulatory, and financial domains. Alongside external validation - through engagement with business experts and startup incubators - we also reflected on our own team’s strengths and gaps, recognizing where further expertise and support would be essential. Together, these activities grounded our project in the realities of entrepreneurship, ensuring that our scientific innovation was coupled with a credible strategy for real-world implementation and growth.
Learn more on our dedicated entrepreneurship page.
All of our official engagements, ordered chronologically and by dimension.
