Dr. Anna Deplazes

Discussion

Ethical Opportunities

Dr. Deplazes emphasized that self-tests can strengthen user autonomy: individuals decide if, when, and how to test without requiring a physician’s approval. She highlighted the value of anonymity, especially in rural settings where a local doctor may know the patient’s family and community. Utilitarians, she suggested, might even argue that the state should make self-testing mandatory, since it reduces the spread of infections and thus promotes overall well-being.

Risks and responsibilities

She warned that significant risks arise if economic interests take precedence over patient needs, or if self-tests replace rather than complement established clinical diagnostics. This could shift responsibility away from healthcare providers towards the patients and potentially reduce investment in traditional testing. She also emphasized the danger of false reassurance: a false negative could be more harmful than no test at all. To be ethically acceptable, the test must be reliable, easy to use, and validated in real-world conditions. Positive results should always be followed up with professional care, ideally through low-threshold options such as telemedicine or anonymous referrals.

Communication and understanding

Dr. Deplazes emphasized that clear communication is essential. She explained that users do not need to understand biochemical details, but they must be able to interpret the meaning of a result correctly. She cautioned that misunderstandings could lead to misuse, for example assuming a negative result equals no risk or using the test as an alternative to safer sex practices. She suggested that interpreting unclear results more cautiously, such as labeling them as “uncertain” rather than “negative,” could reduce this risk. She argued that embedding the test into existing healthcare processes and providing support structures would be more responsible than introducing it in isolation.

Research ethics

She highlighted that engaging directly with affected populations is highly sensitive. She explained that while surveys addressing general wishes and needs are acceptable, collecting personal health data requires approval from the ethics committee (KEK). She stressed that questions should only be asked if they are strictly necessary, and that language must be chosen carefully to avoid stigma or confusion. She also cautioned that research involving high-risk or marginalized groups, such as sex workers, carries additional ethical risks due to stigma and potential psychological burden. Importantly, she advised us not to engage with individuals under 18 in our survey or more generally, noting that parental consent and stricter regulations make such participation complex. For now, she recommended consulting with experts who understand the populations’ circumstances without being directly affected.

Synthetic biology and CRISPR

Dr. Deplazes Zemp clarified that our cell-free diagnostic system, as a medical tool in itself, is not particularly ethically problematic, since no living organisms are involved, there is no risk of spreading genetic modifications. However, she highlighted that public communication matters. She hypothesized that prominently advertising “CRISPR” may cause unwarranted fears, since many associate it with genetic modification in living systems. She recommended not omitting the term entirely, but instead providing clear explanations in the package insert - for example noting that no living organisms are present.

Main Takeaways

• Opportunities: Self-tests promote autonomy and anonymity; they can help contain infections.
• Risks: False negatives are dangerous, and the test must not replace clinical diagnostics. Follow-up should be easy and low-threshold.
• Communication: Users must understand the meaning of results; labeling unclear results could prevent false reassurance.
• Research ethics: Collecting health data requires ethical approval; consult experts rather than high-risk populations and design questions to avoid stigma.
• Synthetic biology: The test as a medical device does not pose any particular risks, but must be handled responsibly.

Integration

Her valuable input was integrated to ensure our project aligns with ethical standards, regulatory requirements, and responsible scientific practices, and that testing is ethically conducted with appropriate follow-up support for patients. We implemented this by:

• Emphasizing user autonomy and anonymity in the design.
• Planning low-threshold follow-up options, including telemedicine or anonymous referrals.
• Creating clear instructions to explain result meaning without requiring biochemical knowledge.
• Considering “uncertain” labels for negative results to avoid false reassurance.
• Providing transparent explanations about CRISPR in the accompanying materials while avoiding overly prominent labeling.
• Designing our survey in a way that no health data is asked and the questions are asked responsibly, not accidentally inducing stigma.
• We decided to include only the general public directly in our research, excluding certain risk groups, patients, and minors. These groups will instead be represented indirectly through relevant stakeholders to avoid causing unnecessary anxiety or distress.

Overall, she helped us design our project responsibly, guiding us from the experimental setup to interview and survey regulations, and finally to the development of the test.