Week 1 HW: Principles and Practices

cover image cover image 1) First, describe a biological engineering application or tool you want to develop and why. This could be inspired by an idea for your HTGAA class project and/or something for which you are already doing in your research, or something you are just curious about.

Inspired by the MELiSSA project (Micro-Ecological Life Support System Alternative) from ESA, this project proposes an ecosystem composed of microorganisms and higher plants using their metabolic waste products as a substrate for the next compartment. This project is designed to study the behavior of artificial ecosystems and to develop the technologies required for future regenerative life-support systems in long-duration human space missions, such as lunar bases or missions to Mars. The system comprises five different compartments, each one colonized respectively by anoxygenic thermophilic bacteria, photoheterotrophic bacteria, nitrifying bacteria, photosynthetic bacteria, higher plants, and the human crew. I would like to conceptually integrate these microorganisms and higher plants with a plasmids-based control system, through the use of reporter genes and inducible regulatory elements. This would increase the security (allowing real-time monitoring of metabolics states, for example) and predictability of the system.

  1. Next, describe one or more governance/policy goals related to ensuring that this application or tool contributes to an “ethical” future, like ensuring non-malfeasance (preventing harm). Break big goals down into two or more specific sub-goals. A) Safety The goal is to guarantee that biotechnological systems used in closed life-support environments do not cause biological, ecological, or health-related harm. Sub-goals: -Biological control: Establish that all microorganisms used in the system are strictly contained within closed bioreactors, with multiple physical and genetic safeguards to prevent unintended survival outside the system. -Genetic stability and monitoring: Ensure continuous monitoring protocols to detect mutations, horizontal gene transfer, or loss of function in engineered plasmids and microbial strains over long mission durations. -Human health protection: Assess and regulate potential risks to astronaut health, including allergenicity, toxin production, or unintended interactions with the human microbiome in confined environments. B) Promote responsible and transparent use of synthetic biology Goal: Ensure that the development of biotechnological life-support systems are governed transparently and responsibly. Sub-goals: -Ethical oversight and review: Require interdisciplinary ethical review (including biologists, engineers, ethicists, and policymakers) before implementing genetically modified organisms in space missions. -Clear responsibility and accountability: Define who is responsible for the design, maintenance, and emergency response related to biotechnological failures during long-term missions. -Open scientific communication: Promote the publication and sharing of safety data, failures, and best practices to avoid repetition of risks and to foster responsible innovation in space biotechnology.

  2. Next, describe at least three different potential governance “actions” by considering the four aspects below (Purpose, Design, Assumptions, Risks of Failure & “Success”). Action: Ethical and biosafety protocols

Actors: Academic institutions & research ethics committees

Purpose: This action proposes to develop a standardized requirement for ethical and biosafety review (chosen by researchers, universities and space agencies) before deploying or publishing biotechnological applications.

Design: Universities and research institutions must require approval from ethics and biosafety committees. Funding agencies could condition grants on compliance. Researchers must submit risk assessments and mitigation plans.

Assumptions: Assumes ethics committees have sufficient expertise and resources. Assumes researchers will comply honestly. Training and standardization significantly reduce human error.

Risks of Failure & “Success”: Failure: Bureaucratic delays could slow innovation. Success risk: Over-standardization may discourage exploratory or low-risk research.

Action: Incentives for safety-by-design practices

Actors: Biotech companies & funding bodies

Purpose: Currently, safety features are often added after development. This action encourages integrating safety mechanisms from the design stage.

Design: Grant programs, tax benefits, or certifications for companies that implement safety-by-design standards. Requires collaboration between engineers, biologists, and policymakers.

Assumptions: Assumes financial incentives are strong enough to change behavior. Assumes safety-by-design standards can be clearly defined across technologies.

Risks of Failure & “Success”: Failure: Incentives may be insufficient. Success risk: Companies may focus on “checking boxes” rather than meaningful safety improvements.

Action: Controlled access and monitoring of biotechnological tools

Actors: Federal regulators & law enforcement

Purpose: At present, access to certain tools or data may be insufficiently monitored. This action proposes tiered access controls to prevent misuse while allowing legitimate research.

Design: Regulators define categories of risk. Developers implement user verification, logging, and auditing systems. Law enforcement intervenes only in cases of credible misuse.

Assumptions: Assumes misuse can be detected through monitoring. Assumes access controls do not excessively burden legitimate users.

Risks of Failure & “Success”: Failure: Overly strict controls may push users toward unregulated alternatives. Success risk: Normalization of surveillance could raise privacy and academic freedom concerns.

  1. Next, score (from 1-3 with, 1 as the best, or n/a) each of your governance actions against your rubric of policy goals. The following is one framework but feel free to make your own:
Does the option:Option 1Option 2Option 3
Enhance Biosecurity
• By preventing incidents211
• By helping respond211
Foster Lab Safety
• By preventing incident111
• By helping respond111
Protect the environment
• By preventing incidents222
• By helping respond331
Other considerations
• Minimizing costs and burdens to stakeholders122
• Feasibility?122
• Not impede research111
• Promote constructive applications111
  1. Last, drawing upon this scoring, describe which governance option, or combination of options, you would prioritize, and why. Outline any trade-offs you considered as well as assumptions and uncertainties. The most important governance option for me would be a combination of the three, emphasizing “Safety-by-design” and “Ethical and biosafety protocols” supported by “Controlled access and monitoring” as a complementary safeguard. For complex projects such as MELiSSA, it is not enough to have only one governance idea, we need some of them in order to control each step properly during the project. Safety-by-design is important because it encourages the integration of biosafety from the beginning, for example through the use of plasmids-based mechanisms as a way to control the metabolic pathways in each step. Ethical and biosafety protocols are more than just formalities; they are tools that ensure shared responsibility and protect scientific integrity through risk prevention and accountability mechanisms.

Prioritizing these governance actions required balancing competing interests. While ‘safety-by-design’ might delay early research and increase budgets, these trade-offs are necessary given the high stakes of life-support failures in space. This strategy relies on the assumption that institutional incentives work and that standards remain consistent across platforms. Despite lingering uncertainties about how space environments affect genetic stability, merging technical guardrails with institutional oversight creates a more resilient framework than relying on a single approach.

Target Audience: This proposal targets international bodies like NASA and ESA, which have the strategic power to align regulations and funding for space biotech. Ethical Reflection: A core concern is accountability within semi-autonomous systems. In setups like MELiSSA, failures might stem from unpredictable biological behaviors rather than human oversight, blurring the lines of responsibility. Furthermore, we must prevent the ‘silent’ transfer of extreme bio-engineering to Earth without public oversight. Proposed Actions: We need explicit accountability frameworks, scenario-based ethical reviews for off-Earth missions, and transparent protocols for knowledge sharing. These steps ensure that space biotech evolves safely and ethically."

Note: This assignment was developed with the assistance of an AI language model (ChatGPT, Gemini), used to help structure ideas and refine wording. The concepts and final decisions were critically reviewed and adapted by the author.