Lesotho is a small developing country contained within South Africa. You and your team of academic researchers (10 in all) are spending the next two weeks traveling to different communities throughout Lesotho to test water sources for disease-causing pathogens. The testing you need to do is simple but requires significant assistance from the community – showing your team all the different locations where individuals get their water from, and places/methods for storing the water. You do not see the need to pay the community members, considering if someone asked you about your water source, you would not mind driving them up to the lake! The ultimate goal of the project is to understand the lifecycle and characteristics of a specific pathogen, which is found only in this region of Lesotho. Several publications are expected from this research study. A comprehensive profile of this pathogen can help in many ways including the development of chemical additives to make the water safe to drink. 

Is it ethical to conduct this research study? What will you do next?

• Is there IRB approval? – maybe we don’t need it because the human factor is not involved directly
• Can there be grants or additional funding obtained to compensate participants so that they can also benefit from this study? 
• Is the benefit for community members outweighed by the health risks of chemical additives and a possible disease-causing pathogen being tested on community members?

Ethical Issue:

• Not compensating community members participating (not immediate assistance)
• Future chemical additives could lead to adverse effects on health and the environment if not thoroughly assessed, if formulated with profit as a main incentive human and environmental well-being is not prioritized 
• Intention: only publishing a paper does not help to solve the actual problem
• Is it ethical to obtain assistance from local communities without compensation, especially when the results could lead to academic and possibly financial gains?

Step 1: Determine the facts in the situation – obtain all of the unbiased facts possible. Clearly state the ethical issue. 

• There is a pathogen only found in this region of Lesotho.
• The testing requires help from the community.
• A profile of the pathogen could result in the development of chemical additives to make the water safe to drink.
• Results can lead to several publications.
• The lifecycle and characteristics of a specific pathogen will be determined through this study.
• There is no running water in this community.

Step 2: Define the Stakeholders – those with a vested interest in the outcome 

• Community members of Lesotho 
• Chemical company that would produce the additive
• Researchers publishing papers
• Whoever funded the research
• Local research/education institute
• Local partner

Step 3: Assess the motivations of the Stakeholders 

• Community members of Lesotho  
  • Safe drinking water and good health
  • Financial assistance (a village without running water in a small developing country)
• Researchers publishing papers 
  • Gathering data, publishing findings, and professional development
• Whoever funded the research- 
  • if research is funded by the chemical company, they could pressure the researchers to produce certain results about the pathogen that encourage the production of chemical additive
  • If research is funded by a university, the motivation is publications
  • If research is funded by the UN, World Bank, etc., motivation could be development in Lesotho
• Chemical company – potential future profit from potential development of additives 

Step 4: Formulate (at least three) alternative solutions – based on the information available, using basic ethical core values as a guide 

Approaches [1/2/3: repeat for every action] 

• Current approach: Conduct the research and do not compensate the community members
• Ethical Principle or code: Duty-based thinking
• Pros: cheaper, save costs and resources
• Cons: uses community members without compensating their time

• Potential solution: Conduct the research and also compensate the community members – a way to pay or credit them
  • Paying – crediting – building this name for the community
• Ethical Principle or code: Care-based thinking
• Pros: Benefits both the community and researchers (Belmont Report)
• Cons: Need to find a source of funding 

• Potential solution: The study suggests a thorough assessment of future chemical additives 
• Ethical Principle or code: Care-based thinking
• Pros: Putting the health of community members first and shifting the research interest to having a positive solution to water-borne diseases 
• Cons: More funding and research required to obtain a comprehensive understanding of chemical additives and pathogens
  • How to make drinking water safe for humans in the local community and protect the environment at the same time 

Step 5: Seek additional assistance, as appropriate – engineering codes of ethics, previous cases, peers, reliance on personal experience, inner reflection 

• Belmont Report: Respect for persons + Beneficience + Justice
  • Justice: Distributing benefits/risks fairly
  • So we should find a way to somehow compensate for the community 
• Is there IRB approval?
  • Is this hit-and-run research? 
  • Is this human-based research or does it not involve human subjects? 

Step 6: Select the best course of action – that which satisfies the highest core ethical values. Explain reasoning and justify. Discuss your stance vis-a-vis other approaches discussed in the class. 

We see that finding a way to compensate the community in any way and taking a step to further encourage future steps to solve the problem are the best courses of action that satisfy the highest core ethical values.

We chose the following courses of action to value the local community members and what is best for their environment and health rather than the profit or status that can come from completing this research study.

• Compensate the community members at a reasonable rate, ask for funding for a small increase
• Credit community members in paper

To contribute further to the community and its environment, we chose the following steps which we believe are achievable within our authority and resources:

• Adding “Future research” & “implications” section in the paper with suggestions
• Identify organizations to do the future research and next steps
• The paper, suggests a thorough assessment of future chemical additives and their effects on health and the environment.

Step 7: (If applicable) What are the implications of your solution on the venture? Explain the impact of your proposed solution on the venture’s technology, economic, social, and environmental aspects. 

• Technology:
  • Potential for new devices & technology to be used in this community so that proper testing of the water/pathogen and chemical additives can be completed; space for implementation of new products 
• Economy: 
  • Compensation or collaboration can mean more costs
  • Awareness of pathogens could bring aid to the community
  • Potential future employment for local community members to assist with research or future testing of pathogen/water 
• Social:
  • Community members feel valued in this research and more open to collaboration
  • Positive impact on the community’s perception of researchers and research in general. Strengthened community-researcher bonds.
  • Make the community aware of the different microorganisms available in water that are harmful to health
• Environmental: 
  • Learning the lifecycle of this certain pathogen might encourage further development of methods/practices to clean the water and prevent related health issues

Introductory Case Study

While trying to develop a low-cost syringe for the developing world context, you (the designer) hit a crossroads. Constructing the syringe to auto-disable after a single use, an important safety feature, significantly adds to the cost of the design – making it potentially unaffordable for some hospitals and clinics. However, if you don’t add the safety feature, you are enabling the potential for the spread of disease. How do you as a designer proceed?

• Step 1: Determine the facts in the situation
  • • The auto-injection feature is an important safety feature
      • Adds cost to the design
      • Product can’t be used for intended community with high cost
    • Without the safety feature of the needle, it could increase the spread of disease
    • Balance question to consider: Is the spread of disease more augmented by decreased cost by not including the feature for more financial access or including it to reduce the risk of spreading?
    • The product must be manufactured properly so the auto-injector always works and it reduces or eliminates the risk of death
• Step 2: Define the Stakeholders
  • • Primary: hospitals & clinics, patients, regulatory body,  manufacturers
    • Secondary: Distributors,  insurance company
• Step 3: Assess the motivations of the Stakeholders
  • • Hospitals & Clinics: patient safety, drug administration time, easy disposal
    • Patients: easy to use, low cost, and accessible
    • Regulatory Body: No violations in safety or ethics
    • Manufacturers: to make a profit, innovation, company reputation
    • Distributors: to make a profit
    • Insurance Companies: to make a profit
• Step 4: Formulate (at least three) alternative solutions
• • • Assess if oral administration is a viable option
      • Ethical principal
        • Nonmaleficence
      • Pros:
        • Easily administrable
      • Cons:
        • Not really solving the problem of needle
    • Have both auto-disable and not disabled
      • Ethical principal
        • Autonomy, beneficence
      • Pros:
        •  Having both options available for the consumer to use
      • Cons:
        • May be difficult to use for the consumer
    • Create a reusable device with replaceable syringes and needles
      • Ethical principal
        • Autonomy
      • Pros:
        •  Environmentally friendly
      • Cons:
        • This can be an issue in terms of disease
        • Difficult to enhance clean protocol by replacing the needles each time

• Step 5: Seek additional assistance, as appropriate
  • Organizations that can contacted; Formulate a proposition that includes the organization(s)’ mission and ties it to more effective health care and/or preventing the spread of disease
  • Seeking grants from different foundations, NGOs, and INGOs.
  • Seeking governmental help
  • Seeking advice or literature from similar ventures in similar settings
• Step 6: Select the best course of action
  • Find the cheapest, safest, and most durable materials to construct a prototype
  • Create a new design for the auto-injector to replace the auto-disable and the medicine inside
    • Adjust size, shape, and needle disposal technique
  • First, auto-disabled needles come with UV light to sterilize the needle
  • Priority is finding funding to make the auto-retracting syringes financially accessible
• Step 7: (If applicable) What are the implications of your solution on the venture
  • If orally taken, might not be a one-time pill. Instead, taking it for a series of days could be a solution. That would cause a non-adherence to taking the pills on time. Can also cause problems with the stomach and digestion
  • Investors/funders could have mandatory manufacturers or designers to go through as requirements for partnership/sponsorship