Ethical Legal Social Issues
Addressing Them One At a Time
We ask ourselves the following questions that pertain to ethical, legal and social issues, below:
Where |
Who |
Concerns |
| University & Businesses | Other scientists/researchers | Is it legal to trademark specific DNA sequences even if they can be found in nature? |
Concerns
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| The Canadian government grants patents on genetic material (DNA, RNA and genes), whether of plant, animal or human origin, as well as on single-celled organisms such as bacteria, some fungi and algae, cell lines and hybridomas[1]. By definition, a patent with the same sequences could also affect the development of similar DNA technologies such as our own. | ||
Potential responses from non-researchers |
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Is the trademarking of DNA sequences by individuals or companies legal and ethical as technically these sequences can be found in nature? Will this trademark affect the development of other similar and dissimilar technologies? The trademark would be on the sequences on the whole and the method to produce them. Furthermore, in terms of the patent for our project, the patent would be on the structure and unique geometry the structure brings as well as the locking mechanism used. Individual sequences do not affect the development of other technologies such as ours, as they would need to be patented on a by-use basis. “By-use basis” asks the purpose of the technology in question. If the use of the technology is the same as the one made by a different company, then it violates the patent and protection made by the original company. |
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Other Applications |
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| Sequences may code for viruses proteins which can be used as biological weapons but are unlikely as DNA strands are really short. | ||
References
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| [1] Biotechnology Ministerial Coordinating Committee (Canada), & Canadian Biotechnology Advisory Committee. (2002). Patenting of higher life forms and related issues : Report. The Adivosry Committee. | ||
Where |
Who |
Concerns |
| Hospitals, Clinics & Homes | Doctors & Patients | False positive or false negative results & Can results change over time? |
Concerns |
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False positive, a positive result that comes from something else binding to the antibodies, or false negative, from the antibodies binding to their specific substrate, does not bind or the antibodies unbinding, can lead to doctors prescribing incorrect diagnoses which could impact the lives of patients using the solution such as increased disease progression, wrong prescription for the diagnosis and emotional strain on friends and family. Patients and doctors may never even know that the result was false which could have long-term effects, for example, worsening conditions and the unknown reason why which could cause stress on the individual and others. |
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Potential responses from non-researchers |
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What regulations are there to maintain a standard of code for medical devices using this solution compared to other more regulated devices? How do we know that using/exposure to the product doesn’t cause any health problems? ie. Allergic responses from where antibodies are produced? rabbits/chickens Extensive warning on what antibodies are there in the kit and reagents will be listed but none of the reagents should be all reletively safe to use. There is no direct contact with the device so using the device should not be an issue. |
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Other Applications |
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References
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Where |
Who |
Concerns |
| Hospitals that lack proper equipment to assemble and utilize the solution(eg. Thermocycler) | Doctors & Patients |
How do people without easy access to advanced equipment utilize the solution?
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Concerns |
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| Not all hospitals, clinics, or homes have access to the equipment needed to build/utilize our solution. | ||
Potential responses from non-researchers |
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| Are there any ways to have prebuilt hinges attached with antibodies on the plate already? How will this affect cost so it is still accessible? | ||
Other Applications |
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References
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Where |
Who |
Concerns |
| Hospitals & homes & clinics | Doctors & Patients | What is the environmental impact ie. waste of the solution? |
Concerns |
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| What is the proper disposal of this device? How much plastic is being used for this product? | ||
Potential responses from non-researchers |
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How to properly dispose of the solution so it does not affect the environmental health and population’s health? DNA and antibodies are considered biological waste but are not considered dangerous as they occur naturally in the environment. There is a possibility that bacteria will absorb the DNA strands and incorporate them into their sequence but this can happen naturally with any DNA in the environment(eg. Dead bacteria). What is the production of the product and can it be produced anywhere/locally to save on transportation emissions and plastic waste? That is a possibility to further reduce waste and emissions from transportation but it depends on the expansion and demand of production. |
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Other Applications |
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References
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Where |
Who |
Concerns |
| Anywhere | Patients | Data security during testing |
Concerns |
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How is the private information of patients that were involved in testing kept safe and confident? Rebuttal: We would pick the testing center that has the best privacy policy but this would be the responsibility of the testing center itself to maintain and uphold. |
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Potential responses from non-researchers |
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| Who are being tested? Is a diverse sample being used of different ages, conditions, gender and background etc. | ||
Other Applications |
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References
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Where |
Who |
Concerns |
| Everywhere | Patients | Preventing diagnostics misuse |
Concerns |
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How can the solution be responsible for preventing diagnostics misuse? We would follow the “Bioethical principles of transparency” which are respect for autonomy, nonmaleficence, beneficence, and justice[1]. We would make an ethical care plan as we have an ethical obligation to benefit the patient first, to prevent harm or minimize it, and to respect the values and preferences[2]. |
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Potential responses from non-researchers |
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How would this ethical care plan be ensured and regulated? We would have a committee in place and consult with a verified impartial third-party organization to ensure that the committee is working towards the goal of creating and maintaining the ethical care plan. |
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Other Applications |
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References
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[1] Varkey B: Principles of Clinical Ethics and Their Application to Practice. Med Princ Pract 2021;30:17-28. doi: 10.1159/000509119 [2] McCormick, T. R. (n.d.). Principles of bioethics. Principles of Bioethics | UW Department of Bioethics & Humanities. Retrieved September 9, 2022, from https://depts.washington.edu/bhdept/ethics-medicine/bioethics-topics/articles/principles-bioethics |
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