| Screening potential ethical impacts and their severity - 'Threshold analysis' |
Screening ethical issues
Via this screen, you can access a decision tree for screening potential ethical issues related to the
manufacturing, transport or use of a product incorporating nanomaterials. This screening tool
should be used during the pre-assessment step of the Risk Governance process. You will be asked
to assess the extent to which your product incorporating nanomaterials gives rise to nine
categories of ethical issues. At this stage, you should just make your best estimate of the severity
of each issue. In addition, you should include a specification on each identified potential ethical
issue in the comment box.
Main question: To what extent will the nanomaterials and products give rise to the following issues?
No = not applicable, 1 = minor; 2 = moderate; 3 =medium; 4= high; 5=severe
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Are the nanomaterials and nanoproducts either used in a health-care context or are ethically sensitive impacts on public health and safety expected?
Ethical issues are minor when the health-related impacts are very unlikely, and/or the health of only few people is affected temporarily to a limited extent.
Ethical issues are severe when the health-related impacts are very likely, and/or a large group of people is affected strongly.
Healthcare is defined in a broad sense, including pharmaceuticals, medical devices, dentistry, cosmeceuticals and other products used in hospitals, at home, and in other locations for improving the health and well-being of people.
Ethically sensitive impacts on health are defined as infringements of human rights to life and well-being guaranteed in international human rights law, including the Universal Declaration on Human Rights, International Covenant on Economic, Social and Cultural Rights, Council of Europe Convention for the protection of human rights and fundamental freedoms, Council of Europe: Convention on human rights and biomedicine (Bioethics or Oviedo Convention, EU Charter of Fundamental Rights, UNESCO Declaration on the human genome and human rights and UNESCO Declaration on bioethics and human rights.
Does the application of nanomaterials involve the collection, processing, storing and/or transfer of personal data?
Ethical issues are minor when the data protection impacts are very unlikely, and/or the privacy of only few people is affected temporarily to a limited extent.
Ethical issues are severe when the data protection impacts are very likely, and/or fundamental human rights of a large group of people are affected strongly.
The privacy and data protection issues are caused by the product in which the nanomaterials are used. Examples include sensors and monitoring devices, data storage devices etc.
Consider whether sensitive personal data are collected relating to health, sexual lifestyle, ethnicity, political opinion, religious or philosophical conviction.
Could the value chain and application of nanomaterial have a negative impact on the rights and liberties of individuals and groups?
Ethical issues are minor when the impacts on human rights and liberties are very unlikely, and/or these rights are only affected briefly with no significant backlash to the persons affected.
Ethical issues are severe when the impacts on human rights and liberties are very likely, and/or the rights of individuals or groups are affected on a large scale or for a long time.
Consider effects on freedom, autonomy, authenticity, identity, privacy, human dignity, human bodily integrity, intellectual property, among others.
When in doubt, check international human rights law, including the Universal Declaration on Human Rights, International Covenant on Civil and Political Rights, Council of Europe Convention for the protection of human rights and fundamental freedoms, EU Charter of Fundamental Rights.
Could the value chain and application of nanomaterial have a negative impact in terms of social justice and equality?
Ethical issues are minor when the impacts on social justice and equality are very unlikely, and/or these rights are only affected briefly with no significant backlash to the communities affected.
Ethical issues are severe when the impacts on social justice and equality are very likely, and/or the social justice and equality are affected on a large scale or for a long time.
Consider effects on the distribution of opportunities, powers and capabilities, civil and political rights, economic resources, income, risks and hazards, and have special consideration for effects on vulnerable, disadvantaged, and under-represented individuals, groups, or communities in society, including future generations and individuals, groups and communities in low income and lower-middle income countries.
Could the value chain and application of nanomaterial have a negative impact on the well-being of individuals or groups, and/or on the common good, including cultural heritage?
Ethical issues are minor when the impacts on well-being and common good are very unlikely, and/or well-being and common good are only affected briefly with no significant backlash to the persons and groups affected.
Ethical issues are severe when the impacts on well-being and common good are very likely, and/or well-being and common good are affected on a large scale or for a long time.
Consider effects on the well-being and interests of individuals and groups in society, including the quality of work, and effects on social institutions and structures, democracy and important aspects of culture and cultural diversity. Cultural heritage includes physical artefacts and intangible attributes of a group or society, such as sites, monuments, artefacts, texts, archives, remains and information about the past.
When in doubt, consider using online Corporate Social Responsibility screening tools such as
https://www.mvorisicochecker.nl/en
Could the value chain and application of nanomaterial have a negative impact on the environment, animals and/or plants?
Ethical issues are minor when the environmental impacts are very unlikely, and/or the environment is only affected temporarily with no significant damage to the ecosystems, animals or plants
Ethical issues are severe when the environmental impacts are very likely, and/or the ecosystems, animals or plants are damaged on a large scale or for a long time.
Consider impacts due to the use of genetically modified organisms (GMOs) or any biological, chemical, radiological, nuclear or explosive elements used, as well as any effects in terms of human encroachment on natural habitats and environmental policy.
Could the value chain or application of nanomaterial limit the likelihood of achieving the 17 Sustainable Development Goals?
Ethical issues are minor when the impacts on the sustainable development goals are very unlikely, and/or these goals are only affected briefly with no significant delays in achieving the goals.
Ethical issues are severe when the impacts on the sustainable development goals are very likely, and/or their achievement is delayed on a large scale or for a long time.
Could the nanomaterial or its application have significant military purposes (dual use)?
Ethical issues are minor when military or dual use potential is very unlikely, and/or the expected concerns are insignificant.
Ethical issues are severe when the military or dual use potential is very likely, and/or the potential effects are strong or wide-ranging.
Could the nanomaterial or nano-enabled product become subject to misuse?
Ethical issues are minor when misuse potential is very unlikely, and/or the expected concerns are insignificant.
Ethical issues are severe when the misuse potential is very likely, and/or the potential effects are strong or wide-ranging.
Consider, amongst others, whether [information about] harmful biological, chemical, radiological, nuclear, or explosive materials, and/or the means of their delivery, can easily [or accidentally] be misused and whether it may easily fall into the hands of terrorists or criminals, and whether it may be abused by governmental and other institutional actors in non-military contexts.
When in doubt, check the guidance on misuse ethical issues used by the European Commission in ethics screening of H2020 funded projects:
http://ec.europa.eu/research/participants/data/ref/h2020/other/hi/guide_research-misuse_en.pdf
The output of the decision tree states the minimum requirements. A medium scale EIA may be performed if deemed appropriate
The output of the decision tree states the minimum requirements. A large-scale EIA may be performed if deemed appropriate
*The output of the decision tree states the minimum requirements. The users can decide to choose a higher EIA scale if they consider this appropriate
**This work project has received funding from European Union Horizon 2020 Programme (H2020) via RiskGONE project under grant agreement nÂș 814425