Ethics and Security self-assessment form

This is a mandatory element of the application for a LEAD AI postdoctoral research fellow position – APPLICATIONS THAT DO NOT INCLUDE THIS WILL NOT BE CONSIDERED, and projects cannot start until all approvals are in place. 

Please fill in, delete instruction text and upload this attachment with the file name: surname_name_ethics.

The LEAD AI Fellowship Programme strictly adheres to the European Commission’s ethical standards laid out for Horizon Europe. All projects funded by LEAD AI must follow the EU and national/local ethics regulations of the Host organisations for both incoming and outgoing mobility. 

EU Horizons Europe has provided a detailed guide on how to complete the following ethics and security self-assessment. If your proposal raises any of the ethical concerns (i.e. you answer YES to any questions) in PART A, please include more details in PART B, including plans needed for obtaining required permissions or documentation, i.e. informed consent, etc. 

Be aware that some fields of research, especially within sensitive technology areas, might be regulated by Norwegian and international regulations regarding Control of the Export of Strategic Goods, Services and Technology. Candidates who by assessment of the application and attachment are seen to conflict with the criteria in these regulations might be prohibited from recruitment at UiB.

PART A – Ethics issue table 
Please answer all questions by placing “X” on either Yes or No

1. Human Embryonic stem cells and human embryos	Yes	No	
Does your activity involve Human Embryonic Stem Cells (hESCs)?			

If yes
	Does your activity involve Human Embryonic Stem Cells (hESCs)?			
	Are they	previously established cells lines? Are the cell lines registered in the European registry for human embryonic stem cell lines?			
Does your activity involve the use of human embryos?			
If yes	Will the activity lead to their destruction?			
Does your activity involve the use of other human embryonic or foetal tissues / cells?			
	
2. Humans	Yes	No	
Does your activity involve human participants? 			

If yes	Are they volunteers?			
	Are they healthy volunteers for medical studies? 			
	Are they patients for medical studies?			
	Are they potentially vulnerable individuals or groups?			
	Are they children/minors?			
	Are there other persons unable to give informed consent? 			
Does your activity involve interventions (physical also including imaging technology, behavioural treatments, tracking and tracing, etc.) on the study participants?			

If yes	Does it involve invasive techniques (e.g. collection of human cells or tissues, surgical or medical interventions, invasive studies on the brain, TMS etc.)?			
	Does it involve collection of biological samples?			
Does your activity involve conducting a clinical study as defined by the Clinical Trial Regulation 536/2014 (using pharmaceuticals, biologicals, radiopharmaceuticals, or advanced therapy medicinal products)?			
If yes	Is it a clinical trial?			
	Is it a low-intervention clinical trial?			
			
3. Human cells or tissues	Yes	No	
Does your activity involve the use of human cells or tissues (other than those covered by section 1)?			

If yes	Are they human embryonic or foetal cells or tissues?			
	Are they available commercially?			
	Are they obtained within this project?			
	Are they obtained from another project, laboratory or institution?			
	Are they obtained from a biobank?			
			
4. Personal data	Yes	No	
Does your activity involve processing of personal data?			

If yes	Does it involve the processing of special categories of personal data (e.g. sexual lifestyle, ethnicity, genetic, biometric and health data, political opinion, religious or philosophical beliefs)?			
	If yes - Does it involve processing of genetic, biometric or health data?			
	Does it involve profiling, systematic monitoring of individuals, or processing of large scale of special categories of data or intrusive methods of data processing (such as, surveillance, geolocation tracking etc.)?			
Does your activity involve further processing of previously collected personal data (including use of pre-existing data sets or sources, merging existing data sets)?			
Is it planned to export personal data (data transfer) from the EU to non-EU countries? Specify the type of personal data and countries involved			
Is it planned to import personal data (data transfer) from non-EU countries into the EU or from a non-EU country to another non-EU country? Specify the type of personal data and countries involved			
Does your activity involve the processing of personal data related to criminal convictions or offences?			
			
5. Animals	Yes	No	
Does your activity involve animals?			

If yes 	Are they vertebrates? 			
	Are they non-human primates (NHP) (e.g. monkeys, chimpanzees, gorillas, etc.)?			
	Are they genetically modified?			
	Are they cloned farm animals?			
	Are they an endangered species? 			
			
6. Non-EU countries	Yes	No	
Will some of the activities be carried out in non-EU countries? Specify the countries (Norway is a non-EU country. Please list any additional country). 			
In case non-EU countries are involved, do the activities undertaken in these countries raise potential ethics issues? Specify the countries			
Is it planned to use local resources (e.g. animal and/or human tissue samples, genetic material, live animals, human remains, materials of historical value, endangered fauna or flora samples, etc.)?			
Is it planned to import any material (other than data) from non-EU countries into the EU or from a non-EU country to another non-EU country?
For data imports, see section 4.
For imports of human cells or tissues, see section 3.
Specify the material and countries involved			
Is it planned to export any material (other than data) from the EU to non-EU countries? 
For data exports, see section 4.
Specify the material and countries involved			
Does your activity involve low and/or lower-middle income countries?
If yes, detail the benefit-sharing actions planned			
Could the situation in the country put the individuals taking part in the activity at risk? 			
			
7. Environment, health and safety	Yes	No	
Does this activity involve the use of substances or processes (or technologies) that may cause harm to the environment, to animals or plants (during the implementation of the activity or further to the use of the results, as a possible impact)?
For activities involving animal experiments, see section 5.			
Does this activity deal with endangered fauna and/or flora / protected areas?			
Does this activity involve the use of substances or processes (or technologies) that may cause harm to humans, including those performing the activity (during the implementation of the activity or further to the use of the results, or the deployment of the technology as a possible impact)?
For activities involving human participants, see section 2.			
			
8. Artificial intelligence		Yes	No	
Does this activity involve the development, deployment and/or use of Artificial Intelligence-based systems?			
Could the AI based system/technique potentially stigmatise or discriminate against people (e.g. based on sex, race, ethnic or social origin, age, genetic features, disability, sexual orientation, language, religion or belief, membership to a political group, or membership to a national minority)?			
Does the AI system/technique have the potential to lead to negative social (e.g. on democracy, media, labour market, freedoms, educational choices, mass surveillance) and/or environmental impacts either through intended applications or plausible alternative uses? 			
Does the AI to be developed/used in the project raise any other ethical issues not covered by the questions above (e.g., subliminal, covert or deceptive AI, AI that is used to stimulate addictive behaviours, life-like humanoid robots, etc.)? 			
			
9. Other ethics issues	Yes	No	
Are there any other ethics issues that should be taken into consideration?
Please specify			
			
10. Crosscutting issue: potential misuse of results 	Yes	No	
Could the materials/methods/technologies and knowledge involved or generated harm humans, animals or the environment if they were modified or enhanced?			
Could the materials/methods/technologies and knowledge involved or generated serve purposes other than those intended? If so, would such use be unethical?			

PART B - Addressing ethical issues 

Text box may be deleted before uploading
If your proposal raises any of the ethical concerns (i.e. you answer YES to any questions) in PART A, please include more details in PART B, including plans needed for obtaining required permissions or documentation, i.e. informed consent, etc. 
For further detailed guidance, see the document: How to complete your ethics self-assessment
For all ethical issues reported, please comment on the following:
1.	How the proposal meets the national legal and ethical requirements of the country or countries where the tasks in question are to be carried out.
2.	How you intend to address the issues raised in Part A (e.g. consent etc).
There is no page limit.   

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