MODULO H

MODULO H

BANDO PUBBLICO PER LA SELEZIONE DI PROPOSTE PROGETTUALI, FINALIZZATE ALLA CONCESSIONE DI FINANZIAMENTI PER ATTIVITA’ COERENTI CON IL PROGRAMMA A VALERE SULLE RISORSE DEL PIANO NAZIONALE RIPRESA E RESILIENZA (PNRR) MISSIONE 4, “ISTRUZIONE E RICERCA” - COMPONENTE 2, “DALLA RICERCA ALL’IMPRESA” - LINEA DI INVESTIMENTO 1.4, FINANZIATO DALL’UNIONE EUROPEA – NEXTGENERATIONEU”, PROGETTO “ICSC” Spoke 8 “In Silico Medicine & Omics Data”, CN00000013, CUP J33C22001180001

RISPETTO DEI PRINCIPI ETICI

Ethics issues table

Please go through the table and indicate which elements concern your proposal by answering ‘Yes’ or ‘No’. If you answer ‘Yes’ to any of the questions,

• indicate in the adjacent box at which page in your full proposal further information relating to that ethics issue can be found, and

• provide additional information on that ethics issue in the Ethics Self-Assessment section.

For more information on each of the ethics issues and how to address them, including detailed legal references, see the guidelines ‘How to Complete your Ethics Self-Assessment’ and further documents. In regard to personal data, please carefully consider the Provisional Guidelines for the Protection of Personal Data for the National Centre for HPC, Big Data and Quantum Computing.

1. HUMAN EMBRYONIC STEM CELLS AND HUMAN EMBRYOS									Page
Does this activity involve Human Embryonic Stem Cells (hESCs)?				Yes	No
If YES:	Will they be directly derived from embryos within this project?			Yes	No
	Are they previously established cells lines?			Yes	No
	Are the cell lines registered in the European registry for human embryonic stem cell lines?			Yes	No
Does this activity involve the use of human embryos?				Yes	No
If YES:	Will the activity lead to their destruction?			Yes	No
2. HUMANS									Page
Does this activity involve human participants?				Yes			No
If YES:	Are they volunteers for non medical studies (e.g. social or human sciences research)?			Yes			No
	Are they healthy volunteers for medical studies?			Yes			No
	Are they patients for medical studies?			Yes			No
	Are they potentially vulnerable individuals or groups?			Yes			No
	Are they children/minors?			Yes			No
	Are there other persons unable to give informed consent?			Yes			No
Does this activity involve interventions (physical also including imaging technology, behavioural treatments, etc.) on the study participants?				Yes			No
If YES:		Does it involve invasive techniques?		Yes			No
		Does it involve collection of biological samples?		Yes			No
Does this activity involve conducting a clinical study as defined by the Clinical Trial Regulation (EU 536/2014)? (using pharmaceuticals, biologicals, radiopharmaceuticals, or advanced therapy medicinal products)				Yes			No
If YES:		Is it a clinical trial?		Yes			No
		Is it a low-intervention clinical trial?		Yes			No
3. HUMAN CELLS / TISSUES (not covered by section 1)									Page
Does this activity involve the use of human cells or tissues?				Yes			No
If YES:	Are they human embryonic or foetal cells or tissues?			Yes			No
	Are they available commercially?			Yes			No
	Are they obtained within this project?			Yes			No
	Are they obtained from another project, laboratory or institution?			Yes			No
	Are they obtained from biobank?			Yes			No
4. PERSONAL DATA									Page
Does this activity involve processing of personal data?				Yes		No
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)?		Yes		No
		If YES:	Does it involve processing of genetic, biometric or health data?	Yes		No
		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.)?		Yes		No
Does this activity involve further processing of previously collected personal data (including use of pre-existing data sets or sources, merging existing data sets)?				Yes				No
Is it planned to export personal data from the EU to non-EU countries?				Yes				No
If YES:		Specify the type of personal data and countries involved:
Is it planned to import personal data from non-EU countries into the EU or from a non-EU country to another non-EU country?				Yes				No
If YES:		Specify the type of personal data and countries involved
Does this activity involve the processing of personal data related to criminal convictions or offences?				Yes				No
5. ANIMALS									Page
Does this activity involve animals?				Yes			No
If YES:		Are they vertebrates?		Yes			No
		Are they non-human primates (NHP)?		Yes			No
		Are they genetically modified?		Yes			No
		Are they cloned farm animals?		Yes			No
		Are they endangered species?		Yes			No
6. NON-EU COUNTRIES									Page
Will some of the activities be carried out in non-EU countries?				Yes			No
If YES:		Specify the countries:
In case non-EU countries are involved, do the activities undertaken in these countries raise potential ethics issues?				Yes			No
If YES:		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.)?				Yes			No
Is it planned to import any material from non-EU countries into the EU or from a non-EU country to another non-EU country? For data imports, see section 4.				Yes			No
If YES:		Specify material and countries involved:
Is it planned to export any material from the EU to non-EU countries?				Yes			No
If YES:		Specify material and countries involved:
Does this activity involve low and/or lower-middle income countries? (if yes, detail the benefit-sharing actions planned in the self-assessment)				Yes			No
Could the situation in the country put the individuals taking part in the activity at risk?				Yes			No
7. ENVIRONMENT, HEALTH and SAFETY									Page
Does this activity involve the use of substances or processes 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)?				Yes			No
Does this activity deal with endangered fauna and/or flora / protected areas?				Yes			No
Does this activity involve the use of substances or processes that may cause harm to humans, including those performing them (during the implementation of the activity or further to the use of the results, as a possible impact)?				Yes			No
8. ARTIFICIAL INTELLIGENCE									Page
Does this activity involve the development, deployment and/or use of Artificial Intelligence? (if yes, detail in the self-assessment whether that could raise ethical concerns related to human rights and values and detail how this will be addressed).				Yes			No
9. OTHER ETHICS ISSUES									Page
Are there any other ethics issues that should be taken into consideration?				Yes			No
Please specify: (Maximum number of characters allowed: 1000)

I confirm that I have taken into account all ethics issues above and that, if any ethics issues apply, I will complete the ethics self-assessment form as described in the guidelines. 

ETHICS SELF-ASSESSMENT

If you have entered any issues in the ethics issue table, you must perform an ethics self-assessment in accordance with the guidelines "How to Complete your Ethics Self-Assessment" and complete the table below.

Ethical dimension of the objectives, methodology and likely impact

Explain in detail the identified issues in relation to:

• objectives of the activities (e.g. study of vulnerable populations, etc.)

• methodology (e.g. clinical trials, involvement of children, protection of personal data, etc.)

• the potential impact of the activities (e.g. environmental damage, stigmatisation of particular social groups, political or financial adverse consequences, misuse, etc.)

Compliance with ethical principles and relevant legislations

Describe how the issue(s) identified in the ethics issues table above will be addressed in order to adhere to the ethical principles and what will be done to ensure that the activities are compliant with the EU/national legal and ethical requirements of the country or countries where the tasks are to be carried out. It is reminded that for activities performed in a non-EU countries, they should also be allowed in at least one EU Member State.

Security issues table

Please indicate, by answering Yes or No to all of the questions in the below table, if the proposed activity will use and/or generate information which might raise security concerns. If an answer is Yes, then indicate in the adjacent box at which page in your full proposal further information relating to that issue can be found.

1. EU classified information (EUCI)1						Page
Does this activity involve information and/or materials requiring protection against unauthorised disclosure (EUCI)?			Yes	No
If YES:	Is the activity going to use classified information as background2 information?		Yes	No
	Is the activity going to generate EU classified foreground3 information as results?		Yes	No
Does this activity involve non-EU countries?			Yes	No
If YES:	Do participants from non-EU countries need to have access to EUCI?		Yes	No
	Do the non-EU countries concerned have a security of information agreement with the EU?		Yes	No
2. MISUSE						Page
Does this activity have the potential for misuse of results?			Yes		No
If YES:		Does the activity provide knowledge, materials and technologies that could be channelled into crime and/or terrorism?	Yes		No
		Could the activity result in the development of chemical, biological, radiological or nuclear (CBRN) weapons and the means for their delivery?	Yes		No
3. OTHER SECURITY ISSUES						Page
Does this activity involve information and/or materials subject to national security restrictions?			Yes		No
If yes, please specify: (Maximum number of characters allowed: 1000)
Are there any other security issues that should be taken into consideration?			Yes		No
If yes, please specify: (Maximum number of characters allowed: 1000)

Firma digitale⁴ del legale rappresentante/procuratore⁵

1 According to the Commission Decision (EU, Euratom) 2015/444 of 13 March 2015 on the security rules for protecting EU classified information, “European Union classified information (EUCI) means any information or material designated by an EU security classification, the unauthorised disclosure of which could cause varying degrees of prejudice to the interests of the European Union or of one or more of the Member States”.

2 Classified background information is information that is already classified by a country and/or international organisation and/or the EU and is going to be used by the project. In this case, the project must have in advance the authorisation from the originator of the classified information, which is the entity (EU institution, EU Member State, third state or international organisation) under whose authority the classified information has been generated.

3 EU classified foreground information is information (documents/deliverables/materials) planned to be generated by the project and that needs to be protected from unauthorised disclosure. The originator of the EUCI generated by the project is the European Commission.

4 Per i soggetti italiani o stranieri residenti in Italia, la dichiarazione deve essere sottoscritta da un legale rappresentante ovvero da un procuratore³ del legale rappresentante, apponendo la firma digitale. Per gli operatori economici stranieri non residenti in Italia, la dichiarazione può essere sottoscritta dai medesimi soggetti apponendo la firma autografa ed allegando copia di un documento di identità del firmatario in corso di validità.

5 Nel caso in cui la dichiarazione sia firmata da un procuratore del legale rappresentante deve essere allegata copia conforme all’originale della procura oppure nel solo caso in cui dalla visura camerale dell’operatore economico risulti l’indicazione espressa dei poteri rappresentativi conferiti con la procura, la dichiarazione sostitutiva resa dal procuratore/legale rappresentante sottoscrittore attestante la sussistenza dei poteri rappresentativi risultanti dalla visura.

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