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Questionnaire 18-19 years

The NINFEA project in which you are participating plans to follow the people who are part of the cohort over time to detect their health status at different times in their lives. To detect their health status, we plan to use information from current statistics databases and some targeted questionnaires on specific conditions.

We therefore invite you to fill in the Questionnaire 18-19 years with questions relating to: personal and contact details, education and any employment status, health conditions and lifestyles.

Information on some of these areas is collected in a standard manner in at least one of the existing NINFEA questionnaires, in line with the project's objective of acquiring data on exposures and outcomes in a longitudinal and repeated manner over time. On the study website (www.progettoninfea.it) you can find a copy of the forms relating to this questionnaire.

Before deciding whether to accept or refuse to participate in the Questionnaire 18-19 years, please read the following carefully. If you need further information and/or clarifications, you can contact Prof. Dr. Lorenzo RICHIARDI, research manager, at:

Epidemiology Unit, Department of Medical Sciences
NINFEA Project: information on the project
Via Santena, 7 - 10126 Turin (TO)
E-mail: info@progettoninfea.it
Telephone: +39 011 633.6744

Purpose of the Questionnaire 18-19 years

The questionnaire aims to collect personal and contact data, and to assess the health and well-being of the young people of the NINFEA cohort.

These data will be processed exclusively for scientific research purposes, aimed at protecting the health of the community in the medical, biomedical and epidemiological fields, and will therefore have no relevance at an individual level.

What does participation in the study involve

Participation in this part of the study involves completing an online questionnaire lasting approximately 15 minutes. We remind you that participation is voluntary, and therefore you can decide not to complete this specific questionnaire and that you can also decide to abandon the study at any time.

Benefits and risks of participation

Participating in this study does not involve direct risks or benefits for the health of participants. However, there is the possibility of contributing, with a little of your time, to the progress of medical knowledge that may translate into concrete prevention actions in the future, to improve people's health and well-being.

Processing of personal data

All information collected as part of the NINFEA project will be processed in compliance with the provisions of the European Regulation on the protection of personal data 679/2016, also known as GDPR, and the Italian legislation regarding the management and protection of personal data.

We inform you that your personal data will be used exclusively for scientific research purposes and only by authorized personnel. The information collected will be strictly confidential and will be used in an aggregate and anonymous manner for the preparation of scientific reports, in which you will not be identifiable in any way. The results will be disclosed in a strictly anonymous and aggregate form.

We inform you that the data will be processed using tools suitable for guaranteeing security and confidentiality and may also be carried out using automated tools to store and manage the data itself, with encryption techniques or the use of identification codes that allow identification only when necessary.

We inform you that the Data Protection Officers (DPO) of the University Hospital Città della Salute e della Scienza of Turin and the University of Turin, joint data controllers, are:

AOU Città della Salute e della Scienza di Torino
Email: dpo@cittadellasalute.to.it

University of Turin
Email: rpd@unito.it

Communication of data

The results of the analyses and the information collected will be used exclusively for scientific research activities.

We also inform you that the data may be communicated or transferred to research institutions and bodies, associations and other public bodies and associations, foundations and non-profit organizations with research purposes, exclusively within the scope of joint projects, while only information without identifying data may be communicated or transferred to the subjects indicated above, who do not participate in joint projects, for scientific purposes directly linked to those for which they were originally collected and clearly determined in writing in the request for data and samples. In this case, the requesting subject undertakes not to process the data for purposes other than those indicated in the request and not to communicate or transfer them further to third parties.

This study will produce results in aggregate form and is not intended to characterize any individual risks of the participants.

Rights of the interested party

Participation is voluntary and consent can be revoked at any time without this entailing any disadvantage or prejudice for the interested party. Revoking consent implies the deletion and elimination of your data from the study.

Research participants can always exercise the following rights: access to data, request for data rectification, deletion of data, limitation of data processing, data portability and opposition to data processing (articles 15, 16, 17, 18, 20, 21 of the GDPR), by sending a request to the scientific director of the study who will forward it to the data protection officers (DPO).

We remind you, in this regard, that you can exercise your rights on your data, as well as know the logic and purposes of the processing, by sending a request to Prof. Lorenzo RICHIARDI, head of research, at:

Epidemiology Unit, Department of Medical Sciences
NINFEA Project: information on the project
Via Santena, 7 - 10126 Turin (TO)
E-mail: info@progettoninfea.it
Telephone: +39 011 633.6744

Approval by the Ethics Committee

The Protocol, the Information Sheets and the Informed Consent forms relating to the NINFEA project have been evaluated and approved by the Ethics Committee of the Health Structure to which the Doctor responsible for the study refers: Inter-company Territorial Ethics Committee AOU Città della Salute e della Scienza di Torino, course Bramante, 88/90 - 10126 Turin (TO).

Informed consent to participate in the study

I declare the following.

• To participate voluntarily in the NINFEA study which involves the periodic completion of online questionnaires on environmental exposures, lifestyles and health status.
• To have had sufficient time to carefully read the document entitled "Information sheet on Questionnaire 18-19 years" which confirms in particular that the trial will be conducted in compliance with international ethical codes, and to have understood the methods of conducting the study and its purposes.
• To have received information on the possible risks or reasonably foreseeable discomforts.
• To be aware that participation is voluntary.
• To have acquired the information relating to the processing of data collected within the NINFEA project as well as to the exercise of the following rights: access to data, request for data rectification, deletion of data, limitation of data processing, data portability and opposition to data processing (articles 15, 16, 17, 18, 20, 21 of the European Regulation on the protection of personal data 679/2016, also known as GDPR).
• To have understood all the information relating to the processing of personal data and to have received the guarantee that for further information I can contact the Data Protection Officers (RPD) / Data Protection Officer (DPO) of the co-Data Controllers:

  AOU Città della Salute e della Scienza di Torino:
  e-mail: dpo@cittadellasalute.to.it

  University of Turin:
  e-mail: rpd@unito.it

• To have been assured:
  • that I can withdraw from the study once it has started at any time, without the obligation on my part to justify the decision, knowing that the withdrawal of consent entails the cancellation and elimination from the study of the data obtained;
  • that the information collected will be strictly confidential and the data will be used for the purposes indicated in the information sheet of the study;
  • that it is my right to have access to the documentation that concerns me and to the evaluation expressed by the Ethics Committee to which I can turn if I deem it appropriate: Inter-company Territorial Ethics Committee AOU Città della Salute e della Scienza di Torino, corso Bramante, 88/90 - 10126 Torino (TO);
  • that I will have access at any time to a copy of the informed consent and the information sheet of the study;
  • that for any problem or for any further information I can contact:

    Prof. Lorenzo RICHIARDI
    Epidemiology Unit, Department of Medical Sciences
    Via Santena, 7 – 10126 Torino (TO)
    E-mail: info@progettoninfea.it
    Telephone: +39 011 633.6744

Information on the processing of personal data and expression of consent

Pursuant to EU Regulation 2016/679 General Data Protection Regulation (GDPR) on the protection of natural persons with regard to the processing of personal data, as well as on the free circulation of such data, the University Hospital (AOU) Città della Salute e della Scienza di Torino and the University of Turin, as joint Data Controllers, inform you that your data will be processed in the manner set out below.

Data controllers

Joint data controllers, i.e. the entities that define the purposes and tools of the processing pursuant to the European privacy regulation, are the AOU Città della Salute e della Scienza di Torino and the University of Turin.

The joint data controllers can be contacted at the following addresses:

AOU Città della Salute e della Scienza di Torino
Corso Bramante, 88/90
10126 Torino
Centralino +39 011 6331633
Certified e-mail address (PEC): protocollo@pec.cittadellasalute.to.it
Legal representative: the General Manager.

Università degli Studi di Torino
Via Verdi, 8
10124 Torino
Centralino +39 011 6706111
Certified e-mail address (PEC): ateneo@pec.unito.it
Legal representative: the Rector.

Data Protection Officers

The Data Protection Officers (DPO) of the AOU Città della Salute e della Scienza di Torino and the University of Turin, co-Data Controllers, are:

AOU Città della Salute e della Scienza di Torino
Email address: dpo@cittadellasalute.to.it

Università degli Studi di Torino
Email address: rpd@unito.it

Purpose of data processing

This processing, concerning personal data (any information relating to a natural person, including a personal identification number) and those relating to your state of health, will be carried out for the purposes of scientific research in the medical, biomedical and epidemiological fields and statistical research aimed at protecting the health of the community.

The AOU Città della Salute e della Scienza di Torino and the University of Turin, each for the areas of their competence and in accordance with the responsibilities established by the rules of good clinical practice (DL 211/2003), will process your personal data (name, surname, place and date of birth, tax code, home address, residential address, email, telephone numbers), your data on lifestyle habits and socioeconomic status, environmental exposures and health, as well as any biological samples provided by you, only to the extent that they are essential in relation to the objective of the study, pursuant to the Provision of the Guarantor for the protection of personal data no. 146 of 5 June 2019, containing the provisions relating to the processing of special categories of data, pursuant to art. 21, paragraph 1 of Legislative Decree 10 August 2018, no. 101, pursuant to the GDPR and Legislative Decree 101/2018 adapting national legislation to the provisions of the GDPR.

The project has received General Authorization from the Guarantor and Approval from the Territorial Ethics Committee "Interaziendale AOU Città della Salute e della Scienza di Torino" (ref. Practice no. 45).

Legal basis for processing personal data

Participation in the experiment is voluntary, free and aware.

Your participation in the project is important because it offers help for the advancement of scientific research and, by increasing the amount of available knowledge, for the progress of society.

Your explicit consent may be freely revoked at any time; any revocation will only be valid for the future, with the processing carried out up to that point remaining valid.

Nature of the data processed

Some of your "common" personal data (such as name and surname, telephone number, e-mail address) and data relating to your health will be processed; based on the purposes of the research and the characteristics of the study, data relating to your medical history, socioeconomic situation and lifestyle will be collected.

Treatment modalities

All information collected as part of the NINFEA project will be processed in compliance with the provisions of the GDPR and Italian legislation regarding the management and protection of personal data.

Your personal data will be treated with the utmost confidentiality, in compliance with the security regulations for computer and paper archives set out in the legislation, and will be used only by authorised personnel exclusively for scientific research purposes.

We also inform you that data processing takes place using tools suitable for guaranteeing security and confidentiality and may also be carried out using automated tools designed to store and manage the data itself, with encryption techniques or the use of identification codes that allow identification only in case of necessity.

The data are pseudonymized because, after collection, they are stored separately from the identifying data (name, surname, etc.), since a code is assigned to the participants that does not allow direct identification. The data are encrypted in compliance with the security measures for the protection of privacy and confidentiality of the data, provided for by the above-mentioned legislation.

Those authorized to process data (doctors, statisticians and other professionals working at the facilities belonging to the co-owners) have access to the data in pseudonymized form whenever unique identification is necessary and in anonymous form in all other instances, always solely for research purposes. Access to personal data only occurs for follow-up needs.

The NINFEA project data are hosted by a cloud computing and backup service (Nivola), provided by CSI Piemonte pursuant to resolution no. 2133 of 27/09/2022 of the AOU Città della Salute e della Scienza di Torino and subsequent amendments, without authorization to access or administer the data by the same, which has only conservation tasks. Access to the virtual machines and software administration of the machines is permitted exclusively to competent personnel belonging to the AOU Città della Salute e della Scienza di Torino.

The information collected is strictly confidential and will be used in an aggregate and anonymous manner for the preparation of scientific reports, in which you will not be identifiable in any way. The results may be disclosed in a strictly anonymous and aggregate manner.

Categories of subjects to whom the data may be communicated

The data will be processed within the co-Controller Bodies by subjects authorised to process under the responsibility of the same co-Controller Bodies for the purposes indicated above in compliance with the rules of ethics and the code of ethics. We also inform you that the data collected will be used in pseudonymised form for statistical and epidemiological analyses and may be communicated to research partner subjects.

All processing operations, carried out only by personnel duly trained and authorised by the joint Data Controllers, will take place in compliance with professional secrecy, official secrecy and the principles of correctness, lawfulness and transparency, as set out in current legislation.

Dissemination and transfer of personal data

The AOU Città della Salute e della Scienza di Torino and the University of Turin, within the scope of collaborative projects with purposes consistent with those of the NINFEA project and following approval by the competent Ethics Committee and the signing of an agreement, may transfer socio-demographic, epidemiological, clinical and molecular data, or any biological samples, in anonymous or pseudonymised form (with the use of fake IDs) to research institutions and bodies, public or private partnerships in the field of scientific research, public bodies, scientific foundations, non-profit associations with research purposes located in countries of the European Union.

With regard to any transfer of data to Third Countries, the joint Controllers hereby declare that the transfer will take place in compliance with Articles 44 et seq. of the GDPR (Transfer on the basis of an adequacy decision, transfer subject to adequate guarantees) with the exclusion of Article 49 concerning "Exceptions in specific situations". Further information is available from the joint Controllers or from the DPOs, by writing to the addresses indicated above.

The study partners formally undertake not to process the data and samples for purposes other than those indicated in the shared project, not to communicate or further transfer them to third parties, not to use them for profit or commercial purposes.

A new specific identification code will be created for each new project. The connection between the new code and the NINFEA project code will be maintained at the AOU Città della Salute e della Scienza di Torino and the University of Turin and will not be accessible externally.

Period of retention of personal data

The data will be stored for a period of 50 years from the end of enrollment (which occurred in 2016). After this period, the data will be irreversibly anonymized and archived. The period indicated is necessary for the purposes of the project, through which we intend to evaluate the long-term effects of early exposures.

Rights of the interested party

In relation to the processing of personal data concerning you, Chapter III of the GDPR recognises specific rights and, in particular, the right, if applicable, to:

1. access your personal data and information relating to them;
2. request the updating, the correction of inaccurate data and the integration of incomplete data;
3. request the deletion of personal data concerning you when one of the conditions indicated in art. 17, paragraph 1 of the GDPR occurs and in compliance with the exceptions provided for in paragraph 3 of the same article and provided that there are no data retention obligations required by law;
4. request the limitation of the processing of your data in the event of one of the hypotheses provided for by art. 18 of the GDPR;
5. request the transmission of your data to another Data Controller in a format readable with the most common computer applications (so-called "right to portability"), where technically possible;
6. to object at any time to the processing of your personal data in the event of particular situations concerning you;
7. revoke consent at any time, limited to cases in which the processing is based on your consent for one or more specific purposes and concerns common personal data or particular categories of data. The processing based on consent, and carried out prior to its revocation, retains, in any case, its lawfulness;
8. submit a complaint to the Personal Data Protection Authority (whose contact details can be found on the website www.garanteprivacy.it) in the event of unlawful processing or delay in the Data Controller's response to a request relating to your rights;
9. interrupt your participation in the study at any time and without providing any justification: in this case, the biological samples related to you will be destroyed. Furthermore, no further data concerning you will be collected, without prejudice to the use of any data already collected to determine, without altering them, the results of the research.

How to exercise your rights

The request for the exercise of the above rights must be submitted by contacting the promoter directly through the Public Relations Offices (URP) of the AOU Città della Salute e della Scienza di Torino:

Presidio Molinette
Corso Bramante, 88 – Torino
Tel. 011-633.5444
e-mail: urpmolinette@cittadellasalute.to.it

Profiling

The joint Controllers do not use automated processes aimed at profiling.

Name and contact details of the principal investigator

Prof. Lorenzo Richiardi, Unità di Epidemiologia, Dipartimento di Scienze Mediche
lorenzo.richiardi@unito.it
Tel. +39 011 633.6744

Consent

Your consent to participate in the study is freely given and can be revoked at any time, without the need to provide any justification and without this resulting in any disadvantage or prejudice to you.

In the event that you withdraw your consent, you have the right to request that all data and/or biological samples previously collected be deleted, unless the data and biological samples, originally or following processing, no longer allow you to be identified. No further new data concerning you will be collected, without prejudice to the use of any data already collected to determine, without altering them, the results of the research.