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Information on the processing of genetic data and biological samples

As part of the NINFEA project (Birth and INFancy: the Effects of the Environment), participants who are 18 years of age or older are asked if they are available to collaborate in the collection of a saliva sample.

Before proceeding, it is important to understand how your genetic data will be processed and used in the context of the ongoing research. To this end, please read this information carefully. If you need further clarification, you may contact Prof. Lorenzo Richiardi, research manager, at: Epidemiology Unit, Department of Biomedical Sciences, Via Santena 7, 10126 - Turin, e-mail: info@progettoninfea.it, tel. 011-6336744.

Definitions

For a better understanding of this information, it is useful to provide the following definitions:

Epigenetic analyses

Epigenetic analyses refer to the study of chemical modifications that occur on DNA and proteins associated with DNA. These modifications can influence the expression of genes and therefore the phenotype of the organism, without changing the DNA sequence. Epigenetic analyses include the mapping and identification of these modifications, such as DNA methylation.

Epigenome

The epigenome refers to the set of all epigenetic modifications present in the cells of an organism, which influence gene expression without altering the DNA sequence. The epigenome is highly dynamic and can change during the development of the organism, in response to environmental factors or during the development of diseases.

Methylome

The methylome refers to the DNA methylation profile of a cell. DNA methylation is one of the major epigenetic modifications and consists of the addition of methyl groups (-CH3) to specific sites in DNA. The methylome therefore represents the distribution and abundance of these methylation modifications in the genome of a cell and can be analyzed to understand the biological processes involved in development, disease and environmental responses.

Purpose of saliva sample collection and purpose of treatment

The main objective of this part of the study is to explore environmental exposures and their interactions with the human genome through epigenetic analyses. The main purposes include:

• to explore environmental exposures and their influences on the human epigenome;
• to evaluate epigenetic modifications, in particular changes in the DNA methylome, as a result of the interaction between environmental and genetic factors;
• to investigate the correlation between epigenetic markers and health status or susceptibility to certain pathological conditions;
• if applicable, to analyze the microbiome in relation to epigenetic variations in the future;
• in case of future use of the sample for purposes other than those explicitly stated in the information, a new consent from the participant will be required.

Your genetic data and/or the biological material collected will be processed exclusively for scientific and statistical research purposes, aimed at protecting the health of the community in the medical, biomedical and epidemiological fields.

What does collecting saliva samples involve

After expressing interest in participating in this part of the study, after some time each participant will receive by mail a special kit for collecting a saliva sample. The kit containing the collected sample (according to the instructions attached to the kit) must then be sent to the Epidemiology Unit of the Department of Medical Sciences of the University of Turin, using a special pre-paid envelope.

Under no circumstances will it be possible to directly identify the donor of the saliva sample from the kit. DNA will then be extracted from the saliva received, which will be stored at the TESEO Biobank of the Department of Medical Sciences of the University of Turin. The genetic information will be stored in such a way that the subjects are not directly identifiable.

Benefits and risks of collecting saliva samples

Participating in this part of the study does not involve any risks. Participants are asked to dedicate approximately ten minutes of their time to collecting and shipping the biological sample. There are no direct health benefits for the participants and their children. However, there is the possibility of contributing to the advancement of medical knowledge. Such progress may translate into improved health for all in the future.

Methods of processing personal data

As required by EU Regulation 2016/679 and by the Provision of the Guarantor Authority no. 146 of 5 June 2019, Annex 1, point 4 "Provisions relating to the processing of genetic data (gen. aut. no. 8/2016)", 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 manner. The collection and analysis of genetic data will be limited to the information strictly necessary to achieve the purposes of the research.

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

We inform you that genetic data and biological samples are stored for a period necessary for the correct fulfillment of the obligations provided for, in relation to the purposes indicated above. In particular, biological samples will be stored for the entire duration of the follow-up of the study, or until the consent for their storage is revoked. This revocation can be exercised by following the procedures described in the "Rights of the interested party" section of this information sheet. The study is conducted on the basis of the study project, also specifying the security measures adopted, which will be kept confidential for at least one year from the conclusion of the research. The information contained in the project is provided to interested parties who request it.

Data Controllers, Data Processor and Persons in Charge of Data Processing

The joint Data Controllers are the AOU Città della Salute e della Scienza di Torino and the University of Turin. You may contact the Data Processor, Prof. Lorenzo Richiardi, Epidemiology Unit, Department of Biomedical Sciences, Via Santena 7, 10126 – Turin, e-mail: info@progettoninfea.it, tel. 011-6336744, to find out the information contained in the research project, the logic and purpose of data processing, or to request its updating, rectification, integration or cancellation. The Data Processor are the natural persons authorised to carry out data processing operations by the Data Processor.

Communication of data

The results of the analyses and the information collected will be used exclusively for scientific research. We also inform you that the genetic data and biological samples 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 the data and samples. In this case, the requesting subject undertakes not to process the data and/or use the samples 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 causing any disadvantage or prejudice to the interested party. Revoking consent entails the cancellation and elimination from the study of your data and the biological samples collected.

We remind you, in this regard, that you can exercise the rights on your data (access, rectification, cancellation, limitation or opposition, portability) indicated in articles 11, 12, 15, 17 and 18 of EU Regulation 2016/679, by writing a specific email or request with the subject "privacy rights NINFEA project" to info@progettoninfea.it, or by contacting Prof. Lorenzo Richiardi, research manager, at: Epidemiology Unit, Department of Biomedical Sciences, Via Santena 7, 10126 - Turin, e-mail: info@progettoninfea.it, tel. 011-6336744.

Approval by the Ethics Committee

The protocol, the information sheet, and the Informed Consent form of 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 and by the competent Health Authorities.