POLICY AND CONSENT MANIFESTATIONTO THE PERSONAL DATA TREATMENTto take part to the observational research Quality

 

Dear User,

in accordance  with article 13 of the UE Regulation n. 679/2016 (also called GDPR) by means of this we provide you with information regarding the procedures and the aims of processing your data collected through our registry  LGMD 2C-2D-2E in the Quality Project, whose constitution is promoted and managed by GFB OdV – Gruppo Familiari Beta-Sarcoglicanopatie.   

The GRUPPO FAMILIARI BETA-SARCOGLICANOPATIE  Odv and the Stem Cell Laboratory, directed by doctor Yvan Torrente, have promoted the described study, each one for their own area of competence and, in accordance with liabilities under standards of good clinical practice (D.L. 211/2003), will process your Personal Data, especially the ones concerning Your state of  health, Your medical history and other confidential data on your life, solely for the registry and Quality Project implementation.

 

We will ask you for the information we need through the completion of an online questionnaire, your adherence to observational research implies the processing of your data as described above.

The purpose of data processing is therefore the implementation of the clinical study and the legal basis that makes it legitimate is the execution of the contract between the parties for the conduct of clinical research activities in the field of health care and/ or therapy on beta-sarcoglycanopathies and other limb girdle muscular dystrophies.

The registry will collect different clinical data relating to your pathology and its course. The registry also contains information on collected biological samples, especially on the performed muscle biopsies, type, collecting date and immunohistochemistry features.

 

We will also ask your consent to reuse the data provided with the completion of the questionnaire, for other studies or research on these very rare forms of muscular dystrophy, such as:

  • Therapy or prevention programmes (trial);

  • Genetic disease diagnosis (diagnostic test);

  • Diagnosis of pathologies described in the rare disease national registry;

  • Prenatal diagnosis;

  • Genetic screening;

  • Genetic pathology prevention in high-risk populations;

  • Prevention of pathologies described in the rare disease national and/or regional registry;

  • Studies on human genome.

 

For transparency sake, we would like to point out that the Personal Data, as the name, date of birth, sex and place of residence are collected and stored separately from the clinical data stored in the registry or from the quality of life data collected in the Quality Project.

These data are never expressed in the registry/Quality Project but they are replaced by alphanumerical pseudonysms automatically created so that it can’t be traced back to the patient identity. With the exception for people involved in the study realization (below mentioned), no user of the registry/Quality Project will be able to link the patient identity to the data collected and recorded in the registry/project.

 

The data stored in the register will still be protected by an encryption system. The identification will be authorized only to the administrator of the LGMD 2C-2D-2E registry and of the Quality project and to the subjects in charge to deal directly with the user according to the processing needs.

Your data  could be made accessible to the following recipients:

  • You, anytime you wish, you wiil be able to have access to information regarding you that are in the registry /Quality project by contacting the physician who has included you in the registry /Quality project. In addition, your physician might explain to you the meaning of hte recorded data, in case of any doubt.

  • Your physician and his team will have access to your clinical data.

  • Physicians of the Centro Dino Ferrari: data stored in the registry could be accessible to the researchers and doctors for scientific studies. Data that are possibly exported, will receive a new pseudonym and they couldn’t be linked to their identity.

  • Researchers (only after an accurate assessment of the access request from the scientific registry of LGMD 2C-2D-2E/ Quality Project): if researchers from other institutes ask for a consultation of the LGMD 2C-2D-2E registry/ Quality Project in order to find patients suitable for specific clinical studies,  the registry/ Quality Project scientific committee will decide whether to allow or not the data access and their transmission. Here too, the data possibly transmitted will be anonymized again and so not traceable to the patient identity. Furthermore, your data could be transmitted anonymously to companies or third parties (Sponsors/Clinical studies Promoters or external companies that act on their behalf also in non-European Union Countries, even if in joint projects with private individuals, public entities (a local, national and international level) research bodies or companies, associations, foundations, bodies, or non-profit associative bodies, clinical laboratories, National Health Service bodies, physicians and medical staff, pharmaceutical companies) that carry out a research activity that requires the registry access.

  • Administrator: the data collected in the registry/Quality project will be visible to the administrator of the computing resources used for the registry. This will happen only if it is necessary to complete a task and i twill be recorded. 

  • Public entities: for the fulfillment of legal obligations, and to the judicial authority, in case of formal request. The  Ethics Committee and the Italian and foreign  Health Authorities can see your data, collected in your original medical documents, solely in order to check the Study procedures and the collected data correctness and accuracy, by taking all the necessary precautions to guarantee your confidentiality identity.

 

All authorised parties are obliged to keep information confidential. All data publication will be anonymous.


 

We also remind you that you’re the right to ask for  your personal data access,  their correction and deletion from research activities or limitation to processing.

You also have the right to revoke, at any time, the express consent and to end the research activities on your data, in the Quality study or in further ones, in which case no other data concerning you will be collected, without prejudice to the use of any data already collected to determine, without altering, the results of the research.

You have the right to  lodge a complaint to the competent Authority referred to in article  77 of the Regulation.

 

You may exercise the rights above mentioned and the right to withdraw the consent by writing GFB Association Odv, at the legal protempore representative, Mrs. VOLA BEATRICE, President of the association,  to the e-mail address volbeat@libero.it; address: Via Civasca 112,  23018 Talamona SO,  www.gfbonlus.it   

 

CONSENT EXPRESSION

 

Having read the above mentioned information and having  completely understood it, by subscription to the present I agree with my personal data processing for the purposes of research within the limits and in the manner indicated in the information for the conduct of the Quality study and further observational research on beta-sarcoglycanopathies and limb girdle muscular  dystrophies

Subject's name and surname*
Date*

I, the undersigned, confirm

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