- INFORMED CONSENT -
All the patients attending the Parkinson Institute are informed about the DNA Bank by means of an information sheet that is given to them at the entrance. The sheet explains the spirit of the initiative and asks them to donate a blood sample independently of diagnosis for the purposes of research, as the results are of immediate practical use to the patient and his/her relatives in very few cases. The donation is voluntary and lack of participation does not have any consequences in terms of access to healthcare. The DNA sample is stored in compliance with the legislation related to privacy: the sample is anonymous and nobody outside the Institute can trace it back to the donor. Should the results be published on a journal or be communicated at a meeting, all information on identify will be omitted.
The patients, after having read the information sheet, can ask their neurologist or the physician specialized in genetics for more details; the attending physician will ensure that the patient has fully understood the initiative before he/she signs the informed consent form. A genetic consultation is recommended whenever the patient has a positive family history for PD, his/her parents belong to the same family or a hereditary movement disorder is suspected. In this way complete information on the family tree can be collected and families that are suitable for linkage studies can be identified; moreover, the patient is given more in-depth information on the risk of recurrence with the family.

- CONFIDENTIALITY -
Once the patient has accepted to take part in the initiative, two samples of venous blood are drawn in EDTA (two X 7 ml samples). One is sent to the Molecular Genetics Laboratory, at Foundation IRCCS “Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena”, Milan, Italy. The test tube sent to the laboratory is labelled only with a code number, so that the DNA is filed and stored in an anonymous, but “identifiable” form. None of the staff of the laboratory are able to identify the patient. The second test tube is stored anonymously at –20°C at the Parkinson Instituted and can be used as an independent control of any result obtained from genetic analyses.

- METHODS -
At the Laboratory the DNA is extracted with a commercial kit and stored at –20°C in a dedicated freezer.
In familial forms, the other person affected is asked to take part in the initiative even if he/she does not attend the Institute. If the patient accepts, he/she is examined by a neurologist and full and all clinical data are collected, together with a DNA sample, as for the patients of the Institute.

All the clinical information of the large number of patients is collected in a “Data-Base” with more than 200 items: Personal details, Minimum dataset, Diagnosis, Onset, Family history, Lifestyle, Pharmacological treatment, Neuroimaging and other investigations, Progression (Hoehn&Yahr stage and UPDRS rating scale). The data collected in the database enable a complete description of the clinical status of the patient and his/her stage of the disease. In particular, the UPDRS rating scale is very popular internationally, because it provides a precise and internationally accepted assessment of the severity of the various parkinsonian signs and symptoms. In essence, it is an accurate report of the outcome of the specialized neurological examination for the assessment of movement disorders.

The data-base can be used to select groups of patients that are of interest for a hypothetical genetic study rapidly, such as patients with an early onset of disease and positive family history for PD, or patients who present with particular clinical manifestations or in whom investigations reveal particular features. Once patients have been identified on the basis of the requests of the scientist who asked for the samples, the corresponding DNA codes and quantities necessary for the study are communicated to the Laboratory.