ETHICAL ISSUES

ETHICAL CONSIDERATIONS REGARDING I.B.AHC

I.B.AHC - Italian Biobank and Clinical Registry for Alternating Hemiplegia  is a project funded and coordinated by the patient association A.I.S.EA Onlus, which represents and operates on behalf of the Italian patients affected by Alternating Hemiplegia (AHC) and of their families.

The patients express their will to participate to the I.B.AHC Biobank and Clinical Registry on a free and voluntary basis, by signing an Informed Consent Form. With this form, they also express their will to be informed about the individual results, if any, deriving from the research projects and studies using their clinical data and biological samples kept in I.B.AHC.

The medical and scientific data of the participating patients and their biological samples are kept anonymous in I.B.AHC and identified only by the CID, the univocal alphanumeric code assigned to the patients when they are enrolled.

The personal data and the related CIDs are kept separately from I.B.AHC, in an external secured off-line data base, accessible only by A.I.S.EA Onlus.

Only A.I.S.EA Onlus is in charge of the management of this external  database and of the direct, personal communication with the patients, with the only purposes of:

1. Enrolment (by signing the Informed Consent Form).
2. Organization of the data and samples collection
3. Information about the results of the studies and the research projects using I.B.AHC

It is impossible for the researchers and the physicians accessing I.B.AHC to retrieve the identities of the participating patients.

The use of I.B.AHC is offered freely, with the only aim to support the research of an effective treatment for Alternating Hemiplegia and to develop a better diagnosis and care for the affected patients.

All users of I.B.AHC must respect the terms of use provided by its protocol and listed in the Usage Request Form, and in general they should respect the dignity of all persons on whom knowledge of the data, information and samples obtained  with the use of I.B.AHC may impact.

The evaluation of the usage requests made by the Scientific Committee of A.I.S.EA Onlus, and the explicit acceptance by the applicant of all the conditions and terms stated in the I.B.AHC protocol, guarantee that only the  requests to use I.B.AHC for ethical and scientifically valuable research projects and studies, are authorized.

RESPONSIBILITIES REGARDING I.B.AHC

A.I.S.EA Onlus is responsible for keeping  and providing appropriate security for the personal data as well as for the privacy of all its participants.

A.I.S.EA Onlus is also responsible for keeping and providing appropriate security to the data and information kept in the I.B.AHC Clinical Registry.

The Scientific Institute E. Medea at Bosisio Parini (LC) - Italy, is responsible for keeping and providing the security for the biological samples of the I.B.AHC Biobank , in full respect of its protocol.

I.B.AHC  is a precious tool for the collection and the efficient use of the data, of the information and of the biological material related to AHC.

Nonetheless, I.B.AHC cannot guarantee the accuracy or reliability of the data and information kept in it, and A.I.S.EA Onlus can take no responsibility for any use, application, or conclusions drawn from the use of the content of I.B.AHC.

A.I.S.EA Onlus herewith informs all users of I.B.AHC, whether as providers or end-users, that they have full and complete responsibility for the data, information and biological material they either provide or use.

A.I.S.EA Onlus, including its members and employees, its Scientific Committee and the Ethic Committee of the Scientific Institute E. Medea disclaim any moral, scientific, or legal responsibility for the accuracy, quality, or use (or misuse) of the data, information and biological material provided in I.B.AHC.