Bambino Gesù Biobank

The Hospital collects biological samples for research purposes, in particular related to rare and complex diseases

A research biobank is a non-profit organization that, respecting the rights of the participants and according to certified quality standards that ensure the complete traceability of all activities, manages the collection, processing, storage, and distribution of biological materials and of the related data. Different types of biological samples are stored (cells, tissues, nucleic acids, biological fluids, and others) and are always associated with a panel of data (clinical, scientific, epidemiological, and genetic data, as well as those related to the family and lifestyle, among others) concerning the participant (patient or healthy subject), which are filed in full compliance with ethical, legal, social and privacy requirements.

The samples stored in research biobanks are of inestimable value, as they help to turn conventional medicine into precision, predictive, and preventive medicine. Therefore, the service provided by a research biobank has a public value, because patients, their families and the whole society are the first beneficiaries of the new diagnostic investigations and of the innovative therapies that can be designed and developed thanks to the samples preserved in the biobank.

In the years following its classification as a Scientific Institute for Research, Hospitalization and Healthcare (1985), Bambino Gesù Hospital has been collecting biological samples for research purposes, mainly related to rare and complex diseases, to genetic and undiagnosed conditions and to onco-hematological diseases.

At present, 4 historical collections are stored in the laboratories of the Bambino Gesù Research Center of San Paolo Fuori le Mura; they include approximately 100,000 samples, taken from more than 45,000 subjects, which fall into 18 different chapters of the International Classification of Diseases and Health-related Problems (ICD10).

In 2017, an update process was launched, in line with the recommendations and the international best practices for the management of biological samples and related data, which led, in 2018, to the achievement of two important objectives:

• the positive evaluation of the biobanking activities by the national node of the BBMRI-ERIC (Biobanking and BioMolecular Resources Research Infrastructure – European Research Infrastructure Consortium), and the subsequent integration of the Bambino Gesù Research Biobank into the international BBMRI-ERIC infrastructure
• the certification of the activities of the Biobank according to the ISO 9001: 2015 standards by the accredited certification body Det Norske Veritas (DNV-GL)  

The Research Biobank of Bambino Gesù Hospital is regulated by specific criteria for the evaluation of requests for storage and use of biological samples and related data, that take into consideration the quality of the research projects motivating the requests. These criteria do not exclude third parties interested in the collections of the Bambino Gesù Research Biobank, with a view to international collaboration with associations, networks, research bodies and private subjects involved in translational and personalized medicine activities.

THE COMMITTEES

The requests for storage or use of biological samples made by researchers are evaluated by the Managing Board of the Research Biobank, which asks for the opinion of the Hospital’s experts of the disease on which the research project focuses. All the research projects must be approved by the Hospital Ethics Committee, to guarantee the protection of the rights of patients and researchers, in compliance with deontological and ethical principles, with the national and international legislation, and with the teaching of the Magisterium of the Catholic Church, as well as with the specific purposes of Bambino Gesù Hospital. All biological samples and related data that are stored in the Research Biobank are associated with an informed consent agreement concerning the activities of the Biobank, in compliance with the current regulatory requirements regarding data processing (see EU Regulation 2016 / 679).