RD-Connect is developing a unique Catalogue of biological samples donated by patients affected by rare diseases. Biobanks collecting rare disease samples contribute to this Catalogue and the entry of new biobanks into the RD-Connect platform is encouraged.
Any European rare disease biobank may join the RD-Connect platform and contribute to the online Catalogue. An approval procedure entailing specific assessment criteria is implemented to ensure adherence to minimal entry conditions and the adoption of any standardisation and harmonisation measures needed for a successful inclusion to the RD-Connect platform.
Application form submitted by the rare disease biobanks will be reviewed by the RD-Connect Panel for Biobank Assessment according to the criteria below. Two rounds of calls are envisaged annually and will be advertised on this web portal.
1.Disease(s) of interest
Interested biobanks must already store collections of rare disease biological samples; the RD-Connect Panel for Biobank Assessment will evaluate the candidate biobank on the basis of the rare disease focus of the sample collection, which must be clearly described.
2.Quality Standards (QS)
Biobanks should have a quality system in place for the operational management, including quality assessment/quality control for sample and data management. QS for sample management should follow best practice guidelines such as those of the OECD or, in the future, the upcoming European standards for pre-analytical treatment of biological samples.
3.Standard Operating Procedures (SOPs)
The biobank should have already adopted SOPs regulating :
- sample (and data) acquisition
- testing to ensure sample (and data) integrity
- sample processing and storage
4.Ethical, Legal and Social Implications (ELSI)
The biobank should adhere to the following ELSI principles:
- samples are collected only if an appropriate informed consent has been previously obtained by the donor
- the consent can be withdrawn and sample (and data) removed anytime by the donor
- confidentiality issues need to be dealt with in compliance with the local government laws
- specific rules and policies for distributing samples (and data) are clearly defined
The biobank should meet the following minimum system requirements:
- centralised or distributed data repository with internet access
- information Management system to manage biobank repositories, resources, samples and data in a structured way
- data identification capabilities (local persistent unique identifiers for samples and sample data)
- data transfer capabilities (exportability of data from the management system to a file format and secure data transfer through the Internet)
Example questions that may be asked in the rare disease biobank Assessment Form via the RD-Connect ID-Card can be downloaded here.