Biospecimen procurement

BWB manages the virtual catalog of samples kept by the participating biobanks. Researchers can access it to find easily where the needed biospecimens can be found. BWB brings them also in contact with the biobank managers in order to facilitate the supply of the requirement material. BWB and its partners can also help to find an appropriate solution for requests that cannot be satisfied within existing collections. All services provided by the biobanks of our network are in accordance with current EU directives and the applicable national laws and BWB ensures that the necessary approval has been obtained by the Ethical Committee as well.

 

Our quality commitment

The use of standardized procedures for the collection, preparation, storage and redistribution on biospecimen samples is necessary so that scientists receive samples that can be used in a reproducible manner. Pre-analytical variations can be eliminated by standardization and validation of procedures ensuring the quality of the downstream biomedical research thereby providing reliable test results.

Our daily concern: guarantee the quality and usability of all biospecimens for research projects.

Our samples are perfectly handled according to current technical standards and operations from our biobanks network, which are run under the control of a well-defined Quality Management System, and in line with law and regulation and ethical principles of human dignity. Furthermore, the best practitioners have studied them in order to establish a reliable diagnostic.

Our quality management is supported by the 4 following pillars:

 

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BWB is a member of the BBMRI-ERIC as one of the 3 network biobank initiatives of the Belgian node (BBMRI.be) and is an active partner in different activities, such as Quality WG (working group). This participation allows BWB to follow the BBMRI-ERIC strategy and adapt it to its networks needs.

 

For more details about BWB’s Quality Management System, please read our Quality Manual.

 

 

Guidance for biobanks

For more information on human biospecimens as biobank manager, some guidelines already published are mandatory to scrutinize in order to support and enrich your activities and your knowledge in biobanking field. The list is not extensive, and we have them sumarized for you right here:

At BWB, we also advise you to follow very closely the elements highlighted below since they will allow you to enhance your biobank, its underlying activities or even its existence:

  • In Belgium, only notified biobanks would be compliant with the national legal framework and would be allowed to collect, store, use and make available the human materials for scientific research purposes. This notification process is described in the Royal Order (see our chapter Belgian Law) of 9 January 2018 on biobanks. More information go to FAMPH.
  • A new ISO standard for Biobanks (ISO 20387). Within the ISO, action for the development of an ISO standard on "Biobanking - General requirements for Biobanking" with the ultimate objective of enabling high-quality biospecimens has started since 2016 and is going to be released in the coming months. Thanks to our Managing Director through his participation to ISO/TC276 (Biotechnology) as expert at NBN (the Belgian national standards body), BWB has been actively involved in this ISO 20387. If you want more information, please go and visite ISO 20387
  • The European Commission for Standardization has released several pre-analytical CEN/TS, which address important pre-analytical workflows applied to molecular in vitro diagnostic. BWB encourages the biobanks to comply with the highest quality requirement by obtaining these CEN/Technical Specifications. More information, please go here.
  • Enhance your biobank visibility by participating to the self-assessment survey conducted by BBMRI-ERIC. If your biobank/sample collection meets the quality criteria according to CEN/TS, it will be labelled in the BBMRI-ERIC Directory – an online catalogue of biobanks allowing users to search samples and data. The BBMRI-ERIC self-assessment survey also allows biobanks to implement their quality requirement and assess their performance.

 

Our ethics

We work with national and international authorities/institutions to ensure that the collection and use of samples and data conform to high ethical standards and safeguard the privacy of the donor. 

All human biospecimen samples provided by our biobanks have been obtained according to the legal requirements and with the approval of an ethics committee. Every donor has the right to withdraw their consent at any time, in which case all of the unused samples will be destroyed and related data deleted. All of our donors’ identities are kept strictly confidential and our data secured. The patient's right to high quality medical care is the priority at all times, with the access to donated tissues being secondary to their medical treatment. 

For more details about BWB’s ethics, please read our common  Ethical Charter

BWB’s Biobank partners have also signed the BBMRI-ERIC Partner Charter as a proof of their commitment to implement quality management and assurance procedures compliant with OECD Best Practice Guidelines for Global Biological Resource Centres Networks. Furthermore, various members of our network belong and actively participate to ethical, legal and social issues (ELSI) WG of BBMRI-ERIC and of BBMRI.be.

For more information, go and visit both the ELSI Knowledge Base and the ELSI Helpdesk pages at BBMRI-ERIC.

For complementary information, BWB also recommends visiting BAREC and FAMPH, the Belgian Association of Research Ethics Committees and the Federal Agency for Medicines and Health Products, respectively.

Given that the appropriate reflection on ELSI is key to any biobanking activity, BWB is opened to receive any questions/comments containing uncertainties/worries on ELSI-related matters relevant in biobanking. Please, do not hesitate to contact us.

 

Our access policy

Our biobanks provide the provision of human biospecimen sample exclusively for scientific research and is not intended for human application. Biospecimens and data provided by our biobanks will only be delivered to ethically and scientifically approved research projects.

BWB's customers use the human biospecimen samples we provide for:

  • to identify the causes and mechanisms of action of diseases
  • to participate in the development of new diagnostic, prognostic and predictive tests
  • to enable the development of new drugs
  • to identify patients predisposed to a disease
  • to predict the response of a patient to a drug
  • to improve treatment for patients

The use of human body material also makes it possible to restore a failling function in the recipient patient. Similarly, this human material also has a very promising potential as a raw material for the manufacturing of advanced therapy drugs. The process from tissues or cells to graft implantation or the manufacture of an advanced therapy product involves a considerable number of complex and interconnected activities. In these scenarios, only banks, intermediate structures or production facilities are allowed to develop such activties, but not biobanks.

 

For more information about these strucutres, please visit the FAMPH page.

 

 

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Belgian law & human materials

The Royal Order (RO) of 9 January 2018 on biobanks, published in the Belgian Official Journal on 05.02.2018 in implementation of Article 22 of the Law of 19 December 2008 regarding the procurement and use of human substances destined for human medical applications or for scientific research purposes, enters into force on 01.11.2018. The RO on Biobanks has important consequences for the organization, functioning and activities of biobanks.

New rules are then applicable, particularly with regard to the procedures for encoding, traceability and donor identification, the opinions to be solicited from the ethics committees, the notification of the biobanks to the FAMPH (Federal Agency for Medicines and Health Products), the data that the register held by the biobank should contain, the establishment of written agreements in case of transmission of human biospecimen samples, the rules relating to the collection of human body material intended for a biobank, the provisions relating to changes to and cessation of the biobank's activities... In addition to the rules it imposes, the RO also brings into force the amendments made in 2013, 2014 and 2016 to the law of 19 December 2008 on the human biospecimen samples.

 

All rules that are defined in the Law 2018 and RO will only start applying from the 1st of November 2018 onwards, with 2 possible scenarios:

  • If your biobank is already collecting and stocking human materials and thus already corresponded to the definition of a biobank on 05.02.2018, you will have to submit your notification no later than six months after the entry into force of the RO (i.e. no later than 01.05.2019).
  • If the biobank is new (i.e. created after 05.02.2018) your biobank must be notified and compliant with the principles immediately before it is established and start to collect and store human materials.

The FAMPH is undertaking an intensive exercise, together with a broad panel of stakeholders (including BWB) to elaborate a Q&A document that will clarify the interpretation of the scope of the legal framework. This guidance document is expected in the coming months.

 

Impacts of the new legislation

The new biobanking legislation has consequences for everybody involved in collecting and using human bodily materials for use in scientific research. As illustrated below, the most critical impacts deal with the import/export activities by amplifying the number of contracts between parties, the high responsabilities of the biobank manager, the notification process and the costs involved in implementing processes to maintain the highest possible legal standards.

Impacts of the new biobanking legislation:

 

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For more information, please read the RO.

 

From legislation to opportunity

At BWB, we consider this new legal framework more as an opportunity than a regulation by itself. First of all, belgian biobanks are now playing a central role in research and development ecosystem. Indeed, any scientist who is willing to investigate his/her hypothesis with human materials has to connect and use materials from notified biobanks. It is also mentionned that biobanks can also extent their collections by deploying strategic axes with new partners. Being a notified biobank will also bring trust within the end-users and soon it would be possible to see the list of these notified biobanks on the FAMPH webpage.

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There are opportunities behind the rules that will allow biobanks to expand and sustain their activities. BWB is here to indicate the paths and proposes solutions to our partners. This is the reason why BWB is taking actions and puts in place processes with regard to this new legislation to help and support its biobank partners and end-users in their daily-life. Some items of our actions are illustrated below. 

 

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Some solutions are also indicated here to support our biobanks network or even biobanks from outside. BWB would be more than happy to help you and guide you through this new legislation.

 

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