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All rules for access and participation in the European Human Frozen Tumor Tissue Bank Network and the responsibilities in the different roles of access and participation are described in the project Deliverables 6.1, and 6.2.
These rules for access to the central database are taken from these deliverables and described here. In addition, some rules were adapted to be in concordance with the Code of Conduct, which describes rules, derived from the highly variable law and ethics in the European union and its participating countries, on exchanging residual tissue and data between the different countries in Europe. The complete Code of Conduct can be found in MS 7.1.

1.Access as a user or requestor to the European Human Frozen Tumor Tissue Bank Network will only be possible after registration and only if the following conditions are met:

a.The requestor must be involved as a researcher at any tumor research group, hospital, university, existing network of tumor banks, national cancer association, research center, collaborative group, European commission, associated countries and international associations and involved in medical research only.

b.The requestor must be familiar with and comply to the European Law and Ethics on residual tissue as described in D 7.1 and MS 7.1 Code of Conduct or if the law and ethics have changed the then current situation.

c.Requestor must be able to give an exact description of all planned research involving the tissue samples.

d.The requestor must have the permission of the local Medical Ethics Commission (or relevant organisation) to execute the planned research.

e.The proposed research must be of sufficient quality to warrant the allocation of valuable tissue samples- this will be judged by the individual collectors involved in the application.

f.Requestor must have sufficient expertise at their disposal to perform the proposed research.

g.Access is limited to those who are prepared to make a reference to the European Human Frozen Tumor Tissue Bank and the involved collectors of the tissue in future publications based on the research results obtained from using the received tissues.

Acknowledgement policy: If research results obtained from using tissues from the European Human Frozen Tumor Tissue Bank Network result in a publication, the following statement should be included in the Acknowledgements or Material and Methods section of the manuscript: “The tissue used in this publication was provided by TuBaFrost the European Human Frozen Tumor Tissue Bank”.

h.In case facilities were used from the collecting institute(s), beyond the sole activity of issuing tissue, which in addition have significantly contributed to a publication, the person(s) involved should be treated as co-author(s) of that publication.

i.The requestor will respect the evaluation of their proposal, which is reviewed by the local collectors involved in the request. If permission is denied, the requestor can submit the request again to other institutes involved in collecting samples. In addition, requests from collectors will be given priority over requests from participants who are solely requestors.

2.In order to participate in the European Human Frozen Tumor Tissue Bank Network and register as a collector, the applying institutes will have to comply with the following criteria:
a.All collector institutes must have availability and access to cancer patient specimens, such as hospitals or existing networks of tumor banks.

b.Collector institutes must have the availability of sufficient personnel (technicians, pathologists, etc) and infrastructure capacity for the development and/or maintenance of a tumor bank, which meets the minimal standards and can collect tissue according to the protocols and rules set by the European Human Frozen Tumor Tissue Bank Network.

c.In order to participate in the European Human Frozen Tumor Tissue Bank Network all or potential collector institutes will establish a tissue bank, collect specimens and corresponding clinical data according to the standardized collection methods and policies of the European Human Frozen Tumor Tissue Bank Network in order to assure quality control of specimens and data as described in MS 3.1.

1.The collector institutes will identify a member of the institute, who is responsible for the scientific tasks of the tumor bank (macroscopic analysis, and selection and harvest of the surgery specimens). Those selected persons should demonstrate their interest in participating in the tumor bank and cancer research. He/she will be responsible for the functional aspects of the tissue bank, such as reception; processing and storing of the samples; quality controls; legal and ethical aspects; management of the information associated with each sample; and the distribution of the samples.

2.The collector institutes must identify a technician who will be responsible for the processing, storing, cryo-preservation, retrieval and shipping of the samples.

3.The collector institutes must indicate the existence of a budget, a physical space and equipment to perform the activities of the tumor bank.

d.The collector institutes are responsible for the association of samples with a locally valid consent (if necessary) or at least an opt out system, where patients can object to the use of their tissues for research purposes, to ensure legal research use of TUBAFROST material by the requestor institutions.

e.The collector institutes will be required to accept and implement the common policies and procedures approved by the TUBAFROST consortium (or the Steering Committee).

f.The collector institutes will be required to accept cooperative action between the tumor banks of the European Human Frozen Tumor Tissue Bank Network.

There can be only be one head collector in each institute, but there can be multiple collectors and requestors. The first person from an institute to join TuBaFrost as a collector is identified as the head collector, whereas other institute members can join as collectors and requestors. These titles should represent hierarchical positions within the institute. New collectors and requestors must be approved by the head collector who also has also the power to remove the requesting/collecting rights of any individual in the institute. If the title of head collector is to be assigned to another individual, it can be either arranged by the head collector, who immediately loses his/her privileges or via a message to the central office, where on a substantiated request the change can be made.

To avoid any mis-use of the tissue bank system, requestors can send complaints to the central office. Numerous and substantiated complaints against a collector can, without convincing feedback of the collector, lead to exclusion of the collector from the community.

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Friday 23rd of June 2017 08:52:11
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