This document describes the procedures of coordination and monitoring of the SCQM-Biobank, including responsibilities and organisation of the SCQM-Biobank.

Biobank: A systematic collection of samples and linked information for research purposes.

Donor: A Person of whom the sample is derived and for whom information is available.

Sample: Samples of human body substances (e.g. blood, cells, tissue etc.) as well as DNA

Information: Details on the donor of the samples (e.g. demographic details, health record etc.).

Reversible anonymization: (or pseudoanonymization). The breakup of the link between person and sample or information, that can be reversed (re-identification), because the adequate key is conserved; with reversible anonymization the conditions under which re-identification is allowed, should be reglemented

Key: The information, that ties samples and or information to a donor/person after a reversible anonymization and allows for re-identification of the donor.

3.1.  The SCQM-Biobank is a Biobank containing samples of patients with inflammatory rheumatic diseases.

3.2.  The SCQM-Biobank is part of the Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) Foundation, which is an independent foundation under the umbrella of the Swiss Society of Rheumatology (SSR), controlled by the Eidgenössische Stiftungsaufsicht (Swiss Federal Agency for the Supervision of Foundations).

3.3.  The SCQM Foundation is financed as follows:

3.3.1.    Has received grants from the Swiss health authorities, i.e. the Federal Office of Public Health (BAG), the Swiss Academy for Medical Sciences (SAMW) and the Swiss Society of Rheumatology (SSR)

3.3.2.    Has received grants from several independent foundations

3.3.3.    Receives regular contributions from several pharmaceutical companies producing and/or selling so-called “biologics”

3.4.  The SCQM-Biobank is financed as follows:

3.4.1.    Has received grants from several independent foundations and pharmaceutical companies producing and/or selling so-called “biologics”

3.5.  The SCQM-Biobank collects samples and information of patients with rheumatic diseases, and keeps these for use in pre-defined (see Addendum 13.1) as well as yet undefined biomedical research.

4.1.  Samples and information can be entered in the SCQM-Biobank when one of the following conditions is met:

4.1.1.    Voluntary, explicit, well-documented consent of the donor, based on antecedent sufficient information, for inclusion of his / her samples and / or information in the SCQM-Biobank for the purpose of yet undefined research projects and research projects as described in Addendum 13.1.

4.2.  With minor or incapacitated persons, the informed consent of the legal representative is required. For minor persons with the ability to judge, their personal consent is also required. When a person reached the age of majority, their informed consent has to be obtained, unless it was already obtained from the person as minor with the ability to judge.

4.3.  The informed consent and possible recall of informed consent have to be administrated in such a way that the administration of the SCQM-Biobank can ascertain the existence of such consent at any time.

5.1.  The samples have to be stored in a manner that protects them from loss, destruction or alteration.

5.2.  The information has to be stored such that they are protected of unauthorized access, loss, destruction and alteration.

5.3.  The samples and information have to be stored reversibly anonymized.

The SCQM-Biobank complies with the following quality and security standards:

6.1.  Swiss Academy for Medical Sciences (SAMW) guidelines for biobanks

7.1.  The samples that are stored in the SCQM-Biobank can only be used for ongoing and / or yet undefined research projects of biomedical nature.

7.2.  Without information of the donors on the specific research project and without the consent of the donors for withdrawal for a specific research project, samples and information can only be used for:

7.2.1.    Biomedical research projects when the informed consent, that led to the collection of samples and information in the SCQM-Biobank, allows for this use (“broad consent”)

7.2.2.    Biomedical research projects that – if the applicable law requires consent – have been authorized by the responsible ethics committee(s), such as the ones described in Addendum 13.1.

7.3.  Any transfer of samples has to be traceably documented and transparently managed in a transfer agreement (Material Transfer Agreement (MTA)).

8.1.  The samples and information stored in the SCQM-Biobank can only be transferred to other biobanks if:

8.1.1.    The informed consent, that authorized collection of samples and information in the SCQM-Biobank, allows for the transfer of samples and information to another biobank, or this transfer has been authorized retrospectively, and

8.1.2.    If it is warranted that the receiving biobank complies to at least the same rules as the SCQM-Biobank, especially concerning collection into the biobank, storage in the biobank, transfer for research projects and rights of donors.

8.2.  The receiving biobank has to warrant that the rights of donors will be assured in an undiminished manner.

8.3.  Every transfer has to be traceably documented and transparently managed in a transfer agreement (Material Transfer Agreement (MTA)).

The re-identification of donors is only permitted:

9.1.  When it is needed in order to collect additional samples / information of the donor or of his / her medical record and the responsible ethics committee has allowed for re-identification 

9.2.  When it is needed in order to inform the donor on evidence based results that are relevant for the diagnostic status and / or therapeutic regimen of the donor. Before disclosure of results, it has to be clarified whether the donor used his right to remain ignorant.

9.3.  Upon direction of regulatory authorities, if this re-identification is needed for clarification of circumstances in case of suspected breach of legal regulations or scientific standards.

10.1.  The rights of donors are regulated under the applicable data-protection law, and specifically include:

10.1.1. The right on information and inspection of his / her personal data and

10.1.2. The right on correction of false personal data.

10.2.  Furthermore, donors have the right of withdrawal: The right to retract the informed consent once given. When donors exercise their right of withdrawal, no new samples and information will be collected in the SCQM-Biobank for this donor. The donor can demand his / her samples and information to be destroyed.

11.1.  SCQM Foundation Board (members see Addendum 13.2.1):

Decision-making body that is responsible for the strategic lead of the SCQM and the SCQM-Biobank. At least one member of the SCQM-Biobank scientific advisory board must also be a member on the SCQM Foundation Board. The Foundation Board is responsible for control of the SCQM-Biobank by assuring that the legal regulations and guidelines, such as the present document, are observed and quality control is complied with.

11.2.  SCQM-Biobank Scientific Advisory Board (members see Addendum 13.2.2.):

The SCQM-Biobank Scientific Advisory Board advises the SCQM Foundation Board on research project requests involving Biobank samples and prepares proposals on strategic and operational issues concerning the SCQM-Biobank. At least one member of the SCQM Foundation Board must also be on the SCQM-Biobank Board.

11.3.  SCQM office:

Responsible for the administrative and operational tasks of the SCQM-Biobank such as:

• Assuring that qualified staff, adequate structures and necessary material for the SCQM-Biobank are provided;
• Preparing communication and information on the SCQM-Biobank;
• Assuring that the guidelines for collection and storage of samples and information are followed in the Biobank Center;
• Assuring that the guidelines for the use of samples and information for research projects are followed. These are described in more detail in the SCQM “Rules for research and collaboration”;
• Assuring that the rights of donors are safeguarded.

11.4.  Biobank Center:

Responsible for the operation of the Biobank:

• Providing trained personnel to carry out the tasks necessary for collection and storage of samples and information as described in guidelines provided by the SCQM-Biobank.
• Allowing the monitor access to information he / she needs to assure that the Biobank is operated according the procedures described in the present document and process specific guidelines.

The SCQM Foundation is a foundation under the surveillance of the Federal Agency of the Supervision of Foundations (Eidgenössische Stiftungsaufsicht).

13.1.  SCQM-Biobank protocol (in English, October 2010)

13.2.  Memberlist

13.2.1. of SCQM Foundation Board

13.2.2.  SCQM Biobank Scientific advisory Board