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AGREEMENT on the transfer of human biological materials
This agreement is not negotiable.
The purpose of this agreement is to regulate each party’s responsibilities when human biological materials and its associated coded personal data is to be transferred from a Swedish biobank to a recipient, who will use the human biological materials for a research project that has been approved by an ethics committee in Sweden.
The agreement is both an agreement to transfer of human biological materials and a personal data processing contract. Moreover, it regulates how human biological materials and coded personal data should be handled on expiry of the agreement so that human biological material and the coded personal data no longer can be used for research or any other purpose by the recipient.
1. PARTIES
This agreement for the transfer of human biological materials ("Agreement") is signed between the Swedish Biobank responsible for samples in Sweden [enter name and address] (the “Biobank”), and the recipient of samples[enter name, address, e-mail and phone] (the “Recipient”), each a “Party” and collectively hereafter referred to, as the “Parties”.
2. BACKGROUND
The Biobank is in possession of a certain human biological materials (the “Materials”) and associated Personal Data (as defined below), which needs to be analyzed within the framework of a research project (enter information about the study in Table 1 below) (the “Project”). The Biobank collaborates with the Responsible researcher[1] for the Project.
The Parties wish the Recipient to be able to analyze the Material for the Project and the Biobank agrees to make the Material and associated coded Personal Data available to the Recipient for the purposes of the Project.
For the purposes of this Agreement, “Personal Data” means any information that identifies or that can be used to identify a natural person who is alive.
Table 1.Study information
Study name:Sample collection working title(if applicable): / Study-ID (if applicable):
Registration no. of the ethical review board’s decision:
Responsible researcher1
Name: / Phone: / E-mail:
Workaddress: / Postcode: / City: / Country:
Sweden
3. TRANSFER OF BIOLOGICAL MATERIALS AND PERSONAL DATA
The Biobank undertakes to assist the Recipient with the Material specified in attachment 1, for specific analyses and associated Personal Data specified in attachment 1. The Material and associated Personal Data for analysis is provided in a pseudo-anonymised form, i.e. coded samples and coded Personal Data so that the individual donor (whether living or deceased)from whom the Materials were obtained (the “Donor”) can only be identified with the key for the code (as described below) [2].
The principal of the Biobankshall keep the key for the code to the Personal Data for the identification of the Materials and the coded Personal Data during the term of this Agreement. The Recipient acknowledges that Biobankwill not provide any information to the Recipient about the Materials or Personal Data that can directly identify or be used to identify the Donor.The Recipient acknowledges that since a key exists, the Personal Data and any information derived by Recipient that uses such Personal Data from the Material are deemed to be Personal Data for which the Biobank is responsible. All rights to and in the transferred Material and associated coded Personal Data remains with the Biobank.
4. PERMITTED USE etc.
The Biobank declares that the collection of biological materials and personal data for the research project has been approved by an ethics committee in Sweden. The Biobank makes no representations that the use does not infringe any rights of third parties.
The Recipient agrees to use the Materials and/or coded Personal Data as described in the research plan inattachment 2 (the “Purpose”). The Recipient also agrees to use the Materials and related coded Personal Data in accordance with this Purpose and not for any other purpose and in accordance with applicable laws, regulations, policies, guidelines, and ethical requirements, together with any constraints set forth by ethical review boards, applicable to the research under the Project and the handling and protection of the Material and/or Personal Data.
The Recipient acknowledges that the Material is made available for experimental use only and should not be used in humans.
In the event of a withdrawal of donor Consent, the Biobank shall promptly inform the Responsible researcher of such changes.
5. ACCESS TO THE BIOLOGICAL MATERIALS AND DATA
The Recipient agrees to ensure that only those persons involved in the Project,shall have access to and the use ofthe Materials and /or coded Personal Data provided by the Biobank.
The Recipient agrees that only authorized laboratory personnel in the Recipient’s business/organization performs analysis of the Materials and processes the coded Personal Data.Unless expressed permission is documented to provide to study sponsor or third party provider.
6. SUBCONTRACTORS
The Recipient shall ensure that this Agreement is forwarded to and completed by any subcontractor or third party provider prior to any transfer of the Materials and /or coded Personal Data. The Recipient shall also ensure that any subcontractor or third party provider shall handle the Material and / or coded Personal Data in accordance with this Agreement.
Recipient agrees that Biobank shall retain title to the Material and the Personal Data, in Recipient’s or any subcontractor’s possession.
7. SECURITY FOR BIOLOGICAL MATERIAL AND PERSONAL DATA
The Biobank principal is the controller of the Personal Data. The Biobank agrees that the Materials and any coded Personal Data will be supplied to the Recipient without any information or data that could result in the Donor being personally identifiable by Recipient, under applicable data protection/privacy laws.
The Recipient agrees to protect the integrity and security of the Materials and associated coded Personal Data from unauthorized access, useor theft in accordance with applicable data protection or human biological material legislation.
The Recipient agrees to meet the requirements and instructions on IT security from the Biobank in attachment 3.
The Recipient acknowledges that it shall not in any circumstance try to usethe coded Personal Data to identify the Donor or to make contact with the Donor. If the Recipient becomes aware of any unauthorized use or disclosure of the use of the coded Personal Data, the Recipient undertakes to promptly contact theBiobank.
8. RESULTS AND PUBLICATIONS
Results and publication of data processed in accordance with this Agreement may be subject to separate agreements between the Responsible researcher and the Recipient.
9. INDEMNITY
The Recipient agrees to indemnify and hold the Biobank and/or its employees harmless from any third party claim, including reasonable legal fees, due to or arising out of any wrongful use, loss or damage as a result of the use, handling, storage, transport or other activities relating to the Materials and/or coded Personal Data under this Agreement.
The Recipient shall not be responsible for any third party claims as a result of the transport of the materials carried out by a subcontractor.
However the Recipient agrees to only contract subcontractors for transport with appropriate insurance which can used to indemnify the Biobank and/or hold its employees harmless from any third party claim arising out of any wrongful use, loss or damage to the Materials and/or coded Personal Data during transport.
10. TERM AND TERMINATION OF THIS AGREEMENT
This Agreement shall come into force on [insert date] and shall remain in force [for five (or X) years or] until research under the Project has been completed, whichever occurs first.
This Agreement may be terminated by either Party for any reason, by giving the other Party thirty (30) day´s written notice.
The Biobank has the right to terminate this Agreement with immediate effect if the Recipient is in material breach of its obligations under this Agreement or becomes bankrupt, liquidated or otherwise becomes insolvent.
11. TERMINATION OF TREATMENT OF BIOLOGICAL MATERIALS AND DATA
The Recipient agrees, on expiry of this Agreement, to stop the use of the Materials and coded Personal Data.
The Recipient agrees to return or destroy any residual Material and copies of the associated coded Personal Data, when the Project is complete or within thirty (30) days after termination or expiration of this Agreement, whichever occurs first.
State the estimated end date for using thebiological materials according to this agreementState when the analysis is planned to be finished (year, month):
Samples will be:
Completely consumed during analysis.
Destroyed after analysis. Estimate date for destruction of samples (year, month):
Returned after analysis. Estimate date for return of samples (year, month):
Other:
The Recipientis responsible for the destruction or return of the Materials and Personal Data.
The Recipient shall have the right to retain such copies as are required to comply with any applicable laws, rules and regulations.
12. OTHER
No provision of this Agreement may be amended or modified, except by written instrument duly executed by an authorized representative of each Party.
All communications concerning this Agreement shall be in writing and shall be delivered to the address indicated below, unless aParty has specifically been notified by the other Party of another address for this purpose.
Message is delivered in person, by mail, e-mail or fax. A receipt shall always be provided for each received message.
13. APPLICABLE LAW AND DISPUTES
Note;If cooperation / funding agreements also exist - check that they harmonize with the terms of this agreements.
This Agreement is governed by Swedish law and any disputes arising under or in connection with this Agreement shall be primarily resolved through negotiations among the parties or mediation under the rules of the Stockholm Chamber of Commerce Mediation Institute (SCC).
If the dispute cannot be resolved by mediation, it shall be settled by means of arbitration administered by the Stockholm Chamber of Commerce Arbitration Institute (SCC).
This Agreement is issued (2) original, where both Parties have taken one (1) copy each.
CONTACT
Sample principal ”Biobank” (name of principal): / Recipient (name of company or laboratory. When the research is commissioned (sponsored), state who the commissioning body is):Name of Biobank: / Biobank no. (IVO):
Authorized representative for Biobank in Sweden / Authorized representative for recipient (for the laboratory/analysis unit or company within or outside Sweden)
Name: / Name:
Address: / Address:
Postcode: / City: / Postcode: / City:
Country:
Sweden / Country:
E-mail: / E-mail:
Phone work: / Phone work:
SIGNATURES
Authorized representative for recipient(for the laboratory/analysis unit or company within or outside Sweden) / Date and city:Name in capitals:
Authorized representative for Biobank in Sweden / Date and city:
Name in capitals::
ATTACHMENT 1: BIOLOGICAL MATERIAL
Attached by responsible researcher
DescribePersonal Data to be transferred.
The Material and associated Personal Data for analysis is provided in pseudo-anonymised form[3].Description of Personal Data:
Describe Biological Materialto be transferred.
Describe the content and extent, for example type of tissue, cells/cell lines, blood or blood plasma, prepared DNA, urine, etc. Antal individer / No. of individuals / No samplesSIGNATURE by the responsible researcher
Date and city:Signature:
Name in capitals:
Responsible researcher = the researcher responsible for the research project in Sweden. For example Principal investigator, National investigator, Clinical Trial Investigator or Sample collections responsible person
ATTACHMENT 2: RESEARCH TO BE CONDUCTED ON CURRENT SAMPLES
Attached by responsible researcher
Detailed specification of the purposes for which biological material and Personal Data may be used. Specify so that only such use that are included in the ethical board decision may be conducted and so that there is no room left for other use.Description of the research project:
SIGNATURE by the responsible researcher
Date and city:Signature:
Name in capitals:
Responsible researcher = the researcher responsible for the research project in Sweden. For example Principal investigator, National investigator, Clinical Trial Investigator or Sample collections responsible person
ATTACHMENT3: IT SECURITY REGULATION
Access protection:
When computer equipment and removable storage media are not under supervision, the equipment and the media are to be locked away to protect them from unauthorized use, tampering and theft. Otherwise, all Personal Data must be encrypted. Personal Data on laptop computers and their removable storage media must always be encrypted.
Back-ups:
Personal Data must be regularly backed up. These copies are to be kept separate and well protected so that the information can be recovered after a crash.
Authorization:
If the computer is used by more than one person, access to Personal Data must be controlled with a technical authorization system. Authorization is to be confined to the person(s) who need the information in their work. Usernames and passwords are personal and non-transferrable. Procedures must be in place for the granting of authorization.
Log:
If the computer is used by more than one person, an automatic log or similar must be installed to make it possible to monitor who has had access to Personal Data at a future date. This log is to list the user, the date and time of access, and the names of the person(s) whose data was retrieved. This information is to be checked as necessary.
Data communication:
External data communication links are to be protected with a callback or other technical function for checking authorization. Personal Data transferred via data link to a computer located outside the jurisdiction of the organization must be encrypted.
Destruction:
When stationary or removable storage media containing Personal Data are no longer to be used for their intended purpose, all storage media must be destroyed. Alternatively, the Personal Data must be erased in a way that is impossible to retrieve.
Repair and service:
When computer equipment is repaired or serviced by a third party, a security agreement must be signed with the service company in question.
When computer equipment is being serviced, all storage media containing Personal Data must be removed; if this is not possible, the service must be carried out under the supervision of the organization.
Service via data link may only proceed after the person performing it has been securely identified. Service personnel are to be given access to the system for the duration of the service only.
If a separate communication channel is in place for service, it must be kept closed when service is not being carried out.
[1]The researcher that is responsible for the research project in Sweden. For example Principal investigator, National investigator, Clinical Trial Investigator or Sample collections responsible person
[2]Note that even encoded or encrypted data is personal data as long as code or encryption key is left, (personal data"), for which the Biobank is responsible
[3]Note that even encoded or encrypted data is personal data as long as code or encryption key is left, (personal data"), for which Biobank principal is responsible.