General Terms of Access to the Arctic Biobank Material

These general terms (“Terms”) apply for the use of biological material and data (“Material”) when Arctic Biobank – University of Oulu (“Arctic Biobank”) has granted access to Material for the recipient party/parties (“Recipient”). Researcher” who applies access to Material must be the Principal investigator of the research project (“Project”), affiliated to the Recipient institute.

• “Material” means all human biological material and/or data Arctic Biobank makes available for a Project, including any subsequent descendants from, derivatives of and modifications to them if they can be directly or indirectly traced back to the original sample or individual level data.

1) Background

Arctic Biobank – University of Oulu was established in 2020 to host large population-based sample collections from Northern Finland. It is a licensed biobank governed by the Biobank Act (688/2021). Arctic Biobank aims to promote research in health and well-being, and in medicine and life sciences. It provides samples and data for high-quality research projects aimed at elucidating the causes of disease and the impact of genetics, environment, and lifestyles on their onset.

2) Granted access

According to the Biobank Act biobanks can provide material for research aiming at: (i) promoting health, (ii) understanding disease mechanisms, and (iii) developing products, services, or treatment practices for health care. The material cannot be used for anything else.

Arctic Biobank may grant access to the Material for research projects that are of high scientific quality and impact, ethically conducted and are in line with the Biobank Act and the research areas of Arctic Biobank. The applications to Arctic Biobank are evaluated by the Scientific Committee consisting of representatives of different research fields relative to the Arctic Biobank’s research scope. Evaluation is based on the following criteria:

• Scientific value of the research and its suitability to the research area of the biobank. Project should be clearly defined and research plan scientifically credible and coherent.
• Regarding biological samples the extent of the request in comparison to the expected research value, and the adequacy of the requested samples.
• Scientific competence of the applicant (established scientific record), appropriately chosen methods, available funding, and data security.

In addition, Arctic Biobank will make sure that

• the Material requested is available for sharing,
• the project proposal does not fully overlap with on-going projects using the same datasets/samples,
• the requested data and analysis plan does not compromise the integrity and rights of the sample donors, privacy, and that the requested Material does not endanger the process to protect immaterial rights.

3) Ownership and Intellectual property

Arctic Biobank confirms that it has acquired the Material and has the right to provide access to it in accordance with the Biobank Act. Arctic Biobank retains ownership and all intellectual property rights pertaining to the Material: it owns the Material, databases, any analyses and assay data and inventions related to its laboratory,sample and information handling methods and procedures.

Without prejudice to Arctic Biobank’s rights to the Material, it claims no ownership to new intellectual property invented or developed solely by or for the Recipient in connection with the Project.
The Recipient covenants not to assert its intellectual property rights arisen from the Project and the Material against Arctic Biobank, its owners, or their successors, in any court or administrative agency, and it shall ensure that its assignees and licensees commit to the same. This covenant applies only regarding activities in the fields of public sector (i) research and/or development and (ii) health/medical services, also including biobank services under the Biobank Act.

4) Application process

Arctic Biobank has set forward processes for consultation (before application) and application (material request) for scientists to get access to the Material. Researcher must follow the instructions provided on Arctic Biobank’s web pages. Guidance and information can be requested from arcticbiobank(at)oulu.fi.

5) Material transfer agreement

Arctic Biobank uses a material transfer agreement (MTA) established by the Finnish Biobank Cooperative (FINBB) when agreeing on terms of data and sample access. The Researcher and their affiliated institution as a Party to the MTA shall ensure that any person dealing with the Material always adheres to these Terms and the entire MTA.

6) Material usage

The Material is provided as pseudonymised and do not contain any direct individual identifiers such as names, addresses, contact information or attributes enabling identification. The Recipient needs to describe in detail the environment the Material (data) will be used. Arctic Biobank’s instructions for data processing must always be followed.

Arctic Biobank will provide information on its website concerning research projects that use its Material. The Researcher is asked to provide a short public description of the Project in the application. The recipient is also asked to provide progress report(s) and a final report at intervals agreed in the MTA.

The Recipient may not use the Material for any other purpose than described in the application or share it with any other party without a written approval from Arctic Biobank.

7) Use of national registry data

National register data can be used together with the Material. Any access to the national register data requires an approval by the relevant register or from the Finnish social and health data permit authority, Findata. Arctic Biobank cannot give any guarantee of the approval or the time required for processing the application and acquiring the data. There are separate fees for national register data application, and additional documentations might be requested.

8) Confidentiality and privacy

The Researcher must protect the Material from unauthorized disclosure. Data protection authorities instruct
that even de-identified material must be handled as identifiable personal data. Thus, also transfers outside of EU are subject to the GDPR and may require for example the EU Commission’s standard contractual clauses in the MTA.

The Recipient is not allowed to decide upon disclosure of the Material or individual level research project results in Open Access portals, such as public databases or Open Access Journals. Instead, how to make this feasible needs to be agreed with Arctic Biobank.

9) No warranty

Arctic Biobank provides the Material and its services on an “as is” basis, without any representations or warranties, whether express or implied. Arctic Biobank’s samples are not routinely tested for any biohazards and should be handled with appropriate safety measures.

10) Payment

Arctic Biobank is a not-for-profit biobank that is accessible for academic and private sector research projects. Arctic Biobank has set pricing for its activities to cover direct project related costs due to the administration, sample and data compilation work, and sample preparation or statistical analyses. The payment term is 30 days from the date of invoice. Arctic Biobank may prevent access and delay any service while full payment is pending.

11) Shipment

The Recipient is responsible for the transportation of Material and any related permissions unless otherwise agreed in writing. Arctic Biobank does not assume any liability for any loss or damage to the Material during or after transport.

12) Obligation to share data

The Recipient must provide Arctic Biobank with all data resulting from assays and analyses on the Material in a format enabling Arctic Biobank to re-identify the results and combine them with its identifiable samples and data for future biobank research purposes. The schedule and other details will be agreed in the MTA. Arctic Biobank may freely use and grant rights to third parties to use the results provided by the Recipient for the purposes of biobank research in accordance with the Biobank Act.

13) Obligation to share individual results

The Recipient acknowledges that the sample donors have a statutory right to get, at request, any information derived from their samples and related to their health. The Recipient agrees to provide Arctic Biobank with all sample-specific data and results within 30 days from Arctic Biobank’s written request specifying the relevant sample/s.

14) Obligation to report and publish

Results from research using biobank material must be made public by some means (after steps to protect IP, where necessary) and Arctic Biobank acknowledged as the origin of the Material in all publications. The schedule and details will be agreed in the MTA.

15) Due care and returns

The Recipient must designate a person to be primarily responsible for the Material and handle and store the Material diligently and with due care to protect it from damage and loss and any unauthorized access or disclosure. The Recipient must return any remaining Material to Arctic Biobank as soon as no longer needed forthe Project, or dispose of it in accordance with Arctic Biobank’s instructions

16) Subcontractors

The Recipient must obtain Arctic Biobank’s written approval before engaging any subcontractors in the Project. It must impose the terms of the MTA, including for the avoidance of doubt also these Terms, on the subcontractors and it shall be liable for their actions and omissions as for its own.

17) Withdrawal of consent

The sample donors can at any time withdraw their consent. If this happens, Arctic Biobank will inform the Researcher, who agrees to exclude the corresponding Material from the Project, if so required by the law and if otherwise reasonable taking into account the nature and phase of the Project and other relevant circumstances.

18) Limitation of liability

Mutual limitations of liability will be included in the MTA. Neither party shall be liable towards the other under or in relation to the MTA for any lost profits, business, or goodwill, or any other indirect, incidental or consequential damage. Liability for direct damage shall be limited to the payments to be paid to Arctic Biobank for its services under the MTA or fifteen thousand euros, whichever is greater. These limitations shall not apply to liability for breaches of privacy and data protection obligations or for damage caused by gross negligence or willful misconduct.

19) Law and jurisdiction

Finnish law shall apply to the MTA. Any dispute, controversy or claim arising out of or relating to the MTA or a breach, termination, or validity thereof, which for any reason the parties have not solved within 60 days from the first written request to negotiate by either party, shall, at the initiative of either party, be finally settled by magistrate’s court in accordance with the Rules of the Magistrate’s court in Oulu, Finland.

General Terms of Access to the Arctic Biobank Material P3.B5.1.D (v 1.0) document in PDF format or further information is available from Arctic Biobank (arcticbiobank(at)oulu.fi)