Requirements applying for data access

To apply for data, you have to be connected to a research institution in Sweden such as a university or a regional health care authority.

The researcher responsible for the project must have a PhD, but the application itself can be registered and filled in by someone who does not have a PhD. In the case of an approved application, however, it is always the responsible researcher who ultimately receives and is responsible for data provided by SCAPIS.

An approval from the Swedish Ethical Review Board (Etikprövningsmyndigheten) for the research project is obligatory before an application for data from SCAPIS. Obtaining the ethics approval is the responsibility of the individual researcher or research group. Individual ethics approvals are also necessary for researchers with their “own” local data generated within the SCAPIS project (“local sub-studies”). You can find the templates on the website of the Swedish Ethical Review Board.

Specific wordings

There are specific wordings that are recommended for inclusion in ethical applications concerning SCAPIS data. We strongly recommend reviewing these. Specific wordings for applications (PDF)

National data

When applying for ethical approval for a study on national SCAPIS data, the common core template (PDF) for informed consent can be used.

Register-derived data

Use of register-derived data including register from Socialstyrelsen is regulated by the research scope described in the two SCAPIS ethics applications “Uppföljning av hjärt-kärlsjukdom och diabetes med registerdata i SCAPIS, Dnr 2023-06241-01” and “Uppföljning av SCAPIS med nationella registerdata avseende lungor, luftvägar och lungfunktion, Dnr 2023-06033-01”.

Research applications outside the scope of these two ethics applications will not be granted access to data. All applications still need to file their own ethics application describing their specific project, with references to one of the SCAPIS ethics applications mentioned above. 

Each application for register-derived data must be supported by both one of the SCAPIS ethical approvals as well as a project-specific ethical approval. 

It is important that the provided register-derived data will be used exclusively for the project presented in your current application, and not for any other project(s).

Local substudies

For local substudies, locally adapted versions of informed consent to the specific center - Göteborg (PDF), Malmö (PDF), Linköping (PDF), Stockholm (PDF), Umeå (PDF), Uppsala (PDF) - may be more appropriate.

The pilot examination

Finally here is a link to informed consent for the pilot examination (PDF).

With regard to ethical approval, the SCAPIS office will review the following:

• that the population described in the ethics application matches the population in the application to SCAPIS
• that the project’s Principal Investigator is involved in the ethics application
• that the organization responsible for the project (”forskningshuvudman”) which applies for data from SCAPIS is specified in the ethical application
• that requested data is relevant to the project based on the description in the ethics application and the description in the project application
• It must be stated in the ethical application that data from SCAPIS will be used
• If register data are requested, this must be adequately described

Within SCAPIS, there are specific scientific topics that are of strategic importance and provide significant value to the SCAPIS cohort. These topics are defined and prioritized as core publications, and they will be coordinated by the SCAPIS team. Applications with similar research questions will not be granted data access during a limited time period.

A list of the core publications is available here (PDF).

SCAPIS data is, as a general rule, subject to confidentiality under Chapter 24, Section 8 of the Swedish Public Access to Information and Secrecy Act (OSL), and Section 7 of the Public Access to Information and Secrecy Ordinance. Within Swedish universities/authorities, confidentiality is typically transferred when data is disclosed for research purposes, which enables the data to be shared with other research-performing universities/authorities. This is because Swedish recipients themselves apply the Public Access to Information and Secrecy Act. The confidentiality protection at the recipient remains unchanged after disclosure. See also Chapter 11, Section 3 of the OSL.

In some cases, the recipient instead applies its own primary confidentiality provision of equivalent strength, which also ensures that the protection remains unchanged after disclosure, thereby making it possible to share the data.

Using SCAPIS data in research involving foreign parties is more complex, but not impossible. It requires that you, as a researcher, seek support from your university’s/authority’s legal and data protection functions to handle the confidentiality and GDPR-related issues that may arise. Each university/authority must make an individual assessment.

SCAPIS considers the following factors to be of great importance when assessing confidentiality in collaboration with a foreign party:

1. The data must be pseudonymized (the key code must not be disclosed).
2. There must be no possibility of so-called indirect identification of individuals in the dataset (this may mean that certain variables need to be removed).
3. The research collaboration must be supported by a Swedish ethical approval.
4. An agreement must be established with the counterpart that includes confidentiality clauses.

The SCAPIS study is a Swedish multicentre collaboration between six host universities and university hospitals, and considerable time and resources have been invested to enable the completion of the study including more than 30,000 participants. In order to appreciate this collaboration, all scientific publications using the full SCAPIS cohort have hitherto included authors from all six host universities.

It is important to continue to acknowledge this unique national collaboration within SCAPIS as well as endorsing these universities in future studies, also after the launch of the SCAPIS database as an open research resource. Accordingly, all forthcoming scientific publications based on the SCAPIS national database should acknowledge this national collaboration and include authors from all six participating universities. The applicant is obliged to invite one co-author from each host university to take part in the study.

The invited host university co-author has the right to renounce co-authorship and contact the local PI to suggest a replacement. The Vancouver guidelines for authorship must be followed.

Researchers will be asked to return any new variables created from SCAPIS data or other SCAPIS resources to the SCAPIS database in a predefined format.

SCAPIS is a collaborative project and a result of the hard work of many people and the generous contributions of the study participants. To make best possible use of the data, the following conditions apply.