Rules and Guidelines

SIMPLER’s database and biobank are available and accessible to scientists in academia, other government agencies, or the business sector. Project requests are handled continuously in a transparent process.

Project requests via an application must be approved by SIMPLER in order to obtain data and/or samples. Approval of a project request entails confirmation of an approved ethical review by a Swedish ethical review board, and verification of funding for the project by the responsible PI. In addition, when appropriate, a Personal Data Processing Agreement or Material Transfer Agreement must be signed before data and/or samples are made available, respectively.

Accessing the database and biobank

• All project requests must follow the procedure for application, as specified in Data Access.
• A project must have an explicit and well-defined hypothesis or research question and a description of relevant analyses. For biological samples, the choice of biomarker must be clearly motivated.
• Each project must have an ethical approval from a valid Swedish ethical review board, i.e. the Swedish Ethical Review Authority. A guide for how to complete your ethical application as it relates to the SIMPLER proposal, you can download this template Pdf, 774 kB. (pdf). The template is only available in Swedish; the ethical application is required to be written in Swedish when it is sent to the Swedish Ethical Review Authority. Note that some headers in the template may have been updated on the EPM submission portal and the headers may not align perfectly.
• If the director of SIMPLER were to reject a project request, the applicant can submit an appeal to the Steering Committee of SIMPLER for a second review.
• Project requests with similar hypotheses or research questions will be approved, but the PIs of the projects will be informed of each other’s projects and encouraged to collaborate. Check the Ongoing Projects page if you want to ensure your project is unique.
• If a project has financed analyses of biological samples, an embargo will be placed on the resulting data before the data is made available to other projects. The embargo period is three years from the day when the analysis has completed.
• Since the biological samples are a finite resource, and SIMPLER has a responsibility towards participants and funders, requests for samples from the entire subcohort or samples with high scientific value that provide the infrastructure with informative data are prioritized. This is decided by the director of SIMPLER and/or Steering Committee of SIMPLER on a case-by-case basis.
• All processing and storage of data must be performed within a secure technical solution for sensitive personal data, as specified within the SIMPLER framework. Users apply for access to this technical solution, and data are delivered to a project-specific folder within this solution. Data must not be moved from this folder; users are only allowed to download result files from the technical solution.

Delimitation of a research project

A project is limited to a maximum of three related and specific research questions, and has a duration of up to five years from when data are first received. Up to five publications/manuscripts are permitted per project application.

To extend the project or to be able to include more than five publications within a single project application, a new application and user fee are required. If users would like to request additional data in an ongoing project, an amendment to the project application must be submitted and approved before analysis can begin. If the earlier-received data and/or samples were to be used in a new project, a new application must be submitted and approved before analysis can begin.

Delimitation of a student project

The following requirements must be met for a project to be considered as a student project:

• In the project application submitted to SIMPLER, the course syllabus and the student's register extract or equivalent documentation (e.g. LADOK or academic transcript) must be attached, in addition to the required documentation.
• The scope of the work must be such that it can result in a maximum of one scientific publication, and a written report that may be required, as specified in the course syllabus.

User obligations

• Users must return newly-generated data and/or variables obtained from independently financed analyses to SIMPLER in order to benefit the infrastructure. This is done in collaboration with SIMPLER office. In addition to the data and/or variables, a report must be included. This report contains the quality control procedures, information about the data and data format, material and methods used to generate the data and/or variables.
• Upon request from the SIMPLER office, the responsible PI is obligated to provide a project progress once a year for SIMPLER’s annual report and report to SIMPLER’s funders.
• The Swedish Research Council, as the primary funder of the SIMPLER infrastructure, may conduct a scientific evaluation of the infrastructure, and SIMPLER requires that users provide SIMPLER and the funder full access to their SIMPLER-related research documentation and material (excluding any sensitive personal data).

Publication policy

For publication of scientific articles and other dissemination of results based on data and/or samples from SIMPLER, refer to Publication policy.