Tutkimuslupa

Research permit 


Scientific research in the wellbeing services county of North Savo requires a research permit. The permit is a prerequisite for the validity of, for example, patient injury insurance and employer obligations. The research permit is applied for through eTutkija. 
 
eTutkija is intended as a tool for researchers to facilitate the processing of research applications and reports as well as permit issues. eTutkija is logged into through the professional side of the OmaKYS e-service. The service uses the Suomi.fi identification service. 
 
All previously saved applications that can be reused are available on eTutkija, for example, when applying for further funding. 
 
Depending on the type of research, other official permits, statements and notifications are also required. (e.g. Fimea's permit for clinical pharmaceutical trials, permit for tissue and device studies, Findata's permit for register studies). The study shall not be initiated until all permits and statements have been granted. 

ORCID researcher identifier 

It is recommended that researchers apply for an international and digital ORCID researcher identifier. The identifier facilitates the researcher's work and improves exposure. In addition, the researcher will be connected with his own publications. For more information, see the website of the ORCID service. 

Permit conditions of the wellbeing services county of North Savo 

Authorisation for scientific research and access to confidential data in accordance with the decision (29.5.2019) shall be granted subject to the following conditions: 

Tutkimuslupa, haitari

  • The permit is granted for a fixed period, in accordance with this decision (including access to information from registers). The time limit may be extended on application, if necessary. 
  • The permit may be cancelled if the terms included in the permit decision or the legislation concerning the processing of personal data are violated. In such a situation, the recipient of the permit must return the information obtained for the research. 
  • The recipient of the permit must notify the wellbeing services county of North Savo (hereinafter WSCNS) of any significant changes relating to the research that may affect the granted permit. The changes may relate to the research plan, schedule, research team, funding, record keeping or other such essential changes. After receiving the notification, the WSCNS will consider whether the notified change necessitates a new permit. 
  • The recipient of the permit is obligated to notify the permit decision to all members of the research group and supervise compliance with the permit terms (including subcontractors). 
  • The recipient of the permit (senior researcher, researcher) undertakes to comply with the legislation and guidelines for conducting scientific research (e.g. the research act and ICH-GCP) as well as ethical principles and the guidelines and procedures of the WSCNS. 
  • The recipient of the permit, who works for THE WSCNS as an employee, commits to assigning and transferring the copyrights of the materials it performs as an employee to the WSCNS to the extent required by legislation, terms of funding and / or other agreements, and sees to the matter on behalf of the research team. 
  • The senior researcher shall be responsible for obtaining all statements and permissions necessary for the research, as well as any changes thereto, contracts, communications, information, registrations, administration, monitoring and practical implementation of the research, as well as reporting and archiving. 
  • The senior researcher shall ensure that qualified personnel, adequate equipment, facilities and devices are available for the study and that the study can be conducted under safe conditions. 
  • Information obtained under a permit is confidential and may only be used for research as defined in the research plan annexed to the permit application. 
  • Under section 23 of the Act on the Openness of Government Activities, senior researchers, research team researchers and persons conducting research are obligated not to reveal any confidential information they have received under this permit, nor to use such information for their own benefit or for the benefit or detriment of another. 
  • Other data used in the research must be obtained legally with an official permit, with the consent of the subject or on some other legal basis. 
  • The controller of the study must perform an impact assessment of the processing of personal data if required by law (article 35 of the EU General Data Protection Regulation (2016/679)). 
  • Information obtained on the basis of a permit (e.g. patient records) may not be supplied, transferred or sold to a third party, nor may it be appended to data or registers other than those obtained for the purpose of this study with an official permit on consent. 
  • During the research, the controller of the study must ensure that, during the research, the research materials resulting from the research that enable the identification of an individual are kept as separate materials from patient records or from other client, service or administrative records, and are protected from unauthorized access to the data at all stages of the processing, both for manual and electronic files, so that only the persons mentioned in the permit have the right to process the data. 
  • Confidential information obtained under the permit is not used in decision-making concerning individual research subjects, and information about an illness, or possibility thereof, may not be transmitted to a place or document where it has not been previously. 
  • At the end of the research, when the personal data is no longer necessary for the purpose of conducting the research or to ensure the appropriateness of its results, the research material enabling the identification of an individual must be destroyed or transferred for archiving, or its data altered to such a format that the subject of the data cannot be identified from them (anonymised material that cannot be returned to personal data). 
  • Any transfer of data outside the EU / EEA received under a permit must comply with the procedures laid down in the EU General Data Protection Regulation for the lawful execution of the transfer. 
  • The results of the study shall be published in such a way that individuals cannot be identified. The reporting and publication of the results must comply with the general ethical guidelines of science.