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Research, Documents to be submitted
Documents to be Submitted
Applications for opinions are sent to the Regional Medical Research Ethics Committee Wellbeing Services County of North Savo for evaluation through eTutkija. eTutkija is logged into through OmaKYS-online service with a certificate card, mobile certificate or banking credentials. Paper versions do not need to be sent separately.
All applications to the Committee (new applications for statements, significant changes, non-significant changes, notifications, annual reports, and additional clarifications and supplements) must be conducted through eTutkija. eTutkija makes the work of researchers easier and faster when submitting applications. In addition, it enhances operations and ensures the security and confidentiality of documents.
Applications for opinions and additional reports must be submitted to the Committee no later than at 12 noon on the due date (documents’ date of submission). Late applications and additional reports will be postponed to be handled in the next meeting. The processing of statements by the Regional Medical Research Ethics Committee takes about 1–2 weeks.
Application Process for an Opinion of the Regional Medical Reserch Ethics Committee (pdf)
If you have questions about your application, you can contact the Committee before submitting your application. If necessary, you will receive personal advice from the senior specialist (kirsi.luoto(at)pshyvinvointialue.fi, tel. 044 717 2102). In addition, you can request a preliminary review of your application if you submit it in time (min. 2–3 days before the due date of application) for viewing. This will ensure an efficient handling of your application by the Committee and speed up the beginning of your study.
Haitari, documents to be submitted
The documents must contain the version number and / or date. The application cannot be processed if the documents are so incomplete that the Committee cannot issue opinion on their basis. A specialist or the chairperson of the Committee shall contact the applicant if the application is found to be incomplete. The opinion application form and the appendices shall be submitted through eTutkija.
The Regional Medical Research Ethics Committee shall be provided with opinion application
- lausuntohakemuslomake (in Finnish, Word) (signed opinion application form)
Appendices
- original research plan (Finnish summary, if necessary)
- the research plan (the use of the Academy of Finland’s template)
- the research plan shall set out the scientific questions of the research/the purpose of the research
- the research plan must also include, among other things, matters related to the recruitment of subjects, sample size and methods used
- the research plan does not contain an assessment of the ethics of the research, it must be drafted separately
- separate assessment of the ethical aspects of the research (pdf)
- informed consent and consent (template) (Word)
- instructions for filling in the informed consent for the research subject (pdf)
- informed consect and consent form for paediatric pharmaceutical studies (FINPEDMEDI templates, link)
- other material to be distributed to the research subject
- other documents and statements
Please note: No privacy statement or impact assessment needs to be submitted to the Regional Medical Research Ethics Committee.
Please check that the following instructions have been taken into account in the research plan and the ethical assessment of the study:
The Regional Medical Research Ethics Committee shall be provided with opinion application
- lausuntohakemus merkittävästä muutoksesta (in Finnish, Word) signed opinion application for a substantial modification
Appendices
- free-form summary on modifications in Finnish
- signed assessment of the ethical aspects of the study (e.g. impact of the modifications on the course of the research)
- new modified documents with version dates and changes clearly marked and also visible in black and white printing (e.g. italics / bold, omissions with strikethrough)
A substantial modification means, generally, a change to the research plan or other document submitted with an application that affects at least one of the following:
- physical or mental integrity of the subjects
- the scientific value and relevance of the research plan
- implementation of the research plan
- quality or safety of the product under investigation
Substantial modification include changes in the research that affects the safety, health or rights of its research subjects or the scientific value of the research, the certainty or reliability of the clinical data generated in the research. In addition, changes in the number of subjects, new examinations performed on the subjects, changes in the number of examination visits, changes in the seetting of the research, changes in the endpoints of the research, changes in the criteria for inclusion and exclusion of the research, and changes in the sponsor or principal investigator are significant modifications.
For more information about significant modifications, see the EU Commission's guidelines and examples of substantial and non-substantial modifications (pdf).
- Lausuntohakemus biopankkitutkimuksesta (in Finnish, Word) application for a opinion on biobank research
- Lausuntohakemus näytteiden siirrosta biopankkiin ja käytöstä biopankkitutkimuksessa (in Finnish, Word) application for a opinion on the transfer of samples to a biobank and use in biobank research
The Regional Medical Research Ethics Committee ethics shall be provided with
- free-form notification or cover letter
- summary of the modifications made
- new modified documents with version dates and modifications clearly marked and also visible in black and white printing (e.g. italics / bold, omissions with strikethrough)
Changes to the Researcher's Information Brochure
The changes to the Investigator's Brochure (IB) shall be accompanied by a Finnish summary as an attachment to the English IB and a statement from the person responsible (Principal Investigator) for the research.
A report on the safety of the research subjects is needed as an attachment to the annual report. Unexpected serious adverse reactions from pharmaceutical studies are reported to Fimea.
The Regional Medical Research Ethics Committee shall be provided with
- response to the requested additional clarifications and a summary of the modofications made
- all modified documents
The modifications must be clearly marked on the documents and visible also in black and white printing (e.g. italics/bold, omissions with strikethrough). If no requested modification have been made, the decisions must be justified in a cover letter.
The remuneration of research subjects must complie with the principles of the decree 82/2011 of the Ministry of Social Affairs and Health.
Fees for opinion issued by the Regional Medical Research Ethics Committee shall be decided by the Regional Government of the Wellbeing Services County of North Savo.
Clinical medicine trials are evaluated by the National Research Ethics Committee (Tukija). The documents and instructions to be used can be found on Tukija's website.
It is not necessary to notify the Regional Medical Research Ethis Committee of North Savo of research which have received a favourable opinion from other regional ethics committee.
More detailed information on data protection regulations can be found on the website of the data protection ombudsman.