FAQ

Here are some of the most common questions and answers to help the researcher. If you have any questions regarding your application, you can contact the Regional Medical Research Ethics Committee before submitting your application. If necessary, you will receive personal counselling from senior specialist (kirsi.luoto(at)pshyvinvointialue.fi, tel. 044 717 2102). In addition, you can request a preliminary review of your application if you deliver the documents in time (min. 2–3 days before the due date of the documents) for viewing. This will ensure an efficient handling of your application by the committee and speed up the beginning of your study.

When do I need an opinion from the Regional Medical Research Ethics Committee?

Regional Medical Research Ethics Committee issues opinions on medical research in accordance with the Medical Research Act (Medical Research Act).

Medical research refers to research that interferes with the physical or mental integrity of a human or human embryo or foetus and is intended to increase knowledge about health, causes, symptoms, diagnostics, treatment, prevention or the essence of diseases in general, and is not a clinical pharmaceutical trial. Included are nursing and health science research, sports science research and nutritional science research.

Interference with integrity means, for example, performing an invasive procedure to the research subject due to the study (e.g. a treatment or rehabilitation procedure), taking a sample (blood sample, a tissue sample) or asking for personal or sensitive health information (e.g. suicidal thoughts, falling ill with cancer).

Research for which an opinion of the Regional Medical Research Ethics Committee is not required under the Research Act include, for example, register studies, where data is retrieved only from registers or patient records, as well as interview or survey studies that do not interfere with the subject's mental integrity. In addition, projects related to quality assurance and evaluation as well as developmental projects do not require the opinion from Regional Medical Research Ethics Committee.

What documents do I have to send to the Regional Medical Research Ethics Committee?

The Regional Medical Research Ethics Committee needs all the latest documents according to which the research is to be conducted. The documents must include a version number and / or date as they are needed e.g. to determine which version of the research plan has had the favourable opinion from the Committee.

A signed application for a opinion and the necessary attachments shall be submitted to the Committee. A opinion must be applied for new medical research, a substantial modification, and for biobank research, unless it is processed in the biobank.

In addition, notifications of non-substantial modifications and notifications of other changes as well as annual reports shall be submitted to the Committee. A list of documents and the Committee’s instructions for researchers can be found on the website of the Regional Medical Research Ethics Committee, Documents to be Submitted.

How will I submit the application to the Regional Medical Research Ethics Committee?

New applications for a opinion, modifications, notifications, annual reports, additional clarification requested by the Committee, suplementary reports and additions will be sent 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.

The instructions for researchers can be found on the website of the Regional Medical Research Ethics Committee, Documents to be submitted.

The documents must be submitted no later than 12 noon on the due date (date of submission of the documents). Applications submitted after this will be postponed to be handled in the next meeting.

What does the Regional Medical Research Ethics Committee pay attention to when assessing a research plan?

The Regional Medical Research Ethics Committee will evaluate the matters stipulated by the Research Act. In addition, the Committee has drafted detailed instructions on matters that the members of the committee will pay attention to when assessing the application. Particular attention will be paid to the safety and the implementation of the rights of the research subjects, the scientific value and validity of the research and the legality of the research. The instructions can be found on the website of the Regional Medical Research Ethics Committee, Documents to be Submitted.

What does the assessment of the ethical aspects of the study include?

The application must be accompanied by a separate assessment of the ethics of the research. This assessment considers, among other things, the relationship between the benefits and risks of the research from the viewpoint of the research subjects and from the viewpoint of the objectives of the research, as well as whether the difference between medical care and research is made understandable to the research subjects. In addition, the assessment should consider the recruitment of the research subjects, their informed consent, and informing them in the beginning and during the research. More detailed instructions can be found on the website of the Regional Medical Research Ethics Committee, Documents to be Submitted.

How do I draft a informed consent and consent for the subject?

There are templates and instructions for drafting informed consect and consent for the research subjects on the website of the Regional Medical Research Ethics Committee, Documents to be Submitted. The templates should be used with consideration to the characteristics of the research in question.

When can I start conducting the research in practice?

Medical research can be started after the research has received a favourable opinion from the Regional Medical Research Ethics Committee, all other official permits required for the research (e.g. Fimea's permit for clinical device research) and the research permit of the organisation. The Regional Medical Research Ethics Committee does not issue a research permit, but provides an opinion on the ethics of the research for the party issuing the permit.

Where can I get help with drafting an application for an opinion from the Regional Medical Research Ethics Committee?

The Regional Medical Research Ethics Committee of the Wellbeing Services County of North Savo has a website that contains instructions and templates for drafting an application for a opinion. In addition, if necessary, you will receive personal counselling from senior specialist (kirsi.luoto(at)pshyvinvointialue.fi, tel. 044 717 2102). It is worth asking for advice in advance. You will also get a preliminary review of your documents if you deliver them in time (min. 2–3 days before the date of return of the documents) for viewing. This will speed up the handling of your application by the Committee.