Regional committee on medical research ethics

Regional Medical Research Ethics Committee of Wellbeing Services County of North Savo

The Regional Medical Research Ethics Committee of the Wellbeing Services County of North Savo issues an opinion on medical studies under the Medical Research Act in its area of responsibility. The Medical Research Act (Research Act) defines the studies that must be addressed by the Committee. Any significant changes to the study plan shall also be submitted to the Committee for consideration before continuing the study in accordance with the changed research plan.

Under the Research Act, medical research refers to research involving intervention in the integrity of a person, human embryo or human foetus for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of diseases in general, and which is not a clinical study on medicinal products, including nursing and health science research, sports science research and nutritional science research.

According to the Research Act, the statement of the Regional Medical Research Ethics Committee is generally not required, for example, for a simple interview and survey studies or studies based on patient records and/or registers that do not interfere with the integrity of the research subjects. Likewise, projects related to normal quality control or evaluation do not require a statement from the regional committee on medical research ethics. If necessary (e.g. for publication), a statement on such studies may be sought from the ethical committee of the university or other corresponding committee.

Duties of the Regional Medical Research Ethics Committee

issues a statement on medical studies in accordance with the research act
issues a statement on a change in the purpose of tissue samples if the consent of the donor of the sample is not obtained and the samples are not obtained from the biobank
issues a statement on significant changes in medical studies
issues a statement on biobank research and the transfer of sample collections to the biobank
monitors and guides the handling of research ethical issues in its area

The task of the Committee is to ensure ethical research. It also ensures that the research takes into account the obligations under the laws, regulations and decrees (e.g. research act, device act, tissue act, data protection act) as well as international obligations regarding the status of research subjects and other regulations and guidelines concerning medical research. In its statement, the Committee must express a reasoned view on whether the study is ethically acceptable. The Committee shall ensure matters related to the safety and rights of the subjects. In addition, the Committee shall monitor, guide and evaluate the handling of research ethical issues in its area.

A research plan must receive a favourable opinion from the Regional Medical Research Ethics Committee before starting of the study. In addition, a study requires, among other things, a research permit from the research site. Medical studies shall be registered in a public and independent international clinical research register before starting of the study.