Finland – Medical Research Act (Amended)

Chapter 1 General provisions

Section 1 (794/2010) Scope of application

This Act applies to medical research, unless otherwise provided by legislation.

Section 2 (295/2004) Definitions

For the purposes of this Act:

(1) medical research means

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; (794/2010)

(2) embryo means

a living group of cells resulting from fertilisation not implanted in a woman’s body;

(3) foetus means

a living embryo implanted in a woman’s body;

(4) researcher means

a medical doctor or dentist or, if it is question of medical research or research pertaining to nursing science or health science other than clinical drug trial, also any other person with adequate professional and scientific qualifications who is in charge of carrying out a clinical trial at a research site; if a trial is carried out at a research site by a research group, researcher refers to the medical doctor, dentist or another person acting as the leader of the group; (794/2010)

(5) commissioning party means

the person, company, institution or organisation that is in charge of starting, directing or financing a clinical trial; if an outside party takes part in carrying out the trial only by financing it, the researcher and financier may agree between themselves that the researcher is also the commissioning party; if the trial is not commissioned by an outside party the researcher is the commissioning party; and

(6) clinical trial on medicinal products means

intervention research on persons for the purpose of finding out effects of a medicinal product in a human being as well as its absorption, distribution, metabolism or excretion in the human body.

Section 3 (23.4.2004/295) General conditions governing medical research

Medical research shall respect the inviolability of human dignity.

Before any research referred to in this Act is undertaken, the ethics committee shall have given a favourable opinion on the research plan. When conducting clinical trials on medicinal products the provisions of Chapter 2a and of the Medicines Act (395/1987) shall be taken into account, in addition.