Finland: Medical Research Act

Unofficial translation Statute No. 488/1999 Medical Research Act Issued in Helsinki on 9 April 1999 Chapter 1 General provisions Section 1 Scope of application This Act applies to medical research carried out on persons, human embryos and human foetuses, save as otherwise provided in law. Section 2 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 the causes, symptoms, diagnosis, treatment and prevention of diseases or the nature of disease in general; (2) ‘embryo' means a living group of cells resulting from fertilisation not implanted in a woman's body; and (3) ‘foetus' means a living embryo implanted in a woman's body. Section 3 General conditions governing medical research Medical research shall respect the inviolability of human dignity. Before any research provided for in this Act is undertaken, the ethics committee shall have given a favourable opinion on the research plan. Where researchers alter their research plan, they shall notify the ethics committee, which shall, if necessary, deliver a new opinion. Where the ethics committee delivers a negative opinion, the researchers may bring the matter before the committee for reconsideration. The ethics committee shall then seek the opinion of the relevant sub-committee of the National Advisory Board on Health Care Ethics.   Chapter 2 Medical research on persons Section 4 Weighing up benefits and harmful effects In medical research the interests and well-being of the research subject shall always be put before any benefits to science or society. Measures shall be taken to prevent any risks or harmful effects to the research subject, as far as possible. Research subjects may be exposed only to measures where the expected health or scientific benefit is unequivocally greater than the potential risks or harm to the research subject. Section 5 People in charge of research Medical research may be conducted only under the responsibility of a medical doctor or dentist with the adequate professional and scientific qualifications. The person in charge of the research shall ensure that there are competent staff and suitable tools and equipment available for the research and that the research is otherwise conducted under safe conditions. The person in charge shall also ensure that the research is conducted in accordance with the provisions of this Act, the international obligations covering the status of research subjects and the rules and guidelines that govern research. The person in charge shall stop the research immediately where required for the safety of the research subject. Section 6 Consent of research subjects Medical research on persons may not be conducted without the research subject's informed consent in writing. Exceptions to this may be made where consent cannot be obtained owing to the urgency of the matter and the patient's state of health and the measure is expected to be of immediate benefit to the patient's health. Research subjects shall have their rights, the purpose and nature of the research and the procedures it involves properly explained to them. The potential risks and harm shall also be properly explained to them. This information shall be given so that research subjects are in a position to give their informed consent as regards issues connected with the research that have a bearing on their decision-making. Research subjects shall be entitled to withdraw their consent at any point prior to the completion of the research. They shall be informed of this right before the start of the research. 2 Further provisions on the content of the document giving consent shall be issued by Decree. Section 7 Research involving persons not able to consent People who, owing to a mental health disorder, retardation or other similar reason, do not have the capacity to give their consent to research may be research subjects only where it is not possible to obtain the same scientific results using other research subjects and where the risk of harming or distressing the research subject is only very slight. It shall be further required that: (1) the research should be likely to be of direct benefit to the research subject's health; or (2) the research should be likely to be of special benefit to the health of people in the same age group or with the same state of health. Persons not able to consent as referred to above may be research subjects in the cases set out in paragraphs 1 and 2 above only where written consent for this has been given by their close relative or other relative or legal representative after being provided with the information referred to in section 6 (2). Consent may be withdrawn on the same terms as set out in section 6 (3). Where a person not able to consent opposes a research measure, it may not be performed on them. Section 8 Research involving minors Minors may be research subjects only where it is not possible to obtain the same scientific results using other research subjects and where the risk of harming or distressing the research subject is only very slight. It shall be further required that: (1) the research should be likely to be of direct benefit to the research subject's health; or (2) the research should be likely to be of special benefit to the health of people in the same age group or with the same state of health. Where the minor has reached the age of 15 and, in view of their age and maturity and the type of illness and research, is capable of understanding the importance of the research procedure and the research is likely to be of direct benefit to their health, it shall be sufficient for them to give their informed consent in writing. In such cases the guardian shall be informed of this. In other cases minors may be research subjects only where written consent for this has been given by their guardian or legal representative after being provided with the information referred to in section 6 (2). Consent may be withdrawn on the same terms as set out in section 6 (3). 3 Where minors who, in accordance with paragraph 3, are not entitled to be research subjects without the consent of their guardian or other legal representative, are capable of understanding the importance of the research procedure to be carried out on them, their written consent shall also be required. Where a minor opposes a research procedure, their opinion shall be complied with, taking account of their age and maturity. Section 9 Research involving pregnant women and nursing mothers Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the same scientific results using other research subjects and: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or nursing mothers, or to foetuses, new-born children or unweaned children. Section 10 Research involving prisoners Prisoners may be research subjects only where the research is likely to be of direct benefit to their own health or the health of people related to them or the health of other prisoners. Chapter 3 Research involving embryos and foetuses Section 11 Conditions governing research involving embryos Research on embryos outside a woman's body may be carried out only by agencies that have been granted the appropriate licence by the National Authority for Medicolegal Affairs. The conditions for the granting of the licence shall be laid down by Decree. Medical research shall be permitted on embryos only if no more than 14 days have passed from their formation. The time during which an embryo is kept frozen shall not count for the purposes of calculating this time limit. Section 12 Consent for research on embryos Research on embryos outside a woman's body may not be undertaken without the written consent of the persons who donated the gametes. The donors shall be provided with the information referred to in section 6 (2). Consent may be withdrawn on the same terms as set out in section 6 (3). Embryos produced from donated gametes may not be used for research once the withdrawal of consent has been received. Research on an embryo inside a woman's body may not be undertaken without her written consent. Section 13 Restrictions on research on embryos The production of embryos exclusively for the purpose of research shall be forbidden. Embryos that have been used for research may not be implanted in a human body or be kept alive for longer than 14 days from their formation, not including any time during which they have been kept frozen. Research may use embryos that have been stored for up to 15 years, after which the embryos must be destroyed. Section 14 Consent for foetal research Research on a foetus may not be undertaken without the written consent of the pregnant woman. The conditions governing the consent procedure and the research subject are as laid down in sections 6-10, as applicable. Section 15 Prohibited research Research on embryos and gametes for the purpose of developing procedures for modifying hereditary properties shall be prohibited, unless the research is for the purpose of curing or preventing a serious hereditary disease. Chapter 4 Ethics committees Section 16 Establishment Each hospital district shall have at least one ethics committee. There may also be joint ethics committees. Section 17 Duties Ethics committees shall be responsible for prior evaluation of research projects and delivering opinions on them. Projects shall be considered by the ethics committee of the region where the person in charge of the research is based or of the region where the research is to be principally conducted. In their opinions ethics committees shall give their reasoned view on whether or not the research is ethically acceptable. Clinical trials on medicinal products that require a national opinion to be delivered shall be considered by the relevant sub-committee of the National Advisory Board on Health Care Ethics, unless that sub-committee has delegated the task to a regional ethics committee. For the purposes of delivering the opinion, ethics committees shall examine whether the research plan has taken account of the provisions of this Act, data protection legislation, the international obligations covering the status of research subjects and the rules and guidelines that govern medical research. Ethics committees shall also monitor and direct the handling of issues in research ethics in their region. Provisions on fees to be charged in respect of opinions shall be laid down by decision of the relevant Ministry. Section 18 Composition Ethics committees shall have a chairperson and at least six other members, one of whom shall be the deputy chairperson. There shall be an appropriate number of substitutes for the members. Apart from medicine, ethics committees shall also contain representatives from other areas. At least two members shall be laypersons. Decisions on opinions shall be taken with the participation of the chairperson or the deputy chairperson and at least half the other members or at least four of the other members, whichever is the greater. When decisions on opinions are taken, the members shall include at least one layperson and two people from outside the research unit. Section 19 Disqualification of a member Disqualification of a member of an ethics committee shall be governed by the provisions on the disqualification in regard to civil servants laid down in the Administrative Procedure Act (598/1982). Section 20 Duty of notification Hospital districts shall notify the Provincial State Office of the setting up or dissolution of ethics committees, their composition and any changes to them and contact details for them. On the basis of these notifications the Provincial State Offices shall keep a register of ethics committees in their area. Chapter 5 Special provisions Section 21 Remuneration of research subjects No payment shall be made for participating in the research to the research subjects, their guardians, close relatives, any other persons closely connected with them, or to their legal representative. However, an appropriate remuneration may be paid in respect of expenses or loss of earnings or for any other inconvenience suffered as a result of the research. Grounds on which payment may be made shall be laid down by the relevant ministry. Section 22 Supervision and withdrawal of licence The National Authority for Medicolegal Affairs can revoke the licence referred to in section 11 if the research organisation fails to observe the provisions or regulations which apply. In the event of defects or irregularities, the National Authority for Medicolegal Affairs may decide that the research shall be suspended until the defects or irregularities have been rectified or may withdraw the licence previously granted. The decision to revoke a licence shall be complied with even if an appeal has been lodged against the decision. For the purposes of overseeing this Act and the provisions and regulations laid down in virtue of it, the National Authority for Medicolegal Affairs shall have the right to inspect the premises and activities of establishments which have been granted a licence as referred to in section 11 and to inspect any documents required for the exercise of this supervision. Section 23 Official accountability and duty of confidentiality Those responsible for research and the members of the ethics committees shall be governed by the principle of official accountability. Confidential information obtained in the course of activities in relation with this Act and relating to research plans, personal information concerning other persons, their state of health, personal circumstances or financial status or business or trade secrets, must not be disclosed to a third party. Section 24 Further provisions Further provisions on the implementation of this Act shall be laid down as necessary by Decree. If necessary, the relevant ministry shall issue more detailed regulations and instructions concerning the drawing up and keeping of research documents and on the information to be given to research subjects. Chapter 6 Penal provisions Section 25 Unlawful research on embryos and gametes Any person who conducts research on embryos without the licence referred to in section 11 or in contravention of the restrictions laid down in sections 11 and 13, or who in contravention of the prohibition in section 15 conducts research on embryos or gametes, shall be fined or imprisoned for a period not exceeding a year for unlawful research on embryos and gametes. Section 26 Unlawful intervention on the genome Any person who conducts research with the aim of : (1) cloning human beings; (2) creating a human being by combining embryos; (3) creating a human being by combining human gametes and genes from animals, shall be fined or imprisoned for a period not exceeding two years for unlawful intervention on the genome. Section 27 Breach of the Medical Research Act Any person who conducts medical research (1) without the consent referred to in sections 6-8, 12 or 14, (2) without the favourable opinion of the ethics committee in violation of section 3, (3) in violation of the conditions laid down in sections 5-10, shall be fined for breach of the Medical Research Act. Section 28 Breach of confidentiality Upon conviction of any breach of the duty of confidentiality laid down in section 23 a penalty may be imposed under Chapter 38, section 1 or 2, of the Penal Code (39/1889), unless the action is punishable under Chapter 40 section 5, or a more severe penalty is laid down by other legislation. Chapter 7 Entry into force and transitional provisions Section 29 Entry into force This Act enters into force on 1 November 1999. Measures necessary for the implementation of the Act may be undertaken before it enters into force. Section 30 Transitional provision The provisions of this Act shall, where applicable, apply to research projects already under way when the Act enters into force. The provisions of the Act shall also apply to the specimens taken of people, human gametes and human embryos that are being stored when the Act enters into force. Every hospital district in which research covered by this Act is being undertaken shall submit a notification in accordance with section 20 within six months of entry into force of this Act. Any institution where research of the type referred to in section 11 is being undertaken when the Act enters into force shall apply to the National Authority for Medicolegal Affairs for a licence for its activities within six months of entry into force of this Act. The work may continue until the application has been processed. The National Authority for Medicolegal Affairs shall decide on a licence application within one year of the date on which the application was received.