79C3C34C52B45572883A05D425EB0F82
Medical Research Act No. 488/1999
http://www.finlex.fi/en/laki/kaannokset/1999/en19990488_20100794.pdf
http://leaux.net/URLS/ConvertAPI Text Files/258189A47693A61D6346E44D139FBD3E.en.txt
Examining the file media/Synopses/258189A47693A61D6346E44D139FBD3E.html:
This file was generated: 2020-12-01 05:49:24
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
p.000005: The party commissioning a clinical trial on medicinal products shall see to it that there is an insurance policy or
p.000005: other appropriate guarantee to cover the liability of the party and the researcher.
p.000005:
p.000005: Section 10 c (780/2009)
p.000005:
p.000005: Start of research
p.000005:
p.000005: A clinical trial on medicinal products may be started only after the ethics committee has delivered an opinion in
p.000005: favour of it, and on the condition that the Finnish Medicines Agency has granted it the licence required in
p.000005: the Medicines Act or it has not informed of any obstacle to starting the research as laid down in the Medicines Act.
p.000005:
p.000005: Section 10 d (295/2004)
p.000005:
p.000005: Opinion of the ethics committee
p.000005:
...
Political / Illegal Activity
Searching for indicator unlawful:
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p.000011: Further provisions on the implementation of this Act are laid down as necessary by Government decree.
p.000011:
p.000011: If necessary, further provisions concerning the drawing up and keeping of research documents, the form for
p.000011: the request for opinion to be made to the ethics committee and the documents to be attached to it, delegating
p.000011: requests for opinion to regional ethics committees and on the information to be given to research
p.000011: subjects are laid down by decree of the Ministry of Social Affairs and Health.
p.000011:
p.000011: Chapter 6 Penal provisions
p.000011: Sections 25–26 were repealed by Act 375/2009.
p.000011:
p.000011: Section 27 (375/2009)
p.000011:
p.000011: Breach of the Medical Research Act
p.000011:
p.000011: Any person who conducts medical research
p.000011:
p.000011: (1) without the consent referred to in sections 6–8,
p.000011:
p.000011: (2) without the favourable opinion of the ethics committee in violation of section 3,
p.000011:
p.000011: (3) in violation of the conditions laid down in sections 5–10,
p.000011:
p.000011: (4) without observing the provisions of sections 10 b, 10 c and 10 e – 10 g in the research,
p.000011:
p.000011: shall be fined for breach of the Medical Research Act.
p.000011:
p.000011: Section 28 (375/2009)
p.000011:
p.000011: References to the Penal Code
p.000011:
p.000011: Penalty for unlawful intervention on the embryo is imposed under Chapter 22, section 3, of the Penal Code (39/1889) and
p.000011: penalty for unlawful intervention on the genome under its Chapter 22, section 4. Upon conviction of any breach of the
p.000011: duty of confidentiality
p.000012: 12
p.000012:
p.000012: laid down in section 23 a of this Act penalty may be imposed under Chapter 38, section 1 or 2, of the Penal Code,
p.000012: unless the action is punishable under Chapter 40, section 5, or a more severe penalty is laid down by other
p.000012: legislation.
p.000012:
p.000012: Chapter 7
p.000012:
p.000012: Entry into force and transitional provisions Section 29
p.000012: Entry into force
p.000012:
p.000012: This Act enters into force on 1 November 1999.
p.000012:
p.000012: Measures necessary for the implementation of the Act may be undertaken before its entry into force.
p.000012:
p.000012: Section 30
p.000012:
p.000012: Transitional provision
p.000012:
p.000012: The provisions of this Act shall, where applicable, apply to research projects already under way when the
p.000012: Act enters into force. The provisions of the Act shall also apply to the specimens taken of people, human gametes and
p.000012: human embryos that are being stored when the Act enters into force.
p.000012:
p.000012: Every hospital district in which research covered by this Act is being conducted shall submit a
p.000012: notification in accordance with section 20 within six months of entry into force of this Act.
p.000012:
p.000012: Any institution where research of the type referred to in section 11 is being conducted when the Act enters into
p.000012: force shall apply to the National Authority for Medicolegal Affairs for a licence for its activities within six
p.000012: months of entry into force of this Act. The work may continue until the application has been processed. The National
...
Political / political affiliation
Searching for indicator party:
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p.000002: No. 488/1999
p.000002:
p.000002: Medical Research Act
p.000002:
p.000002:
p.000002: Chapter 1 General provisions Section 1 (794/2010) Scope of application
p.000002: This Act applies to medical research, unless otherwise provided by legislation.
p.000002:
p.000002: Section 2 (295/2004)
p.000002:
p.000002: Definitions
p.000002:
p.000002: For the purposes of this Act:
p.000002:
p.000002: (1) medical research means research involving intervention in the integrity of a person, human embryo or human foetus
p.000002: for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of
p.000002: diseases or the nature of diseases in general; (794/2010)
p.000002:
p.000002: (2) embryo means a living group of cells resulting from fertilisation not implanted in a woman’s body;
p.000002:
p.000002: (3) foetus means a living embryo implanted in a woman’s body;
p.000002:
p.000002: (4) researcher means a medical doctor or dentist or, if it is question of medical research or research pertaining to
p.000002: nursing science or health science other than clinical drug trial, also any other person with adequate professional
p.000002: and scientific qualifications who is in charge of carrying out a clinical trial at a research site; if a trial is
p.000002: carried out at a research site by a research group, researcher refers to the medical doctor, dentist or another person
p.000002: acting as the leader of the group; (794/2010)
p.000002:
p.000002: (5) commissioning party means the person, company, institution or organisation that is in charge of starting,
p.000002: directing or financing a clinical trial; if an outside party takes part in carrying out the trial only by financing it,
p.000002: the researcher and financier may agree between themselves that the researcher is also the commissioning party; if the
p.000002: trial is not commissioned by an outside party the researcher is the commissioning party; and
p.000002:
p.000002: (6) clinical trial on medicinal products means intervention research on persons for the purpose of finding out effects
p.000002: of a medicinal product in a human being as well as its absorption, distribution, metabolism or excretion in the human
p.000002: body.
p.000002:
p.000002: Section 3 (295/2004)
p.000002:
p.000002: General conditions governing medical research
p.000002:
p.000002: Medical research shall respect the inviolability of human dignity.
p.000002:
p.000002: Before any research referred to in this Act is undertaken, the ethics committee shall have given a favourable
p.000002: opinion on the research plan. When conducting clinical trials on medicinal products the provisions of Chapter
p.000002: 2 a and of the Medicines Act (395/1987) shall be taken into account, in addition.
p.000002:
p.000002: Where the commissioning party alters the research plan so that the alteration may affect the safety of the research
p.000002: subjects or the alteration has a bearing on the interpretation of the scientific documents used in support of
p.000002: the research or where the alteration is otherwise considerable, the party shall inform the ethics committee about
p.000002: it. The research may not be continued in accordance with the altered plan until the ethics committee has delivered a
p.000002: favourable opinion on it. If the committee’s opinion is negative, the plan shall be adjusted in the way called
p.000002: for in the opinion before continuing the research or, alternatively, the research can be continued
p.000002: according to the original plan unless the safety of the research subjects requires that the research is suspended
p.000002: or terminated. In addition, the Finnish Medicines Agency (FIMEA) shall be informed about any alteration to the research
p.000002: plan regarding a clinical trial on medicinal products as laid down in the Medicines Act. (780/2009)
p.000002:
p.000002: Where the ethics committee delivers a negative opinion, the commissioning party may bring the matter before the
p.000002: committee for reconsideration. The regional ethics committee shall at the request of the commissioning party
p.000002: seek the opinion of the National Committee on Medical Research Ethics before delivering a new opinion on the
p.000002: matter. (794/2010)
p.000002:
p.000002: Chapter 2
p.000002:
p.000002: Medical research on persons Section 4
p.000002: Weighing up benefits and harmful effects
p.000002:
p.000002: In medical research the interests and well-being of the research subject shall always be put before any benefits to
p.000002: science or society. Measures shall be taken to prevent any risks or harmful effects to the research subject, as far as
p.000002: possible.
p.000002:
p.000002: Research subjects may be exposed only to measures where the expected health or scientific benefit is
p.000002: unequivocally greater than the potential risks or harm to the research subject.
p.000002:
p.000002: Section 5
p.000002:
p.000002: People in charge of research
p.000002:
p.000002: Medical research may be undertaken only under the responsibility of a medical doctor or dentist with the adequate
p.000002: professional and scientific qualifications. If it is question of research other than clinical drug trial,
p.000002: also another person than a medical doctor or
p.000002:
p.000002: 2
p.000002:
p.000002: dentist may be responsible for the research, provided that the person has the professional and scientific
p.000002: qualifications required for the research concerned. (794/2010)
p.000002:
p.000002: The person in charge of the research shall ensure that there are competent staff and suitable tools and
p.000002: equipment available for the research and that the research is otherwise conducted under safe conditions. The person in
p.000002: charge shall also ensure that the research is conducted in accordance with the provisions of this Act, the
p.000002: international obligations concerning the status of research subjects and the rules and guidelines that
p.000002: govern research.
p.000002:
p.000002: The person in charge of the research shall suspend the research immediately where required for the safety
p.000002: of the research subject. If new knowledge related to the carrying out of the research or the medicinal product used in
p.000002: the research that has a bearing on the safety of the research subjects emerges in the course of the research, the
p.000002: person in charge of the research and the commissioning party shall immediately undertake precautionary measures to
p.000002: protect the research subjects. The commissioning party shall immediately inform the ethics committee of
p.000002: such new knowledge and of the measures undertaken based thereon. In addition, information and
p.000002: measures regarding clinical trials on medicinal products shall be immediately communicated to the
p.000002: Finnish Medicines Agency. (780/2009)
p.000002:
p.000002: Section 6 (295/2004)
p.000002:
p.000002: Consent of research subjects
p.000002:
p.000002: Medical research on persons may not be conducted without the research subject’s informed consent in writing.
p.000002: Exceptions to this may be made where consent cannot be obtained owing to the urgency of the matter and the
p.000002: patient’s state of health and the measure is expected to be of immediate benefit to the patient’s
p.000002: health. If the research subject is not able to write he or she can give the consent orally in the presence of at
p.000002: least one witness who is not dependent on the research. It is allowed to deviate from the requirement
p.000002: for written consent in research other than clinical trials on medicinal products also when giving personal
p.000002: data would be in contrary to the research subject’s interests and the research will only involve minor stress to the
...
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
p.000005: The party commissioning a clinical trial on medicinal products shall see to it that there is an insurance policy or
p.000005: other appropriate guarantee to cover the liability of the party and the researcher.
p.000005:
p.000005: Section 10 c (780/2009)
p.000005:
p.000005: Start of research
p.000005:
p.000005: A clinical trial on medicinal products may be started only after the ethics committee has delivered an opinion in
p.000005: favour of it, and on the condition that the Finnish Medicines Agency has granted it the licence required in
p.000005: the Medicines Act or it has not informed of any obstacle to starting the research as laid down in the Medicines Act.
p.000005:
p.000005: Section 10 d (295/2004)
p.000005:
p.000005: Opinion of the ethics committee
p.000005:
p.000005: The provisions of sections 3 and 17 shall apply to the opinions of the ethics committee. In addition, an opinion on a
p.000005: clinical trial on medicinal products shall take into account in particular the following circumstances:
p.000005:
p.000005: 1) appropriateness of the trial and its planning;
p.000005:
p.000005: 2) appropriateness of the assessment of its benefit and risks and justifiability of any conclusions
p.000005: regarding them;
p.000005:
p.000005: 3) the research plan;
p.000005:
p.000005: 4) suitability of the researcher and staff;
p.000005:
p.000005: 5) the researcher’s information package containing clinical and other information on the medicinal product or products
p.000005: used in the trial that is of significance when testing those medicinal products on people;
p.000005:
p.000005: 6) quality of the premises and equipment to be used in the trial;
p.000005:
p.000005: 7) sufficiency and coverage of the written information given to obtain the informed written consent and the
p.000005: procedure for obtaining the consent, and grounds for trials to be carried out on persons not able to give their
p.000005: consent;
p.000005:
p.000005: 8) the grounds on which damages possibly caused by the trial are compensated and insurance policies and
p.000005: other arrangements for covering a compensation payable on account of damages or death;
p.000005:
p.000005: 9) amount of the fee or remuneration to be paid to researchers and research subjects or the criteria for determining it
p.000005: and procedures possibly related to the matter, as well as the main content of the agreement to be concluded between the
p.000005: commissioning party and the research site; and
p.000005:
p.000005: 10) detailed procedures relating to choosing the research subjects.
p.000005:
p.000005: The ethics committee shall give its opinion to the body asking it within 60 days of having received an appropriate
p.000005: request for opinion as well as communicate it to the Finnish Medicines Agency for information. If the
p.000005: trial concerns medicinal products meant for
p.000006: 6
p.000006:
p.000006: gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms, the
p.000006: opinion must be delivered within 90 days. The committee can however extend this time limit by up to 90 days,
p.000006: if the giving of the opinion requires extensive further investigations. The ethics committee may
p.000006: ask once additional information from the party asking for opinion. There is no defined period for giving an opinion
p.000006: on xenogenic cell therapy. (780/2009)
p.000006:
p.000006: The ethics committee shall deliver its opinion on an alteration to the research plan within 35 days of having received
p.000006: the notification of alteration.
p.000006:
p.000006: The period of time during which further information is requested or delivered shall not count for the purposes of
p.000006: calculating the time limits referred to in paragraphs 2 and 3.
p.000006:
p.000006: Section 10 e (295/2004)
p.000006:
p.000006: Notification of adverse events
p.000006:
p.000006: The researcher shall immediately notify the commissioning party of any serious adverse events, except for those adverse
p.000006: events that it is not necessary to notify according to the research plan or the researcher’s information package.
p.000006: After the notification a written detailed report shall be given on the adverse event. In the
p.000006: notification and report the research subjects are identified by code numbers.
p.000006:
p.000006: The commissioning party shall be notified within the defined periods laid down in the research plan of any adverse
p.000006: events and deviating laboratory results that are defined in the research plan to be significant from the point of view
p.000006: of safety evaluation.
p.000006:
p.000006: The researcher shall communicate to the commissioning party and the ethics committee any information requested by them
p.000006: about deaths of research subjects.
p.000006:
p.000006: Section 10 f (794/2010)
p.000006:
p.000006: Notification of serious adverse effects
p.000006:
p.000006: The commissioning party shall notify the Finnish Medicines Agency and the competent authorities of the Member States of
p.000006: the European Union which the matter concerns of any fatal or life threatening unexpected adverse effects as soon as
p.000006: possible, at the latest in seven days from the day on which the commissioning party received information on such an
p.000006: adverse effect. Significant additional information on the adverse effect shall be notified within eight
p.000006: days from the day on which the first notification of the adverse effect was made.
p.000006:
p.000006: The commissioning party shall notify any other suspicions of unexpected serious adverse effects than those referred to
p.000006: in paragraph 1 to the Finnish Medicines Agency and the competent authorities of the Member States of the
p.000006: European Union which the matter concerns as soon as possible and at the latest in 15 days from the
p.000006: day when the commissioning party for the first time received information on them.
p.000006:
p.000006: The commissioning party shall also notify other researchers of the circumstances referred to in paragraphs 1 and 2.
p.000006:
p.000006: Section 10 g (295/2004)
p.000006:
p.000006: List of adverse events and effects
p.000007: 7
p.000007:
p.000007: The commissioning party shall draw up separately detailed lists of all the notifications made by the researcher or
p.000007: researchers to it on the basis of sections 10 e and 10 f. The information on a list of adverse events shall be
p.000007: communicated, at request, to those Member States of the European Union in whose territory the trial is being
p.000007: conducted.
p.000007:
p.000007: The list of suspected serious adverse effects shall be forwarded once a year all through the period a clinical
p.000007: trial goes on to those Member States of the European Union in whose territory the trial is being conducted,
p.000007: as well as to the relevant ethics committee. A report on the safety of the research subjects shall be furnished in
p.000007: addition.
p.000007:
p.000007: Section 10 h (780/2009)
p.000007:
p.000007: Notification of termination of research
p.000007:
p.000007: The commissioning party or the researcher shall within 90 days from the termination of a clinical trial on medicinal
p.000007: products notify the Finnish Medicines Agency and the ethics committee that the research has been terminated. If
p.000007: the research has been terminated before planned, the notification shall be made within 15 days from the
p.000007: termination. The reasons for the premature termination must be specified in the notification.
p.000007:
p.000007: A report on the outcome of a clinical trial on medicinal products shall be submitted to the Finnish Medicines Agency
p.000007: and the ethics committee within one year of completion of the trial.
p.000007:
p.000007: Section 10 i (780/2009)
p.000007:
p.000007: Further regulations
p.000007:
p.000007: The Finnish Medicines Agency issues necessary regulations on the good clinical practice referred to in section 10 a, on
p.000007: the content, drawing up, verification and presentation of the notifications referred to in sections 10 e - 10 h, and on
p.000007: the procedures for analysis of unexpected and serious adverse effects. Furthermore, the Finnish Medicines Agency may
p.000007: issue regulations for observance of international scientific guidelines and practices regarding clinical
p.000007: trials on medicinal products.
p.000007:
p.000007: Chapter 3
p.000007:
p.000007: Research involving embryos and foetuses Section 11
p.000007: Conditions governing research involving embryos
p.000007:
p.000007: Research on embryos outside a woman’s body may be carried out only by agencies that have been granted the
...
p.000010: research organisation fails to observe the provisions or regulations which apply. In the event of
p.000010: defects or irregularities, the National Authority for Medicolegal Affairs may decide that the research shall be
p.000010: suspended until the defects or irregularities have been rectified or may withdraw the licence previously granted.
p.000010:
p.000010: The decision to revoke a licence shall be complied with even if an appeal has been lodged against the
p.000010: decision.
p.000010:
p.000010: For the purposes of overseeing this Act and the provisions and regulations laid down in virtue of it, the National
p.000010: Authority for Medicolegal Affairs shall have the right to inspect the premises and activities of establishments
p.000010: which have been granted a licence as referred to in section 11 and to inspect any documents required for the
p.000010: exercise of this supervision.
p.000011: 11
p.000011:
p.000011: Section 23
p.000011:
p.000011: Official accountability and duty of confidentiality
p.000011:
p.000011: Those responsible for research and the members of the ethics committees shall be governed by the principle
p.000011: of official accountability.
p.000011:
p.000011: Confidential information obtained in the course of activities in relation with this Act and relating to research plans,
p.000011: personal information concerning other persons, their state of health, personal circumstances or financial status or
p.000011: business or trade secrets, must not be disclosed to a third party.
p.000011:
p.000011: Section 24 (295/2004)
p.000011:
p.000011: Further provisions
p.000011:
p.000011: Further provisions on the implementation of this Act are laid down as necessary by Government decree.
p.000011:
p.000011: If necessary, further provisions concerning the drawing up and keeping of research documents, the form for
p.000011: the request for opinion to be made to the ethics committee and the documents to be attached to it, delegating
p.000011: requests for opinion to regional ethics committees and on the information to be given to research
p.000011: subjects are laid down by decree of the Ministry of Social Affairs and Health.
p.000011:
p.000011: Chapter 6 Penal provisions
p.000011: Sections 25–26 were repealed by Act 375/2009.
p.000011:
p.000011: Section 27 (375/2009)
p.000011:
p.000011: Breach of the Medical Research Act
p.000011:
p.000011: Any person who conducts medical research
p.000011:
p.000011: (1) without the consent referred to in sections 6–8,
p.000011:
p.000011: (2) without the favourable opinion of the ethics committee in violation of section 3,
p.000011:
p.000011: (3) in violation of the conditions laid down in sections 5–10,
p.000011:
p.000011: (4) without observing the provisions of sections 10 b, 10 c and 10 e – 10 g in the research,
p.000011:
p.000011: shall be fined for breach of the Medical Research Act.
p.000011:
p.000011: Section 28 (375/2009)
p.000011:
...
Health / Drug Usage
Searching for indicator drug:
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p.000002: Ministry of Social Affairs and Health, Finland
p.000002:
p.000002: N.B. Unofficial translation. Legally binding only in Finnish and Swedish
p.000002:
p.000002:
p.000002: No. 488/1999
p.000002:
p.000002: Medical Research Act
p.000002:
p.000002:
p.000002: Chapter 1 General provisions Section 1 (794/2010) Scope of application
p.000002: This Act applies to medical research, unless otherwise provided by legislation.
p.000002:
p.000002: Section 2 (295/2004)
p.000002:
p.000002: Definitions
p.000002:
p.000002: For the purposes of this Act:
p.000002:
p.000002: (1) medical research means research involving intervention in the integrity of a person, human embryo or human foetus
p.000002: for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of
p.000002: diseases or the nature of diseases in general; (794/2010)
p.000002:
p.000002: (2) embryo means a living group of cells resulting from fertilisation not implanted in a woman’s body;
p.000002:
p.000002: (3) foetus means a living embryo implanted in a woman’s body;
p.000002:
p.000002: (4) researcher means a medical doctor or dentist or, if it is question of medical research or research pertaining to
p.000002: nursing science or health science other than clinical drug trial, also any other person with adequate professional
p.000002: and scientific qualifications who is in charge of carrying out a clinical trial at a research site; if a trial is
p.000002: carried out at a research site by a research group, researcher refers to the medical doctor, dentist or another person
p.000002: acting as the leader of the group; (794/2010)
p.000002:
p.000002: (5) commissioning party means the person, company, institution or organisation that is in charge of starting,
p.000002: directing or financing a clinical trial; if an outside party takes part in carrying out the trial only by financing it,
p.000002: the researcher and financier may agree between themselves that the researcher is also the commissioning party; if the
p.000002: trial is not commissioned by an outside party the researcher is the commissioning party; and
p.000002:
p.000002: (6) clinical trial on medicinal products means intervention research on persons for the purpose of finding out effects
p.000002: of a medicinal product in a human being as well as its absorption, distribution, metabolism or excretion in the human
p.000002: body.
p.000002:
p.000002: Section 3 (295/2004)
p.000002:
p.000002: General conditions governing medical research
p.000002:
p.000002: Medical research shall respect the inviolability of human dignity.
p.000002:
p.000002: Before any research referred to in this Act is undertaken, the ethics committee shall have given a favourable
...
p.000002: committee for reconsideration. The regional ethics committee shall at the request of the commissioning party
p.000002: seek the opinion of the National Committee on Medical Research Ethics before delivering a new opinion on the
p.000002: matter. (794/2010)
p.000002:
p.000002: Chapter 2
p.000002:
p.000002: Medical research on persons Section 4
p.000002: Weighing up benefits and harmful effects
p.000002:
p.000002: In medical research the interests and well-being of the research subject shall always be put before any benefits to
p.000002: science or society. Measures shall be taken to prevent any risks or harmful effects to the research subject, as far as
p.000002: possible.
p.000002:
p.000002: Research subjects may be exposed only to measures where the expected health or scientific benefit is
p.000002: unequivocally greater than the potential risks or harm to the research subject.
p.000002:
p.000002: Section 5
p.000002:
p.000002: People in charge of research
p.000002:
p.000002: Medical research may be undertaken only under the responsibility of a medical doctor or dentist with the adequate
p.000002: professional and scientific qualifications. If it is question of research other than clinical drug trial,
p.000002: also another person than a medical doctor or
p.000002:
p.000002: 2
p.000002:
p.000002: dentist may be responsible for the research, provided that the person has the professional and scientific
p.000002: qualifications required for the research concerned. (794/2010)
p.000002:
p.000002: The person in charge of the research shall ensure that there are competent staff and suitable tools and
p.000002: equipment available for the research and that the research is otherwise conducted under safe conditions. The person in
p.000002: charge shall also ensure that the research is conducted in accordance with the provisions of this Act, the
p.000002: international obligations concerning the status of research subjects and the rules and guidelines that
p.000002: govern research.
p.000002:
p.000002: The person in charge of the research shall suspend the research immediately where required for the safety
p.000002: of the research subject. If new knowledge related to the carrying out of the research or the medicinal product used in
p.000002: the research that has a bearing on the safety of the research subjects emerges in the course of the research, the
p.000002: person in charge of the research and the commissioning party shall immediately undertake precautionary measures to
p.000002: protect the research subjects. The commissioning party shall immediately inform the ethics committee of
p.000002: such new knowledge and of the measures undertaken based thereon. In addition, information and
p.000002: measures regarding clinical trials on medicinal products shall be immediately communicated to the
...
p.000008: set up by the board of the
p.000008:
p.000009: 9
p.000009:
p.000009: hospital district. The provisions of the Local Government Act (365/1995) on committees apply to the regional ethics
p.000009: committees.
p.000009:
p.000009: The Government sets up the National Committee on Medical Research Ethics for four years at one time. The Committee
p.000009: shall:
p.000009:
p.000009: 1) act as an expert in issues pertaining to research ethics;
p.000009:
p.000009: 2) monitor, guide and coordinate the handling of issues pertaining to research ethics;
p.000009:
p.000009: 3) take part in international cooperation of the relevant authorities;
p.000009:
p.000009: Further provisions on the National Committee on Medical Research Ethics are laid down by Government decree.
p.000009:
p.000009: Section 17 (794/2010)
p.000009:
p.000009: Evaluation of a research project
p.000009:
p.000009: Prior evaluation of research projects and delivering opinions on them is the responsibility of the ethics committee
p.000009: of the region where the person in charge of the research is based or of the region where the research is to be
p.000009: principally conducted. The National Committee on Medical Research Ethics shall deliver an opinion on clinical drug
p.000009: trials, unless it has delegated the task to a regional ethics committee.
p.000009:
p.000009: For the purposes of delivering the opinion, the committee shall examine whether the research plan has
p.000009: taken account of the provisions and regulations regarding medical research laid down in this Act and other law
p.000009: and the provisions laid down in virtue of it. In its opinions the ethics committee shall give its reasoned view on
p.000009: whether or not the research is ethically acceptable.
p.000009:
p.000009: Provisions on fees to be charged in respect of opinions shall be laid down by decree of the Ministry of Social Affairs
p.000009: and Health.
p.000009:
p.000009: Section 18
p.000009:
p.000009: Composition
p.000009:
p.000009: Ethics committees shall have a chairperson and at least six other members, one of whom shall be the deputy chairperson.
p.000009: There shall be an appropriate number of substitutes for the members.
p.000009:
p.000009: The committees shall contain representatives from research ethics, medicine, health science or nursing
p.000009: science, and science of law. At least two members shall be laypersons. (794/2010)
p.000009:
p.000009: Decisions on opinions shall be taken with the participation of the chairperson or the deputy chairperson
p.000009: and at least half the other members or at least four of the other members, whichever is the greater. When
p.000009: decisions on opinions are taken, the members shall include at least one layperson and two people from outside the
p.000009: research unit.
p.000009:
...
Health / Physically Disabled
Searching for indicator illness:
(return to top)
p.000003: section 6 (2). The consent must be in accordance with the research subject’s supposed will. Consent may be withdrawn on
p.000003: the same terms as laid down in section 6 (4). (295/2004)
p.000003:
p.000003: In addition, the research subjects shall be given, taking into account their capacity of understanding,
p.000003: information about the research as well as of its risks and benefits. Where a person not able to consent opposes a
p.000003: research measure, it may not be performed on the person. (295/2004)
p.000003:
p.000003: Section 8
p.000003:
p.000003: Research involving minors
p.000003:
p.000003: Minors may be research subjects only where it is not possible to obtain the same scientific results
p.000003: using other research subjects and where the risk of harming or distressing the research subject is only very
p.000003: slight.
p.000003:
p.000003: It shall be further required that:
p.000003:
p.000003: (1) the research should be likely to be of direct benefit to the research subject’s health; or
p.000003:
p.000003: (2) the research should be likely to be of special benefit to the health of people in the same age group or with the
p.000003: same state of health.
p.000003:
p.000003: Where the minor has reached the age of 15 and, in view of his/her age and maturity and the type of illness and
p.000003: research, is capable of understanding the importance of the
p.000004: 4
p.000004:
p.000004: research procedure and the research is likely to be of direct benefit to the minor’s health, it shall be sufficient for
p.000004: the minor to give his/her informed consent in writing. In such cases the guardian shall be informed of this. In
p.000004: other cases minors may be research subjects only where written consent for this has been given by
p.000004: their guardian or legal representative after being provided with the information referred to in section 6 (2). The
p.000004: consent must be in accordance with the minor’s supposed will. Consent may be withdrawn on the same terms as
p.000004: set out in section 6 (4). (295/2004)
p.000004:
p.000004: Minors shall receive within their capacity of understanding information about the themes of the research as well
p.000004: as about its risks and benefits from staff with experience from working with minors. Where minors who,
p.000004: in accordance with paragraph 3, are not entitled to be research subjects without the consent of their
p.000004: guardian or other legal representative, are capable of understanding the importance of the research procedure to be
...
p.000009:
p.000009: Provisions on fees to be charged in respect of opinions shall be laid down by decree of the Ministry of Social Affairs
p.000009: and Health.
p.000009:
p.000009: Section 18
p.000009:
p.000009: Composition
p.000009:
p.000009: Ethics committees shall have a chairperson and at least six other members, one of whom shall be the deputy chairperson.
p.000009: There shall be an appropriate number of substitutes for the members.
p.000009:
p.000009: The committees shall contain representatives from research ethics, medicine, health science or nursing
p.000009: science, and science of law. At least two members shall be laypersons. (794/2010)
p.000009:
p.000009: Decisions on opinions shall be taken with the participation of the chairperson or the deputy chairperson
p.000009: and at least half the other members or at least four of the other members, whichever is the greater. When
p.000009: decisions on opinions are taken, the members shall include at least one layperson and two people from outside the
p.000009: research unit.
p.000009:
p.000009: When dealing with a clinical trial on medicinal products to be conducted on minors ethics committees
p.000009: shall have as a member or consult a specialist in paediatrics. When dealing with a clinical trial on
p.000009: medicinal products to be conducted on an adult not able to
p.000010: 10
p.000010:
p.000010: give consent ethics committees shall have as a member or consult a specialist in the illness and patient
p.000010: group concerned. Instead of consulting, ethics committees may request a written opinion from a specialist representing
p.000010: the area in question. (295/2004)
p.000010:
p.000010: Section 19 (295/2004)
p.000010:
p.000010: Disqualification of a member
p.000010:
p.000010: Disqualification of a member of an ethics committee shall be governed by the provisions on the disqualification in
p.000010: regard to civil servants laid down in the Administrative Procedure Act (434/2003).
p.000010:
p.000010: Section 20 (794/2010)
p.000010:
p.000010: Duty of notification
p.000010:
p.000010: Hospital districts shall notify the National Committee on Medical Research Ethics of the setting up of ethics
p.000010: committees, their composition and any changes to them and contact details for them.
p.000010:
p.000010: Chapter 5 Miscellaneous provisions
p.000010: Section 21
p.000010:
p.000010: Remuneration of research subjects
p.000010:
p.000010: No payment shall be made for participating in the research to the research subjects, their guardians, close
p.000010: relatives, any other persons closely connected with them, or to their legal representative. However, an
p.000010: appropriate remuneration may be paid in respect of expenses or loss of earnings or for any other inconvenience suffered
p.000010: as a result of the research.
p.000010:
p.000010: Grounds on which payment may be made are laid down by the relevant ministry.
p.000010:
p.000010: Section 22
p.000010:
p.000010: Supervision and withdrawal of licence
p.000010:
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000004: their guardian or legal representative after being provided with the information referred to in section 6 (2). The
p.000004: consent must be in accordance with the minor’s supposed will. Consent may be withdrawn on the same terms as
p.000004: set out in section 6 (4). (295/2004)
p.000004:
p.000004: Minors shall receive within their capacity of understanding information about the themes of the research as well
p.000004: as about its risks and benefits from staff with experience from working with minors. Where minors who,
p.000004: in accordance with paragraph 3, are not entitled to be research subjects without the consent of their
p.000004: guardian or other legal representative, are capable of understanding the importance of the research procedure to be
p.000004: carried out on them, their written consent shall also be required. (295/2004)
p.000004:
p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
p.000005: The party commissioning a clinical trial on medicinal products shall see to it that there is an insurance policy or
p.000005: other appropriate guarantee to cover the liability of the party and the researcher.
p.000005:
...
p.000008: 8
p.000008:
p.000008: Research on embryos outside a woman’s body may not be undertaken without the written consent of the persons who donated
p.000008: the gametes. The donors shall be provided with the information referred to in section 6 (2). Consent may be withdrawn
p.000008: on the same terms as set out in section 6 (3).
p.000008:
p.000008: Embryos produced from donated gametes may not be used for research once the withdrawal of consent has been
p.000008: received.
p.000008:
p.000008: Research on an embryo inside a woman’s body may not be undertaken without her written consent.
p.000008:
p.000008: Section 13
p.000008:
p.000008: Restrictions on research on embryos
p.000008:
p.000008: The production of embryos exclusively for the purpose of research shall be forbidden.
p.000008:
p.000008: Embryos that have been used for research may not be implanted in a human body or be kept alive for longer than 14 days
p.000008: from their formation, not including any time during which they have been kept frozen.
p.000008:
p.000008: Research may use embryos that have been stored for up to 15 years, after which the embryos must be
p.000008: destroyed.
p.000008:
p.000008: Section 14
p.000008:
p.000008: Consent for foetal research
p.000008:
p.000008: Research on a foetus may not be undertaken without the written consent of the pregnant woman.
p.000008:
p.000008: The conditions governing the consent procedure and the research subject are as laid down in sections 6-10,
p.000008: as applicable.
p.000008:
p.000008: Section 15
p.000008:
p.000008: Prohibited research
p.000008:
p.000008: Research on embryos and gametes for the purpose of developing procedures for modifying hereditary
p.000008: properties shall be prohibited, unless the research is for the purpose of curing or preventing a serious
p.000008: hereditary disease.
p.000008:
p.000008: Chapter 4 Ethics committees
p.000008: Section 16 (794/2010)
p.000008:
p.000008: Regional and national ethics committees
p.000008:
p.000008: Each hospital district with a university providing medical education in its region shall have at least
p.000008: one ethics committee (regional ethics committee). The regional ethics committee shall monitor, guide and
p.000008: evaluate the handling of matters pertaining to research ethics in its region. The regional ethics committee is
p.000008: set up by the board of the
p.000008:
p.000009: 9
p.000009:
p.000009: hospital district. The provisions of the Local Government Act (365/1995) on committees apply to the regional ethics
p.000009: committees.
p.000009:
...
Health / forensic patients
Searching for indicator forensic patients:
(return to top)
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
p.000005: The party commissioning a clinical trial on medicinal products shall see to it that there is an insurance policy or
p.000005: other appropriate guarantee to cover the liability of the party and the researcher.
p.000005:
p.000005: Section 10 c (780/2009)
p.000005:
p.000005: Start of research
p.000005:
p.000005: A clinical trial on medicinal products may be started only after the ethics committee has delivered an opinion in
p.000005: favour of it, and on the condition that the Finnish Medicines Agency has granted it the licence required in
p.000005: the Medicines Act or it has not informed of any obstacle to starting the research as laid down in the Medicines Act.
p.000005:
p.000005: Section 10 d (295/2004)
p.000005:
p.000005: Opinion of the ethics committee
p.000005:
p.000005: The provisions of sections 3 and 17 shall apply to the opinions of the ethics committee. In addition, an opinion on a
...
Social / Age
Searching for indicator age:
(return to top)
p.000002: research. They shall be informed of this right before the start of the
p.000003: 3
p.000003:
p.000003: research. Withdrawal of consent and resulting withdrawal from the research shall not involve any negative
p.000003: consequences for the research subject.
p.000003:
p.000003: Further provisions on the content of the document giving consent and on the information concerning oral consent to
p.000003: be recorded in the research documents are issued by Government Decree.
p.000003:
p.000003: Section 7
p.000003:
p.000003: Research involving persons not able to consent
p.000003:
p.000003: People who, owing to a mental health disorder, retardation or other similar reason, do not have the capacity to give
p.000003: their consent to research may be research subjects only where it is not possible to obtain the same scientific
p.000003: results using other research subjects and where the risk of harming or distressing the research subject is only
p.000003: very slight.
p.000003:
p.000003: It shall be further required that:
p.000003:
p.000003: (1) the research should be likely to be of direct benefit to the research subject’s health; or
p.000003:
p.000003: (2) the research should be likely to be of special benefit to the health of people in the same age group or with the
p.000003: same state of health.
p.000003:
p.000003: Persons not able to consent as referred to above may be research subjects in the cases set out in paragraphs 1 and 2
p.000003: above only where written consent for this has been given by their close relative or other person closely
p.000003: connected with the person or legal representative after being provided with the information referred to in
p.000003: section 6 (2). The consent must be in accordance with the research subject’s supposed will. Consent may be withdrawn on
p.000003: the same terms as laid down in section 6 (4). (295/2004)
p.000003:
p.000003: In addition, the research subjects shall be given, taking into account their capacity of understanding,
p.000003: information about the research as well as of its risks and benefits. Where a person not able to consent opposes a
p.000003: research measure, it may not be performed on the person. (295/2004)
p.000003:
p.000003: Section 8
p.000003:
p.000003: Research involving minors
p.000003:
p.000003: Minors may be research subjects only where it is not possible to obtain the same scientific results
p.000003: using other research subjects and where the risk of harming or distressing the research subject is only very
p.000003: slight.
p.000003:
p.000003: It shall be further required that:
p.000003:
p.000003: (1) the research should be likely to be of direct benefit to the research subject’s health; or
p.000003:
p.000003: (2) the research should be likely to be of special benefit to the health of people in the same age group or with the
p.000003: same state of health.
p.000003:
p.000003: Where the minor has reached the age of 15 and, in view of his/her age and maturity and the type of illness and
p.000003: research, is capable of understanding the importance of the
p.000004: 4
p.000004:
p.000004: research procedure and the research is likely to be of direct benefit to the minor’s health, it shall be sufficient for
p.000004: the minor to give his/her informed consent in writing. In such cases the guardian shall be informed of this. In
p.000004: other cases minors may be research subjects only where written consent for this has been given by
p.000004: their guardian or legal representative after being provided with the information referred to in section 6 (2). The
p.000004: consent must be in accordance with the minor’s supposed will. Consent may be withdrawn on the same terms as
p.000004: set out in section 6 (4). (295/2004)
p.000004:
p.000004: Minors shall receive within their capacity of understanding information about the themes of the research as well
p.000004: as about its risks and benefits from staff with experience from working with minors. Where minors who,
p.000004: in accordance with paragraph 3, are not entitled to be research subjects without the consent of their
p.000004: guardian or other legal representative, are capable of understanding the importance of the research procedure to be
p.000004: carried out on them, their written consent shall also be required. (295/2004)
p.000004:
p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
...
Social / Child
Searching for indicator child:
(return to top)
p.000004: as about its risks and benefits from staff with experience from working with minors. Where minors who,
p.000004: in accordance with paragraph 3, are not entitled to be research subjects without the consent of their
p.000004: guardian or other legal representative, are capable of understanding the importance of the research procedure to be
p.000004: carried out on them, their written consent shall also be required. (295/2004)
p.000004:
p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
...
Searching for indicator children:
(return to top)
p.000004: carried out on them, their written consent shall also be required. (295/2004)
p.000004:
p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
p.000005: The party commissioning a clinical trial on medicinal products shall see to it that there is an insurance policy or
p.000005: other appropriate guarantee to cover the liability of the party and the researcher.
p.000005:
p.000005: Section 10 c (780/2009)
p.000005:
p.000005: Start of research
p.000005:
p.000005: A clinical trial on medicinal products may be started only after the ethics committee has delivered an opinion in
...
Social / Fetus/Neonate
Searching for indicator foetus:
(return to top)
p.000002: Ministry of Social Affairs and Health, Finland
p.000002:
p.000002: N.B. Unofficial translation. Legally binding only in Finnish and Swedish
p.000002:
p.000002:
p.000002: No. 488/1999
p.000002:
p.000002: Medical Research Act
p.000002:
p.000002:
p.000002: Chapter 1 General provisions Section 1 (794/2010) Scope of application
p.000002: This Act applies to medical research, unless otherwise provided by legislation.
p.000002:
p.000002: Section 2 (295/2004)
p.000002:
p.000002: Definitions
p.000002:
p.000002: For the purposes of this Act:
p.000002:
p.000002: (1) medical research means research involving intervention in the integrity of a person, human embryo or human foetus
p.000002: for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of
p.000002: diseases or the nature of diseases in general; (794/2010)
p.000002:
p.000002: (2) embryo means a living group of cells resulting from fertilisation not implanted in a woman’s body;
p.000002:
p.000002: (3) foetus means a living embryo implanted in a woman’s body;
p.000002:
p.000002: (4) researcher means a medical doctor or dentist or, if it is question of medical research or research pertaining to
p.000002: nursing science or health science other than clinical drug trial, also any other person with adequate professional
p.000002: and scientific qualifications who is in charge of carrying out a clinical trial at a research site; if a trial is
p.000002: carried out at a research site by a research group, researcher refers to the medical doctor, dentist or another person
p.000002: acting as the leader of the group; (794/2010)
p.000002:
p.000002: (5) commissioning party means the person, company, institution or organisation that is in charge of starting,
p.000002: directing or financing a clinical trial; if an outside party takes part in carrying out the trial only by financing it,
p.000002: the researcher and financier may agree between themselves that the researcher is also the commissioning party; if the
p.000002: trial is not commissioned by an outside party the researcher is the commissioning party; and
p.000002:
p.000002: (6) clinical trial on medicinal products means intervention research on persons for the purpose of finding out effects
p.000002: of a medicinal product in a human being as well as its absorption, distribution, metabolism or excretion in the human
p.000002: body.
p.000002:
p.000002: Section 3 (295/2004)
p.000002:
p.000002: General conditions governing medical research
p.000002:
...
p.000007:
p.000007: Section 12
p.000007:
p.000007: Consent for research on embryos
p.000008: 8
p.000008:
p.000008: Research on embryos outside a woman’s body may not be undertaken without the written consent of the persons who donated
p.000008: the gametes. The donors shall be provided with the information referred to in section 6 (2). Consent may be withdrawn
p.000008: on the same terms as set out in section 6 (3).
p.000008:
p.000008: Embryos produced from donated gametes may not be used for research once the withdrawal of consent has been
p.000008: received.
p.000008:
p.000008: Research on an embryo inside a woman’s body may not be undertaken without her written consent.
p.000008:
p.000008: Section 13
p.000008:
p.000008: Restrictions on research on embryos
p.000008:
p.000008: The production of embryos exclusively for the purpose of research shall be forbidden.
p.000008:
p.000008: Embryos that have been used for research may not be implanted in a human body or be kept alive for longer than 14 days
p.000008: from their formation, not including any time during which they have been kept frozen.
p.000008:
p.000008: Research may use embryos that have been stored for up to 15 years, after which the embryos must be
p.000008: destroyed.
p.000008:
p.000008: Section 14
p.000008:
p.000008: Consent for foetal research
p.000008:
p.000008: Research on a foetus may not be undertaken without the written consent of the pregnant woman.
p.000008:
p.000008: The conditions governing the consent procedure and the research subject are as laid down in sections 6-10,
p.000008: as applicable.
p.000008:
p.000008: Section 15
p.000008:
p.000008: Prohibited research
p.000008:
p.000008: Research on embryos and gametes for the purpose of developing procedures for modifying hereditary
p.000008: properties shall be prohibited, unless the research is for the purpose of curing or preventing a serious
p.000008: hereditary disease.
p.000008:
p.000008: Chapter 4 Ethics committees
p.000008: Section 16 (794/2010)
p.000008:
p.000008: Regional and national ethics committees
p.000008:
p.000008: Each hospital district with a university providing medical education in its region shall have at least
p.000008: one ethics committee (regional ethics committee). The regional ethics committee shall monitor, guide and
p.000008: evaluate the handling of matters pertaining to research ethics in its region. The regional ethics committee is
p.000008: set up by the board of the
p.000008:
p.000009: 9
p.000009:
...
Searching for indicator foetuses:
(return to top)
p.000004: guardian or other legal representative, are capable of understanding the importance of the research procedure to be
p.000004: carried out on them, their written consent shall also be required. (295/2004)
p.000004:
p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
p.000005: The party commissioning a clinical trial on medicinal products shall see to it that there is an insurance policy or
p.000005: other appropriate guarantee to cover the liability of the party and the researcher.
p.000005:
p.000005: Section 10 c (780/2009)
p.000005:
p.000005: Start of research
p.000005:
...
p.000007: addition.
p.000007:
p.000007: Section 10 h (780/2009)
p.000007:
p.000007: Notification of termination of research
p.000007:
p.000007: The commissioning party or the researcher shall within 90 days from the termination of a clinical trial on medicinal
p.000007: products notify the Finnish Medicines Agency and the ethics committee that the research has been terminated. If
p.000007: the research has been terminated before planned, the notification shall be made within 15 days from the
p.000007: termination. The reasons for the premature termination must be specified in the notification.
p.000007:
p.000007: A report on the outcome of a clinical trial on medicinal products shall be submitted to the Finnish Medicines Agency
p.000007: and the ethics committee within one year of completion of the trial.
p.000007:
p.000007: Section 10 i (780/2009)
p.000007:
p.000007: Further regulations
p.000007:
p.000007: The Finnish Medicines Agency issues necessary regulations on the good clinical practice referred to in section 10 a, on
p.000007: the content, drawing up, verification and presentation of the notifications referred to in sections 10 e - 10 h, and on
p.000007: the procedures for analysis of unexpected and serious adverse effects. Furthermore, the Finnish Medicines Agency may
p.000007: issue regulations for observance of international scientific guidelines and practices regarding clinical
p.000007: trials on medicinal products.
p.000007:
p.000007: Chapter 3
p.000007:
p.000007: Research involving embryos and foetuses Section 11
p.000007: Conditions governing research involving embryos
p.000007:
p.000007: Research on embryos outside a woman’s body may be carried out only by agencies that have been granted the
p.000007: appropriate licence by the National Authority for Medicolegal Affairs. The conditions for the granting of the
p.000007: licence shall be laid down by Decree.
p.000007:
p.000007: Medical research on embryos is permitted only if no more than 14 days have passed from their formation. The time during
p.000007: which an embryo is kept frozen shall not count for the purposes of calculating this time limit.
p.000007:
p.000007: Section 12
p.000007:
p.000007: Consent for research on embryos
p.000008: 8
p.000008:
p.000008: Research on embryos outside a woman’s body may not be undertaken without the written consent of the persons who donated
p.000008: the gametes. The donors shall be provided with the information referred to in section 6 (2). Consent may be withdrawn
p.000008: on the same terms as set out in section 6 (3).
p.000008:
p.000008: Embryos produced from donated gametes may not be used for research once the withdrawal of consent has been
p.000008: received.
p.000008:
p.000008: Research on an embryo inside a woman’s body may not be undertaken without her written consent.
p.000008:
p.000008: Section 13
p.000008:
p.000008: Restrictions on research on embryos
p.000008:
...
Social / Mothers
Searching for indicator mothers:
(return to top)
p.000004: their guardian or legal representative after being provided with the information referred to in section 6 (2). The
p.000004: consent must be in accordance with the minor’s supposed will. Consent may be withdrawn on the same terms as
p.000004: set out in section 6 (4). (295/2004)
p.000004:
p.000004: Minors shall receive within their capacity of understanding information about the themes of the research as well
p.000004: as about its risks and benefits from staff with experience from working with minors. Where minors who,
p.000004: in accordance with paragraph 3, are not entitled to be research subjects without the consent of their
p.000004: guardian or other legal representative, are capable of understanding the importance of the research procedure to be
p.000004: carried out on them, their written consent shall also be required. (295/2004)
p.000004:
p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
p.000005: The party commissioning a clinical trial on medicinal products shall see to it that there is an insurance policy or
p.000005: other appropriate guarantee to cover the liability of the party and the researcher.
p.000005:
p.000005: Section 10 c (780/2009)
p.000005:
p.000005: Start of research
p.000005:
...
Social / Religion
Searching for indicator conviction:
(return to top)
p.000011: requests for opinion to regional ethics committees and on the information to be given to research
p.000011: subjects are laid down by decree of the Ministry of Social Affairs and Health.
p.000011:
p.000011: Chapter 6 Penal provisions
p.000011: Sections 25–26 were repealed by Act 375/2009.
p.000011:
p.000011: Section 27 (375/2009)
p.000011:
p.000011: Breach of the Medical Research Act
p.000011:
p.000011: Any person who conducts medical research
p.000011:
p.000011: (1) without the consent referred to in sections 6–8,
p.000011:
p.000011: (2) without the favourable opinion of the ethics committee in violation of section 3,
p.000011:
p.000011: (3) in violation of the conditions laid down in sections 5–10,
p.000011:
p.000011: (4) without observing the provisions of sections 10 b, 10 c and 10 e – 10 g in the research,
p.000011:
p.000011: shall be fined for breach of the Medical Research Act.
p.000011:
p.000011: Section 28 (375/2009)
p.000011:
p.000011: References to the Penal Code
p.000011:
p.000011: Penalty for unlawful intervention on the embryo is imposed under Chapter 22, section 3, of the Penal Code (39/1889) and
p.000011: penalty for unlawful intervention on the genome under its Chapter 22, section 4. Upon conviction of any breach of the
p.000011: duty of confidentiality
p.000012: 12
p.000012:
p.000012: laid down in section 23 a of this Act penalty may be imposed under Chapter 38, section 1 or 2, of the Penal Code,
p.000012: unless the action is punishable under Chapter 40, section 5, or a more severe penalty is laid down by other
p.000012: legislation.
p.000012:
p.000012: Chapter 7
p.000012:
p.000012: Entry into force and transitional provisions Section 29
p.000012: Entry into force
p.000012:
p.000012: This Act enters into force on 1 November 1999.
p.000012:
p.000012: Measures necessary for the implementation of the Act may be undertaken before its entry into force.
p.000012:
p.000012: Section 30
p.000012:
p.000012: Transitional provision
p.000012:
p.000012: The provisions of this Act shall, where applicable, apply to research projects already under way when the
p.000012: Act enters into force. The provisions of the Act shall also apply to the specimens taken of people, human gametes and
p.000012: human embryos that are being stored when the Act enters into force.
p.000012:
p.000012: Every hospital district in which research covered by this Act is being conducted shall submit a
p.000012: notification in accordance with section 20 within six months of entry into force of this Act.
p.000012:
p.000012: Any institution where research of the type referred to in section 11 is being conducted when the Act enters into
p.000012: force shall apply to the National Authority for Medicolegal Affairs for a licence for its activities within six
p.000012: months of entry into force of this Act. The work may continue until the application has been processed. The National
...
Social / Trade Union Membership
Searching for indicator union:
(return to top)
p.000006: the notification of alteration.
p.000006:
p.000006: The period of time during which further information is requested or delivered shall not count for the purposes of
p.000006: calculating the time limits referred to in paragraphs 2 and 3.
p.000006:
p.000006: Section 10 e (295/2004)
p.000006:
p.000006: Notification of adverse events
p.000006:
p.000006: The researcher shall immediately notify the commissioning party of any serious adverse events, except for those adverse
p.000006: events that it is not necessary to notify according to the research plan or the researcher’s information package.
p.000006: After the notification a written detailed report shall be given on the adverse event. In the
p.000006: notification and report the research subjects are identified by code numbers.
p.000006:
p.000006: The commissioning party shall be notified within the defined periods laid down in the research plan of any adverse
p.000006: events and deviating laboratory results that are defined in the research plan to be significant from the point of view
p.000006: of safety evaluation.
p.000006:
p.000006: The researcher shall communicate to the commissioning party and the ethics committee any information requested by them
p.000006: about deaths of research subjects.
p.000006:
p.000006: Section 10 f (794/2010)
p.000006:
p.000006: Notification of serious adverse effects
p.000006:
p.000006: The commissioning party shall notify the Finnish Medicines Agency and the competent authorities of the Member States of
p.000006: the European Union which the matter concerns of any fatal or life threatening unexpected adverse effects as soon as
p.000006: possible, at the latest in seven days from the day on which the commissioning party received information on such an
p.000006: adverse effect. Significant additional information on the adverse effect shall be notified within eight
p.000006: days from the day on which the first notification of the adverse effect was made.
p.000006:
p.000006: The commissioning party shall notify any other suspicions of unexpected serious adverse effects than those referred to
p.000006: in paragraph 1 to the Finnish Medicines Agency and the competent authorities of the Member States of the
p.000006: European Union which the matter concerns as soon as possible and at the latest in 15 days from the
p.000006: day when the commissioning party for the first time received information on them.
p.000006:
p.000006: The commissioning party shall also notify other researchers of the circumstances referred to in paragraphs 1 and 2.
p.000006:
p.000006: Section 10 g (295/2004)
p.000006:
p.000006: List of adverse events and effects
p.000007: 7
p.000007:
p.000007: The commissioning party shall draw up separately detailed lists of all the notifications made by the researcher or
p.000007: researchers to it on the basis of sections 10 e and 10 f. The information on a list of adverse events shall be
p.000007: communicated, at request, to those Member States of the European Union in whose territory the trial is being
p.000007: conducted.
p.000007:
p.000007: The list of suspected serious adverse effects shall be forwarded once a year all through the period a clinical
p.000007: trial goes on to those Member States of the European Union in whose territory the trial is being conducted,
p.000007: as well as to the relevant ethics committee. A report on the safety of the research subjects shall be furnished in
p.000007: addition.
p.000007:
p.000007: Section 10 h (780/2009)
p.000007:
p.000007: Notification of termination of research
p.000007:
p.000007: The commissioning party or the researcher shall within 90 days from the termination of a clinical trial on medicinal
p.000007: products notify the Finnish Medicines Agency and the ethics committee that the research has been terminated. If
p.000007: the research has been terminated before planned, the notification shall be made within 15 days from the
p.000007: termination. The reasons for the premature termination must be specified in the notification.
p.000007:
p.000007: A report on the outcome of a clinical trial on medicinal products shall be submitted to the Finnish Medicines Agency
p.000007: and the ethics committee within one year of completion of the trial.
p.000007:
p.000007: Section 10 i (780/2009)
p.000007:
p.000007: Further regulations
p.000007:
p.000007: The Finnish Medicines Agency issues necessary regulations on the good clinical practice referred to in section 10 a, on
p.000007: the content, drawing up, verification and presentation of the notifications referred to in sections 10 e - 10 h, and on
p.000007: the procedures for analysis of unexpected and serious adverse effects. Furthermore, the Finnish Medicines Agency may
p.000007: issue regulations for observance of international scientific guidelines and practices regarding clinical
p.000007: trials on medicinal products.
p.000007:
p.000007: Chapter 3
p.000007:
...
Social / Women
Searching for indicator women:
(return to top)
p.000004: their guardian or legal representative after being provided with the information referred to in section 6 (2). The
p.000004: consent must be in accordance with the minor’s supposed will. Consent may be withdrawn on the same terms as
p.000004: set out in section 6 (4). (295/2004)
p.000004:
p.000004: Minors shall receive within their capacity of understanding information about the themes of the research as well
p.000004: as about its risks and benefits from staff with experience from working with minors. Where minors who,
p.000004: in accordance with paragraph 3, are not entitled to be research subjects without the consent of their
p.000004: guardian or other legal representative, are capable of understanding the importance of the research procedure to be
p.000004: carried out on them, their written consent shall also be required. (295/2004)
p.000004:
p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
p.000005: The party commissioning a clinical trial on medicinal products shall see to it that there is an insurance policy or
p.000005: other appropriate guarantee to cover the liability of the party and the researcher.
p.000005:
p.000005: Section 10 c (780/2009)
p.000005:
p.000005: Start of research
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000002: such new knowledge and of the measures undertaken based thereon. In addition, information and
p.000002: measures regarding clinical trials on medicinal products shall be immediately communicated to the
p.000002: Finnish Medicines Agency. (780/2009)
p.000002:
p.000002: Section 6 (295/2004)
p.000002:
p.000002: Consent of research subjects
p.000002:
p.000002: Medical research on persons may not be conducted without the research subject’s informed consent in writing.
p.000002: Exceptions to this may be made where consent cannot be obtained owing to the urgency of the matter and the
p.000002: patient’s state of health and the measure is expected to be of immediate benefit to the patient’s
p.000002: health. If the research subject is not able to write he or she can give the consent orally in the presence of at
p.000002: least one witness who is not dependent on the research. It is allowed to deviate from the requirement
p.000002: for written consent in research other than clinical trials on medicinal products also when giving personal
p.000002: data would be in contrary to the research subject’s interests and the research will only involve minor stress to the
p.000002: research subject and is not harmful to the research subject’s health. Oral consent may then be given
p.000002: without the presence of a witness, and the personal data of the research subject are not recorded in the research
p.000002: documents.
p.000002:
p.000002: If a person taking part in a clinical trial on medicinal products is not able to give consent on taking part in the
p.000002: trial, the person may not, deviating from the provision in paragraph 1, be research subject unless the person’s close
p.000002: relative or other person closely connected with the person or his/her legal representative, after having been
p.000002: informed about the nature, meaning, effects and risks of the clinical trial, gives consent to taking part in the
p.000002: trial. The consent must be in accordance with the research subject’s supposed will.
p.000002:
p.000002: Research subjects shall have their rights, the purpose and nature of the research and the procedures it involves
p.000002: properly explained to them. The potential risks and harm shall also be properly explained to them. This information
p.000002: shall be given so that research subjects are in a position to give their informed consent as regards issues
p.000002: connected with the research that have a bearing on their decision-making.
p.000002:
p.000002: Research subjects shall be entitled to withdraw their consent at any point prior to the completion of the
...
p.000003: connected with the person or legal representative after being provided with the information referred to in
p.000003: section 6 (2). The consent must be in accordance with the research subject’s supposed will. Consent may be withdrawn on
p.000003: the same terms as laid down in section 6 (4). (295/2004)
p.000003:
p.000003: In addition, the research subjects shall be given, taking into account their capacity of understanding,
p.000003: information about the research as well as of its risks and benefits. Where a person not able to consent opposes a
p.000003: research measure, it may not be performed on the person. (295/2004)
p.000003:
p.000003: Section 8
p.000003:
p.000003: Research involving minors
p.000003:
p.000003: Minors may be research subjects only where it is not possible to obtain the same scientific results
p.000003: using other research subjects and where the risk of harming or distressing the research subject is only very
p.000003: slight.
p.000003:
p.000003: It shall be further required that:
p.000003:
p.000003: (1) the research should be likely to be of direct benefit to the research subject’s health; or
p.000003:
p.000003: (2) the research should be likely to be of special benefit to the health of people in the same age group or with the
p.000003: same state of health.
p.000003:
p.000003: Where the minor has reached the age of 15 and, in view of his/her age and maturity and the type of illness and
p.000003: research, is capable of understanding the importance of the
p.000004: 4
p.000004:
p.000004: research procedure and the research is likely to be of direct benefit to the minor’s health, it shall be sufficient for
p.000004: the minor to give his/her informed consent in writing. In such cases the guardian shall be informed of this. In
p.000004: other cases minors may be research subjects only where written consent for this has been given by
p.000004: their guardian or legal representative after being provided with the information referred to in section 6 (2). The
p.000004: consent must be in accordance with the minor’s supposed will. Consent may be withdrawn on the same terms as
p.000004: set out in section 6 (4). (295/2004)
p.000004:
p.000004: Minors shall receive within their capacity of understanding information about the themes of the research as well
p.000004: as about its risks and benefits from staff with experience from working with minors. Where minors who,
p.000004: in accordance with paragraph 3, are not entitled to be research subjects without the consent of their
p.000004: guardian or other legal representative, are capable of understanding the importance of the research procedure to be
p.000004: carried out on them, their written consent shall also be required. (295/2004)
p.000004:
p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
...
Social / education
Searching for indicator education:
(return to top)
p.000008:
p.000008: Embryos that have been used for research may not be implanted in a human body or be kept alive for longer than 14 days
p.000008: from their formation, not including any time during which they have been kept frozen.
p.000008:
p.000008: Research may use embryos that have been stored for up to 15 years, after which the embryos must be
p.000008: destroyed.
p.000008:
p.000008: Section 14
p.000008:
p.000008: Consent for foetal research
p.000008:
p.000008: Research on a foetus may not be undertaken without the written consent of the pregnant woman.
p.000008:
p.000008: The conditions governing the consent procedure and the research subject are as laid down in sections 6-10,
p.000008: as applicable.
p.000008:
p.000008: Section 15
p.000008:
p.000008: Prohibited research
p.000008:
p.000008: Research on embryos and gametes for the purpose of developing procedures for modifying hereditary
p.000008: properties shall be prohibited, unless the research is for the purpose of curing or preventing a serious
p.000008: hereditary disease.
p.000008:
p.000008: Chapter 4 Ethics committees
p.000008: Section 16 (794/2010)
p.000008:
p.000008: Regional and national ethics committees
p.000008:
p.000008: Each hospital district with a university providing medical education in its region shall have at least
p.000008: one ethics committee (regional ethics committee). The regional ethics committee shall monitor, guide and
p.000008: evaluate the handling of matters pertaining to research ethics in its region. The regional ethics committee is
p.000008: set up by the board of the
p.000008:
p.000009: 9
p.000009:
p.000009: hospital district. The provisions of the Local Government Act (365/1995) on committees apply to the regional ethics
p.000009: committees.
p.000009:
p.000009: The Government sets up the National Committee on Medical Research Ethics for four years at one time. The Committee
p.000009: shall:
p.000009:
p.000009: 1) act as an expert in issues pertaining to research ethics;
p.000009:
p.000009: 2) monitor, guide and coordinate the handling of issues pertaining to research ethics;
p.000009:
p.000009: 3) take part in international cooperation of the relevant authorities;
p.000009:
p.000009: Further provisions on the National Committee on Medical Research Ethics are laid down by Government decree.
p.000009:
p.000009: Section 17 (794/2010)
p.000009:
p.000009: Evaluation of a research project
p.000009:
p.000009: Prior evaluation of research projects and delivering opinions on them is the responsibility of the ethics committee
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.000002: Ministry of Social Affairs and Health, Finland
p.000002:
p.000002: N.B. Unofficial translation. Legally binding only in Finnish and Swedish
p.000002:
p.000002:
p.000002: No. 488/1999
p.000002:
p.000002: Medical Research Act
p.000002:
p.000002:
p.000002: Chapter 1 General provisions Section 1 (794/2010) Scope of application
p.000002: This Act applies to medical research, unless otherwise provided by legislation.
p.000002:
p.000002: Section 2 (295/2004)
p.000002:
p.000002: Definitions
p.000002:
p.000002: For the purposes of this Act:
p.000002:
p.000002: (1) medical research means research involving intervention in the integrity of a person, human embryo or human foetus
p.000002: for the purpose of increasing knowledge of health, the causes, symptoms, diagnosis, treatment and prevention of
p.000002: diseases or the nature of diseases in general; (794/2010)
p.000002:
p.000002: (2) embryo means a living group of cells resulting from fertilisation not implanted in a woman’s body;
p.000002:
p.000002: (3) foetus means a living embryo implanted in a woman’s body;
p.000002:
p.000002: (4) researcher means a medical doctor or dentist or, if it is question of medical research or research pertaining to
p.000002: nursing science or health science other than clinical drug trial, also any other person with adequate professional
p.000002: and scientific qualifications who is in charge of carrying out a clinical trial at a research site; if a trial is
p.000002: carried out at a research site by a research group, researcher refers to the medical doctor, dentist or another person
p.000002: acting as the leader of the group; (794/2010)
p.000002:
p.000002: (5) commissioning party means the person, company, institution or organisation that is in charge of starting,
p.000002: directing or financing a clinical trial; if an outside party takes part in carrying out the trial only by financing it,
p.000002: the researcher and financier may agree between themselves that the researcher is also the commissioning party; if the
p.000002: trial is not commissioned by an outside party the researcher is the commissioning party; and
p.000002:
p.000002: (6) clinical trial on medicinal products means intervention research on persons for the purpose of finding out effects
p.000002: of a medicinal product in a human being as well as its absorption, distribution, metabolism or excretion in the human
p.000002: body.
p.000002:
p.000002: Section 3 (295/2004)
p.000002:
p.000002: General conditions governing medical research
p.000002:
p.000002: Medical research shall respect the inviolability of human dignity.
p.000002:
...
p.000007: the research has been terminated before planned, the notification shall be made within 15 days from the
p.000007: termination. The reasons for the premature termination must be specified in the notification.
p.000007:
p.000007: A report on the outcome of a clinical trial on medicinal products shall be submitted to the Finnish Medicines Agency
p.000007: and the ethics committee within one year of completion of the trial.
p.000007:
p.000007: Section 10 i (780/2009)
p.000007:
p.000007: Further regulations
p.000007:
p.000007: The Finnish Medicines Agency issues necessary regulations on the good clinical practice referred to in section 10 a, on
p.000007: the content, drawing up, verification and presentation of the notifications referred to in sections 10 e - 10 h, and on
p.000007: the procedures for analysis of unexpected and serious adverse effects. Furthermore, the Finnish Medicines Agency may
p.000007: issue regulations for observance of international scientific guidelines and practices regarding clinical
p.000007: trials on medicinal products.
p.000007:
p.000007: Chapter 3
p.000007:
p.000007: Research involving embryos and foetuses Section 11
p.000007: Conditions governing research involving embryos
p.000007:
p.000007: Research on embryos outside a woman’s body may be carried out only by agencies that have been granted the
p.000007: appropriate licence by the National Authority for Medicolegal Affairs. The conditions for the granting of the
p.000007: licence shall be laid down by Decree.
p.000007:
p.000007: Medical research on embryos is permitted only if no more than 14 days have passed from their formation. The time during
p.000007: which an embryo is kept frozen shall not count for the purposes of calculating this time limit.
p.000007:
p.000007: Section 12
p.000007:
p.000007: Consent for research on embryos
p.000008: 8
p.000008:
p.000008: Research on embryos outside a woman’s body may not be undertaken without the written consent of the persons who donated
p.000008: the gametes. The donors shall be provided with the information referred to in section 6 (2). Consent may be withdrawn
p.000008: on the same terms as set out in section 6 (3).
p.000008:
p.000008: Embryos produced from donated gametes may not be used for research once the withdrawal of consent has been
p.000008: received.
p.000008:
p.000008: Research on an embryo inside a woman’s body may not be undertaken without her written consent.
p.000008:
p.000008: Section 13
p.000008:
p.000008: Restrictions on research on embryos
p.000008:
p.000008: The production of embryos exclusively for the purpose of research shall be forbidden.
p.000008:
p.000008: Embryos that have been used for research may not be implanted in a human body or be kept alive for longer than 14 days
p.000008: from their formation, not including any time during which they have been kept frozen.
p.000008:
p.000008: Research may use embryos that have been stored for up to 15 years, after which the embryos must be
p.000008: destroyed.
p.000008:
p.000008: Section 14
p.000008:
p.000008: Consent for foetal research
p.000008:
p.000008: Research on a foetus may not be undertaken without the written consent of the pregnant woman.
p.000008:
p.000008: The conditions governing the consent procedure and the research subject are as laid down in sections 6-10,
p.000008: as applicable.
p.000008:
p.000008: Section 15
p.000008:
p.000008: Prohibited research
p.000008:
p.000008: Research on embryos and gametes for the purpose of developing procedures for modifying hereditary
p.000008: properties shall be prohibited, unless the research is for the purpose of curing or preventing a serious
p.000008: hereditary disease.
p.000008:
p.000008: Chapter 4 Ethics committees
p.000008: Section 16 (794/2010)
p.000008:
...
p.000011:
p.000011: If necessary, further provisions concerning the drawing up and keeping of research documents, the form for
p.000011: the request for opinion to be made to the ethics committee and the documents to be attached to it, delegating
p.000011: requests for opinion to regional ethics committees and on the information to be given to research
p.000011: subjects are laid down by decree of the Ministry of Social Affairs and Health.
p.000011:
p.000011: Chapter 6 Penal provisions
p.000011: Sections 25–26 were repealed by Act 375/2009.
p.000011:
p.000011: Section 27 (375/2009)
p.000011:
p.000011: Breach of the Medical Research Act
p.000011:
p.000011: Any person who conducts medical research
p.000011:
p.000011: (1) without the consent referred to in sections 6–8,
p.000011:
p.000011: (2) without the favourable opinion of the ethics committee in violation of section 3,
p.000011:
p.000011: (3) in violation of the conditions laid down in sections 5–10,
p.000011:
p.000011: (4) without observing the provisions of sections 10 b, 10 c and 10 e – 10 g in the research,
p.000011:
p.000011: shall be fined for breach of the Medical Research Act.
p.000011:
p.000011: Section 28 (375/2009)
p.000011:
p.000011: References to the Penal Code
p.000011:
p.000011: Penalty for unlawful intervention on the embryo is imposed under Chapter 22, section 3, of the Penal Code (39/1889) and
p.000011: penalty for unlawful intervention on the genome under its Chapter 22, section 4. Upon conviction of any breach of the
p.000011: duty of confidentiality
p.000012: 12
p.000012:
p.000012: laid down in section 23 a of this Act penalty may be imposed under Chapter 38, section 1 or 2, of the Penal Code,
p.000012: unless the action is punishable under Chapter 40, section 5, or a more severe penalty is laid down by other
p.000012: legislation.
p.000012:
p.000012: Chapter 7
p.000012:
p.000012: Entry into force and transitional provisions Section 29
p.000012: Entry into force
p.000012:
p.000012: This Act enters into force on 1 November 1999.
p.000012:
p.000012: Measures necessary for the implementation of the Act may be undertaken before its entry into force.
p.000012:
p.000012: Section 30
p.000012:
p.000012: Transitional provision
p.000012:
p.000012: The provisions of this Act shall, where applicable, apply to research projects already under way when the
p.000012: Act enters into force. The provisions of the Act shall also apply to the specimens taken of people, human gametes and
p.000012: human embryos that are being stored when the Act enters into force.
p.000012:
p.000012: Every hospital district in which research covered by this Act is being conducted shall submit a
p.000012: notification in accordance with section 20 within six months of entry into force of this Act.
p.000012:
p.000012: Any institution where research of the type referred to in section 11 is being conducted when the Act enters into
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000002: and scientific qualifications who is in charge of carrying out a clinical trial at a research site; if a trial is
p.000002: carried out at a research site by a research group, researcher refers to the medical doctor, dentist or another person
p.000002: acting as the leader of the group; (794/2010)
p.000002:
p.000002: (5) commissioning party means the person, company, institution or organisation that is in charge of starting,
p.000002: directing or financing a clinical trial; if an outside party takes part in carrying out the trial only by financing it,
p.000002: the researcher and financier may agree between themselves that the researcher is also the commissioning party; if the
p.000002: trial is not commissioned by an outside party the researcher is the commissioning party; and
p.000002:
p.000002: (6) clinical trial on medicinal products means intervention research on persons for the purpose of finding out effects
p.000002: of a medicinal product in a human being as well as its absorption, distribution, metabolism or excretion in the human
p.000002: body.
p.000002:
p.000002: Section 3 (295/2004)
p.000002:
p.000002: General conditions governing medical research
p.000002:
p.000002: Medical research shall respect the inviolability of human dignity.
p.000002:
p.000002: Before any research referred to in this Act is undertaken, the ethics committee shall have given a favourable
p.000002: opinion on the research plan. When conducting clinical trials on medicinal products the provisions of Chapter
p.000002: 2 a and of the Medicines Act (395/1987) shall be taken into account, in addition.
p.000002:
p.000002: Where the commissioning party alters the research plan so that the alteration may affect the safety of the research
p.000002: subjects or the alteration has a bearing on the interpretation of the scientific documents used in support of
p.000002: the research or where the alteration is otherwise considerable, the party shall inform the ethics committee about
p.000002: it. The research may not be continued in accordance with the altered plan until the ethics committee has delivered a
p.000002: favourable opinion on it. If the committee’s opinion is negative, the plan shall be adjusted in the way called
p.000002: for in the opinion before continuing the research or, alternatively, the research can be continued
p.000002: according to the original plan unless the safety of the research subjects requires that the research is suspended
p.000002: or terminated. In addition, the Finnish Medicines Agency (FIMEA) shall be informed about any alteration to the research
p.000002: plan regarding a clinical trial on medicinal products as laid down in the Medicines Act. (780/2009)
p.000002:
p.000002: Where the ethics committee delivers a negative opinion, the commissioning party may bring the matter before the
p.000002: committee for reconsideration. The regional ethics committee shall at the request of the commissioning party
p.000002: seek the opinion of the National Committee on Medical Research Ethics before delivering a new opinion on the
p.000002: matter. (794/2010)
p.000002:
p.000002: Chapter 2
p.000002:
p.000002: Medical research on persons Section 4
p.000002: Weighing up benefits and harmful effects
p.000002:
p.000002: In medical research the interests and well-being of the research subject shall always be put before any benefits to
p.000002: science or society. Measures shall be taken to prevent any risks or harmful effects to the research subject, as far as
p.000002: possible.
p.000002:
p.000002: Research subjects may be exposed only to measures where the expected health or scientific benefit is
p.000002: unequivocally greater than the potential risks or harm to the research subject.
p.000002:
p.000002: Section 5
p.000002:
p.000002: People in charge of research
p.000002:
p.000002: Medical research may be undertaken only under the responsibility of a medical doctor or dentist with the adequate
p.000002: professional and scientific qualifications. If it is question of research other than clinical drug trial,
p.000002: also another person than a medical doctor or
p.000002:
p.000002: 2
p.000002:
p.000002: dentist may be responsible for the research, provided that the person has the professional and scientific
p.000002: qualifications required for the research concerned. (794/2010)
p.000002:
p.000002: The person in charge of the research shall ensure that there are competent staff and suitable tools and
p.000002: equipment available for the research and that the research is otherwise conducted under safe conditions. The person in
p.000002: charge shall also ensure that the research is conducted in accordance with the provisions of this Act, the
...
p.000004: the minor to give his/her informed consent in writing. In such cases the guardian shall be informed of this. In
p.000004: other cases minors may be research subjects only where written consent for this has been given by
p.000004: their guardian or legal representative after being provided with the information referred to in section 6 (2). The
p.000004: consent must be in accordance with the minor’s supposed will. Consent may be withdrawn on the same terms as
p.000004: set out in section 6 (4). (295/2004)
p.000004:
p.000004: Minors shall receive within their capacity of understanding information about the themes of the research as well
p.000004: as about its risks and benefits from staff with experience from working with minors. Where minors who,
p.000004: in accordance with paragraph 3, are not entitled to be research subjects without the consent of their
p.000004: guardian or other legal representative, are capable of understanding the importance of the research procedure to be
p.000004: carried out on them, their written consent shall also be required. (295/2004)
p.000004:
p.000004: Where a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of
p.000004: his/her age and maturity. (295/2004)
p.000004:
p.000004: Section 9
p.000004:
p.000004: Research involving pregnant women and nursing mothers
p.000004:
p.000004: Pregnant women and nursing mothers may be research subjects only where it is not possible to obtain the
p.000004: same scientific results using other research subjects and:
p.000004:
p.000004: (1) the research is likely to be of direct benefit to the health of the woman or the unborn child; or
p.000004:
p.000004: (2) the research is likely to be of benefit to the health of people related to the woman, or to pregnant women or
p.000004: nursing mothers, or to foetuses, newborn children or unweaned children.
p.000004:
p.000004: Section 10 (794/2010)
p.000004:
p.000004: Research involving prisoners or forensic patients
p.000004:
p.000004: Prisoners or forensic patients may be research subjects only where the research is likely to be of direct benefit to
p.000004: their own health or the health of people related to them or the health of other prisoners or forensic patients.
p.000004:
p.000004: Chapter 2 a (295/2004)
p.000004:
p.000004: Clinical trials on medicinal products Section 10 a (295/2004)
p.000004: Good clinical research practice
p.000004:
p.000004: All clinical trials on medicinal products shall be planned, conducted and reported on observing the
p.000004: principles of good clinical research practice.
p.000004:
p.000004: Section 10 b (295/2004)
p.000004:
p.000004: Insurance or other guarantee
p.000005: 5
p.000005:
p.000005: The party commissioning a clinical trial on medicinal products shall see to it that there is an insurance policy or
p.000005: other appropriate guarantee to cover the liability of the party and the researcher.
p.000005:
p.000005: Section 10 c (780/2009)
p.000005:
p.000005: Start of research
p.000005:
p.000005: A clinical trial on medicinal products may be started only after the ethics committee has delivered an opinion in
p.000005: favour of it, and on the condition that the Finnish Medicines Agency has granted it the licence required in
p.000005: the Medicines Act or it has not informed of any obstacle to starting the research as laid down in the Medicines Act.
p.000005:
p.000005: Section 10 d (295/2004)
p.000005:
p.000005: Opinion of the ethics committee
p.000005:
p.000005: The provisions of sections 3 and 17 shall apply to the opinions of the ethics committee. In addition, an opinion on a
p.000005: clinical trial on medicinal products shall take into account in particular the following circumstances:
p.000005:
p.000005: 1) appropriateness of the trial and its planning;
p.000005:
p.000005: 2) appropriateness of the assessment of its benefit and risks and justifiability of any conclusions
p.000005: regarding them;
p.000005:
p.000005: 3) the research plan;
p.000005:
p.000005: 4) suitability of the researcher and staff;
p.000005:
p.000005: 5) the researcher’s information package containing clinical and other information on the medicinal product or products
p.000005: used in the trial that is of significance when testing those medicinal products on people;
p.000005:
p.000005: 6) quality of the premises and equipment to be used in the trial;
p.000005:
p.000005: 7) sufficiency and coverage of the written information given to obtain the informed written consent and the
p.000005: procedure for obtaining the consent, and grounds for trials to be carried out on persons not able to give their
p.000005: consent;
p.000005:
p.000005: 8) the grounds on which damages possibly caused by the trial are compensated and insurance policies and
p.000005: other arrangements for covering a compensation payable on account of damages or death;
p.000005:
p.000005: 9) amount of the fee or remuneration to be paid to researchers and research subjects or the criteria for determining it
p.000005: and procedures possibly related to the matter, as well as the main content of the agreement to be concluded between the
p.000005: commissioning party and the research site; and
p.000005:
p.000005: 10) detailed procedures relating to choosing the research subjects.
p.000005:
p.000005: The ethics committee shall give its opinion to the body asking it within 60 days of having received an appropriate
p.000005: request for opinion as well as communicate it to the Finnish Medicines Agency for information. If the
p.000005: trial concerns medicinal products meant for
p.000006: 6
p.000006:
p.000006: gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms, the
p.000006: opinion must be delivered within 90 days. The committee can however extend this time limit by up to 90 days,
p.000006: if the giving of the opinion requires extensive further investigations. The ethics committee may
p.000006: ask once additional information from the party asking for opinion. There is no defined period for giving an opinion
p.000006: on xenogenic cell therapy. (780/2009)
p.000006:
p.000006: The ethics committee shall deliver its opinion on an alteration to the research plan within 35 days of having received
p.000006: the notification of alteration.
p.000006:
p.000006: The period of time during which further information is requested or delivered shall not count for the purposes of
p.000006: calculating the time limits referred to in paragraphs 2 and 3.
p.000006:
p.000006: Section 10 e (295/2004)
p.000006:
p.000006: Notification of adverse events
p.000006:
p.000006: The researcher shall immediately notify the commissioning party of any serious adverse events, except for those adverse
p.000006: events that it is not necessary to notify according to the research plan or the researcher’s information package.
p.000006: After the notification a written detailed report shall be given on the adverse event. In the
p.000006: notification and report the research subjects are identified by code numbers.
p.000006:
p.000006: The commissioning party shall be notified within the defined periods laid down in the research plan of any adverse
p.000006: events and deviating laboratory results that are defined in the research plan to be significant from the point of view
p.000006: of safety evaluation.
p.000006:
p.000006: The researcher shall communicate to the commissioning party and the ethics committee any information requested by them
p.000006: about deaths of research subjects.
p.000006:
p.000006: Section 10 f (794/2010)
p.000006:
p.000006: Notification of serious adverse effects
p.000006:
p.000006: The commissioning party shall notify the Finnish Medicines Agency and the competent authorities of the Member States of
...
p.000008: evaluate the handling of matters pertaining to research ethics in its region. The regional ethics committee is
p.000008: set up by the board of the
p.000008:
p.000009: 9
p.000009:
p.000009: hospital district. The provisions of the Local Government Act (365/1995) on committees apply to the regional ethics
p.000009: committees.
p.000009:
p.000009: The Government sets up the National Committee on Medical Research Ethics for four years at one time. The Committee
p.000009: shall:
p.000009:
p.000009: 1) act as an expert in issues pertaining to research ethics;
p.000009:
p.000009: 2) monitor, guide and coordinate the handling of issues pertaining to research ethics;
p.000009:
p.000009: 3) take part in international cooperation of the relevant authorities;
p.000009:
p.000009: Further provisions on the National Committee on Medical Research Ethics are laid down by Government decree.
p.000009:
p.000009: Section 17 (794/2010)
p.000009:
p.000009: Evaluation of a research project
p.000009:
p.000009: Prior evaluation of research projects and delivering opinions on them is the responsibility of the ethics committee
p.000009: of the region where the person in charge of the research is based or of the region where the research is to be
p.000009: principally conducted. The National Committee on Medical Research Ethics shall deliver an opinion on clinical drug
p.000009: trials, unless it has delegated the task to a regional ethics committee.
p.000009:
p.000009: For the purposes of delivering the opinion, the committee shall examine whether the research plan has
p.000009: taken account of the provisions and regulations regarding medical research laid down in this Act and other law
p.000009: and the provisions laid down in virtue of it. In its opinions the ethics committee shall give its reasoned view on
p.000009: whether or not the research is ethically acceptable.
p.000009:
p.000009: Provisions on fees to be charged in respect of opinions shall be laid down by decree of the Ministry of Social Affairs
p.000009: and Health.
p.000009:
p.000009: Section 18
p.000009:
p.000009: Composition
p.000009:
p.000009: Ethics committees shall have a chairperson and at least six other members, one of whom shall be the deputy chairperson.
p.000009: There shall be an appropriate number of substitutes for the members.
p.000009:
p.000009: The committees shall contain representatives from research ethics, medicine, health science or nursing
p.000009: science, and science of law. At least two members shall be laypersons. (794/2010)
p.000009:
p.000009: Decisions on opinions shall be taken with the participation of the chairperson or the deputy chairperson
p.000009: and at least half the other members or at least four of the other members, whichever is the greater. When
p.000009: decisions on opinions are taken, the members shall include at least one layperson and two people from outside the
p.000009: research unit.
p.000009:
p.000009: When dealing with a clinical trial on medicinal products to be conducted on minors ethics committees
p.000009: shall have as a member or consult a specialist in paediatrics. When dealing with a clinical trial on
p.000009: medicinal products to be conducted on an adult not able to
p.000010: 10
p.000010:
p.000010: give consent ethics committees shall have as a member or consult a specialist in the illness and patient
p.000010: group concerned. Instead of consulting, ethics committees may request a written opinion from a specialist representing
p.000010: the area in question. (295/2004)
p.000010:
p.000010: Section 19 (295/2004)
p.000010:
p.000010: Disqualification of a member
p.000010:
p.000010: Disqualification of a member of an ethics committee shall be governed by the provisions on the disqualification in
p.000010: regard to civil servants laid down in the Administrative Procedure Act (434/2003).
p.000010:
p.000010: Section 20 (794/2010)
p.000010:
p.000010: Duty of notification
p.000010:
p.000010: Hospital districts shall notify the National Committee on Medical Research Ethics of the setting up of ethics
p.000010: committees, their composition and any changes to them and contact details for them.
p.000010:
p.000010: Chapter 5 Miscellaneous provisions
p.000010: Section 21
p.000010:
p.000010: Remuneration of research subjects
p.000010:
p.000010: No payment shall be made for participating in the research to the research subjects, their guardians, close
p.000010: relatives, any other persons closely connected with them, or to their legal representative. However, an
p.000010: appropriate remuneration may be paid in respect of expenses or loss of earnings or for any other inconvenience suffered
p.000010: as a result of the research.
p.000010:
p.000010: Grounds on which payment may be made are laid down by the relevant ministry.
p.000010:
p.000010: Section 22
p.000010:
p.000010: Supervision and withdrawal of licence
p.000010:
p.000010: The National Authority for Medicolegal Affairs can revoke the licence referred to in section 11 if the
...
p.000010:
p.000010: The decision to revoke a licence shall be complied with even if an appeal has been lodged against the
p.000010: decision.
p.000010:
p.000010: For the purposes of overseeing this Act and the provisions and regulations laid down in virtue of it, the National
p.000010: Authority for Medicolegal Affairs shall have the right to inspect the premises and activities of establishments
p.000010: which have been granted a licence as referred to in section 11 and to inspect any documents required for the
p.000010: exercise of this supervision.
p.000011: 11
p.000011:
p.000011: Section 23
p.000011:
p.000011: Official accountability and duty of confidentiality
p.000011:
p.000011: Those responsible for research and the members of the ethics committees shall be governed by the principle
p.000011: of official accountability.
p.000011:
p.000011: Confidential information obtained in the course of activities in relation with this Act and relating to research plans,
p.000011: personal information concerning other persons, their state of health, personal circumstances or financial status or
p.000011: business or trade secrets, must not be disclosed to a third party.
p.000011:
p.000011: Section 24 (295/2004)
p.000011:
p.000011: Further provisions
p.000011:
p.000011: Further provisions on the implementation of this Act are laid down as necessary by Government decree.
p.000011:
p.000011: If necessary, further provisions concerning the drawing up and keeping of research documents, the form for
p.000011: the request for opinion to be made to the ethics committee and the documents to be attached to it, delegating
p.000011: requests for opinion to regional ethics committees and on the information to be given to research
p.000011: subjects are laid down by decree of the Ministry of Social Affairs and Health.
p.000011:
p.000011: Chapter 6 Penal provisions
p.000011: Sections 25–26 were repealed by Act 375/2009.
p.000011:
p.000011: Section 27 (375/2009)
p.000011:
p.000011: Breach of the Medical Research Act
p.000011:
p.000011: Any person who conducts medical research
p.000011:
p.000011: (1) without the consent referred to in sections 6–8,
p.000011:
p.000011: (2) without the favourable opinion of the ethics committee in violation of section 3,
p.000011:
p.000011: (3) in violation of the conditions laid down in sections 5–10,
p.000011:
p.000011: (4) without observing the provisions of sections 10 b, 10 c and 10 e – 10 g in the research,
p.000011:
p.000011: shall be fined for breach of the Medical Research Act.
p.000011:
p.000011: Section 28 (375/2009)
p.000011:
p.000011: References to the Penal Code
p.000011:
p.000011: Penalty for unlawful intervention on the embryo is imposed under Chapter 22, section 3, of the Penal Code (39/1889) and
p.000011: penalty for unlawful intervention on the genome under its Chapter 22, section 4. Upon conviction of any breach of the
p.000011: duty of confidentiality
p.000012: 12
p.000012:
p.000012: laid down in section 23 a of this Act penalty may be imposed under Chapter 38, section 1 or 2, of the Penal Code,
p.000012: unless the action is punishable under Chapter 40, section 5, or a more severe penalty is laid down by other
p.000012: legislation.
p.000012:
p.000012: Chapter 7
p.000012:
p.000012: Entry into force and transitional provisions Section 29
p.000012: Entry into force
p.000012:
p.000012: This Act enters into force on 1 November 1999.
p.000012:
p.000012: Measures necessary for the implementation of the Act may be undertaken before its entry into force.
p.000012:
p.000012: Section 30
p.000012:
p.000012: Transitional provision
p.000012:
p.000012: The provisions of this Act shall, where applicable, apply to research projects already under way when the
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.000002: the research that has a bearing on the safety of the research subjects emerges in the course of the research, the
p.000002: person in charge of the research and the commissioning party shall immediately undertake precautionary measures to
p.000002: protect the research subjects. The commissioning party shall immediately inform the ethics committee of
p.000002: such new knowledge and of the measures undertaken based thereon. In addition, information and
p.000002: measures regarding clinical trials on medicinal products shall be immediately communicated to the
p.000002: Finnish Medicines Agency. (780/2009)
p.000002:
p.000002: Section 6 (295/2004)
p.000002:
p.000002: Consent of research subjects
p.000002:
p.000002: Medical research on persons may not be conducted without the research subject’s informed consent in writing.
p.000002: Exceptions to this may be made where consent cannot be obtained owing to the urgency of the matter and the
p.000002: patient’s state of health and the measure is expected to be of immediate benefit to the patient’s
p.000002: health. If the research subject is not able to write he or she can give the consent orally in the presence of at
p.000002: least one witness who is not dependent on the research. It is allowed to deviate from the requirement
p.000002: for written consent in research other than clinical trials on medicinal products also when giving personal
p.000002: data would be in contrary to the research subject’s interests and the research will only involve minor stress to the
p.000002: research subject and is not harmful to the research subject’s health. Oral consent may then be given
p.000002: without the presence of a witness, and the personal data of the research subject are not recorded in the research
p.000002: documents.
p.000002:
p.000002: If a person taking part in a clinical trial on medicinal products is not able to give consent on taking part in the
p.000002: trial, the person may not, deviating from the provision in paragraph 1, be research subject unless the person’s close
p.000002: relative or other person closely connected with the person or his/her legal representative, after having been
p.000002: informed about the nature, meaning, effects and risks of the clinical trial, gives consent to taking part in the
p.000002: trial. The consent must be in accordance with the research subject’s supposed will.
p.000002:
p.000002: Research subjects shall have their rights, the purpose and nature of the research and the procedures it involves
p.000002: properly explained to them. The potential risks and harm shall also be properly explained to them. This information
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000007: products notify the Finnish Medicines Agency and the ethics committee that the research has been terminated. If
p.000007: the research has been terminated before planned, the notification shall be made within 15 days from the
p.000007: termination. The reasons for the premature termination must be specified in the notification.
p.000007:
p.000007: A report on the outcome of a clinical trial on medicinal products shall be submitted to the Finnish Medicines Agency
p.000007: and the ethics committee within one year of completion of the trial.
p.000007:
p.000007: Section 10 i (780/2009)
p.000007:
p.000007: Further regulations
p.000007:
p.000007: The Finnish Medicines Agency issues necessary regulations on the good clinical practice referred to in section 10 a, on
p.000007: the content, drawing up, verification and presentation of the notifications referred to in sections 10 e - 10 h, and on
p.000007: the procedures for analysis of unexpected and serious adverse effects. Furthermore, the Finnish Medicines Agency may
p.000007: issue regulations for observance of international scientific guidelines and practices regarding clinical
p.000007: trials on medicinal products.
p.000007:
p.000007: Chapter 3
p.000007:
p.000007: Research involving embryos and foetuses Section 11
p.000007: Conditions governing research involving embryos
p.000007:
p.000007: Research on embryos outside a woman’s body may be carried out only by agencies that have been granted the
p.000007: appropriate licence by the National Authority for Medicolegal Affairs. The conditions for the granting of the
p.000007: licence shall be laid down by Decree.
p.000007:
p.000007: Medical research on embryos is permitted only if no more than 14 days have passed from their formation. The time during
p.000007: which an embryo is kept frozen shall not count for the purposes of calculating this time limit.
p.000007:
p.000007: Section 12
p.000007:
p.000007: Consent for research on embryos
p.000008: 8
p.000008:
p.000008: Research on embryos outside a woman’s body may not be undertaken without the written consent of the persons who donated
p.000008: the gametes. The donors shall be provided with the information referred to in section 6 (2). Consent may be withdrawn
p.000008: on the same terms as set out in section 6 (3).
p.000008:
p.000008: Embryos produced from donated gametes may not be used for research once the withdrawal of consent has been
p.000008: received.
p.000008:
p.000008: Research on an embryo inside a woman’s body may not be undertaken without her written consent.
p.000008:
p.000008: Section 13
p.000008:
p.000008: Restrictions on research on embryos
p.000008:
p.000008: The production of embryos exclusively for the purpose of research shall be forbidden.
p.000008:
p.000008: Embryos that have been used for research may not be implanted in a human body or be kept alive for longer than 14 days
p.000008: from their formation, not including any time during which they have been kept frozen.
p.000008:
...
p.000010: the area in question. (295/2004)
p.000010:
p.000010: Section 19 (295/2004)
p.000010:
p.000010: Disqualification of a member
p.000010:
p.000010: Disqualification of a member of an ethics committee shall be governed by the provisions on the disqualification in
p.000010: regard to civil servants laid down in the Administrative Procedure Act (434/2003).
p.000010:
p.000010: Section 20 (794/2010)
p.000010:
p.000010: Duty of notification
p.000010:
p.000010: Hospital districts shall notify the National Committee on Medical Research Ethics of the setting up of ethics
p.000010: committees, their composition and any changes to them and contact details for them.
p.000010:
p.000010: Chapter 5 Miscellaneous provisions
p.000010: Section 21
p.000010:
p.000010: Remuneration of research subjects
p.000010:
p.000010: No payment shall be made for participating in the research to the research subjects, their guardians, close
p.000010: relatives, any other persons closely connected with them, or to their legal representative. However, an
p.000010: appropriate remuneration may be paid in respect of expenses or loss of earnings or for any other inconvenience suffered
p.000010: as a result of the research.
p.000010:
p.000010: Grounds on which payment may be made are laid down by the relevant ministry.
p.000010:
p.000010: Section 22
p.000010:
p.000010: Supervision and withdrawal of licence
p.000010:
p.000010: The National Authority for Medicolegal Affairs can revoke the licence referred to in section 11 if the
p.000010: research organisation fails to observe the provisions or regulations which apply. In the event of
p.000010: defects or irregularities, the National Authority for Medicolegal Affairs may decide that the research shall be
p.000010: suspended until the defects or irregularities have been rectified or may withdraw the licence previously granted.
p.000010:
p.000010: The decision to revoke a licence shall be complied with even if an appeal has been lodged against the
p.000010: decision.
p.000010:
p.000010: For the purposes of overseeing this Act and the provisions and regulations laid down in virtue of it, the National
p.000010: Authority for Medicolegal Affairs shall have the right to inspect the premises and activities of establishments
p.000010: which have been granted a licence as referred to in section 11 and to inspect any documents required for the
p.000010: exercise of this supervision.
p.000011: 11
p.000011:
p.000011: Section 23
p.000011:
p.000011: Official accountability and duty of confidentiality
p.000011:
p.000011: Those responsible for research and the members of the ethics committees shall be governed by the principle
p.000011: of official accountability.
p.000011:
p.000011: Confidential information obtained in the course of activities in relation with this Act and relating to research plans,
p.000011: personal information concerning other persons, their state of health, personal circumstances or financial status or
p.000011: business or trade secrets, must not be disclosed to a third party.
p.000011:
p.000011: Section 24 (295/2004)
p.000011:
p.000011: Further provisions
p.000011:
p.000011: Further provisions on the implementation of this Act are laid down as necessary by Government decree.
p.000011:
p.000011: If necessary, further provisions concerning the drawing up and keeping of research documents, the form for
p.000011: the request for opinion to be made to the ethics committee and the documents to be attached to it, delegating
p.000011: requests for opinion to regional ethics committees and on the information to be given to research
...
p.000011: penalty for unlawful intervention on the genome under its Chapter 22, section 4. Upon conviction of any breach of the
p.000011: duty of confidentiality
p.000012: 12
p.000012:
p.000012: laid down in section 23 a of this Act penalty may be imposed under Chapter 38, section 1 or 2, of the Penal Code,
p.000012: unless the action is punishable under Chapter 40, section 5, or a more severe penalty is laid down by other
p.000012: legislation.
p.000012:
p.000012: Chapter 7
p.000012:
p.000012: Entry into force and transitional provisions Section 29
p.000012: Entry into force
p.000012:
p.000012: This Act enters into force on 1 November 1999.
p.000012:
p.000012: Measures necessary for the implementation of the Act may be undertaken before its entry into force.
p.000012:
p.000012: Section 30
p.000012:
p.000012: Transitional provision
p.000012:
p.000012: The provisions of this Act shall, where applicable, apply to research projects already under way when the
p.000012: Act enters into force. The provisions of the Act shall also apply to the specimens taken of people, human gametes and
p.000012: human embryos that are being stored when the Act enters into force.
p.000012:
p.000012: Every hospital district in which research covered by this Act is being conducted shall submit a
p.000012: notification in accordance with section 20 within six months of entry into force of this Act.
p.000012:
p.000012: Any institution where research of the type referred to in section 11 is being conducted when the Act enters into
p.000012: force shall apply to the National Authority for Medicolegal Affairs for a licence for its activities within six
p.000012: months of entry into force of this Act. The work may continue until the application has been processed. The National
p.000012: Authority for Medicolegal Affairs shall decide on a licence application within one year of the date on which the
p.000012: application was received.
p.000012:
p.000012: Entry into force of amended Acts:
p.000012:
p.000012: 1556/2009:
p.000012:
p.000012: This Act enters into force on 1 January 2010. 794/2010:
p.000012: This Act enters into force on 1 October 2010.
p.000012:
p.000012: A research project under consideration at the ethics committee of a hospital district at the entry into force of
p.000012: this Act shall be handled and decided in accordance with the provisions that were in force at the entry into
p.000012: force of the Act.
p.000012:
p.000012: Measures necessary for the implementation of the Act may be undertaken before its entry into force.
p.000012:
p.000012:
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| children | Child |
| conviction | Religion |
| dependent | Dependent |
| drug | Drug Usage |
| education | education |
| embryo | embryo |
| foetus | Fetus/Neonate |
| foetuses | Fetus/Neonate |
| forensic patients | forensic patients |
| illness | Physically Disabled |
| minor | Youth/Minors |
| mothers | Mothers |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| union | Trade Union Membership |
| unlawful | Illegal Activity |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| foetus | ['foetuses'] |
| foetuses | ['foetus'] |
Trigger Words
capacity
consent
developing
ethics
harm
protect
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input