79C3C34C52B45572883A05D425EB0F82
Decree on Medical Research Nos. 986/1999, 313/2004, and 65/2016
http://www.finlex.fi/en/laki/kaannokset/1999/en19990986.pdf
http://leaux.net/URLS/ConvertAPI Text Files/2BD0EFC45049F9E111EE49FEB5BDD726.en.txt
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This file was generated: 2020-12-01 05:49:58
| 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
Social / Unemployment
Searching for indicator not employed:
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p.(None): that shall be given to the research subject and appended to the document of consent.
p.(None):
p.(None): Section 4
p.(None): Conditions governing institutions that are carrying out research involving embryos
p.(None):
p.(None): The condition for granting a licence referred to in section 11 of the Medical Research Act is that the institution has
p.(None): appropriate research facilities and equipment, as well as the staff needed for the activity.
p.(None):
p.(None): When an institution applies for a licence referred to in paragraph 1 from the National Authority for Medicolegal
p.(None): Affairs, the institution shall append to the application information about:
p.(None):
p.(None): 1) the content and extent of the research;
p.(None): 2) the facilities used for the research;
p.(None): 3) devices and equipment used for the research;
p.(None): 4) staff engaged in the research;
p.(None): 5) quality assurance of the research; and
p.(None): 6) the ethics committee assessing the research.
p.(None):
p.(None): If the applicant is an institution referred to in the Private Health Care Act (152/1990), to the application shall be
p.(None): attached, in addition, information about the licence granted to the institution.
p.(None):
p.(None): The National Authority for Medicolegal Affairs will issue, if necessary, further instructions for the application
p.(None): procedure.
p.(None):
p.(None): Section 5
p.(None): Persons outside the research unit
p.(None):
p.(None): By a person outside the research unit referred to in section 18 of the Medical Research Act is meant a person who is
p.(None): not employed by or otherwise dependent on the unit, clinic or department of the hospital or institution in which the
p.(None): research is chiefly carried out.
p.(None):
p.(None): Section 6
p.(None): Entry into force
p.(None):
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): Unofficial translation
p.(None): © Ministry of Social Affairs and Health
p.(None):
p.(None):
p.(None):
p.(None): No. 986/1999
p.(None):
p.(None): Medical Research Decree
p.(None):
p.(None): Issued in Helsinki on 29 October 1999
p.(None):
p.(None):
p.(None): Section 1
p.(None): Submitting a research plan to the ethics committee
p.(None):
p.(None): The research plan shall be submitted for the opinion of the ethics committee referred to in section 3 of the Medical
p.(None): Research Act (488/1999) to the ethics committee of the hospital district in whose area the person responsible for the
p.(None): research operates and in whose area the major part of the research is to be carried out. The ethics committee of some
p.(None): other public or private health care unit, institution, community or company cannot deliver such an opinion by an ethics
p.(None): committee as is referred to in the Act.
p.(None):
p.(None): Section 2 (29.4.2004/313)
p.(None): Deliverer of opinion in certain cases
p.(None):
p.(None): Opinions referred to in section 3 (4) and section 17 (2) of the Medical Research Act are given by the Sub-Committee on
p.(None): Medical Research Ethics of the National Advisory Board on Health Care Ethics.
p.(None):
p.(None): Section 3 (29.4.2004/313)
p.(None): Content of the document where consent is given
p.(None):
p.(None): The document of consent referred to in section 6 of the Medical Research Act shall include the following:
p.(None):
p.(None): 1) the research subject’s name, personal identity code or date of birth, and address;
p.(None): 2) that the information referred to in section 6 (2) has been given to the research subject and data about the giver
p.(None): of the information;
p.(None): 3) which other sources information concerning the research subject will be gathered from;
p.(None): 4) whom the information gathered in the context of the research can be delivered to and how the confidentiality of
p.(None): the information is protected;
p.(None): 5) the research subject’s voluntary consent; and
p.(None): 6) a mention of the right to withdraw the consent without it affecting the research subject’s right to receive the
p.(None): care he or she is in need of.
p.(None):
p.(None): The document of consent shall be dated, and it shall be signed by both the person who gives and the person who receives
...
General/Other / Dependent
Searching for indicator dependent:
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p.(None): Medical Research Ethics of the National Advisory Board on Health Care Ethics.
p.(None):
p.(None): Section 3 (29.4.2004/313)
p.(None): Content of the document where consent is given
p.(None):
p.(None): The document of consent referred to in section 6 of the Medical Research Act shall include the following:
p.(None):
p.(None): 1) the research subject’s name, personal identity code or date of birth, and address;
p.(None): 2) that the information referred to in section 6 (2) has been given to the research subject and data about the giver
p.(None): of the information;
p.(None): 3) which other sources information concerning the research subject will be gathered from;
p.(None): 4) whom the information gathered in the context of the research can be delivered to and how the confidentiality of
p.(None): the information is protected;
p.(None): 5) the research subject’s voluntary consent; and
p.(None): 6) a mention of the right to withdraw the consent without it affecting the research subject’s right to receive the
p.(None): care he or she is in need of.
p.(None):
p.(None): The document of consent shall be dated, and it shall be signed by both the person who gives and the person who receives
p.(None): the consent. If the research subject has given the consent orally because he or she is not able to write, a witness not
p.(None): dependent on the research shall sign the document of consent. The witness’ signature shall be appended with
p.(None): clarification of the name and contact information. In case the ethics committee has approved the carrying out of the
p.(None): research so that no written consent is
p.(None):
p.(None): required on the basis of the 4th sentence in section 6 (1) of the Medical Research Act, the information referred to in
p.(None): paragraph 1 (1) is not recorded in the document of consent and the research subject need not sign the document if he or
p.(None): she forbids recording the information and refuses to sign the document. Such information on the research subject that
p.(None): is necessary for the research shall however be recorded in the document of consent. A copy of the document shall be
p.(None): given to the giver of the consent.
p.(None):
p.(None): The Ministry of Social Affairs and Health will issue, if necessary, separate instructions concerning the information
p.(None): that shall be given to the research subject and appended to the document of consent.
p.(None):
p.(None): Section 4
p.(None): Conditions governing institutions that are carrying out research involving embryos
p.(None):
p.(None): The condition for granting a licence referred to in section 11 of the Medical Research Act is that the institution has
p.(None): appropriate research facilities and equipment, as well as the staff needed for the activity.
p.(None):
p.(None): When an institution applies for a licence referred to in paragraph 1 from the National Authority for Medicolegal
p.(None): Affairs, the institution shall append to the application information about:
p.(None):
p.(None): 1) the content and extent of the research;
p.(None): 2) the facilities used for the research;
p.(None): 3) devices and equipment used for the research;
p.(None): 4) staff engaged in the research;
p.(None): 5) quality assurance of the research; and
p.(None): 6) the ethics committee assessing the research.
p.(None):
p.(None): If the applicant is an institution referred to in the Private Health Care Act (152/1990), to the application shall be
p.(None): attached, in addition, information about the licence granted to the institution.
p.(None):
p.(None): The National Authority for Medicolegal Affairs will issue, if necessary, further instructions for the application
p.(None): procedure.
p.(None):
p.(None): Section 5
p.(None): Persons outside the research unit
p.(None):
p.(None): By a person outside the research unit referred to in section 18 of the Medical Research Act is meant a person who is
p.(None): not employed by or otherwise dependent on the unit, clinic or department of the hospital or institution in which the
p.(None): research is chiefly carried out.
p.(None):
p.(None): Section 6
p.(None): Entry into force
p.(None):
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): clarification of the name and contact information. In case the ethics committee has approved the carrying out of the
p.(None): research so that no written consent is
p.(None):
p.(None): required on the basis of the 4th sentence in section 6 (1) of the Medical Research Act, the information referred to in
p.(None): paragraph 1 (1) is not recorded in the document of consent and the research subject need not sign the document if he or
p.(None): she forbids recording the information and refuses to sign the document. Such information on the research subject that
p.(None): is necessary for the research shall however be recorded in the document of consent. A copy of the document shall be
p.(None): given to the giver of the consent.
p.(None):
p.(None): The Ministry of Social Affairs and Health will issue, if necessary, separate instructions concerning the information
p.(None): that shall be given to the research subject and appended to the document of consent.
p.(None):
p.(None): Section 4
p.(None): Conditions governing institutions that are carrying out research involving embryos
p.(None):
p.(None): The condition for granting a licence referred to in section 11 of the Medical Research Act is that the institution has
p.(None): appropriate research facilities and equipment, as well as the staff needed for the activity.
p.(None):
p.(None): When an institution applies for a licence referred to in paragraph 1 from the National Authority for Medicolegal
p.(None): Affairs, the institution shall append to the application information about:
p.(None):
p.(None): 1) the content and extent of the research;
p.(None): 2) the facilities used for the research;
p.(None): 3) devices and equipment used for the research;
p.(None): 4) staff engaged in the research;
p.(None): 5) quality assurance of the research; and
p.(None): 6) the ethics committee assessing the research.
p.(None):
p.(None): If the applicant is an institution referred to in the Private Health Care Act (152/1990), to the application shall be
p.(None): attached, in addition, information about the licence granted to the institution.
p.(None):
p.(None): The National Authority for Medicolegal Affairs will issue, if necessary, further instructions for the application
p.(None): procedure.
p.(None):
p.(None): Section 5
p.(None): Persons outside the research unit
p.(None):
p.(None): By a person outside the research unit referred to in section 18 of the Medical Research Act is meant a person who is
p.(None): not employed by or otherwise dependent on the unit, clinic or department of the hospital or institution in which the
p.(None): research is chiefly carried out.
p.(None):
p.(None): Section 6
p.(None): Entry into force
p.(None):
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.(None): Unofficial translation
p.(None): © Ministry of Social Affairs and Health
p.(None):
p.(None):
p.(None):
p.(None): No. 986/1999
p.(None):
p.(None): Medical Research Decree
p.(None):
p.(None): Issued in Helsinki on 29 October 1999
p.(None):
p.(None):
p.(None): Section 1
p.(None): Submitting a research plan to the ethics committee
p.(None):
p.(None): The research plan shall be submitted for the opinion of the ethics committee referred to in section 3 of the Medical
p.(None): Research Act (488/1999) to the ethics committee of the hospital district in whose area the person responsible for the
p.(None): research operates and in whose area the major part of the research is to be carried out. The ethics committee of some
p.(None): other public or private health care unit, institution, community or company cannot deliver such an opinion by an ethics
p.(None): committee as is referred to in the Act.
p.(None):
p.(None): Section 2 (29.4.2004/313)
p.(None): Deliverer of opinion in certain cases
p.(None):
p.(None): Opinions referred to in section 3 (4) and section 17 (2) of the Medical Research Act are given by the Sub-Committee on
p.(None): Medical Research Ethics of the National Advisory Board on Health Care Ethics.
p.(None):
p.(None): Section 3 (29.4.2004/313)
p.(None): Content of the document where consent is given
p.(None):
p.(None): The document of consent referred to in section 6 of the Medical Research Act shall include the following:
p.(None):
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| dependent | Dependent |
| helsinki | declaration of helsinki |
| not employed | Unemployment |
| opinion | philosophical differences/differences of opinion |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
Applicable Type / Vulnerability / Indicator Overlay for this Input