0A4F4F9BD490A749D5437F821CF06DF1
Executive Order No. 1464 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects (2016)
https://www.retsinformation.dk/Forms/R0710.aspx?id=185233
http://leaux.net/URLS/ConvertAPI Text Files/73628C3186CC2BDA4DB5F76C5D944CF2.en.txt
Examining the file media/Synopses/73628C3186CC2BDA4DB5F76C5D944CF2.html:
This file was generated: 2020-07-14 08:24:41
| 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
Health / Drug Usage
Searching for indicator drug:
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p.(None): research project pursuant to section 5, the committee system's notification form must be used.
p.(None): § 4. An experimental protocol must contain a description of the research project's objectives, design, methodology,
p.(None): organization, statistical considerations, scientific ethical considerations, financial matters, publication matters,
p.(None): and how participants will be informed.
p.(None): PCS. 2. The trial protocol must be dated and the version number applied. If the following is not part of
p.(None): the trial protocol, the trial protocol must be attached to the following Annex:
p.(None): 1) Summary of protocol, drawn up in Danish, indicating the title of the trial and the name and sponsor's name and sponsor's place of study.
p.(None): and description of the purpose of the experiment, the method of the experiment, the involvement of subjects, including inclusion and
p.(None): exclusion criteria, side effects, risks and disadvantages, financial conditions, recruitment of trial participants, publication of
p.(None): trial results and science ethics account.
p.(None): 2) Written participant information.
p.(None): 3) Description of oral participant information procedures.
p.(None): 4) Form for obtaining consent.
p.(None): 5) Any material, including advertisements, etc., for the acquisition of participants.
p.(None): 6) Any questionnaires and other written material provided to the subject.
p.(None): PCS. 3. An experimental protocol relating to a health science research project with drugs shall, in addition to those referred to in paragraph 1. 2
p.(None): said Annex, also attached to the Investigators Brochure (IB). If there is a marketing authorization for
p.(None): trial drug, the SPC can be used instead of Investigator Brochure.
p.(None): § 5. An Additional Protocol shall contain a description of significant changes in the experimental protocol and the reasons for them
p.(None): proposed changes.
p.(None): PCS. 2. The Additional Protocol shall be annexed to the following Annex, if the changes to the Protocol require this:
p.(None): 1) Dated, modified trial protocol added version number containing marked changes.
p.(None): 2) Dated, amended documents bearing version number on written participant information and oral procedures
p.(None): participant information and consent declaration where the changes necessitate this.
p.(None): 3) Other documents which are amended in accordance with the adjustments referred to in paragraph 1. 1 and 2, Nos. 1 and 2.
p.(None): Chapter 2
p.(None): Information and consent for participation in health science research projects
p.(None): Content of the information
p.(None): § 6. The research subject must be informed in writing and orally about the content of a health science research project,
p.(None): foreseeable risks and benefits prior to consent.
p.(None): PCS. 2. Information for the research subject must include an understandable presentation of the research project without the use of
p.(None): technical or value-laden terms. The information must be given in a considerate manner and adapted to that of the recipient
p.(None): individual assumptions regarding age, maturity, experience, etc. The information must include information on
p.(None): any foreseeable risks, side effects, complications and disadvantages, and that there may be unpredictable risks; and
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): Content of the information
p.(None): § 6. The research subject must be informed in writing and orally about the content of a health science research project,
p.(None): foreseeable risks and benefits prior to consent.
p.(None): PCS. 2. Information for the research subject must include an understandable presentation of the research project without the use of
p.(None): technical or value-laden terms. The information must be given in a considerate manner and adapted to that of the recipient
p.(None): individual assumptions regarding age, maturity, experience, etc. The information must include information on
p.(None): any foreseeable risks, side effects, complications and disadvantages, and that there may be unpredictable risks; and
p.(None): stresses associated with participation in a health science research project.
p.(None): PCS. 3. A patient who wishes to be involved as a research subject in a health science research project with boats
p.(None): scientific and therapeutic purposes, must be informed of other possible treatment methods and whether
p.(None): in connection with the research project, information is collected from the patient's journal.
p.(None): PCS. 4. Furthermore, the test subject is deemed to be unaware of matters that are of significance to the test subject
p.(None): participation, the information must be adapted to include such conditions.
p.(None): PCS. 5. Information to the test subject must include a description of the extent of the informed consent, including that
p.(None): the consent provides direct access for sponsor and sponsor representatives and investigator to obtain information in
p.(None): the patient's record, etc., including the electronic record, for the purpose of viewing information about the subject
p.(None): health conditions that are needed as part of self-monitoring of the research project, including quality control and
p.(None): monitoring that these are required to perform.
p.(None): Especially about written information to the subject
p.(None): § 7. The written information must indicate that it is a request for participation in a health science
p.(None): research project. The information must be presented in such a way as to enable the subject to take
p.(None): state whether he wishes to participate in the research project and include information on:
p.(None): 1) purpose and method and the importance, nature and scope of the research project, including the practical organization of
p.(None): project
p.(None): 2) use of approved and unapproved drugs, their names and dosage and use of
p.(None): randomization, blind preparations, treatment-free periods including any known interactions with other drugs,
p.(None): 3) any predictable risks, side effects, including known long-term side effects, complications and disadvantages of
p.(None): participation in the research project, and that there may be unpredictable risks and stresses associated with participation in it.
p.(None): health science research project,
p.(None): 4) the possible utility of the research project, where there is a distinction between utility for the individual subject, utility for
p.(None): other and scientific progress,
p.(None): 5) under which circumstances the test subject can be excluded from further participation in the research project without his own
p.(None): desire, and under what circumstances the project as a whole can be canceled, and
p.(None): 6) the name, address, email address and telephone number of a contact person associated with the research project.
p.(None): § 8. The written information must indicate the rights of the test subject by stating:
p.(None): 1) that participation in the research project is voluntary and that participation only occurs after both written and oral information is
p.(None): given and written consent is obtained,
p.(None): 2) that the test subject may at any time, orally, in writing or by any other clear expression, consent to
p.(None): participation and withdrawal from the research project without affecting the right to present or future treatment
p.(None): or any other rights the subject may have,
p.(None): 3) that the subject has the right to report time before consent is given, just as the subject has the right to wish,
p.(None): bring a bystander upon receipt of the oral information,
p.(None): 4) information on the subject's health, other purely private matters and other confidential information
p.(None): the research subject who emerges in connection with the research project is subject to professional secrecy,
p.(None): 5) the storage of personally identifiable data, including tissues, blood tests etc., is done in compliance with the Act on the treatment of
p.(None): personal data and the Health Act,
p.(None): 6) the possibility of gaining access to trial protocols in accordance with the provisions of public law, and
p.(None): 7) redress, redress, compensation or other compensation for damages resulting from
p.(None): the research project.
p.(None): PCS. 2. Information on rights, as described in subsection (2). 1, can be attached to the information about the individual
p.(None): health science research project as an independent appendix.
p.(None): § 9. The written information must contain a statement of the financial support of the probation officer
p.(None): recipient from private companies, foundations, etc. for the implementation of the health science concerned
p.(None): research project. The information must be presented in such a way as to enable the subject to take
p.(None): to determine if he / she wishes to participate in the research project.
p.(None): PCS. 2. The financial aid information shall include:
p.(None): 1) who initiated the health science research project;
p.(None): 2) names of both commercial and non-commercial sponsors;
p.(None): (3) the amount of aid for each donor and the manner in which the aid is included in the research project, including whether the aid is paid out;
p.(None): as a fixed sum or as a consideration per and whether the support is paid directly to the probation officer, to
p.(None): its department / institute, to a joint research fund or other, and
p.(None): 4) whether the probation officer otherwise has a financial connection with private companies, foundations etc. who have interests in
p.(None): the research project in question.
p.(None): Especially about information and consent when involving subjects exposed to pressure or coercion
...
Social / Age
Searching for indicator age:
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p.(None): said Annex, also attached to the Investigators Brochure (IB). If there is a marketing authorization for
p.(None): trial drug, the SPC can be used instead of Investigator Brochure.
p.(None): § 5. An Additional Protocol shall contain a description of significant changes in the experimental protocol and the reasons for them
p.(None): proposed changes.
p.(None): PCS. 2. The Additional Protocol shall be annexed to the following Annex, if the changes to the Protocol require this:
p.(None): 1) Dated, modified trial protocol added version number containing marked changes.
p.(None): 2) Dated, amended documents bearing version number on written participant information and oral procedures
p.(None): participant information and consent declaration where the changes necessitate this.
p.(None): 3) Other documents which are amended in accordance with the adjustments referred to in paragraph 1. 1 and 2, Nos. 1 and 2.
p.(None): Chapter 2
p.(None): Information and consent for participation in health science research projects
p.(None): Content of the information
p.(None): § 6. The research subject must be informed in writing and orally about the content of a health science research project,
p.(None): foreseeable risks and benefits prior to consent.
p.(None): PCS. 2. Information for the research subject must include an understandable presentation of the research project without the use of
p.(None): technical or value-laden terms. The information must be given in a considerate manner and adapted to that of the recipient
p.(None): individual assumptions regarding age, maturity, experience, etc. The information must include information on
p.(None): any foreseeable risks, side effects, complications and disadvantages, and that there may be unpredictable risks; and
p.(None): stresses associated with participation in a health science research project.
p.(None): PCS. 3. A patient who wishes to be involved as a research subject in a health science research project with boats
p.(None): scientific and therapeutic purposes, must be informed of other possible treatment methods and whether
p.(None): in connection with the research project, information is collected from the patient's journal.
p.(None): PCS. 4. Furthermore, the test subject is deemed to be unaware of matters that are of significance to the test subject
p.(None): participation, the information must be adapted to include such conditions.
p.(None): PCS. 5. Information to the test subject must include a description of the extent of the informed consent, including that
p.(None): the consent provides direct access for sponsor and sponsor representatives and investigator to obtain information in
p.(None): the patient's record, etc., including the electronic record, for the purpose of viewing information about the subject
p.(None): health conditions that are needed as part of self-monitoring of the research project, including quality control and
p.(None): monitoring that these are required to perform.
p.(None): Especially about written information to the subject
p.(None): § 7. The written information must indicate that it is a request for participation in a health science
p.(None): research project. The information must be presented in such a way as to enable the subject to take
...
p.(None): to give informed consent, the committee may, after a specific assessment, decide that the subject's consent to
p.(None): participation in the research project must be made to a person approved by the committee. The Committee may also decide that:
p.(None): the information in such cases is supplemented with information that the conduct of the research project must be monitored by a
p.(None): independent expert.
p.(None): PCS. 2. Persons who are detained under the Detention Act and other compulsions in psychiatry cannot
p.(None): assist as research subjects in health science research projects.
p.(None): Submission of information and receipt of consent
p.(None): § 11. The written information must be provided in paper form or electronically. The subject can always claim to receive
p.(None): the information in paper form.
p.(None): PCS. 2. An informed consent must be in writing, dated and signed or submitted using electronic signature.
p.(None): Section 12. Information is given and consent is received by the probation officer or a person authorized thereto, who has the
p.(None): professional prerequisites for communicating the content of the research project and having a direct connection to it.
p.(None): PCS. 2. The information for minors shall be provided by a person familiar with the area to which the project relates; and
p.(None): who have the educational prerequisites for disseminating the information to the age group of the research project
p.(None): includes.
p.(None): PCS. 3. By authorizing a person to provide information and receive consent, cf. 1, as well as by
p.(None): authorization for attestation, cf. 2, there must be a written agreement to this effect. Responsibility for notification
p.(None): complete information in accordance with the law is the responsibility of the probation officer.
p.(None): § 13. Consent to participate in a health science research project must be given as soon as received
p.(None): information. However, the subject has the right to report time.
p.(None): PCS. 2. The probation officer or a person authorized to do so must certify that the written information has been provided to
p.(None): the subject, and that oral information was provided. At the request of the subject, it must
p.(None): the person responsible for the trial or a person authorized to do so shall provide a copy of the written consent.
p.(None): Chapter 3
p.(None): Information and consent during the course of the health sciences research project
p.(None): § 14. The test subject gains or regains his ability to act during the course of the health sciences
p.(None): Before the project can be continued, informed consent must be obtained from the research project.
p.(None): PCS. 2. A health science research project cannot be carried out on the basis of a deputy consent if
p.(None): however, the subject protests verbally or by action.
...
Social / Child
Searching for indicator children:
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p.(None): All circulars, guides, etc. to
p.(None): health science research projects as well as on notification of and this notice
p.(None): Decisions taken pursuant to this
p.(None): provision
p.(None): supervision of health science research projects Reports by the Ombudsman,
p.(None): applying this legal regulation
p.(None): Pursuant to section 7, section 15, subs. 3, § 16, par. 2, § 27 (2). 5, § 28 (2). 4 and § 41 (2). 2, of Act No. 593 of June 14, 2011 on
p.(None): scientific ethical treatment of health science research projects is determined:
p.(None): Chapter 1
p.(None): Review of a health science research project and content in an experimental protocol and an additional protocol
p.(None): § 1. Reporting of health science research projects shall be made to the regional committee for the area in which
p.(None): the probation officer has his job. Health science research projects relating to particularly complex areas,
p.(None): cf. section 2, however, must be reported to the National Science Ethics Committee. The obligation to notify rests with the investigator and
p.(None): sponsor in association, and both must sign the review.
p.(None): PCS. 2. Cross-border multicenter trials must always be reported in this country. Are there more probation officers in Denmark,
p.(None): and the research project is not covered by par. 1, second paragraph, the multicenter trial must be notified to the regional committee where it
p.(None): coordinating probation officers have their job.
p.(None): § 2. A health science research project that relates to a particularly complex area is understood to mean:
p.(None): 1) health science research project with children regarding clinical trials of drugs and which are reported via
p.(None): Voluntary Harmonization Procedure (VHP),
p.(None): 2) health science research project, which deals with advanced therapy drugs;
p.(None): 3) health science research project, which deals with extensive mapping of the individual's genetic heritage, which is sought
p.(None): on the exemption pursuant to section 10 of Act No. 593 of 14 June 2011 on scientific ethical treatment of health sciences
p.(None): research projects, or
p.(None): 4) health science research project related to psychosurgery.
p.(None): § 3. The notification system of the committee system must be used for notification. In connection with the notification, the following should be
p.(None): Annex is attached:
p.(None): 1) Documentation of sponsorship and the identity of the probation officer and the probation officer's training and experience;
p.(None): including clinical experience and research experience. If the trial concerns clinical trials of drugs and the trial is performed
p.(None): at several different test sites in Denmark, they must in the first paragraph. said documents are submitted for each of them
p.(None): probation officers from each trial site in Denmark.
p.(None): 2) Trial protocol and appendices thereto pursuant to section 4
p.(None): PCS. 2. When notifying significant changes to an experimental protocol for an approved health scientist
p.(None): research project pursuant to section 5, the committee system's notification form must be used.
p.(None): § 4. An experimental protocol must contain a description of the research project's objectives, design, methodology,
p.(None): organization, statistical considerations, scientific ethical considerations, financial matters, publication matters,
...
Social / Elderly
Searching for indicator elderly:
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p.(None): To the front page of court information.dk
p.(None): Overview (table of contents) BEK no 1464 of 02/12/2016 Historic
p.(None): (Information Order)
p.(None): Publication date: 06-12-2016
p.(None): Ministry of Health and Elderly
p.(None): Chapter 1 Review of a health science research project and content in an experimental protocol and one
p.(None): Show more...
p.(None): Additional Protocol
p.(None): Chapter 2 Information and consent for participation in health science research projects Later changes to the regulations
p.(None): BEK No. 498 of 13/05/2018
p.(None): Chapter 3 Information and consent during the course of the health sciences research project
p.(None): Chapter 4 Supervision of the Scientific Ethics Committees
p.(None): Legislation the regulation concerns
p.(None): Chapter 5 Penalty LBK No. 1083 of 15/09/2017
p.(None): Chapter 6 Entry into force
p.(None): Changes in / cancels
p.(None): The full text BEK No. 710 of 01/06/2016
p.(None): Notice of information and consent to participation in Additional documents:
p.(None): All circulars, guides, etc. to
p.(None): health science research projects as well as on notification of and this notice
p.(None): Decisions taken pursuant to this
p.(None): provision
p.(None): supervision of health science research projects Reports by the Ombudsman,
p.(None): applying this legal regulation
p.(None): Pursuant to section 7, section 15, subs. 3, § 16, par. 2, § 27 (2). 5, § 28 (2). 4 and § 41 (2). 2, of Act No. 593 of June 14, 2011 on
p.(None): scientific ethical treatment of health science research projects is determined:
p.(None): Chapter 1
p.(None): Review of a health science research project and content in an experimental protocol and an additional protocol
p.(None): § 1. Reporting of health science research projects shall be made to the regional committee for the area in which
...
p.(None): and about any consequences for the individual.
p.(None): Chapter 4
p.(None): Supervision of the Science Ethics Committees
p.(None): § 17. A scientific ethics committee's supervision of an approved register research project requiring consent or
p.(None): Deputy consent is waived because the project does not involve health risks and not otherwise after
p.(None): otherwise the circumstances are a burden on the subject or where it is impossible or disproportionately difficult
p.(None): obtaining informed consent or deputy consent is made without processing personal data from
p.(None): subjects.
p.(None): Chapter 5
p.(None): Punishment
p.(None): § 18. Unless higher penalties are stipulated in other legislation, the person who initiates a research project is penalized in contravention of
p.(None): Sections 6-16 of this Order, with fine.
p.(None): Chapter 6
p.(None): Entry into force
p.(None): Section 19. The Executive Order enters into force on 1 January 2017 and applies to health sciences
p.(None): research projects submitted to a science ethics committee from that date.
p.(None): PCS. 2. Executive Order No. 710 of June 1, 2016 on information and consent for participation in health sciences
p.(None): cancellation of research projects and the notification and supervision of health science research projects.
p.(None): Ministry of Health and Elderly, December 2, 2016
p.(None): Ellen Trane Nørby
p.(None): / Anna Skat Nielsen
p.(None): rettinformation.dk always uses a temporary cookie (session cookie) on all pages. A session cookie expires when Accept cookies
p.(None): one has closed the browser. If you accept cookies, courtsinformation.dk saves this choice and whether you have one
p.(None): used simple search or field search of a cookie, which always expires after 12 months. Read more
...
Social / Occupation
Searching for indicator job:
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p.(None): Show more...
p.(None): Additional Protocol
p.(None): Chapter 2 Information and consent for participation in health science research projects Later changes to the regulations
p.(None): BEK No. 498 of 13/05/2018
p.(None): Chapter 3 Information and consent during the course of the health sciences research project
p.(None): Chapter 4 Supervision of the Scientific Ethics Committees
p.(None): Legislation the regulation concerns
p.(None): Chapter 5 Penalty LBK No. 1083 of 15/09/2017
p.(None): Chapter 6 Entry into force
p.(None): Changes in / cancels
p.(None): The full text BEK No. 710 of 01/06/2016
p.(None): Notice of information and consent to participation in Additional documents:
p.(None): All circulars, guides, etc. to
p.(None): health science research projects as well as on notification of and this notice
p.(None): Decisions taken pursuant to this
p.(None): provision
p.(None): supervision of health science research projects Reports by the Ombudsman,
p.(None): applying this legal regulation
p.(None): Pursuant to section 7, section 15, subs. 3, § 16, par. 2, § 27 (2). 5, § 28 (2). 4 and § 41 (2). 2, of Act No. 593 of June 14, 2011 on
p.(None): scientific ethical treatment of health science research projects is determined:
p.(None): Chapter 1
p.(None): Review of a health science research project and content in an experimental protocol and an additional protocol
p.(None): § 1. Reporting of health science research projects shall be made to the regional committee for the area in which
p.(None): the probation officer has his job. Health science research projects relating to particularly complex areas,
p.(None): cf. section 2, however, must be reported to the National Science Ethics Committee. The obligation to notify rests with the investigator and
p.(None): sponsor in association, and both must sign the review.
p.(None): PCS. 2. Cross-border multicenter trials must always be reported in this country. Are there more probation officers in Denmark,
p.(None): and the research project is not covered by par. 1, second paragraph, the multicenter trial must be notified to the regional committee where it
p.(None): coordinating probation officers have their job.
p.(None): § 2. A health science research project that relates to a particularly complex area is understood to mean:
p.(None): 1) health science research project with children regarding clinical trials of drugs and which are reported via
p.(None): Voluntary Harmonization Procedure (VHP),
p.(None): 2) health science research project, which deals with advanced therapy drugs;
p.(None): 3) health science research project, which deals with extensive mapping of the individual's genetic heritage, which is sought
p.(None): on the exemption pursuant to section 10 of Act No. 593 of 14 June 2011 on scientific ethical treatment of health sciences
p.(None): research projects, or
p.(None): 4) health science research project related to psychosurgery.
p.(None): § 3. The notification system of the committee system must be used for notification. In connection with the notification, the following should be
p.(None): Annex is attached:
p.(None): 1) Documentation of sponsorship and the identity of the probation officer and the probation officer's training and experience;
p.(None): including clinical experience and research experience. If the trial concerns clinical trials of drugs and the trial is performed
p.(None): at several different test sites in Denmark, they must in the first paragraph. said documents are submitted for each of them
p.(None): probation officers from each trial site in Denmark.
p.(None): 2) Trial protocol and appendices thereto pursuant to section 4
p.(None): PCS. 2. When notifying significant changes to an experimental protocol for an approved health scientist
p.(None): research project pursuant to section 5, the committee system's notification form must be used.
...
Social / Police Officer
Searching for indicator officer:
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p.(None): Chapter 1 Review of a health science research project and content in an experimental protocol and one
p.(None): Show more...
p.(None): Additional Protocol
p.(None): Chapter 2 Information and consent for participation in health science research projects Later changes to the regulations
p.(None): BEK No. 498 of 13/05/2018
p.(None): Chapter 3 Information and consent during the course of the health sciences research project
p.(None): Chapter 4 Supervision of the Scientific Ethics Committees
p.(None): Legislation the regulation concerns
p.(None): Chapter 5 Penalty LBK No. 1083 of 15/09/2017
p.(None): Chapter 6 Entry into force
p.(None): Changes in / cancels
p.(None): The full text BEK No. 710 of 01/06/2016
p.(None): Notice of information and consent to participation in Additional documents:
p.(None): All circulars, guides, etc. to
p.(None): health science research projects as well as on notification of and this notice
p.(None): Decisions taken pursuant to this
p.(None): provision
p.(None): supervision of health science research projects Reports by the Ombudsman,
p.(None): applying this legal regulation
p.(None): Pursuant to section 7, section 15, subs. 3, § 16, par. 2, § 27 (2). 5, § 28 (2). 4 and § 41 (2). 2, of Act No. 593 of June 14, 2011 on
p.(None): scientific ethical treatment of health science research projects is determined:
p.(None): Chapter 1
p.(None): Review of a health science research project and content in an experimental protocol and an additional protocol
p.(None): § 1. Reporting of health science research projects shall be made to the regional committee for the area in which
p.(None): the probation officer has his job. Health science research projects relating to particularly complex areas,
p.(None): cf. section 2, however, must be reported to the National Science Ethics Committee. The obligation to notify rests with the investigator and
p.(None): sponsor in association, and both must sign the review.
p.(None): PCS. 2. Cross-border multicenter trials must always be reported in this country. Are there more probation officers in Denmark,
p.(None): and the research project is not covered by par. 1, second paragraph, the multicenter trial must be notified to the regional committee where it
p.(None): coordinating probation officers have their job.
p.(None): § 2. A health science research project that relates to a particularly complex area is understood to mean:
p.(None): 1) health science research project with children regarding clinical trials of drugs and which are reported via
p.(None): Voluntary Harmonization Procedure (VHP),
p.(None): 2) health science research project, which deals with advanced therapy drugs;
p.(None): 3) health science research project, which deals with extensive mapping of the individual's genetic heritage, which is sought
p.(None): on the exemption pursuant to section 10 of Act No. 593 of 14 June 2011 on scientific ethical treatment of health sciences
p.(None): research projects, or
p.(None): 4) health science research project related to psychosurgery.
p.(None): § 3. The notification system of the committee system must be used for notification. In connection with the notification, the following should be
p.(None): Annex is attached:
p.(None): 1) Documentation of sponsorship and the identity of the probation officer and the probation officer's training and experience;
p.(None): including clinical experience and research experience. If the trial concerns clinical trials of drugs and the trial is performed
p.(None): at several different test sites in Denmark, they must in the first paragraph. said documents are submitted for each of them
p.(None): probation officers from each trial site in Denmark.
p.(None): 2) Trial protocol and appendices thereto pursuant to section 4
p.(None): PCS. 2. When notifying significant changes to an experimental protocol for an approved health scientist
p.(None): research project pursuant to section 5, the committee system's notification form must be used.
p.(None): § 4. An experimental protocol must contain a description of the research project's objectives, design, methodology,
p.(None): organization, statistical considerations, scientific ethical considerations, financial matters, publication matters,
p.(None): and how participants will be informed.
p.(None): PCS. 2. The trial protocol must be dated and the version number applied. If the following is not part of
p.(None): the trial protocol, the trial protocol must be attached to the following Annex:
p.(None): 1) Summary of protocol, drawn up in Danish, indicating the title of the trial and the name and sponsor's name and sponsor's place of study.
p.(None): and description of the purpose of the experiment, the method of the experiment, the involvement of subjects, including inclusion and
p.(None): exclusion criteria, side effects, risks and disadvantages, financial conditions, recruitment of trial participants, publication of
p.(None): trial results and science ethics account.
p.(None): 2) Written participant information.
p.(None): 3) Description of oral participant information procedures.
p.(None): 4) Form for obtaining consent.
...
p.(None): 1) that participation in the research project is voluntary and that participation only occurs after both written and oral information is
p.(None): given and written consent is obtained,
p.(None): 2) that the test subject may at any time, orally, in writing or by any other clear expression, consent to
p.(None): participation and withdrawal from the research project without affecting the right to present or future treatment
p.(None): or any other rights the subject may have,
p.(None): 3) that the subject has the right to report time before consent is given, just as the subject has the right to wish,
p.(None): bring a bystander upon receipt of the oral information,
p.(None): 4) information on the subject's health, other purely private matters and other confidential information
p.(None): the research subject who emerges in connection with the research project is subject to professional secrecy,
p.(None): 5) the storage of personally identifiable data, including tissues, blood tests etc., is done in compliance with the Act on the treatment of
p.(None): personal data and the Health Act,
p.(None): 6) the possibility of gaining access to trial protocols in accordance with the provisions of public law, and
p.(None): 7) redress, redress, compensation or other compensation for damages resulting from
p.(None): the research project.
p.(None): PCS. 2. Information on rights, as described in subsection (2). 1, can be attached to the information about the individual
p.(None): health science research project as an independent appendix.
p.(None): § 9. The written information must contain a statement of the financial support of the probation officer
p.(None): recipient from private companies, foundations, etc. for the implementation of the health science concerned
p.(None): research project. The information must be presented in such a way as to enable the subject to take
p.(None): to determine if he / she wishes to participate in the research project.
p.(None): PCS. 2. The financial aid information shall include:
p.(None): 1) who initiated the health science research project;
p.(None): 2) names of both commercial and non-commercial sponsors;
p.(None): (3) the amount of aid for each donor and the manner in which the aid is included in the research project, including whether the aid is paid out;
p.(None): as a fixed sum or as a consideration per and whether the support is paid directly to the probation officer, to
p.(None): its department / institute, to a joint research fund or other, and
p.(None): 4) whether the probation officer otherwise has a financial connection with private companies, foundations etc. who have interests in
p.(None): the research project in question.
p.(None): Especially about information and consent when involving subjects exposed to pressure or coercion
p.(None): § 10. Where the test subject is due to institutional placement, detention, employment or similar
p.(None): exposed to special pressure for participation in a health science research project, but where the person is otherwise able to
p.(None): to give informed consent, the committee may, after a specific assessment, decide that the subject's consent to
p.(None): participation in the research project must be made to a person approved by the committee. The Committee may also decide that:
p.(None): the information in such cases is supplemented with information that the conduct of the research project must be monitored by a
p.(None): independent expert.
p.(None): PCS. 2. Persons who are detained under the Detention Act and other compulsions in psychiatry cannot
p.(None): assist as research subjects in health science research projects.
p.(None): Submission of information and receipt of consent
p.(None): § 11. The written information must be provided in paper form or electronically. The subject can always claim to receive
p.(None): the information in paper form.
p.(None): PCS. 2. An informed consent must be in writing, dated and signed or submitted using electronic signature.
p.(None): Section 12. Information is given and consent is received by the probation officer or a person authorized thereto, who has the
p.(None): professional prerequisites for communicating the content of the research project and having a direct connection to it.
p.(None): PCS. 2. The information for minors shall be provided by a person familiar with the area to which the project relates; and
p.(None): who have the educational prerequisites for disseminating the information to the age group of the research project
p.(None): includes.
p.(None): PCS. 3. By authorizing a person to provide information and receive consent, cf. 1, as well as by
p.(None): authorization for attestation, cf. 2, there must be a written agreement to this effect. Responsibility for notification
p.(None): complete information in accordance with the law is the responsibility of the probation officer.
p.(None): § 13. Consent to participate in a health science research project must be given as soon as received
p.(None): information. However, the subject has the right to report time.
p.(None): PCS. 2. The probation officer or a person authorized to do so must certify that the written information has been provided to
p.(None): the subject, and that oral information was provided. At the request of the subject, it must
p.(None): the person responsible for the trial or a person authorized to do so shall provide a copy of the written consent.
p.(None): Chapter 3
p.(None): Information and consent during the course of the health sciences research project
p.(None): § 14. The test subject gains or regains his ability to act during the course of the health sciences
p.(None): Before the project can be continued, informed consent must be obtained from the research project.
p.(None): PCS. 2. A health science research project cannot be carried out on the basis of a deputy consent if
p.(None): however, the subject protests verbally or by action.
p.(None): § 15. If significant results emerge during the implementation of a health science research project
p.(None): information on the health of the subject, the subject must be informed, unless the subject
p.(None): has unequivocally stated that the person does not want this.
p.(None): § 16. If new information is obtained during the implementation of a health science research project
p.(None): effect, risks, side effects, complications or disadvantages of the trial or if the research design of the research project changes
p.(None): Significantly in relation to the subject's safety, the subject must be informed. In such situations,
p.(None): the test subject reconsidered.
p.(None): PCS. 2. If the research project is interrupted, the subject must be informed of the reason for this.
...
Social / education
Searching for indicator educational:
(return to top)
p.(None): exposed to special pressure for participation in a health science research project, but where the person is otherwise able to
p.(None): to give informed consent, the committee may, after a specific assessment, decide that the subject's consent to
p.(None): participation in the research project must be made to a person approved by the committee. The Committee may also decide that:
p.(None): the information in such cases is supplemented with information that the conduct of the research project must be monitored by a
p.(None): independent expert.
p.(None): PCS. 2. Persons who are detained under the Detention Act and other compulsions in psychiatry cannot
p.(None): assist as research subjects in health science research projects.
p.(None): Submission of information and receipt of consent
p.(None): § 11. The written information must be provided in paper form or electronically. The subject can always claim to receive
p.(None): the information in paper form.
p.(None): PCS. 2. An informed consent must be in writing, dated and signed or submitted using electronic signature.
p.(None): Section 12. Information is given and consent is received by the probation officer or a person authorized thereto, who has the
p.(None): professional prerequisites for communicating the content of the research project and having a direct connection to it.
p.(None): PCS. 2. The information for minors shall be provided by a person familiar with the area to which the project relates; and
p.(None): who have the educational prerequisites for disseminating the information to the age group of the research project
p.(None): includes.
p.(None): PCS. 3. By authorizing a person to provide information and receive consent, cf. 1, as well as by
p.(None): authorization for attestation, cf. 2, there must be a written agreement to this effect. Responsibility for notification
p.(None): complete information in accordance with the law is the responsibility of the probation officer.
p.(None): § 13. Consent to participate in a health science research project must be given as soon as received
p.(None): information. However, the subject has the right to report time.
p.(None): PCS. 2. The probation officer or a person authorized to do so must certify that the written information has been provided to
p.(None): the subject, and that oral information was provided. At the request of the subject, it must
p.(None): the person responsible for the trial or a person authorized to do so shall provide a copy of the written consent.
p.(None): Chapter 3
p.(None): Information and consent during the course of the health sciences research project
p.(None): § 14. The test subject gains or regains his ability to act during the course of the health sciences
p.(None): Before the project can be continued, informed consent must be obtained from the research project.
p.(None): PCS. 2. A health science research project cannot be carried out on the basis of a deputy consent if
...
Social / genetic heritage
Searching for indicator genetic heritage:
(return to top)
p.(None): scientific ethical treatment of health science research projects is determined:
p.(None): Chapter 1
p.(None): Review of a health science research project and content in an experimental protocol and an additional protocol
p.(None): § 1. Reporting of health science research projects shall be made to the regional committee for the area in which
p.(None): the probation officer has his job. Health science research projects relating to particularly complex areas,
p.(None): cf. section 2, however, must be reported to the National Science Ethics Committee. The obligation to notify rests with the investigator and
p.(None): sponsor in association, and both must sign the review.
p.(None): PCS. 2. Cross-border multicenter trials must always be reported in this country. Are there more probation officers in Denmark,
p.(None): and the research project is not covered by par. 1, second paragraph, the multicenter trial must be notified to the regional committee where it
p.(None): coordinating probation officers have their job.
p.(None): § 2. A health science research project that relates to a particularly complex area is understood to mean:
p.(None): 1) health science research project with children regarding clinical trials of drugs and which are reported via
p.(None): Voluntary Harmonization Procedure (VHP),
p.(None): 2) health science research project, which deals with advanced therapy drugs;
p.(None): 3) health science research project, which deals with extensive mapping of the individual's genetic heritage, which is sought
p.(None): on the exemption pursuant to section 10 of Act No. 593 of 14 June 2011 on scientific ethical treatment of health sciences
p.(None): research projects, or
p.(None): 4) health science research project related to psychosurgery.
p.(None): § 3. The notification system of the committee system must be used for notification. In connection with the notification, the following should be
p.(None): Annex is attached:
p.(None): 1) Documentation of sponsorship and the identity of the probation officer and the probation officer's training and experience;
p.(None): including clinical experience and research experience. If the trial concerns clinical trials of drugs and the trial is performed
p.(None): at several different test sites in Denmark, they must in the first paragraph. said documents are submitted for each of them
p.(None): probation officers from each trial site in Denmark.
p.(None): 2) Trial protocol and appendices thereto pursuant to section 4
p.(None): PCS. 2. When notifying significant changes to an experimental protocol for an approved health scientist
p.(None): research project pursuant to section 5, the committee system's notification form must be used.
p.(None): § 4. An experimental protocol must contain a description of the research project's objectives, design, methodology,
p.(None): organization, statistical considerations, scientific ethical considerations, financial matters, publication matters,
p.(None): and how participants will be informed.
p.(None): PCS. 2. The trial protocol must be dated and the version number applied. If the following is not part of
p.(None): the trial protocol, the trial protocol must be attached to the following Annex:
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| children | Child |
| drug | Drug Usage |
| educational | education |
| elderly | Elderly |
| genetic heritage | genetic heritage |
| job | Occupation |
| officer | Police Officer |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
coercion
consent
ethics
Applicable Type / Vulnerability / Indicator Overlay for this Input