79C3C34C52B45572883A05D425EB0F82

Executive Order No. 1464 on Information and Consent at Inclusion of trial Subjects in Biomedical Research Projects (2018)

https://www.retsinformation.dk/Forms/R0710.aspx?id=201254

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This file was generated: 2020-12-01 05:46:34

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

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalperson in detention centerdetained1
HealthDrug Usagedrug1
Healthvisual impairmentblind1
SocialAccess to Social Goodsaccess2
SocialAgeage2
SocialChildchildren1
SocialElderlyelderly2
SocialOccupationjob2
SocialPolice Officerofficer9
Socialeducationeducational1
Socialgenetic heritagegenetic heritage1

Political / person in detention center

Searching for indicator detained:

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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 and Other Compulsion Act 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.
...

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 trial, the method of the trial, 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): predictable risks and benefits prior to consent.
p.(None): PCS. 2. Information for the subject must contain 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.
...

Health / visual impairment

Searching for indicator blind:

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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 considered 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 which 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, as well as the significance, 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,
...

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): predictable risks and benefits prior to consent.
p.(None): PCS. 2. Information for the subject must contain 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 considered 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 which 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, as well as the significance, 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 about the subject's health, other purely private matters and other confidential information
p.(None): the research subject who appears in connection with the research project is subject to a duty of confidentiality,
p.(None): 5) processing of personally identifiable data, including tissues, blood tests, etc., is done in compliance with the European Parliament's
p.(None): and Council Regulation No 2016/679 of 27 April 2016 on the protection of individuals with regard to the treatment of
p.(None): personal data and on the free exchange of such information, the Data Protection Act and the Health Act,
p.(None): 6) that it is possible to gain 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): whether he wants 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): predictable risks and benefits prior to consent.
p.(None): PCS. 2. Information for the subject must contain 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 considered 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 which 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 and Other Compulsion Act 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): research project, before the project can be continued, informed consent must be obtained from the subject.
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): this Order
p.(None): health science research projects as well as the notification and decisions taken accordingly
p.(None): provision
p.(None): Reports from the Ombudsman,
p.(None): supervision of health science research projects 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 the Act on the Scientific Ethical Treatment of
p.(None): health science research projects, cf. Statutory Order No. 1083 of 15 September 2017 stipulated:
p.(None): Chapter 1
p.(None): Review of a health science research project and content of 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 498 of 13/05/2018 Applicable
p.(None): Publication date: 23-05-2018
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 a Show more ...
p.(None): Additional Protocol
p.(None): Later changes to the regulation
p.(None): Chapter 2 Information and consent for participation in health science research projects
p.(None): BEK No. 709 of 03/07/2019
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 The legislation relates to
p.(None): LBK No. 1083 of 15/09/2017
p.(None): Chapter 5 Penalty
p.(None): Chapter 6 Entry into force
p.(None): Changes in / cancels
p.(None): BEK No. 1464 of 02/12/2016
p.(None): the whole text
p.(None): Notice of information and consent to participation in Additional documents:
p.(None): All circulars, guides, etc. to
p.(None): this Order
p.(None): health science research projects as well as the notification and decisions taken accordingly
p.(None): provision
p.(None): Reports from the Ombudsman,
p.(None): supervision of health science research projects 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 the Act on the Scientific Ethical Treatment of
p.(None): health science research projects, cf. Statutory Order No. 1083 of 15 September 2017 stipulated:
p.(None): Chapter 1
p.(None): Review of a health science research project and content of 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.
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 May 25, 2018 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. 1464 of December 2, 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, May 13, 2018
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): Additional Protocol
p.(None): Later changes to the regulation
p.(None): Chapter 2 Information and consent for participation in health science research projects
p.(None): BEK No. 709 of 03/07/2019
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 The legislation relates to
p.(None): LBK No. 1083 of 15/09/2017
p.(None): Chapter 5 Penalty
p.(None): Chapter 6 Entry into force
p.(None): Changes in / cancels
p.(None): BEK No. 1464 of 02/12/2016
p.(None): the whole text
p.(None): Notice of information and consent to participation in Additional documents:
p.(None): All circulars, guides, etc. to
p.(None): this Order
p.(None): health science research projects as well as the notification and decisions taken accordingly
p.(None): provision
p.(None): Reports from the Ombudsman,
p.(None): supervision of health science research projects 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 the Act on the Scientific Ethical Treatment of
p.(None): health science research projects, cf. Statutory Order No. 1083 of 15 September 2017 stipulated:
p.(None): Chapter 1
p.(None): Review of a health science research project and content of 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:

(return to top)
p.(None): Additional Protocol
p.(None): Later changes to the regulation
p.(None): Chapter 2 Information and consent for participation in health science research projects
p.(None): BEK No. 709 of 03/07/2019
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 The legislation relates to
p.(None): LBK No. 1083 of 15/09/2017
p.(None): Chapter 5 Penalty
p.(None): Chapter 6 Entry into force
p.(None): Changes in / cancels
p.(None): BEK No. 1464 of 02/12/2016
p.(None): the whole text
p.(None): Notice of information and consent to participation in Additional documents:
p.(None): All circulars, guides, etc. to
p.(None): this Order
p.(None): health science research projects as well as the notification and decisions taken accordingly
p.(None): provision
p.(None): Reports from the Ombudsman,
p.(None): supervision of health science research projects 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 the Act on the Scientific Ethical Treatment of
p.(None): health science research projects, cf. Statutory Order No. 1083 of 15 September 2017 stipulated:
p.(None): Chapter 1
p.(None): Review of a health science research project and content of 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 trial, the method of the trial, 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): 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 about the subject's health, other purely private matters and other confidential information
p.(None): the research subject who appears in connection with the research project is subject to a duty of confidentiality,
p.(None): 5) processing of personally identifiable data, including tissues, blood tests, etc., is done in compliance with the European Parliament's
p.(None): and Council Regulation No 2016/679 of 27 April 2016 on the protection of individuals with regard to the treatment of
p.(None): personal data and on the free exchange of such information, the Data Protection Act and the Health Act,
p.(None): 6) that it is possible to gain 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): whether he wants 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 and Other Compulsion Act 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): research project, before the project can be continued, informed consent must be obtained from the subject.
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 research subject must be informed of the reason for this.
...

Social / education

Searching for indicator educational:

(return to top)
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 and Other Compulsion Act 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): research project, before the project can be continued, informed consent must be obtained from the subject.
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): health science research projects, cf. Statutory Order No. 1083 of 15 September 2017 stipulated:
p.(None): Chapter 1
p.(None): Review of a health science research project and content of 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

IndicatorVulnerability
accessAccess to Social Goods
ageAge
blindvisual impairment
childrenChild
detainedperson in detention center
drugDrug Usage
educationaleducation
elderlyElderly
genetic heritagegenetic heritage
jobOccupation
officerPolice Officer

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers

Trigger Words

coercion

consent

ethics

protection


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalperson in detention centerdetained1
HealthDrug Usagedrug1
Healthvisual impairmentblind1
SocialAccess to Social Goodsaccess2
SocialAgeage2
SocialChildchildren1
SocialElderlyelderly2
SocialOccupationjob2
SocialPolice Officerofficer9
Socialeducationeducational1
Socialgenetic heritagegenetic heritage1