79C3C34C52B45572883A05D425EB0F82
Act No. 1083 on Research Ethics Review of Health Research Projects (2013)
http://en.nvk.dk/rules-and-guidelines/act-on-research-ethics-review-of-health-research-projects
http://leaux.net/URLS/ConvertAPI Text Files/30600E3EFC73F2B798E032A827EAAD90.en.txt
Examining the file media/Synopses/30600E3EFC73F2B798E032A827EAAD90.html:
This file was generated: 2020-12-01 05:45:58
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / criminal
Searching for indicator criminal:
(return to top)
p.(None):
p.(None): (4) Members of the national research ethics committee appointed according to Section 38 (1) no. 4 and any alternates shall be paid
p.(None): subsistence allowances, compensation for lost earnings and reimbursement of expenditure according to Section 16a in the act on
p.(None): municipal governance. The costs shall be borne by the regional council that has recommended the member in question as member of the
p.(None): committee.
p.(None):
p.(None): Part 9
p.(None):
p.(None): Penalties and compensation
p.(None):
p.(None): Section 41
p.(None):
p.(None): (1) Unless a more severe punishment is deserved according to other legislation, a fine or up to 4 months of imprisonment is incurred by
p.(None): anyone who
p.(None):
p.(None): 1) commences a project in contravention of Sections 13, 14 or 27 or commences a project in contravention of the conditions provided for
p.(None): in the permission given, cf. Section 17 (2),
p.(None):
p.(None): 2) fails to comply with the notification obligation according to Section 30,
p.(None):
p.(None): 3) fails to comply with an injunction or disclosure obligation provided for in Section 28 (3) or Section 29 (1),
p.(None):
p.(None): 4) acts in contravention of injunctions issued according to Section 28 (3), or
p.(None):
p.(None): 5) denies access of the supervisory authority according to Section 29 (2).
p.(None):
p.(None): (2) Rules laid down pursuant to this act may include provisions on punishment in the form of penalties for contravention of provisions
p.(None): contained in these rules.
p.(None):
p.(None): (3) Companies etc. (legal persons) may incur criminal liability according to Part 5 of the penal code.
p.(None):
p.(None): Section 42
p.(None):
p.(None): (1) The sponsor or, if the sponsor does not belong under Danish jurisdiction, the investigator, shall pay a compensation of DKK 1350 to
p.(None): persons who have participated in a project commenced in contravention of Sections 13, 14 or 27 or who have not given informed consent
p.(None): or when proxy consent has not been obtained, cf. Sections 3 to 5 and Section 12 unless the investigator or the sponsor are able to
p.(None): substantiate that this contravention is not caused by any error on the part of the investigator or the sponsor.
p.(None):
p.(None): (2) The amount of this compensation shall be regulated annually as of January 1 by 2 per cent to which shall be added the adjustment
p.(None): percentage for the fiscal year in question, cf. act on rate adjustment. The resulting amounts shall be rounded up to a figure divisible by an
p.(None): amount of DKK 50. Adjustment shall be undertaken on the basis of the amounts applicable at the time of adjustment prior to rounding up.
p.(None):
p.(None): (3) Compensation shall be fixed on the basis of the amounts applicable at the time when the trial subject took part in the project.
p.(None):
p.(None): (4) The provision of (1) above shall be without prejudice to an individual’s access to or the amount of any indemnity according to general
p.(None): Danish legislation.
p.(None):
p.(None): Part 10
p.(None):
p.(None): Coming into force, transition arrangements etc.
p.(None):
p.(None): Section 43
p.(None):
p.(None): (1) This act shall come into force on January 1 2012 and shall be applicable to health research projects that are notified after its coming
p.(None): into force.
p.(None):
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.(None): altogether at least one third of the members of the committee express a wish to this effect, the research project shall be put before the
p.(None): national committee which will take a final decision.
p.(None):
p.(None): (4) The chair of a regional committee may decide on behalf of the committee in cases that are deemed not to provide any reason for
p.(None): doubt.
p.(None):
p.(None): Communication of permission and orientation
p.(None):
p.(None): Section 25
p.(None):
p.(None): (1) The competent committee shall communicate its decision whether a health research project may be permitted, or its decision
p.(None): according to Section 24 (3), to the investigator and the sponsor.
p.(None):
p.(None): (2) If a decision has been taken by the chair, the remaining members of the committee must be informed of this decision at a time
p.(None): reasonably ahead of the time when the decision is communicated to the investigator and the sponsor.
p.(None):
p.(None): (3) The competent committee shall inform the Medicines Agency about decisions that concern clinical trial of medicines or clinical trial of
p.(None): medical devices.
p.(None):
p.(None): (4) The competent committee shall inform other affected regional committees and the national committee about decisions on multi-
p.(None): centre trials.
p.(None):
p.(None): Complaints procedures
p.(None):
p.(None): Section 26
p.(None):
p.(None): (1) Within a time period of 30 days after having been informed of a decision on approval of a notified research project by a regional
p.(None): committee, the investigator and the sponsor may together put this decision before the national committee with a view to renewed
p.(None): processing and decision. Within a delay of 30 days after a decision any person who otherwise is party to the case, may put a decision taken
p.(None): by a regional committee before the national committee with a view to renewed processing and decision. The complaint must be submitted
p.(None): electronically with the use of digital signature.
p.(None): (2) Complaints concerning legal aspects of decisions on research projects that concern especially complex areas taken by the national
p.(None): committee, cf. Section 15, shall be put before the Ministry of the Interior and Health. The provisions of (1) above also apply to these
p.(None): complaints.
p.(None):
p.(None): Part 6
p.(None):
p.(None): The carrying out of health research projects, follow up, control and other tasks of the committee system
p.(None):
p.(None):
p.(None):
p.(None): Amendment of approved health research projects
p.(None):
p.(None): Section 27
p.(None):
p.(None): (1) Significant amendments of the trial protocol for an approved health research project may only be introduced following permission
p.(None): from the committee system. If a research project involves clinical trial of medicines or clinical trial of medical devices that must be
p.(None): approved by the Medicines Agency, the permission of the committee system to introduce amendments of the protocol presupposes the
p.(None): permission required according to the medicines act and the medical devices act respectively. The sponsor or the investigator must secure
p.(None): the required emergency procedures in order to protect the involved trial subjects.
p.(None):
p.(None): (2) Amendments covered by (1) above must be notified to the committee that has approved the research project in question. This
p.(None): notification must be submitted electronically using digital signature along with the amended protocol and other information required for
...
Health / stem cells
Searching for indicator stem cells:
(return to top)
p.(None): research ethics committee.
p.(None):
p.(None): (2) If a research project involves clinical trial of medicines or clinical trial of medical devices that must be approved by the Medicines
p.(None): Agency, the permission of the committee system to undertake the project presupposes the permission required according to the
p.(None): medicines act and the medical devices act respectively.
p.(None):
p.(None):
p.(None):
p.(None): Notification obligation
p.(None):
p.(None): Section 14
p.(None):
p.(None): (1) Any health research project must be notified to the system of research ethics committees, cf., however, (2) to (5) below.
p.(None):
p.(None): (2) Notification of questionnaire surveys and medical database research projects to the system of research ethics committee system is
p.(None): only required if the project involves human biological material.
p.(None):
p.(None): (3) Health research projects that solely involve anonymous human biological material collected in accordance with legislation at the site
p.(None): of collection need only be notified to the system of research ethics committees if the research project is regulated under Section 25 in the
p.(None): act on artificial insemination in connection with medical treatment, diagnostics and research etc.
p.(None):
p.(None): (4) Trials involving cell lines etc. which originate from a trial regarding the collection of cells or tissue, and which have obtained the
p.(None): required permission, need only be notified if the trial concerns the use of fertilised eggs, stem cells and stem cell lines from these, cf.
p.(None): Sections 25 and 27 (2) of the act on artificial insemination in connection with medical treatment, diagnostics and research etc.
p.(None):
p.(None): (5) The Minister for the Interior and Health may lay down further rules on exemption from the notification obligation pursuant to (4) above.
p.(None): Following recommendation from the national committee the Minister for the Interior and Health may, furthermore, lay down rules on
p.(None): notification obligations for further defined new fields of research which would otherwise be exempt from the obligation pursuant to (4)
p.(None): above.
p.(None):
p.(None): Competence
p.(None):
p.(None): Section 15
p.(None): (1) Notification of health research projects must be addressed to the regional committee for the area in which the investigator is active.
p.(None): Health research projects that concern especially complex areas must, however, be notified to the national committee. The notification
p.(None): obligation rests with the investigator as well as with the sponsor, and both must sign the notification.
p.(None):
p.(None): (2) Cross border multi-centre trials must always be notified in this country. If there are several investigators in Denmark and if the research
p.(None): project is not covered by (1) 2nd sentence above, the multi-centre project must be notified to the regional committee where the
p.(None): coordinating investigator is active.
p.(None):
p.(None): (3) On the basis of recommendation from the national committee the Minister for the Interior and Health shall lay down further rules
p.(None): concerning what health research projects must be notified to the national committee pursuant to (1) 2nd sentence above.
p.(None):
p.(None): Notification format
p.(None):
p.(None): Section 16
p.(None):
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): question as described in the trial protocol.
p.(None):
p.(None): 17) Serious adverse event or serious adverse reaction: An adverse event or an adverse reaction which regardless of e.g. dose is fatal, is
p.(None): life-threatening, leads to hospital admission or prolongation of ongoing hospital stay, results in lasting or considerable disablement or
p.(None): incapacity for work or leads to congenital anomaly or malformation.
p.(None):
p.(None): Part 3
p.(None):
p.(None): Informed consent for participation in health research projects
p.(None):
p.(None): Section 3
p.(None):
p.(None): (1) Health research projects that must be notified to the committee system according to Section 14, may include trials on humans if the
p.(None): trial subject has given informed consent for participation prior to the trial, cf., however, (2) below.
p.(None):
p.(None): (2) Consent must be given as proxy consent according to Section 4 if the trial subject
p.(None):
p.(None): 1) is a minor,
p.(None):
p.(None): 2) is under guardianship that includes powers to give informed consent for participation in health research projects, cf. the Guardianship
p.(None): Act Section 5 (1), or
p.(None):
p.(None): 3) otherwise is an incapacitated adult.
p.(None):
p.(None): (3) Consent includes access to the communication and processing of required information on the trial subject’s health, other wholly
p.(None): personal matters and other confidential information as part of own control of the research project including quality control and
p.(None): monitoring which a sponsor or a possible monitor is under obligation to undertake.
p.(None):
p.(None): (4) Consent may be withdrawn at any time without this being detrimental to the trial subject.
p.(None):
p.(None): (5) In connection with research ethics evaluation of concrete health research projects the committee may deviate from (1) and (2) above
p.(None): according to the criteria laid down in Sections 8 to 12.
p.(None):
p.(None): Section 4
p.(None): (1) Proxy consent on behalf of trial subjects that are minors, must be given by the holder of custody.
p.(None):
p.(None): (2) Proxy consent on behalf of trial subjects under guardianship that includes powers to give informed consent for participation in health
p.(None): research projects, cf. the Guardianship Act Section 5 (1), must be given by the guardian.
p.(None):
p.(None): (3) Proxy consent on behalf of other incapacitated adult trial subjects must be given by their nearest relative and their general practitioner
p.(None): or, if the general practitioner is not available, the National Board of Health.
p.(None):
p.(None): (4) Proxy consent must express the trial subject’s interests. The trial subject’s declarations should be taken into consideration to the extent
...
p.(None):
p.(None): 2) the project is likely to directly lead to great benefits for the patient group that falls within the same age group or who suffer from the
p.(None): same disease or condition as the trial subject, and
p.(None):
p.(None): 3) the project involves minimal risks and discomfort for the trial subject.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) to (3) above.
p.(None):
p.(None): Section 20
p.(None):
p.(None): (1) In order for permission to be given for health research projects, it is furthermore a condition that
p.(None):
p.(None): 1) the investigator is qualified to take treatment decisions and has proper training and clinical experience,
p.(None):
p.(None): 2) it is clear from written or electronic information what financial support the investigator receives from private companies, foundations
p.(None): etc. for the undertaking of the research project in question and whether the investigator otherwise has any financial affiliation to private
p.(None): companies, foundations etc. who have an interest in the research project under consideration.
p.(None):
p.(None): 3) any payment or other compensation for trial subjects in return for participation in a health research project is not such as to affect the
p.(None): giving of consent,
p.(None):
p.(None): 4) the trial subject’s right to physical and mental integrity and the right to privacy are respected and information concerning the trial
p.(None): subject is protected according to the act on data protection,
p.(None):
p.(None): 5) the principal investigator has secured that the trial subject has access to further information on the project,
p.(None):
p.(None): 6) projects that involve export of biological material and information to third countries must be undertaken in accordance with the rules
p.(None): laid down in the act on the processing of personal data,
p.(None):
p.(None): 7) there is a compensation or indemnification arrangement if the trial subject suffers any harm or dies as a consequence of the project,
p.(None): and an insurance has been taken out or other compensation arrangement is in place to cover the liability of the investigator and the
p.(None): sponsor vis-à-vis the participating trial subjects, and
p.(None):
p.(None): 8) publication is undertaken in accordance with the act on the processing of personal data both with regard to negative, inconclusive
p.(None): and positive trial results as soon as this is possible and justifiable from a professional point of view.
p.(None):
p.(None): (2) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.
p.(None):
p.(None): Section 21
p.(None):
p.(None): (1) In order to get permission for a health research project that involves clinical trial of medicines covered by the medicines act or clinical
p.(None): trial of medical devices covered by the act on medical devices, it is a condition that
p.(None):
p.(None): 1) the Medicines Agency is involved in the approval of the project, cf. Section 13 (2), and
p.(None):
p.(None): 2) the investigator is qualified to take treatment decisions and has appropriate medical training as a doctor or, when this is relevant, a
p.(None): dentist, and has clinical experience.
p.(None):
p.(None): (2) Furthermore the competent committee must ensure the extent of and the detailed rules for the payment of any fee or any
...
p.(None): of approved health research projects that involve clinical trial of medicines is taken care of by the Medicines Agency according the
p.(None): medicines act.
p.(None):
p.(None): (2) The supervising committee may follow the course of a research project and demand that the final research report or publication is sent
p.(None): to the committee.
p.(None):
p.(None): (3) As part of its supervision of a project that does not involve clinical trial of medicines covered by the medicines act, the supervising
p.(None): committee may require that the project is amended or is temporarily suspended, and in special cases the committee may prohibit a
p.(None): project. These powers also cover notifiable research projects that have been commenced without due permission.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down further rules on the supervision by and the powers of the committees according
p.(None): to (1) to (3) above.
p.(None):
p.(None): Access to information etc. in connection with supervision
p.(None):
p.(None): Section 29
p.(None):
p.(None): (1) The supervising committee or a representative of this committee may require surrender of all information on the research project that
p.(None): is required for the purposes of supervision. Communication of and processing of required information on the health condition of trial
p.(None): subjects, other purely private matters and confidential information otherwise may take place as part of supervisory activity without the
p.(None): consent of the trial subject.
p.(None):
p.(None): (2) Against proof of identity and without any court order the supervising committee or a representative of this committee shall have access
p.(None): to companies, hospitals, medical practices and other sites that are affected by the implementation of the research project in order to
p.(None): gather information that is required for the carrying out of the committee’s supervision.
p.(None):
p.(None): (3) Buildings or parts of buildings that are used solely for private residence are not covered by (2) above.
p.(None):
p.(None): Obligation to notify adverse reactions and adverse events
p.(None): Section 30
p.(None):
p.(None): (1) The sponsor or the investigator shall immediately inform the supervising committee if during the implementation of a health research
p.(None): project there is any assumption of serious unexpected adverse reactions as a consequence of the project. Unless the research project
p.(None): concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the medicines act, the notification
p.(None): obligation furthermore covers serious adverse events. When serious adverse events are reported, the supervising committee may require
p.(None): any information from the investigator that the committee finds is relevant for its supervision.
p.(None):
p.(None): (2) Once a year throughout the trial period the sponsor or the investigator shall send to the supervising committee a list of all presumed
p.(None): serious unexpected adverse reactions that have occurred during the trial period and provide information on the safety of the trial subjects.
p.(None): Unless the research project concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the
p.(None): Medicines Act, the notification obligation furthermore covers serious adverse events.
p.(None):
p.(None):
p.(None):
p.(None): Notification on the termination of health research projects
p.(None):
p.(None): Section 31
p.(None):
...
p.(None):
p.(None): (6) The chair and the members appointed according to (1) nos. 2 and 3 above may not be members of the Folketing or of regional or
p.(None): municipal councils.
p.(None):
p.(None): (7) The committee selects its deputy chair among the members appointed.
p.(None):
p.(None): (8) The committee shall draw up a proposal for rules of procedure to be approved by the Minister for the Interior and Health.
p.(None):
p.(None): (9) Committee members are appointed for 4 years corresponding to the electoral period of the regional councils. Members may be
p.(None): reappointed twice. Alternates may be appointed.
p.(None):
p.(None): (10) The previous committee shall continue its activity until new members have been appointed and the new committee has elected its
p.(None): officers.
p.(None): Part 8
p.(None):
p.(None): Financing
p.(None):
p.(None): Section 39
p.(None):
p.(None): (1)The costs of the regional committees shall be borne by the relevant regional council.
p.(None):
p.(None): (2) Research institutions etc. and private companies and hospitals shall pay a fee per project or amendment of a project that is notified to
p.(None): the region in question in order to cover part of the cost. The Minister for the Interior and Health shall lay down rules on the amount of such
p.(None): fees and their collection.
p.(None):
p.(None): (3) Members of the regional committees and any alternates shall receive reimbursement of expenditure according to the provision of
p.(None): Section 11 of the act on the regions.
p.(None):
p.(None): (4) The Minister for the Interior and Health shall lay down further rules on access for the regions to provide supplementing reimbursement
p.(None): for members of the regional committees and any alternates.
p.(None):
p.(None): Section 40
p.(None):
p.(None): (1) The costs of the national research ethics committee shall be borne by the Ministry for the Interior and Health. The Minister for the
p.(None): Interior and Health provides the required administrative assistance for the national committee.
p.(None):
p.(None): (2) In order to partially cover the cost of processing notifications concerning especially complex areas, cf. Section 15 (1), research
p.(None): institutions etc. and private companies and hospitals shall pay a fee per project or amendment that is notified to the national research
p.(None): ethics committee. The Minister for the Interior and Health shall lay down rules on the amount of such fees and their collection.
p.(None):
p.(None): (3) The chair and the deputy chair of the national research ethics committee and the 7 members appointed according to Section 38 (1)
p.(None): nos. 2 and 3 and any alternates are paid according to agreement with the Minister for the Interior and Health who shall also bear the cost.
p.(None):
p.(None): (4) Members of the national research ethics committee appointed according to Section 38 (1) no. 4 and any alternates shall be paid
p.(None): subsistence allowances, compensation for lost earnings and reimbursement of expenditure according to Section 16a in the act on
p.(None): municipal governance. The costs shall be borne by the regional council that has recommended the member in question as member of the
p.(None): committee.
p.(None):
p.(None): Part 9
p.(None):
p.(None): Penalties and compensation
p.(None):
p.(None): Section 41
p.(None):
p.(None): (1) Unless a more severe punishment is deserved according to other legislation, a fine or up to 4 months of imprisonment is incurred by
p.(None): anyone who
p.(None):
p.(None): 1) commences a project in contravention of Sections 13, 14 or 27 or commences a project in contravention of the conditions provided for
p.(None): in the permission given, cf. Section 17 (2),
p.(None):
p.(None): 2) fails to comply with the notification obligation according to Section 30,
p.(None):
p.(None): 3) fails to comply with an injunction or disclosure obligation provided for in Section 28 (3) or Section 29 (1),
p.(None):
p.(None): 4) acts in contravention of injunctions issued according to Section 28 (3), or
p.(None):
p.(None): 5) denies access of the supervisory authority according to Section 29 (2).
p.(None):
p.(None): (2) Rules laid down pursuant to this act may include provisions on punishment in the form of penalties for contravention of provisions
p.(None): contained in these rules.
p.(None):
p.(None): (3) Companies etc. (legal persons) may incur criminal liability according to Part 5 of the penal code.
p.(None):
p.(None): Section 42
p.(None):
p.(None): (1) The sponsor or, if the sponsor does not belong under Danish jurisdiction, the investigator, shall pay a compensation of DKK 1350 to
p.(None): persons who have participated in a project commenced in contravention of Sections 13, 14 or 27 or who have not given informed consent
p.(None): or when proxy consent has not been obtained, cf. Sections 3 to 5 and Section 12 unless the investigator or the sponsor are able to
p.(None): substantiate that this contravention is not caused by any error on the part of the investigator or the sponsor.
p.(None):
p.(None): (2) The amount of this compensation shall be regulated annually as of January 1 by 2 per cent to which shall be added the adjustment
p.(None): percentage for the fiscal year in question, cf. act on rate adjustment. The resulting amounts shall be rounded up to a figure divisible by an
p.(None): amount of DKK 50. Adjustment shall be undertaken on the basis of the amounts applicable at the time of adjustment prior to rounding up.
p.(None):
p.(None): (3) Compensation shall be fixed on the basis of the amounts applicable at the time when the trial subject took part in the project.
p.(None):
p.(None): (4) The provision of (1) above shall be without prejudice to an individual’s access to or the amount of any indemnity according to general
p.(None): Danish legislation.
p.(None):
p.(None): Part 10
p.(None):
p.(None): Coming into force, transition arrangements etc.
p.(None):
p.(None): Section 43
p.(None):
p.(None): (1) This act shall come into force on January 1 2012 and shall be applicable to health research projects that are notified after its coming
p.(None): into force.
p.(None):
p.(None): (2) At the same time act no. 402 of May 28 2003 on a research ethics committees system and review of biomedical research projects shall
p.(None): be repealed.
p.(None):
p.(None): (3) Rules laid down pursuant to act on a research ethics committee system and review of biomedical research projects shall remain in
p.(None): force until they are repealed through provisions laid down pursuant to the present act.
p.(None):
p.(None): (4) Rules in force till now continue to be applicable to health research projects that have been notified prior to the coming into force of this
p.(None): act.
p.(None):
p.(None): (5) Members of the existing regional committees shall continue their activity in the regional committees in accordance with the present act
p.(None): until expiry of the period for which they have been appointed. Appointment as member of a regional committee pursuant to the act on a
p.(None): research ethics committee system and review of biomedical research projects shall be taken into account when it is assessed whether a
p.(None): given individual may be appointed as member of a regional committee pursuant to Section 36 (5) of the present act.
p.(None):
...
p.(None):
p.(None): Section 45
p.(None):
p.(None): In Act no. 440 of June 9 2004 on the Ethics Council as amended by Section 16 of Act no. 545 of June 24 2005 the following amendment
p.(None): shall be made:
p.(None):
p.(None): 1. In Section 9 (1) “the Central Research Ethics Committee” shall be changed into: “the National Committee on Health Research
p.(None): Ethics”.
p.(None):
p.(None): Section 46
p.(None):
p.(None): In Act no. 1180 of December 12 2005 on medicines as amended through Section 81 of Act no. 538 of June 8 2006, Section 1 in Act no. 1557
p.(None): of December 20 2006, Section 1 in Act no. 534 of June 17 2008 and Section 1 in Act no. 464 of May 18 2011, the following amendment shall
p.(None): be made:
p.(None):
p.(None): 1. In Section 88 (1) and (6) “act on a research ethics committee system and review of biomedical research projects” shall be changed
p.(None): into “act on research ethics review of health research projects”.
p.(None):
p.(None): Section 47
p.(None):
p.(None): In the act on artificial insemination in connection with medical treatment, diagnostics and research etc., cf. Consolidation Act no. 923 of
p.(None): September 4 2006 as amended by Section 1 of Act no. 1546 of December 21 2010, the following amendments shall be made:
p.(None):
p.(None): 1. In Section 25 (1) “biomedical” shall be changed into “health”.
p.(None): 2. In Section 27 (1) “biomedical” shall be changed into “health”.
p.(None):
p.(None): Section 48
p.(None): In the act on complaints and access to compensation in the health care services, cf. Consolidation act no. 24 of January 21 2009 as
p.(None): amended by Section 1 of Act no. 706 of June 25 2010 the following amendment shall be made:
p.(None):
p.(None): 1. In Section 19 (2), Section 38 (2), Section 40 (4) and Section 50 (3) “biomedical” shall be changed into “health”.
p.(None):
p.(None): Section 49
p.(None):
p.(None): This act does not apply to the Faroe Islands and Greenland, but Sections 1 to 45 as well as Sections 47 and 48 may through Royal Decree be
p.(None): put into force for the Faroe Islands wholly or in part with the adjustments suggested by Faroese conditions.
p.(None):
p.(None): Done at Christiansborg Palace, June 14 2011
p.(None):
p.(None): Margrethe R
p.(None):
p.(None): / Bertel Haarder
p.(None):
p.(None):
p.(None):
p.(None): This act contains provisions that implement parts of Directive 2001/20/EC of the European Parliament and the European Council of April 4
p.(None): 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of
p.(None): good clinical practice in the conduct of clinical trials on medicinal products for human use, Official Journal 2001 no. L 121 pages 34-44 as
p.(None): well as parts of directive 2005/28/EC of the European Parliament and the European Council of April 8 2005, Official Journal no. L 91 pages
p.(None): 13-19.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): THE DANISH NATIONAL COMMITTEE ON HEALTH RESEARCH ETHICS
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ×
p.(None): Danish
...
Searching for indicator accessXtoXinformation:
(return to top)
p.(None): what other information is required for the assessment by the committee system of whether an amendment is to be approved, cf.(2) 2nd
p.(None): sentence above.
p.(None):
p.(None): Supervision
p.(None):
p.(None): Section 28
p.(None):
p.(None): (1) The regional committee that has approved the carrying out of a research project shall supervise that an approved health research
p.(None): project which does not involve clinical trial of medicines, is carried out in accordance with this act. If the approval has been given by the
p.(None): national committee, supervision is taken care of by the regional committee in the area where the investigator is active unless because of
p.(None): the complexity of the project the regional committee in question requests the national committee to supervise a given project. Supervision
p.(None): of approved health research projects that involve clinical trial of medicines is taken care of by the Medicines Agency according the
p.(None): medicines act.
p.(None):
p.(None): (2) The supervising committee may follow the course of a research project and demand that the final research report or publication is sent
p.(None): to the committee.
p.(None):
p.(None): (3) As part of its supervision of a project that does not involve clinical trial of medicines covered by the medicines act, the supervising
p.(None): committee may require that the project is amended or is temporarily suspended, and in special cases the committee may prohibit a
p.(None): project. These powers also cover notifiable research projects that have been commenced without due permission.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down further rules on the supervision by and the powers of the committees according
p.(None): to (1) to (3) above.
p.(None):
p.(None): Access to information etc. in connection with supervision
p.(None):
p.(None): Section 29
p.(None):
p.(None): (1) The supervising committee or a representative of this committee may require surrender of all information on the research project that
p.(None): is required for the purposes of supervision. Communication of and processing of required information on the health condition of trial
p.(None): subjects, other purely private matters and confidential information otherwise may take place as part of supervisory activity without the
p.(None): consent of the trial subject.
p.(None):
p.(None): (2) Against proof of identity and without any court order the supervising committee or a representative of this committee shall have access
p.(None): to companies, hospitals, medical practices and other sites that are affected by the implementation of the research project in order to
p.(None): gather information that is required for the carrying out of the committee’s supervision.
p.(None):
p.(None): (3) Buildings or parts of buildings that are used solely for private residence are not covered by (2) above.
p.(None):
p.(None): Obligation to notify adverse reactions and adverse events
p.(None): Section 30
p.(None):
p.(None): (1) The sponsor or the investigator shall immediately inform the supervising committee if during the implementation of a health research
p.(None): project there is any assumption of serious unexpected adverse reactions as a consequence of the project. Unless the research project
p.(None): concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the medicines act, the notification
p.(None): obligation furthermore covers serious adverse events. When serious adverse events are reported, the supervising committee may require
...
Social / Age
Searching for indicator age:
(return to top)
p.(None): or, if the general practitioner is not available, the National Board of Health.
p.(None):
p.(None): (4) Proxy consent must express the trial subject’s interests. The trial subject’s declarations should be taken into consideration to the extent
p.(None): that these declarations are topical and relevant.
p.(None):
p.(None): (5) Complaint against a general practitioner’s proxy consent cannot be put to the National Agency for Patients' Rights and Complaints or to
p.(None): the health care disciplinary board under the act on complaints and compensation in the healthcare sector.
p.(None):
p.(None): Section 5
p.(None):
p.(None): (1) Consent according to Sections 3 and 4 must be given against the background of written and oral information on the content of as well
p.(None): as foreseeable risks and benefits of the research project. It must be clear from the information that consent may be withdrawn at any time.
p.(None):
p.(None): (2) If the trial subject is a minor, under personal guardianship or otherwise is an incapacitated adult, the information must be adapted to
p.(None): the trial subject's capacity for understanding. Information for minors must be provided by a person with knowledge of the field that the
p.(None): project concerns, and who has the pedagogical competences required for communication of such information to the age group covered
p.(None): by the research project.
p.(None):
p.(None): (3) The information mentioned in (1) above must also be communicated to persons who are entitled to give proxy consent on behalf of a
p.(None): trial subject.
p.(None):
p.(None): Section 6
p.(None):
p.(None): The consent requirements laid down in Sections 3 to 5 also apply to the removal of tissue and other biological material in connection with
p.(None): concrete research projects with a view to storage in a research biobank.
p.(None):
p.(None): Section 7
p.(None):
p.(None): The Minister for the Interior and Health may lay down further rules on consent and information according to Sections 3 to 5. Unless
p.(None): consent requirements follow from other legislation, the Minister for the Interior and Health may lay down further rules for the obtaining of
p.(None): informed consent or proxy consent for use in connection with notifiable health research projects that do not involve trial subjects.
p.(None):
p.(None): Health research projects that involve deceased persons
p.(None):
p.(None): Section 8
p.(None):
p.(None): (1) Health research projects may involve the use of tissue or other biological material from deceased persons that is removed in
p.(None): connection with autopsy according to Part 56 of the Health Care Act, if consent for use of the material for research purposes has been
p.(None): obtained either from the deceased person or from the nearest relative according to Section 187 of the Health Care Act on consent for
p.(None): autopsy for health research purposes. Tissue and other biological material removed in connection with forensic autopsies prior to the
p.(None): coming into force of this act may be used for health research without consent being obtained according to sentence 1 above.
p.(None):
p.(None): (2) Health research projects may involve the use of tissue and other biological material from deceased persons without the removal being
p.(None): covered by Part 56 of the Health Care Act on autopsy, if the nearest relative has given consent for use of the material for research
p.(None): purposes. Consent by the nearest relative must be given against the background of written and oral information on the content of the
p.(None): research project.
p.(None):
p.(None): Exemption from the consent requirement for 15 to 17-year-olds
p.(None):
p.(None): Section 9
p.(None):
p.(None): (1) The committee may grant exemption from the requirement of proxy consent from the holder of custody, cf. Section 3 (2) no. 1, and
p.(None): Section 4 (1) in the case of a trial subject that has turned fifteen years of age but has not yet come of age if the minor in question gives
p.(None): informed consent. A decision to grant exemption must be taken with consideration for the nature as well as the risk and the strain of the
p.(None): research project.
p.(None):
p.(None): (2) When the minor's own informed consent is deemed sufficient, cf. (1) above, the holder of custody must be given the same information
p.(None): as the minor and must be involved in the minor's decision process.
p.(None):
p.(None): Database research projects
p.(None):
p.(None): Section 10
p.(None):
p.(None): (1) The committee may grant exemption from the requirement of consent or proxy consent according to Sections 3 to 5 if a notifiable
p.(None): database research project does not involve any health risks and if under the given conditions the research project cannot otherwise put a
p.(None): strain on the trial subject.
p.(None):
p.(None): This also applies if it would be impossible or disproportionately difficult to obtain informed consent or proxy consent respectively.
p.(None):
p.(None): (2) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.
p.(None):
p.(None): Research in acute situations
p.(None):
p.(None): Section 11
p.(None):
...
p.(None):
p.(None): (3) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) and (2) above.
p.(None):
p.(None): Section 19
p.(None):
p.(None): (1) In order for permission to be given to health research projects which include trial subjects that are unable to give informed consent, it
p.(None): is a condition furthermore that
p.(None):
p.(None): 1) the project is decisive in order to verify data obtained from trials involving persons who are able to give informed consent or through
p.(None): other trial methods,
p.(None):
p.(None): 2) the project is directly linked to the intended trial subject’s clinical condition, and
p.(None): 3) the project may be expected to benefit the patient group.
p.(None):
p.(None): (2) If the conditions in (1) above are not met, and if the notified health research project does not involve clinical trial of medicines, it is,
p.(None): however, a condition, cf. (3) below, that
p.(None):
p.(None): 1) the project cannot be carried out with similar benefits using trial subjects who are able to give informed consent, and
p.(None):
p.(None): 2) the project is likely to benefit the trial subject directly.
p.(None):
p.(None): (3) If neither the conditions in (1) or (2) above are met, and if the notified health research project does not involve clinical trial of
p.(None): medicines, it is a condition that
p.(None):
p.(None): 1) the project can only be implemented by involving persons of a given age group or persons who have a given disease or condition,
p.(None):
p.(None): 2) the project is likely to directly lead to great benefits for the patient group that falls within the same age group or who suffer from the
p.(None): same disease or condition as the trial subject, and
p.(None):
p.(None): 3) the project involves minimal risks and discomfort for the trial subject.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) to (3) above.
p.(None):
p.(None): Section 20
p.(None):
p.(None): (1) In order for permission to be given for health research projects, it is furthermore a condition that
p.(None):
p.(None): 1) the investigator is qualified to take treatment decisions and has proper training and clinical experience,
p.(None):
p.(None): 2) it is clear from written or electronic information what financial support the investigator receives from private companies, foundations
p.(None): etc. for the undertaking of the research project in question and whether the investigator otherwise has any financial affiliation to private
p.(None): companies, foundations etc. who have an interest in the research project under consideration.
p.(None):
p.(None): 3) any payment or other compensation for trial subjects in return for participation in a health research project is not such as to affect the
p.(None): giving of consent,
p.(None):
p.(None): 4) the trial subject’s right to physical and mental integrity and the right to privacy are respected and information concerning the trial
p.(None): subject is protected according to the act on data protection,
p.(None):
p.(None): 5) the principal investigator has secured that the trial subject has access to further information on the project,
p.(None):
p.(None): 6) projects that involve export of biological material and information to third countries must be undertaken in accordance with the rules
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): who have no training within health care and who do not at the time of membership have any affiliation to the health care professions.
p.(None):
p.(None): (4) The act lays down the legal framework for the research ethics evaluation of health research projects by the committees and lays down
p.(None): the tasks of the committee system on this basis.
p.(None):
p.(None): Part 2
p.(None):
p.(None): Definitions
p.(None):
p.(None): Section 2
p.(None):
p.(None): (1) For the purposes of this act the following definitions shall apply:
p.(None):
p.(None): 1) Health research project: A project that includes trials involving liveborn human individuals, human gametes intended for fertilization,
p.(None): fertilized human eggs, embryonic cells and embryos, tissue, cells and genetic material from humans, embryos etc. or deceased persons.
p.(None): Also included are clinical trials of medicines in humans, cf. no. 2) below, and clinical trials of medical devices, cf. no. 3) below.
p.(None):
p.(None): 2) Health research project that concerns clinical trial of medicines: Any trial on humans with the aim of uncovering or verifying the
p.(None): clinical, pharmacological or other pharmacodynamic effect of one or several trial medicines or to identify adverse reactions to one or
p.(None): several trial medicines or to investigate absorption, distribution, metabolism or excretion of one or several trial medicines with a view to
p.(None): assessing their effect or safety.
p.(None):
p.(None): 3) Health research project that concerns clinical trial of medical devices: Any trial on humans with the aim of uncovering or verifying the
p.(None): safety or the performance of medical devices.
p.(None):
p.(None): 4) Multi-centre trial: A trial that is undertaken on the basis of a single trial protocol but in different sites with a coordinating investigator
p.(None): or with several investigators. Trial sites may all be located in Denmark or in Denmark and in other EU member states or third countries.
p.(None):
p.(None): 5) Sponsor: A natural or legal person who takes responsibility for the initiation, management or financing of a health research project.
p.(None): 6) Investigator: An individual who exercises a profession that is approved for the carrying out of research, e.g. though employment as a
p.(None): researcher or Ph.d. student or otherwise through involvement in concrete research, and who is responsible for the practical carrying out of
p.(None): the trial at a given site.
p.(None):
p.(None): 7) Trial protocol: A document that describes objectives, design, methodology, organisation, statistical considerations, research ethics
p.(None): considerations, financial aspects, publication issues as well as how participants in a health research project are to be informed.
p.(None):
p.(None): 8) Trial subject: An individual who takes part in a health research project regardless of whether this individual is given trial preparations
p.(None): etc. or is part of a control group.
p.(None):
p.(None): 9) Incapacitated adult: An individual who is covered by the definition in Section 5 of the Guardianship Act, including when guardianship
p.(None): has been established in a manner that includes powers to give informed consent for participation in health research projects.
p.(None):
...
p.(None): (3) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.
p.(None):
p.(None): Assistance by consultants
p.(None):
p.(None): Section 22
p.(None):
p.(None): (1) The competent committee must use assistance from consultants in cases when the committee itself does not have the professional
p.(None): expertise required to evaluate notified projects.
p.(None):
p.(None): (2) In connection with the processing of notified research projects that involve incapacitated adults, the trial protocol must be assessed by
p.(None): an expert who has knowledge of the group of individuals in question. In connection with the processing of notified research projects that
p.(None): involve minors, the trial protocol must be evaluated by an expert in paediatrics if the minor is involved an intervention trial.
p.(None):
p.(None): Time-limits for processing etc.
p.(None):
p.(None): Section 23
p.(None):
p.(None): (1) The committee must decide on approval of a project within 60 days of having received an appropriately presented notification, cf.
p.(None): Section 16, cf., however, (2) to (4) below.
p.(None):
p.(None): (2) The time-limit pursuant to (1) above is prolonged by 30 days if a notification concerns trials involving genetic therapy, somatic cell
p.(None): therapy or medicines that contain genetically modified organisms. The time-limit of 90 days is prolonged by another 90 days if public
p.(None): boards and committees are to be heard. If a notification concerns trial involving xenogeneic cell therapy, there is no time-limit for the
p.(None): processing of the notification.
p.(None):
p.(None): (3) Within the period during which the notification is being processed, the committee may on a single occasion request information in
p.(None): addition to what has already been provided by the applicant with the effect that the time-limit in (1) and (2) above is suspended until the
p.(None): supplementing information has been received.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down rules requiring the research ethics committees to decide on the approval of
p.(None): projects within shorter time-limits than laid down in (1) to (3) above against charging a special fee for speedy processing.
p.(None):
p.(None): (5) Following recommendation from the national committee the Minister for the Interior and Health may in special cases lay down rules to
p.(None): the effect that research projects within further defined new fields of research that do not involve clinical trial of medicines in special cases
p.(None): may be suspended for a determined period until general ethical or scientific clarification has been obtained.
p.(None):
p.(None): Decision procedures
p.(None):
p.(None): Section 24
p.(None):
p.(None): (1) If in the competent committee it is not possible to reach agreement on the evaluation of a health research project, the committee shall
p.(None): take a vote to decide whether the project is to be approved and its implementation should be permitted, cf., however, (3) and (4) below.
p.(None): The project is approved if a qualified majority, cf. (2) below, of the members of the competent committee based on a research ethics
p.(None): evaluation according to Section 17 find that the research project may be approved, possibly on certain conditions. In the case of parity the
p.(None): vote of the committee’s chair shall be decisive, and if the chair is unavailable, the vote of the deputy chair shall be decisive.
p.(None):
...
Social / Student
Searching for indicator student:
(return to top)
p.(None):
p.(None): 1) Health research project: A project that includes trials involving liveborn human individuals, human gametes intended for fertilization,
p.(None): fertilized human eggs, embryonic cells and embryos, tissue, cells and genetic material from humans, embryos etc. or deceased persons.
p.(None): Also included are clinical trials of medicines in humans, cf. no. 2) below, and clinical trials of medical devices, cf. no. 3) below.
p.(None):
p.(None): 2) Health research project that concerns clinical trial of medicines: Any trial on humans with the aim of uncovering or verifying the
p.(None): clinical, pharmacological or other pharmacodynamic effect of one or several trial medicines or to identify adverse reactions to one or
p.(None): several trial medicines or to investigate absorption, distribution, metabolism or excretion of one or several trial medicines with a view to
p.(None): assessing their effect or safety.
p.(None):
p.(None): 3) Health research project that concerns clinical trial of medical devices: Any trial on humans with the aim of uncovering or verifying the
p.(None): safety or the performance of medical devices.
p.(None):
p.(None): 4) Multi-centre trial: A trial that is undertaken on the basis of a single trial protocol but in different sites with a coordinating investigator
p.(None): or with several investigators. Trial sites may all be located in Denmark or in Denmark and in other EU member states or third countries.
p.(None):
p.(None): 5) Sponsor: A natural or legal person who takes responsibility for the initiation, management or financing of a health research project.
p.(None): 6) Investigator: An individual who exercises a profession that is approved for the carrying out of research, e.g. though employment as a
p.(None): researcher or Ph.d. student or otherwise through involvement in concrete research, and who is responsible for the practical carrying out of
p.(None): the trial at a given site.
p.(None):
p.(None): 7) Trial protocol: A document that describes objectives, design, methodology, organisation, statistical considerations, research ethics
p.(None): considerations, financial aspects, publication issues as well as how participants in a health research project are to be informed.
p.(None):
p.(None): 8) Trial subject: An individual who takes part in a health research project regardless of whether this individual is given trial preparations
p.(None): etc. or is part of a control group.
p.(None):
p.(None): 9) Incapacitated adult: An individual who is covered by the definition in Section 5 of the Guardianship Act, including when guardianship
p.(None): has been established in a manner that includes powers to give informed consent for participation in health research projects.
p.(None):
p.(None): 10) Informed consent: A decision to participate in a health research project which has been communicated in writing duly dated and
p.(None): signed or has been communicated electronically with the use of digital signature, and which has been taken freely by an individual able to
p.(None): give consent who has received adequate information on the project’s nature, significance, implications and risks as well as adequate
p.(None): documentation.
p.(None):
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): system,
p.(None):
p.(None): 2) general development trends within health research,
p.(None):
p.(None): 3) significant issues of research ethics discussed in the committees, and
p.(None):
p.(None): 4) the reasoning underlying decisions in significant cases.
p.(None):
p.(None): Part 7
p.(None):
p.(None): Establishing of research ethics committees
p.(None):
p.(None): The regional research ethics committees
p.(None):
p.(None): Section 35
p.(None):
p.(None): (1) The regional councils shall set up regional research ethics committees. A regional council may set up one or several committees within
p.(None): its geographical area. A committee may also be set up by several regional councils.
p.(None):
p.(None): (2) The regional councils may agree on a division of received notifications among themselves.
p.(None):
p.(None): Section 36
p.(None):
p.(None): (1) A regional committee shall consist of at least 7 members of which 3 are active within health research. If the regional council finds that
p.(None): considerations for the activity of a regional committee, the number of projects or other reasons indicate this, a committee may consist of 9
p.(None): or 11 members. If there are 9 or 11 members, 4 or 5 members respectively must be active within health research.
p.(None):
p.(None): (2) Members of the regional committees must be affiliated to the region or regions that the committee in question covers. The members
p.(None): active within research shall be appointed following recommendation from relevant research fora, cf (7) below. Recommendations shall, if
p.(None): possible, include an equal number of women and men. On appointment it shall be secured to the extent possible that in the committee
p.(None): one gender outnumbers the other by only one member.
p.(None):
p.(None): (3) The regional committee shall select its chair among the appointed members active within research and a deputy chair among the
p.(None): appointed lay members.
p.(None):
p.(None): (4) The regional committee shall propose rules of procedure that must be approved by the national research ethics committee.
p.(None):
p.(None): (5) Committee members are appointed for 4 years corresponding to the electoral period of the regional councils. Members may be
p.(None): reappointed twice. Alternates may be appointed.
p.(None):
p.(None): (6) The previous committee shall continue its activity until new members have been appointed and the new committee has elected its
p.(None): officers.
p.(None):
p.(None): (7) The Minister for the Interior and Health may lay down further rules on what fora are considered relevant research fora, cf. (2) above.
p.(None):
p.(None): The national research ethics committee
p.(None):
p.(None): Section 37
p.(None):
p.(None): The Minister for the Interior and Health shall set up the national research ethics committee.
p.(None):
p.(None): Section 38
p.(None):
p.(None): (1) The national research ethics committee consists of 13 members to be appointed as follows:
p.(None):
p.(None): 1) The Minister for the Interior and Health shall appoint the chair of the national research ethics committee.
p.(None):
p.(None): 2) 2 members shall be appointed by the Minister for the Interior and Health following joint recommendation from governing boards of
p.(None): the Danish Council for Strategic Research and the Danish Council for Independent Research.
p.(None):
p.(None): 3) 5 members shall be appointed by the Minister for the Interior and Health in consultation with the minister for science, technology and
p.(None): development following open advertisement.
p.(None):
p.(None): 4) 5 members shall be appointed by the Minister for the Interior and Health on the basis of recommendations from the individual
p.(None): regions.
p.(None):
p.(None): (2) To the extent possible an equal number of men and women shall be recommended pursuant to (1) no. 2 above, respectively (1) no. 4
p.(None): above. Recommendations pursuant to (1) no. 4 shall include as many lay persons as persons who are active within health research.
p.(None):
p.(None): (3) In connection with appointment it shall be secured that the committee is constituted such as to cover a broad range of members who
p.(None): are active within health research and lay members. On appointment it shall be secured to the extent possible that in the committee one
p.(None): gender outnumbers the other by only one member.
p.(None):
p.(None): (4) The chair shall represent state research interests as well as interests pertaining to general education, research ethics, general culture or
p.(None): social considerations that are significant to the activity of the national committee.
p.(None):
p.(None): (5) Members appointed according to (1) nos. 2 and 3 above shall represent research interests as well as interests pertaining to general
p.(None): education, research ethics, general culture or social considerations that are significant to the activity of the national committee.
p.(None):
p.(None): (6) The chair and the members appointed according to (1) nos. 2 and 3 above may not be members of the Folketing or of regional or
p.(None): municipal councils.
p.(None):
p.(None): (7) The committee selects its deputy chair among the members appointed.
p.(None):
p.(None): (8) The committee shall draw up a proposal for rules of procedure to be approved by the Minister for the Interior and Health.
p.(None):
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): individuals.
p.(None):
p.(None): 14) Adverse event: Any unwanted event in a trial subject who participates in a research project following activity as described in the trial
p.(None): protocol without necessarily a relationship between this activity and the adverse event.
p.(None):
p.(None): 15) Adverse reaction: Any harmful and unwanted reaction to an activity as a result of participation in the research project.
p.(None):
p.(None): 16) Unexpected adverse reaction: An adverse reaction whose character or severity does not match the risk incurred by the activity in
p.(None): question as described in the trial protocol.
p.(None):
p.(None): 17) Serious adverse event or serious adverse reaction: An adverse event or an adverse reaction which regardless of e.g. dose is fatal, is
p.(None): life-threatening, leads to hospital admission or prolongation of ongoing hospital stay, results in lasting or considerable disablement or
p.(None): incapacity for work or leads to congenital anomaly or malformation.
p.(None):
p.(None): Part 3
p.(None):
p.(None): Informed consent for participation in health research projects
p.(None):
p.(None): Section 3
p.(None):
p.(None): (1) Health research projects that must be notified to the committee system according to Section 14, may include trials on humans if the
p.(None): trial subject has given informed consent for participation prior to the trial, cf., however, (2) below.
p.(None):
p.(None): (2) Consent must be given as proxy consent according to Section 4 if the trial subject
p.(None):
p.(None): 1) is a minor,
p.(None):
p.(None): 2) is under guardianship that includes powers to give informed consent for participation in health research projects, cf. the Guardianship
p.(None): Act Section 5 (1), or
p.(None):
p.(None): 3) otherwise is an incapacitated adult.
p.(None):
p.(None): (3) Consent includes access to the communication and processing of required information on the trial subject’s health, other wholly
p.(None): personal matters and other confidential information as part of own control of the research project including quality control and
p.(None): monitoring which a sponsor or a possible monitor is under obligation to undertake.
p.(None):
p.(None): (4) Consent may be withdrawn at any time without this being detrimental to the trial subject.
p.(None):
p.(None): (5) In connection with research ethics evaluation of concrete health research projects the committee may deviate from (1) and (2) above
p.(None): according to the criteria laid down in Sections 8 to 12.
p.(None):
p.(None): Section 4
p.(None): (1) Proxy consent on behalf of trial subjects that are minors, must be given by the holder of custody.
p.(None):
p.(None): (2) Proxy consent on behalf of trial subjects under guardianship that includes powers to give informed consent for participation in health
p.(None): research projects, cf. the Guardianship Act Section 5 (1), must be given by the guardian.
p.(None):
p.(None): (3) Proxy consent on behalf of other incapacitated adult trial subjects must be given by their nearest relative and their general practitioner
p.(None): or, if the general practitioner is not available, the National Board of Health.
p.(None):
p.(None): (4) Proxy consent must express the trial subject’s interests. The trial subject’s declarations should be taken into consideration to the extent
p.(None): that these declarations are topical and relevant.
p.(None):
p.(None): (5) Complaint against a general practitioner’s proxy consent cannot be put to the National Agency for Patients' Rights and Complaints or to
p.(None): the health care disciplinary board under the act on complaints and compensation in the healthcare sector.
p.(None):
p.(None): Section 5
p.(None):
p.(None): (1) Consent according to Sections 3 and 4 must be given against the background of written and oral information on the content of as well
p.(None): as foreseeable risks and benefits of the research project. It must be clear from the information that consent may be withdrawn at any time.
p.(None):
p.(None): (2) If the trial subject is a minor, under personal guardianship or otherwise is an incapacitated adult, the information must be adapted to
p.(None): the trial subject's capacity for understanding. Information for minors must be provided by a person with knowledge of the field that the
p.(None): project concerns, and who has the pedagogical competences required for communication of such information to the age group covered
p.(None): by the research project.
p.(None):
p.(None): (3) The information mentioned in (1) above must also be communicated to persons who are entitled to give proxy consent on behalf of a
p.(None): trial subject.
p.(None):
p.(None): Section 6
p.(None):
p.(None): The consent requirements laid down in Sections 3 to 5 also apply to the removal of tissue and other biological material in connection with
p.(None): concrete research projects with a view to storage in a research biobank.
p.(None):
p.(None): Section 7
p.(None):
p.(None): The Minister for the Interior and Health may lay down further rules on consent and information according to Sections 3 to 5. Unless
p.(None): consent requirements follow from other legislation, the Minister for the Interior and Health may lay down further rules for the obtaining of
p.(None): informed consent or proxy consent for use in connection with notifiable health research projects that do not involve trial subjects.
p.(None):
p.(None): Health research projects that involve deceased persons
...
p.(None): obtained either from the deceased person or from the nearest relative according to Section 187 of the Health Care Act on consent for
p.(None): autopsy for health research purposes. Tissue and other biological material removed in connection with forensic autopsies prior to the
p.(None): coming into force of this act may be used for health research without consent being obtained according to sentence 1 above.
p.(None):
p.(None): (2) Health research projects may involve the use of tissue and other biological material from deceased persons without the removal being
p.(None): covered by Part 56 of the Health Care Act on autopsy, if the nearest relative has given consent for use of the material for research
p.(None): purposes. Consent by the nearest relative must be given against the background of written and oral information on the content of the
p.(None): research project.
p.(None):
p.(None): Exemption from the consent requirement for 15 to 17-year-olds
p.(None):
p.(None): Section 9
p.(None):
p.(None): (1) The committee may grant exemption from the requirement of proxy consent from the holder of custody, cf. Section 3 (2) no. 1, and
p.(None): Section 4 (1) in the case of a trial subject that has turned fifteen years of age but has not yet come of age if the minor in question gives
p.(None): informed consent. A decision to grant exemption must be taken with consideration for the nature as well as the risk and the strain of the
p.(None): research project.
p.(None):
p.(None): (2) When the minor's own informed consent is deemed sufficient, cf. (1) above, the holder of custody must be given the same information
p.(None): as the minor and must be involved in the minor's decision process.
p.(None):
p.(None): Database research projects
p.(None):
p.(None): Section 10
p.(None):
p.(None): (1) The committee may grant exemption from the requirement of consent or proxy consent according to Sections 3 to 5 if a notifiable
p.(None): database research project does not involve any health risks and if under the given conditions the research project cannot otherwise put a
p.(None): strain on the trial subject.
p.(None):
p.(None): This also applies if it would be impossible or disproportionately difficult to obtain informed consent or proxy consent respectively.
p.(None):
p.(None): (2) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.
p.(None):
p.(None): Research in acute situations
p.(None):
p.(None): Section 11
p.(None):
p.(None): (1) The committee may allow that a health research project that does not concern clinical trial of medicines is undertaken without prior
p.(None): consent according to Sections 3 to 5 if the nature of the research project is such that it can only be undertaken in acute situations in which
p.(None): the trial subject is not able to give informed consent and when it is not possible to obtain proxy consent, if
p.(None):
p.(None): 1) participation in the trial may improve the person's health in the long term, or
p.(None):
p.(None): 2) the trial may improve the condition of other patients with the same disease as the trial subject and participation in the trial involves
...
p.(None):
p.(None): Section 21
p.(None):
p.(None): (1) In order to get permission for a health research project that involves clinical trial of medicines covered by the medicines act or clinical
p.(None): trial of medical devices covered by the act on medical devices, it is a condition that
p.(None):
p.(None): 1) the Medicines Agency is involved in the approval of the project, cf. Section 13 (2), and
p.(None):
p.(None): 2) the investigator is qualified to take treatment decisions and has appropriate medical training as a doctor or, when this is relevant, a
p.(None): dentist, and has clinical experience.
p.(None):
p.(None): (2) Furthermore the competent committee must ensure the extent of and the detailed rules for the payment of any fee or any
p.(None): compensation to the investigator and the trial subjects as well as the content of the relevant provisions of any considered contract
p.(None): between the sponsor and the site of the trial.
p.(None):
p.(None): (3) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.
p.(None):
p.(None): Assistance by consultants
p.(None):
p.(None): Section 22
p.(None):
p.(None): (1) The competent committee must use assistance from consultants in cases when the committee itself does not have the professional
p.(None): expertise required to evaluate notified projects.
p.(None):
p.(None): (2) In connection with the processing of notified research projects that involve incapacitated adults, the trial protocol must be assessed by
p.(None): an expert who has knowledge of the group of individuals in question. In connection with the processing of notified research projects that
p.(None): involve minors, the trial protocol must be evaluated by an expert in paediatrics if the minor is involved an intervention trial.
p.(None):
p.(None): Time-limits for processing etc.
p.(None):
p.(None): Section 23
p.(None):
p.(None): (1) The committee must decide on approval of a project within 60 days of having received an appropriately presented notification, cf.
p.(None): Section 16, cf., however, (2) to (4) below.
p.(None):
p.(None): (2) The time-limit pursuant to (1) above is prolonged by 30 days if a notification concerns trials involving genetic therapy, somatic cell
p.(None): therapy or medicines that contain genetically modified organisms. The time-limit of 90 days is prolonged by another 90 days if public
p.(None): boards and committees are to be heard. If a notification concerns trial involving xenogeneic cell therapy, there is no time-limit for the
p.(None): processing of the notification.
p.(None):
p.(None): (3) Within the period during which the notification is being processed, the committee may on a single occasion request information in
p.(None): addition to what has already been provided by the applicant with the effect that the time-limit in (1) and (2) above is suspended until the
p.(None): supplementing information has been received.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down rules requiring the research ethics committees to decide on the approval of
p.(None): projects within shorter time-limits than laid down in (1) to (3) above against charging a special fee for speedy processing.
p.(None):
p.(None): (5) Following recommendation from the national committee the Minister for the Interior and Health may in special cases lay down rules to
p.(None): the effect that research projects within further defined new fields of research that do not involve clinical trial of medicines in special cases
...
Social / education
Searching for indicator education:
(return to top)
p.(None): notification obligations for further defined new fields of research which would otherwise be exempt from the obligation pursuant to (4)
p.(None): above.
p.(None):
p.(None): Competence
p.(None):
p.(None): Section 15
p.(None): (1) Notification of health research projects must be addressed to the regional committee for the area in which the investigator is active.
p.(None): Health research projects that concern especially complex areas must, however, be notified to the national committee. The notification
p.(None): obligation rests with the investigator as well as with the sponsor, and both must sign the notification.
p.(None):
p.(None): (2) Cross border multi-centre trials must always be notified in this country. If there are several investigators in Denmark and if the research
p.(None): project is not covered by (1) 2nd sentence above, the multi-centre project must be notified to the regional committee where the
p.(None): coordinating investigator is active.
p.(None):
p.(None): (3) On the basis of recommendation from the national committee the Minister for the Interior and Health shall lay down further rules
p.(None): concerning what health research projects must be notified to the national committee pursuant to (1) 2nd sentence above.
p.(None):
p.(None): Notification format
p.(None):
p.(None): Section 16
p.(None):
p.(None): (1) Notification must be submitted electronically using a digital signature to the competent research ethics committee along with the trial
p.(None): protocol and other information required for the committee’s assessment of whether the research project may be permitted, cf. Section 17
p.(None): (1) and Sections 18 to 21, including documentation regarding the identities of the sponsor and the notifying investigator as well as the
p.(None): investigator’s education and training.
p.(None):
p.(None): (2) The Minister for the Interior and Health shall lay down further rules with regard to the format of trial protocols and on what other
p.(None): information is required for assessment by the committee system, cf. (1) above, and the Minister may lay down further rules on notification
p.(None): procedures.
p.(None):
p.(None): Part 5
p.(None):
p.(None): Research ethics evaluation and administrative procedures of the committees
p.(None):
p.(None): Research ethics evaluation
p.(None):
p.(None): Section 17
p.(None):
p.(None): (1) The committees undertake a research ethics evaluation of notifiable health research projects on the basis of criteria laid down in this
p.(None): act, including Sections 18 to 22, as well as an evaluation of whether the research project is designed in such a way that the required
p.(None): consent for the participation of trial subjects in the project will be sought and given, cf. Part 3. On the basis of the evaluation the
p.(None): competent committee decides whether a given project shall be permitted.
p.(None):
p.(None): (2) The competent committee may attach conditions to its permission.
p.(None):
p.(None): (3) In connection with a decision on permission the competent committee decides how the carrying out of a trial shall be monitored, cf.
p.(None): Section 28.
p.(None):
p.(None): Section 18
p.(None):
p.(None): (1) It is a condition for the granting of permission that
p.(None):
p.(None): 1) the extent of the risks that the trial may involve is not unjustifiable, neither as such nor in relation to the foreseeable benefits of the
p.(None): trial,
p.(None):
...
p.(None):
p.(None): (1) The national research ethics committee consists of 13 members to be appointed as follows:
p.(None):
p.(None): 1) The Minister for the Interior and Health shall appoint the chair of the national research ethics committee.
p.(None):
p.(None): 2) 2 members shall be appointed by the Minister for the Interior and Health following joint recommendation from governing boards of
p.(None): the Danish Council for Strategic Research and the Danish Council for Independent Research.
p.(None):
p.(None): 3) 5 members shall be appointed by the Minister for the Interior and Health in consultation with the minister for science, technology and
p.(None): development following open advertisement.
p.(None):
p.(None): 4) 5 members shall be appointed by the Minister for the Interior and Health on the basis of recommendations from the individual
p.(None): regions.
p.(None):
p.(None): (2) To the extent possible an equal number of men and women shall be recommended pursuant to (1) no. 2 above, respectively (1) no. 4
p.(None): above. Recommendations pursuant to (1) no. 4 shall include as many lay persons as persons who are active within health research.
p.(None):
p.(None): (3) In connection with appointment it shall be secured that the committee is constituted such as to cover a broad range of members who
p.(None): are active within health research and lay members. On appointment it shall be secured to the extent possible that in the committee one
p.(None): gender outnumbers the other by only one member.
p.(None):
p.(None): (4) The chair shall represent state research interests as well as interests pertaining to general education, research ethics, general culture or
p.(None): social considerations that are significant to the activity of the national committee.
p.(None):
p.(None): (5) Members appointed according to (1) nos. 2 and 3 above shall represent research interests as well as interests pertaining to general
p.(None): education, research ethics, general culture or social considerations that are significant to the activity of the national committee.
p.(None):
p.(None): (6) The chair and the members appointed according to (1) nos. 2 and 3 above may not be members of the Folketing or of regional or
p.(None): municipal councils.
p.(None):
p.(None): (7) The committee selects its deputy chair among the members appointed.
p.(None):
p.(None): (8) The committee shall draw up a proposal for rules of procedure to be approved by the Minister for the Interior and Health.
p.(None):
p.(None): (9) Committee members are appointed for 4 years corresponding to the electoral period of the regional councils. Members may be
p.(None): reappointed twice. Alternates may be appointed.
p.(None):
p.(None): (10) The previous committee shall continue its activity until new members have been appointed and the new committee has elected its
p.(None): officers.
p.(None): Part 8
p.(None):
p.(None): Financing
p.(None):
p.(None): Section 39
p.(None):
p.(None): (1)The costs of the regional committees shall be borne by the relevant regional council.
p.(None):
p.(None): (2) Research institutions etc. and private companies and hospitals shall pay a fee per project or amendment of a project that is notified to
p.(None): the region in question in order to cover part of the cost. The Minister for the Interior and Health shall lay down rules on the amount of such
p.(None): fees and their collection.
p.(None):
p.(None): (3) Members of the regional committees and any alternates shall receive reimbursement of expenditure according to the provision of
p.(None): Section 11 of the act on the regions.
p.(None):
p.(None): (4) The Minister for the Interior and Health shall lay down further rules on access for the regions to provide supplementing reimbursement
...
Social / gender
Searching for indicator gender:
(return to top)
p.(None):
p.(None): 4) the reasoning underlying decisions in significant cases.
p.(None):
p.(None): Part 7
p.(None):
p.(None): Establishing of research ethics committees
p.(None):
p.(None): The regional research ethics committees
p.(None):
p.(None): Section 35
p.(None):
p.(None): (1) The regional councils shall set up regional research ethics committees. A regional council may set up one or several committees within
p.(None): its geographical area. A committee may also be set up by several regional councils.
p.(None):
p.(None): (2) The regional councils may agree on a division of received notifications among themselves.
p.(None):
p.(None): Section 36
p.(None):
p.(None): (1) A regional committee shall consist of at least 7 members of which 3 are active within health research. If the regional council finds that
p.(None): considerations for the activity of a regional committee, the number of projects or other reasons indicate this, a committee may consist of 9
p.(None): or 11 members. If there are 9 or 11 members, 4 or 5 members respectively must be active within health research.
p.(None):
p.(None): (2) Members of the regional committees must be affiliated to the region or regions that the committee in question covers. The members
p.(None): active within research shall be appointed following recommendation from relevant research fora, cf (7) below. Recommendations shall, if
p.(None): possible, include an equal number of women and men. On appointment it shall be secured to the extent possible that in the committee
p.(None): one gender outnumbers the other by only one member.
p.(None):
p.(None): (3) The regional committee shall select its chair among the appointed members active within research and a deputy chair among the
p.(None): appointed lay members.
p.(None):
p.(None): (4) The regional committee shall propose rules of procedure that must be approved by the national research ethics committee.
p.(None):
p.(None): (5) Committee members are appointed for 4 years corresponding to the electoral period of the regional councils. Members may be
p.(None): reappointed twice. Alternates may be appointed.
p.(None):
p.(None): (6) The previous committee shall continue its activity until new members have been appointed and the new committee has elected its
p.(None): officers.
p.(None):
p.(None): (7) The Minister for the Interior and Health may lay down further rules on what fora are considered relevant research fora, cf. (2) above.
p.(None):
p.(None): The national research ethics committee
p.(None):
p.(None): Section 37
p.(None):
p.(None): The Minister for the Interior and Health shall set up the national research ethics committee.
p.(None):
p.(None): Section 38
p.(None):
p.(None): (1) The national research ethics committee consists of 13 members to be appointed as follows:
p.(None):
p.(None): 1) The Minister for the Interior and Health shall appoint the chair of the national research ethics committee.
p.(None):
p.(None): 2) 2 members shall be appointed by the Minister for the Interior and Health following joint recommendation from governing boards of
p.(None): the Danish Council for Strategic Research and the Danish Council for Independent Research.
p.(None):
p.(None): 3) 5 members shall be appointed by the Minister for the Interior and Health in consultation with the minister for science, technology and
p.(None): development following open advertisement.
p.(None):
p.(None): 4) 5 members shall be appointed by the Minister for the Interior and Health on the basis of recommendations from the individual
p.(None): regions.
p.(None):
p.(None): (2) To the extent possible an equal number of men and women shall be recommended pursuant to (1) no. 2 above, respectively (1) no. 4
p.(None): above. Recommendations pursuant to (1) no. 4 shall include as many lay persons as persons who are active within health research.
p.(None):
p.(None): (3) In connection with appointment it shall be secured that the committee is constituted such as to cover a broad range of members who
p.(None): are active within health research and lay members. On appointment it shall be secured to the extent possible that in the committee one
p.(None): gender outnumbers the other by only one member.
p.(None):
p.(None): (4) The chair shall represent state research interests as well as interests pertaining to general education, research ethics, general culture or
p.(None): social considerations that are significant to the activity of the national committee.
p.(None):
p.(None): (5) Members appointed according to (1) nos. 2 and 3 above shall represent research interests as well as interests pertaining to general
p.(None): education, research ethics, general culture or social considerations that are significant to the activity of the national committee.
p.(None):
p.(None): (6) The chair and the members appointed according to (1) nos. 2 and 3 above may not be members of the Folketing or of regional or
p.(None): municipal councils.
p.(None):
p.(None): (7) The committee selects its deputy chair among the members appointed.
p.(None):
p.(None): (8) The committee shall draw up a proposal for rules of procedure to be approved by the Minister for the Interior and Health.
p.(None):
p.(None): (9) Committee members are appointed for 4 years corresponding to the electoral period of the regional councils. Members may be
p.(None): reappointed twice. Alternates may be appointed.
p.(None):
p.(None): (10) The previous committee shall continue its activity until new members have been appointed and the new committee has elected its
p.(None): officers.
p.(None): Part 8
p.(None):
p.(None): Financing
p.(None):
p.(None): Section 39
p.(None):
p.(None): (1)The costs of the regional committees shall be borne by the relevant regional council.
p.(None):
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): any information from the investigator that the committee finds is relevant for its supervision.
p.(None):
p.(None): (2) Once a year throughout the trial period the sponsor or the investigator shall send to the supervising committee a list of all presumed
p.(None): serious unexpected adverse reactions that have occurred during the trial period and provide information on the safety of the trial subjects.
p.(None): Unless the research project concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the
p.(None): Medicines Act, the notification obligation furthermore covers serious adverse events.
p.(None):
p.(None):
p.(None):
p.(None): Notification on the termination of health research projects
p.(None):
p.(None): Section 31
p.(None):
p.(None): (1) No later than 90 days after the termination of a notifiable health research project the investigator and the sponsor shall jointly inform
p.(None): the supervising committee that the project has been terminated.
p.(None):
p.(None): (2) If a research project is discontinued before its planned termination, the investigator and the sponsor shall jointly inform the
p.(None): supervising committee about the project’s discontinuation no later than 15 days following the decision to discontinue the project. The
p.(None): reasons for discontinuation of the project must be stated. If necessary the supervising committee may require that the investigator and
p.(None): the sponsor submit an explanatory report.
p.(None):
p.(None): Other tasks
p.(None):
p.(None): Section 32
p.(None):
p.(None): (1) The national committee shall coordinate activity in the regional committees, shall lay down recommended guidelines and shall express
p.(None): its opinion on fundamental issues that are not related to the approval of any concrete research project.
p.(None):
p.(None): (2) The national committee may suggest to the Minister for the Interior and Health that further rules are laid down as provided for in the
p.(None): present act.
p.(None):
p.(None): Section 33
p.(None):
p.(None): (1) The committees shall follow development within health care research and try to promote understanding of the ethical issues that this
p.(None): development may lead to in relation to the health care services and health research environments.
p.(None):
p.(None): (2) The committee system shall actively cooperate with and coordinate tasks with relevant national and international authorities and
p.(None): organisations etc.
p.(None):
p.(None): (3) The committee system shall secure quality development, quality assurance and learning processes within the committee system. The
p.(None): Minister for the Interior and Health may lay down further rules in this regard.
p.(None):
p.(None): Section 34
p.(None):
p.(None): (1) The regional committees and the national committee shall submit a joint annual report with details on the activity and practice of the
p.(None): committees during the previous year.
p.(None):
p.(None): (2) The annual report, which is to be published, shall include a list of all notified projects and shall describe
p.(None):
p.(None): 1) general tendencies in the development of the activity of the committee system including cooperation according to Section 33 (2) and
p.(None): activity according to Section 33 (3) in relation to quality development, quality assurance and learning processes within the committee
p.(None): system,
p.(None):
p.(None): 2) general development trends within health research,
p.(None):
p.(None): 3) significant issues of research ethics discussed in the committees, and
p.(None):
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.(None): assessing their effect or safety.
p.(None):
p.(None): 3) Health research project that concerns clinical trial of medical devices: Any trial on humans with the aim of uncovering or verifying the
p.(None): safety or the performance of medical devices.
p.(None):
p.(None): 4) Multi-centre trial: A trial that is undertaken on the basis of a single trial protocol but in different sites with a coordinating investigator
p.(None): or with several investigators. Trial sites may all be located in Denmark or in Denmark and in other EU member states or third countries.
p.(None):
p.(None): 5) Sponsor: A natural or legal person who takes responsibility for the initiation, management or financing of a health research project.
p.(None): 6) Investigator: An individual who exercises a profession that is approved for the carrying out of research, e.g. though employment as a
p.(None): researcher or Ph.d. student or otherwise through involvement in concrete research, and who is responsible for the practical carrying out of
p.(None): the trial at a given site.
p.(None):
p.(None): 7) Trial protocol: A document that describes objectives, design, methodology, organisation, statistical considerations, research ethics
p.(None): considerations, financial aspects, publication issues as well as how participants in a health research project are to be informed.
p.(None):
p.(None): 8) Trial subject: An individual who takes part in a health research project regardless of whether this individual is given trial preparations
p.(None): etc. or is part of a control group.
p.(None):
p.(None): 9) Incapacitated adult: An individual who is covered by the definition in Section 5 of the Guardianship Act, including when guardianship
p.(None): has been established in a manner that includes powers to give informed consent for participation in health research projects.
p.(None):
p.(None): 10) Informed consent: A decision to participate in a health research project which has been communicated in writing duly dated and
p.(None): signed or has been communicated electronically with the use of digital signature, and which has been taken freely by an individual able to
p.(None): give consent who has received adequate information on the project’s nature, significance, implications and risks as well as adequate
p.(None): documentation.
p.(None):
p.(None): 11) Consent by proxy: A decision to participate in a health research project which has been obtained from the legal representative, the
p.(None): holder of custody or the trial guardian or from the nearest relative and the general practitioner or, if the general practitioner is not
p.(None): available, the National Board of Health, and which has been communicated in writing duly signed and dated or communicated
p.(None): electronically with the use of digital signature.
p.(None):
p.(None): 12) Trial guardian: A unit consisting of two doctors who in acute situations, cf. Section 12, may give proxy consent on behalf of the trial
p.(None): subject for participation in a health research project that concerns clinical trial of medicines. The trial guardian must safeguard the trial
p.(None): subject’s interests and be independent of the investigator’s interests and interests in the research project otherwise.
...
p.(None):
p.(None): 16) Unexpected adverse reaction: An adverse reaction whose character or severity does not match the risk incurred by the activity in
p.(None): question as described in the trial protocol.
p.(None):
p.(None): 17) Serious adverse event or serious adverse reaction: An adverse event or an adverse reaction which regardless of e.g. dose is fatal, is
p.(None): life-threatening, leads to hospital admission or prolongation of ongoing hospital stay, results in lasting or considerable disablement or
p.(None): incapacity for work or leads to congenital anomaly or malformation.
p.(None):
p.(None): Part 3
p.(None):
p.(None): Informed consent for participation in health research projects
p.(None):
p.(None): Section 3
p.(None):
p.(None): (1) Health research projects that must be notified to the committee system according to Section 14, may include trials on humans if the
p.(None): trial subject has given informed consent for participation prior to the trial, cf., however, (2) below.
p.(None):
p.(None): (2) Consent must be given as proxy consent according to Section 4 if the trial subject
p.(None):
p.(None): 1) is a minor,
p.(None):
p.(None): 2) is under guardianship that includes powers to give informed consent for participation in health research projects, cf. the Guardianship
p.(None): Act Section 5 (1), or
p.(None):
p.(None): 3) otherwise is an incapacitated adult.
p.(None):
p.(None): (3) Consent includes access to the communication and processing of required information on the trial subject’s health, other wholly
p.(None): personal matters and other confidential information as part of own control of the research project including quality control and
p.(None): monitoring which a sponsor or a possible monitor is under obligation to undertake.
p.(None):
p.(None): (4) Consent may be withdrawn at any time without this being detrimental to the trial subject.
p.(None):
p.(None): (5) In connection with research ethics evaluation of concrete health research projects the committee may deviate from (1) and (2) above
p.(None): according to the criteria laid down in Sections 8 to 12.
p.(None):
p.(None): Section 4
p.(None): (1) Proxy consent on behalf of trial subjects that are minors, must be given by the holder of custody.
p.(None):
p.(None): (2) Proxy consent on behalf of trial subjects under guardianship that includes powers to give informed consent for participation in health
p.(None): research projects, cf. the Guardianship Act Section 5 (1), must be given by the guardian.
p.(None):
p.(None): (3) Proxy consent on behalf of other incapacitated adult trial subjects must be given by their nearest relative and their general practitioner
p.(None): or, if the general practitioner is not available, the National Board of Health.
p.(None):
p.(None): (4) Proxy consent must express the trial subject’s interests. The trial subject’s declarations should be taken into consideration to the extent
p.(None): that these declarations are topical and relevant.
p.(None):
p.(None): (5) Complaint against a general practitioner’s proxy consent cannot be put to the National Agency for Patients' Rights and Complaints or to
p.(None): the health care disciplinary board under the act on complaints and compensation in the healthcare sector.
p.(None):
p.(None): Section 5
p.(None):
p.(None): (1) Consent according to Sections 3 and 4 must be given against the background of written and oral information on the content of as well
p.(None): as foreseeable risks and benefits of the research project. It must be clear from the information that consent may be withdrawn at any time.
p.(None):
p.(None): (2) If the trial subject is a minor, under personal guardianship or otherwise is an incapacitated adult, the information must be adapted to
p.(None): the trial subject's capacity for understanding. Information for minors must be provided by a person with knowledge of the field that the
p.(None): project concerns, and who has the pedagogical competences required for communication of such information to the age group covered
p.(None): by the research project.
p.(None):
p.(None): (3) The information mentioned in (1) above must also be communicated to persons who are entitled to give proxy consent on behalf of a
p.(None): trial subject.
p.(None):
p.(None): Section 6
p.(None):
p.(None): The consent requirements laid down in Sections 3 to 5 also apply to the removal of tissue and other biological material in connection with
p.(None): concrete research projects with a view to storage in a research biobank.
p.(None):
p.(None): Section 7
p.(None):
p.(None): The Minister for the Interior and Health may lay down further rules on consent and information according to Sections 3 to 5. Unless
p.(None): consent requirements follow from other legislation, the Minister for the Interior and Health may lay down further rules for the obtaining of
p.(None): informed consent or proxy consent for use in connection with notifiable health research projects that do not involve trial subjects.
p.(None):
p.(None): Health research projects that involve deceased persons
p.(None):
p.(None): Section 8
p.(None):
...
p.(None): 8) publication is undertaken in accordance with the act on the processing of personal data both with regard to negative, inconclusive
p.(None): and positive trial results as soon as this is possible and justifiable from a professional point of view.
p.(None):
p.(None): (2) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.
p.(None):
p.(None): Section 21
p.(None):
p.(None): (1) In order to get permission for a health research project that involves clinical trial of medicines covered by the medicines act or clinical
p.(None): trial of medical devices covered by the act on medical devices, it is a condition that
p.(None):
p.(None): 1) the Medicines Agency is involved in the approval of the project, cf. Section 13 (2), and
p.(None):
p.(None): 2) the investigator is qualified to take treatment decisions and has appropriate medical training as a doctor or, when this is relevant, a
p.(None): dentist, and has clinical experience.
p.(None):
p.(None): (2) Furthermore the competent committee must ensure the extent of and the detailed rules for the payment of any fee or any
p.(None): compensation to the investigator and the trial subjects as well as the content of the relevant provisions of any considered contract
p.(None): between the sponsor and the site of the trial.
p.(None):
p.(None): (3) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.
p.(None):
p.(None): Assistance by consultants
p.(None):
p.(None): Section 22
p.(None):
p.(None): (1) The competent committee must use assistance from consultants in cases when the committee itself does not have the professional
p.(None): expertise required to evaluate notified projects.
p.(None):
p.(None): (2) In connection with the processing of notified research projects that involve incapacitated adults, the trial protocol must be assessed by
p.(None): an expert who has knowledge of the group of individuals in question. In connection with the processing of notified research projects that
p.(None): involve minors, the trial protocol must be evaluated by an expert in paediatrics if the minor is involved an intervention trial.
p.(None):
p.(None): Time-limits for processing etc.
p.(None):
p.(None): Section 23
p.(None):
p.(None): (1) The committee must decide on approval of a project within 60 days of having received an appropriately presented notification, cf.
p.(None): Section 16, cf., however, (2) to (4) below.
p.(None):
p.(None): (2) The time-limit pursuant to (1) above is prolonged by 30 days if a notification concerns trials involving genetic therapy, somatic cell
p.(None): therapy or medicines that contain genetically modified organisms. The time-limit of 90 days is prolonged by another 90 days if public
p.(None): boards and committees are to be heard. If a notification concerns trial involving xenogeneic cell therapy, there is no time-limit for the
p.(None): processing of the notification.
p.(None):
p.(None): (3) Within the period during which the notification is being processed, the committee may on a single occasion request information in
p.(None): addition to what has already been provided by the applicant with the effect that the time-limit in (1) and (2) above is suspended until the
p.(None): supplementing information has been received.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down rules requiring the research ethics committees to decide on the approval of
p.(None): projects within shorter time-limits than laid down in (1) to (3) above against charging a special fee for speedy processing.
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): committee, the investigator and the sponsor may together put this decision before the national committee with a view to renewed
p.(None): processing and decision. Within a delay of 30 days after a decision any person who otherwise is party to the case, may put a decision taken
p.(None): by a regional committee before the national committee with a view to renewed processing and decision. The complaint must be submitted
p.(None): electronically with the use of digital signature.
p.(None): (2) Complaints concerning legal aspects of decisions on research projects that concern especially complex areas taken by the national
p.(None): committee, cf. Section 15, shall be put before the Ministry of the Interior and Health. The provisions of (1) above also apply to these
p.(None): complaints.
p.(None):
p.(None): Part 6
p.(None):
p.(None): The carrying out of health research projects, follow up, control and other tasks of the committee system
p.(None):
p.(None):
p.(None):
p.(None): Amendment of approved health research projects
p.(None):
p.(None): Section 27
p.(None):
p.(None): (1) Significant amendments of the trial protocol for an approved health research project may only be introduced following permission
p.(None): from the committee system. If a research project involves clinical trial of medicines or clinical trial of medical devices that must be
p.(None): approved by the Medicines Agency, the permission of the committee system to introduce amendments of the protocol presupposes the
p.(None): permission required according to the medicines act and the medical devices act respectively. The sponsor or the investigator must secure
p.(None): the required emergency procedures in order to protect the involved trial subjects.
p.(None):
p.(None): (2) Amendments covered by (1) above must be notified to the committee that has approved the research project in question. This
p.(None): notification must be submitted electronically using digital signature along with the amended protocol and other information required for
p.(None): the committee’s assessment of whether the amendment may be approved.
p.(None):
p.(None): (3) The competent committee shall decide according to Sections 17 to 25 whether the amendment under consideration can be approved.
p.(None): There is a time-limit for processing, however, of 35 days from the reception of an adequately presented notification.
p.(None):
p.(None): (4) Section 26 also applies to decisions regarding amendment of an approved health research project.
p.(None):
p.(None): (5) The Minister for the Interior and Health shall lay down further rules with regard to the format of amended protocols and with regard to
p.(None): what other information is required for the assessment by the committee system of whether an amendment is to be approved, cf.(2) 2nd
p.(None): sentence above.
p.(None):
p.(None): Supervision
p.(None):
p.(None): Section 28
p.(None):
p.(None): (1) The regional committee that has approved the carrying out of a research project shall supervise that an approved health research
p.(None): project which does not involve clinical trial of medicines, is carried out in accordance with this act. If the approval has been given by the
p.(None): national committee, supervision is taken care of by the regional committee in the area where the investigator is active unless because of
p.(None): the complexity of the project the regional committee in question requests the national committee to supervise a given project. Supervision
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None):
p.(None): (3) The chair and the deputy chair of the national research ethics committee and the 7 members appointed according to Section 38 (1)
p.(None): nos. 2 and 3 and any alternates are paid according to agreement with the Minister for the Interior and Health who shall also bear the cost.
p.(None):
p.(None): (4) Members of the national research ethics committee appointed according to Section 38 (1) no. 4 and any alternates shall be paid
p.(None): subsistence allowances, compensation for lost earnings and reimbursement of expenditure according to Section 16a in the act on
p.(None): municipal governance. The costs shall be borne by the regional council that has recommended the member in question as member of the
p.(None): committee.
p.(None):
p.(None): Part 9
p.(None):
p.(None): Penalties and compensation
p.(None):
p.(None): Section 41
p.(None):
p.(None): (1) Unless a more severe punishment is deserved according to other legislation, a fine or up to 4 months of imprisonment is incurred by
p.(None): anyone who
p.(None):
p.(None): 1) commences a project in contravention of Sections 13, 14 or 27 or commences a project in contravention of the conditions provided for
p.(None): in the permission given, cf. Section 17 (2),
p.(None):
p.(None): 2) fails to comply with the notification obligation according to Section 30,
p.(None):
p.(None): 3) fails to comply with an injunction or disclosure obligation provided for in Section 28 (3) or Section 29 (1),
p.(None):
p.(None): 4) acts in contravention of injunctions issued according to Section 28 (3), or
p.(None):
p.(None): 5) denies access of the supervisory authority according to Section 29 (2).
p.(None):
p.(None): (2) Rules laid down pursuant to this act may include provisions on punishment in the form of penalties for contravention of provisions
p.(None): contained in these rules.
p.(None):
p.(None): (3) Companies etc. (legal persons) may incur criminal liability according to Part 5 of the penal code.
p.(None):
p.(None): Section 42
p.(None):
p.(None): (1) The sponsor or, if the sponsor does not belong under Danish jurisdiction, the investigator, shall pay a compensation of DKK 1350 to
p.(None): persons who have participated in a project commenced in contravention of Sections 13, 14 or 27 or who have not given informed consent
p.(None): or when proxy consent has not been obtained, cf. Sections 3 to 5 and Section 12 unless the investigator or the sponsor are able to
p.(None): substantiate that this contravention is not caused by any error on the part of the investigator or the sponsor.
p.(None):
p.(None): (2) The amount of this compensation shall be regulated annually as of January 1 by 2 per cent to which shall be added the adjustment
p.(None): percentage for the fiscal year in question, cf. act on rate adjustment. The resulting amounts shall be rounded up to a figure divisible by an
p.(None): amount of DKK 50. Adjustment shall be undertaken on the basis of the amounts applicable at the time of adjustment prior to rounding up.
p.(None):
p.(None): (3) Compensation shall be fixed on the basis of the amounts applicable at the time when the trial subject took part in the project.
p.(None):
p.(None): (4) The provision of (1) above shall be without prejudice to an individual’s access to or the amount of any indemnity according to general
...
General/Other / participants in a control group
Searching for indicator control group:
(return to top)
p.(None): several trial medicines or to investigate absorption, distribution, metabolism or excretion of one or several trial medicines with a view to
p.(None): assessing their effect or safety.
p.(None):
p.(None): 3) Health research project that concerns clinical trial of medical devices: Any trial on humans with the aim of uncovering or verifying the
p.(None): safety or the performance of medical devices.
p.(None):
p.(None): 4) Multi-centre trial: A trial that is undertaken on the basis of a single trial protocol but in different sites with a coordinating investigator
p.(None): or with several investigators. Trial sites may all be located in Denmark or in Denmark and in other EU member states or third countries.
p.(None):
p.(None): 5) Sponsor: A natural or legal person who takes responsibility for the initiation, management or financing of a health research project.
p.(None): 6) Investigator: An individual who exercises a profession that is approved for the carrying out of research, e.g. though employment as a
p.(None): researcher or Ph.d. student or otherwise through involvement in concrete research, and who is responsible for the practical carrying out of
p.(None): the trial at a given site.
p.(None):
p.(None): 7) Trial protocol: A document that describes objectives, design, methodology, organisation, statistical considerations, research ethics
p.(None): considerations, financial aspects, publication issues as well as how participants in a health research project are to be informed.
p.(None):
p.(None): 8) Trial subject: An individual who takes part in a health research project regardless of whether this individual is given trial preparations
p.(None): etc. or is part of a control group.
p.(None):
p.(None): 9) Incapacitated adult: An individual who is covered by the definition in Section 5 of the Guardianship Act, including when guardianship
p.(None): has been established in a manner that includes powers to give informed consent for participation in health research projects.
p.(None):
p.(None): 10) Informed consent: A decision to participate in a health research project which has been communicated in writing duly dated and
p.(None): signed or has been communicated electronically with the use of digital signature, and which has been taken freely by an individual able to
p.(None): give consent who has received adequate information on the project’s nature, significance, implications and risks as well as adequate
p.(None): documentation.
p.(None):
p.(None): 11) Consent by proxy: A decision to participate in a health research project which has been obtained from the legal representative, the
p.(None): holder of custody or the trial guardian or from the nearest relative and the general practitioner or, if the general practitioner is not
p.(None): available, the National Board of Health, and which has been communicated in writing duly signed and dated or communicated
p.(None): electronically with the use of digital signature.
p.(None):
p.(None): 12) Trial guardian: A unit consisting of two doctors who in acute situations, cf. Section 12, may give proxy consent on behalf of the trial
p.(None): subject for participation in a health research project that concerns clinical trial of medicines. The trial guardian must safeguard the trial
...
Orphaned Trigger Words
p.(None): or with several investigators. Trial sites may all be located in Denmark or in Denmark and in other EU member states or third countries.
p.(None):
p.(None): 5) Sponsor: A natural or legal person who takes responsibility for the initiation, management or financing of a health research project.
p.(None): 6) Investigator: An individual who exercises a profession that is approved for the carrying out of research, e.g. though employment as a
p.(None): researcher or Ph.d. student or otherwise through involvement in concrete research, and who is responsible for the practical carrying out of
p.(None): the trial at a given site.
p.(None):
p.(None): 7) Trial protocol: A document that describes objectives, design, methodology, organisation, statistical considerations, research ethics
p.(None): considerations, financial aspects, publication issues as well as how participants in a health research project are to be informed.
p.(None):
p.(None): 8) Trial subject: An individual who takes part in a health research project regardless of whether this individual is given trial preparations
p.(None): etc. or is part of a controlXgroup.
p.(None):
p.(None): 9) Incapacitated adult: An individual who is covered by the definition in Section 5 of the Guardianship Act, including when guardianship
p.(None): has been established in a manner that includes powers to give informed consent for participation in health research projects.
p.(None):
p.(None): 10) Informed consent: A decision to participate in a health research project which has been communicated in writing duly dated and
p.(None): signed or has been communicated electronically with the use of digital signature, and which has been taken freely by an individual able to
p.(None): give consent who has received adequate information on the project’s nature, significance, implications and risks as well as adequate
p.(None): documentation.
p.(None):
p.(None): 11) Consent by proxy: A decision to participate in a health research project which has been obtained from the legal representative, the
p.(None): holder of custody or the trial guardian or from the nearest relative and the general practitioner or, if the general practitioner is not
p.(None): available, the National Board of Health, and which has been communicated in writing duly signed and dated or communicated
p.(None): electronically with the use of digital signature.
p.(None):
p.(None): 12) Trial guardian: A unit consisting of two doctors who in acute situations, cf. Section 12, may give proxy consent on behalf of the trial
p.(None): subject for participation in a health research project that concerns clinical trial of medicines. The trial guardian must safeguard the trial
p.(None): subject’s interests and be independent of the investigator’s interests and interests in the research project otherwise.
p.(None):
p.(None): 13) Research biobank: A structured collection of human biological material that is kept with a view to a concrete health research project,
p.(None): and which may be accessed according to defined criteria and where information bound in the biological material may be traced to
p.(None): individuals.
p.(None):
p.(None): 14) Adverse event: Any unwanted event in a trial subject who participates in a research project following activity as described in the trial
p.(None): protocol without necessarily a relationship between this activity and the adverse event.
p.(None):
p.(None): 15) Adverse reaction: Any harmful and unwanted reaction to an activity as a result of participation in the research project.
p.(None):
p.(None): 16) Unexpected adverse reaction: An adverse reaction whose character or severity does not match the risk incurred by the activity in
p.(None): question as described in the trial protocol.
p.(None):
p.(None): 17) Serious adverse event or serious adverse reaction: An adverse event or an adverse reaction which regardless of e.g. dose is fatal, is
p.(None): life-threatening, leads to hospital admission or prolongation of ongoing hospital stay, results in lasting or considerable disablement or
p.(None): incapacity for work or leads to congenital anomaly or malformation.
p.(None):
p.(None): Part 3
p.(None):
p.(None): Informed consent for participation in health research projects
p.(None):
p.(None): Section 3
p.(None):
p.(None): (1) Health research projects that must be notified to the committee system according to Section 14, may include trials on humans if the
p.(None): trial subject has given informed consent for participation prior to the trial, cf., however, (2) below.
p.(None):
p.(None): (2) Consent must be given as proxy consent according to Section 4 if the trial subject
p.(None):
p.(None): 1) is a minor,
p.(None):
p.(None): 2) is under guardianship that includes powers to give informed consent for participation in health research projects, cf. the Guardianship
p.(None): Act Section 5 (1), or
p.(None):
p.(None): 3) otherwise is an incapacitated adult.
p.(None):
p.(None): (3) Consent includes access to the communication and processing of required information on the trial subject’s health, other wholly
p.(None): personal matters and other confidential information as part of own control of the research project including quality control and
p.(None): monitoring which a sponsor or a possible monitor is under obligation to undertake.
p.(None):
p.(None): (4) Consent may be withdrawn at any time without this being detrimental to the trial subject.
p.(None):
p.(None): (5) In connection with research ethics evaluation of concrete health research projects the committee may deviate from (1) and (2) above
p.(None): according to the criteria laid down in Sections 8 to 12.
p.(None):
p.(None): Section 4
p.(None): (1) Proxy consent on behalf of trial subjects that are minors, must be given by the holder of custody.
p.(None):
p.(None): (2) Proxy consent on behalf of trial subjects under guardianship that includes powers to give informed consent for participation in health
p.(None): research projects, cf. the Guardianship Act Section 5 (1), must be given by the guardian.
p.(None):
p.(None): (3) Proxy consent on behalf of other incapacitated adult trial subjects must be given by their nearest relative and their general practitioner
p.(None): or, if the general practitioner is not available, the National Board of Health.
p.(None):
p.(None): (4) Proxy consent must express the trial subject’s interests. The trial subject’s declarations should be taken into consideration to the extent
p.(None): that these declarations are topical and relevant.
p.(None):
p.(None): (5) Complaint against a general practitioner’s proxy consent cannot be put to the National Agency for Patients' Rights and Complaints or to
p.(None): the health care disciplinary board under the act on complaints and compensation in the healthcare sector.
p.(None):
p.(None): Section 5
p.(None):
p.(None): (1) Consent according to Sections 3 and 4 must be given against the background of written and oral information on the content of as well
p.(None): as foreseeable risks and benefits of the research project. It must be clear from the information that consent may be withdrawn at any time.
p.(None):
p.(None): (2) If the trial subject is a minor, under personal guardianship or otherwise is an incapacitated adult, the information must be adapted to
p.(None): the trial subject's capacity for understanding. Information for minors must be provided by a person with knowledge of the field that the
p.(None): project concerns, and who has the pedagogical competences required for communication of such information to the age group covered
p.(None): by the research project.
p.(None):
p.(None): (3) The information mentioned in (1) above must also be communicated to persons who are entitled to give proxy consent on behalf of a
p.(None): trial subject.
p.(None):
p.(None): Section 6
p.(None):
p.(None): The consent requirements laid down in Sections 3 to 5 also apply to the removal of tissue and other biological material in connection with
p.(None): concrete research projects with a view to storage in a research biobank.
p.(None):
p.(None): Section 7
p.(None):
p.(None): The Minister for the Interior and Health may lay down further rules on consent and information according to Sections 3 to 5. Unless
p.(None): consent requirements follow from other legislation, the Minister for the Interior and Health may lay down further rules for the obtaining of
p.(None): informed consent or proxy consent for use in connection with notifiable health research projects that do not involve trial subjects.
p.(None):
p.(None): Health research projects that involve deceased persons
p.(None):
p.(None): Section 8
p.(None):
p.(None): (1) Health research projects may involve the use of tissue or other biological material from deceased persons that is removed in
p.(None): connection with autopsy according to Part 56 of the Health Care Act, if consent for use of the material for research purposes has been
p.(None): obtained either from the deceased person or from the nearest relative according to Section 187 of the Health Care Act on consent for
p.(None): autopsy for health research purposes. Tissue and other biological material removed in connection with forensic autopsies prior to the
p.(None): coming into force of this act may be used for health research without consent being obtained according to sentence 1 above.
p.(None):
p.(None): (2) Health research projects may involve the use of tissue and other biological material from deceased persons without the removal being
p.(None): covered by Part 56 of the Health Care Act on autopsy, if the nearest relative has given consent for use of the material for research
p.(None): purposes. Consent by the nearest relative must be given against the background of written and oral information on the content of the
p.(None): research project.
p.(None):
p.(None): Exemption from the consent requirement for 15 to 17-year-olds
p.(None):
p.(None): Section 9
p.(None):
p.(None): (1) The committee may grant exemption from the requirement of proxy consent from the holder of custody, cf. Section 3 (2) no. 1, and
p.(None): Section 4 (1) in the case of a trial subject that has turned fifteen years of age but has not yet come of age if the minor in question gives
p.(None): informed consent. A decision to grant exemption must be taken with consideration for the nature as well as the risk and the strain of the
p.(None): research project.
p.(None):
p.(None): (2) When the minor's own informed consent is deemed sufficient, cf. (1) above, the holder of custody must be given the same information
...
p.(None): required permission, need only be notified if the trial concerns the use of fertilised eggs, stemXcells and stem cell lines from these, cf.
p.(None): Sections 25 and 27 (2) of the act on artificial insemination in connection with medical treatment, diagnostics and research etc.
p.(None):
p.(None): (5) The Minister for the Interior and Health may lay down further rules on exemption from the notification obligation pursuant to (4) above.
p.(None): Following recommendation from the national committee the Minister for the Interior and Health may, furthermore, lay down rules on
p.(None): notification obligations for further defined new fields of research which would otherwise be exempt from the obligation pursuant to (4)
p.(None): above.
p.(None):
p.(None): Competence
p.(None):
p.(None): Section 15
p.(None): (1) Notification of health research projects must be addressed to the regional committee for the area in which the investigator is active.
p.(None): Health research projects that concern especially complex areas must, however, be notified to the national committee. The notification
p.(None): obligation rests with the investigator as well as with the sponsor, and both must sign the notification.
p.(None):
p.(None): (2) Cross border multi-centre trials must always be notified in this country. If there are several investigators in Denmark and if the research
p.(None): project is not covered by (1) 2nd sentence above, the multi-centre project must be notified to the regional committee where the
p.(None): coordinating investigator is active.
p.(None):
p.(None): (3) On the basis of recommendation from the national committee the Minister for the Interior and Health shall lay down further rules
p.(None): concerning what health research projects must be notified to the national committee pursuant to (1) 2nd sentence above.
p.(None):
p.(None): Notification format
p.(None):
p.(None): Section 16
p.(None):
p.(None): (1) Notification must be submitted electronically using a digital signature to the competent research ethics committee along with the trial
p.(None): protocol and other information required for the committee’s assessment of whether the research project may be permitted, cf. Section 17
p.(None): (1) and Sections 18 to 21, including documentation regarding the identities of the sponsor and the notifying investigator as well as the
p.(None): investigator’s education and training.
p.(None):
p.(None): (2) The Minister for the Interior and Health shall lay down further rules with regard to the format of trial protocols and on what other
p.(None): information is required for assessment by the committee system, cf. (1) above, and the Minister may lay down further rules on notification
p.(None): procedures.
p.(None):
p.(None): Part 5
p.(None):
p.(None): Research ethics evaluation and administrative procedures of the committees
p.(None):
p.(None): Research ethics evaluation
p.(None):
p.(None): Section 17
p.(None):
p.(None): (1) The committees undertake a research ethics evaluation of notifiable health research projects on the basis of criteria laid down in this
p.(None): act, including Sections 18 to 22, as well as an evaluation of whether the research project is designed in such a way that the required
p.(None): consent for the participation of trial subjects in the project will be sought and given, cf. Part 3. On the basis of the evaluation the
p.(None): competent committee decides whether a given project shall be permitted.
p.(None):
p.(None): (2) The competent committee may attach conditions to its permission.
p.(None):
p.(None): (3) In connection with a decision on permission the competent committee decides how the carrying out of a trial shall be monitored, cf.
p.(None): Section 28.
p.(None):
p.(None): Section 18
p.(None):
p.(None): (1) It is a condition for the granting of permission that
p.(None):
p.(None): 1) the extent of the risks that the trial may involve is not unjustifiable, neither as such nor in relation to the foreseeable benefits of the
p.(None): trial,
p.(None):
p.(None): 2) the expected benefits from a therapeutical perspective as well as from a public health perspective may justify the project,
p.(None):
p.(None): 3) the project’s scientific standard meets the requirement that the project should lead to new knowledge or investigate existing
p.(None): knowledge, which justifies the implementation of the research project, cf. Section 1 (1) 2nd sentence, and
p.(None):
p.(None): 4) there is sufficient reason to undertake the project and expectations as to the project’s conclusions are justified.
p.(None):
p.(None): (2) The competent committee must balance the foreseeable risks and drawbacks in relation to the benefit for the individual trial subject
p.(None): and for other present and future patients, including whether pain, discomfort, fear and other foreseeable risks are minimised in relation to
p.(None): the trial subject’s disease and stage of development, cf. Section 1 (1) 2nd sentence. This balancing must take into account whether the trial
p.(None): subject is able to give informed consent or whether informed consent must be obtained in the form of proxy consent.
p.(None):
p.(None): (3) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) and (2) above.
p.(None):
p.(None): Section 19
p.(None):
p.(None): (1) In order for permission to be given to health research projects which include trial subjects that are unable to give informed consent, it
p.(None): is a condition furthermore that
p.(None):
p.(None): 1) the project is decisive in order to verify data obtained from trials involving persons who are able to give informed consent or through
p.(None): other trial methods,
p.(None):
p.(None): 2) the project is directly linked to the intended trial subject’s clinical condition, and
p.(None): 3) the project may be expected to benefit the patient group.
p.(None):
p.(None): (2) If the conditions in (1) above are not met, and if the notified health research project does not involve clinical trial of medicines, it is,
p.(None): however, a condition, cf. (3) below, that
p.(None):
p.(None): 1) the project cannot be carried out with similar benefits using trial subjects who are able to give informed consent, and
p.(None):
p.(None): 2) the project is likely to benefit the trial subject directly.
p.(None):
p.(None): (3) If neither the conditions in (1) or (2) above are met, and if the notified health research project does not involve clinical trial of
p.(None): medicines, it is a condition that
p.(None):
p.(None): 1) the project can only be implemented by involving persons of a given age group or persons who have a given disease or condition,
p.(None):
p.(None): 2) the project is likely to directly lead to great benefits for the patient group that falls within the same age group or who suffer from the
p.(None): same disease or condition as the trial subject, and
p.(None):
p.(None): 3) the project involves minimal risks and discomfort for the trial subject.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) to (3) above.
p.(None):
p.(None): Section 20
p.(None):
p.(None): (1) In order for permission to be given for health research projects, it is furthermore a condition that
p.(None):
p.(None): 1) the investigator is qualified to take treatment decisions and has proper training and clinical experience,
p.(None):
p.(None): 2) it is clear from written or electronic information what financial support the investigator receives from private companies, foundations
p.(None): etc. for the undertaking of the research project in question and whether the investigator otherwise has any financial affiliation to private
p.(None): companies, foundations etc. who have an interest in the research project under consideration.
p.(None):
p.(None): 3) any payment or other compensation for trial subjects in return for participation in a health research project is not such as to affect the
p.(None): giving of consent,
p.(None):
p.(None): 4) the trial subject’s right to physical and mental integrity and the right to privacy are respected and information concerning the trial
p.(None): subject is protected according to the act on data protection,
p.(None):
p.(None): 5) the principal investigator has secured that the trial subject has access to further information on the project,
p.(None):
p.(None): 6) projects that involve export of biological material and information to third countries must be undertaken in accordance with the rules
p.(None): laid down in the act on the processing of personal data,
p.(None):
p.(None): 7) there is a compensation or indemnification arrangement if the trial subject suffers any harm or dies as a consequence of the project,
p.(None): and an insurance has been taken out or other compensation arrangement is in place to cover the liability of the investigator and the
p.(None): sponsor vis-à-vis the participating trial subjects, and
p.(None):
p.(None): 8) publication is undertaken in accordance with the act on the processing of personal data both with regard to negative, inconclusive
p.(None): and positive trial results as soon as this is possible and justifiable from a professional point of view.
p.(None):
p.(None): (2) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.
p.(None):
p.(None): Section 21
p.(None):
p.(None): (1) In order to get permission for a health research project that involves clinical trial of medicines covered by the medicines act or clinical
p.(None): trial of medical devices covered by the act on medical devices, it is a condition that
p.(None):
p.(None): 1) the Medicines Agency is involved in the approval of the project, cf. Section 13 (2), and
p.(None):
p.(None): 2) the investigator is qualified to take treatment decisions and has appropriate medical training as a doctor or, when this is relevant, a
p.(None): dentist, and has clinical experience.
p.(None):
p.(None): (2) Furthermore the competent committee must ensure the extent of and the detailed rules for the payment of any fee or any
p.(None): compensation to the investigator and the trial subjects as well as the content of the relevant provisions of any considered contract
p.(None): between the sponsor and the site of the trial.
p.(None):
p.(None): (3) The Minister for the Interior and Health may lay down further rules on the issues mentioned in (1) above.
p.(None):
p.(None): Assistance by consultants
p.(None):
p.(None): Section 22
p.(None):
p.(None): (1) The competent committee must use assistance from consultants in cases when the committee itself does not have the professional
p.(None): expertise required to evaluate notified projects.
p.(None):
p.(None): (2) In connection with the processing of notified research projects that involve incapacitated adults, the trial protocol must be assessed by
p.(None): an expert who has knowledge of the group of individuals in question. In connection with the processing of notified research projects that
p.(None): involve minors, the trial protocol must be evaluated by an expert in paediatrics if the minor is involved an intervention trial.
p.(None):
p.(None): Time-limits for processing etc.
p.(None):
p.(None): Section 23
p.(None):
p.(None): (1) The committee must decide on approval of a project within 60 days of having received an appropriately presented notification, cf.
p.(None): Section 16, cf., however, (2) to (4) below.
p.(None):
p.(None): (2) The time-limit pursuant to (1) above is prolonged by 30 days if a notification concerns trials involving genetic therapy, somatic cell
p.(None): therapy or medicines that contain genetically modified organisms. The time-limit of 90 days is prolonged by another 90 days if public
p.(None): boards and committees are to be heard. If a notification concerns trial involving xenogeneic cell therapy, there is no time-limit for the
p.(None): processing of the notification.
p.(None):
p.(None): (3) Within the period during which the notification is being processed, the committee may on a single occasion request information in
p.(None): addition to what has already been provided by the applicant with the effect that the time-limit in (1) and (2) above is suspended until the
p.(None): supplementing information has been received.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down rules requiring the research ethics committees to decide on the approval of
p.(None): projects within shorter time-limits than laid down in (1) to (3) above against charging a special fee for speedy processing.
p.(None):
p.(None): (5) Following recommendation from the national committee the Minister for the Interior and Health may in special cases lay down rules to
p.(None): the effect that research projects within further defined new fields of research that do not involve clinical trial of medicines in special cases
p.(None): may be suspended for a determined period until general ethical or scientific clarification has been obtained.
p.(None):
p.(None): Decision procedures
p.(None):
p.(None): Section 24
p.(None):
p.(None): (1) If in the competent committee it is not possible to reach agreement on the evaluation of a health research project, the committee shall
p.(None): take a vote to decide whether the project is to be approved and its implementation should be permitted, cf., however, (3) and (4) below.
p.(None): The project is approved if a qualified majority, cf. (2) below, of the members of the competent committee based on a research ethics
p.(None): evaluation according to Section 17 find that the research project may be approved, possibly on certain conditions. In the case of parity the
p.(None): vote of the committee’s chair shall be decisive, and if the chair is unavailable, the vote of the deputy chair shall be decisive.
p.(None):
p.(None): (2) The chair or if the chair is not available the deputy chair, must be part of the majority. In a regional committee there must, furthermore,
p.(None): be a majority for the decision both among lay members and among medical members.
p.(None):
p.(None): (3) If in connection with a regional committee’s processing of a notified project both lay members and medically appointed members and
p.(None): altogether at least one third of the members of the committee express a wish to this effect, the research project shall be put before the
p.(None): national committee which will take a final decision.
p.(None):
p.(None): (4) The chair of a regional committee may decide on behalf of the committee in cases that are deemed not to provide any reason for
p.(None): doubt.
p.(None):
p.(None): Communication of permission and orientation
p.(None):
p.(None): Section 25
p.(None):
p.(None): (1) The competent committee shall communicate its decision whether a health research project may be permitted, or its decision
p.(None): according to Section 24 (3), to the investigator and the sponsor.
p.(None):
p.(None): (2) If a decision has been taken by the chair, the remaining members of the committee must be informed of this decision at a time
p.(None): reasonably ahead of the time when the decision is communicated to the investigator and the sponsor.
p.(None):
p.(None): (3) The competent committee shall inform the Medicines Agency about decisions that concern clinical trial of medicines or clinical trial of
p.(None): medical devices.
p.(None):
p.(None): (4) The competent committee shall inform other affected regional committees and the national committee about decisions on multi-
p.(None): centre trials.
p.(None):
p.(None): Complaints procedures
p.(None):
p.(None): Section 26
p.(None):
p.(None): (1) Within a time period of 30 days after having been informed of a decision on approval of a notified research project by a regional
p.(None): committee, the investigator and the sponsor may together put this decision before the national committee with a view to renewed
p.(None): processing and decision. Within a delay of 30 days after a decision any person who otherwise is party to the case, may put a decision taken
p.(None): by a regional committee before the national committee with a view to renewed processing and decision. The complaint must be submitted
p.(None): electronically with the use of digital signature.
p.(None): (2) Complaints concerning legal aspects of decisions on research projects that concern especially complex areas taken by the national
p.(None): committee, cf. Section 15, shall be put before the Ministry of the Interior and Health. The provisions of (1) above also apply to these
p.(None): complaints.
p.(None):
p.(None): Part 6
p.(None):
p.(None): The carrying out of health research projects, follow up, control and other tasks of the committee system
p.(None):
p.(None):
p.(None):
p.(None): Amendment of approved health research projects
p.(None):
p.(None): Section 27
p.(None):
p.(None): (1) Significant amendments of the trial protocol for an approved health research project may only be introduced following permission
p.(None): from the committee system. If a research project involves clinical trial of medicines or clinical trial of medical devices that must be
p.(None): approved by the Medicines Agency, the permission of the committee system to introduce amendments of the protocol presupposes the
p.(None): permission required according to the medicines act and the medical devices act respectively. The sponsor or the investigator must secure
p.(None): the required emergency procedures in order to protect the involved trial subjects.
p.(None):
p.(None): (2) Amendments covered by (1) above must be notified to the committee that has approved the research project in question. This
p.(None): notification must be submitted electronically using digital signature along with the amended protocol and other information required for
p.(None): the committee’s assessment of whether the amendment may be approved.
p.(None):
p.(None): (3) The competent committee shall decide according to Sections 17 to 25 whether the amendment under consideration can be approved.
p.(None): There is a time-limit for processing, however, of 35 days from the reception of an adequately presented notification.
p.(None):
p.(None): (4) Section 26 also applies to decisions regarding amendment of an approved health research project.
p.(None):
p.(None): (5) The Minister for the Interior and Health shall lay down further rules with regard to the format of amended protocols and with regard to
p.(None): what other information is required for the assessment by the committee system of whether an amendment is to be approved, cf.(2) 2nd
p.(None): sentence above.
p.(None):
p.(None): Supervision
p.(None):
p.(None): Section 28
p.(None):
p.(None): (1) The regional committee that has approved the carrying out of a research project shall supervise that an approved health research
p.(None): project which does not involve clinical trial of medicines, is carried out in accordance with this act. If the approval has been given by the
p.(None): national committee, supervision is taken care of by the regional committee in the area where the investigator is active unless because of
p.(None): the complexity of the project the regional committee in question requests the national committee to supervise a given project. Supervision
p.(None): of approved health research projects that involve clinical trial of medicines is taken care of by the Medicines Agency according the
p.(None): medicines act.
p.(None):
p.(None): (2) The supervising committee may follow the course of a research project and demand that the final research report or publication is sent
p.(None): to the committee.
p.(None):
p.(None): (3) As part of its supervision of a project that does not involve clinical trial of medicines covered by the medicines act, the supervising
p.(None): committee may require that the project is amended or is temporarily suspended, and in special cases the committee may prohibit a
p.(None): project. These powers also cover notifiable research projects that have been commenced without due permission.
p.(None):
p.(None): (4) The Minister for the Interior and Health may lay down further rules on the supervision by and the powers of the committees according
p.(None): to (1) to (3) above.
p.(None):
p.(None): AccessXtoXinformation etc. in connection with supervision
p.(None):
p.(None): Section 29
p.(None):
p.(None): (1) The supervising committee or a representative of this committee may require surrender of all information on the research project that
p.(None): is required for the purposes of supervision. Communication of and processing of required information on the health condition of trial
p.(None): subjects, other purely private matters and confidential information otherwise may take place as part of supervisory activity without the
p.(None): consent of the trial subject.
p.(None):
p.(None): (2) Against proof of identity and without any court order the supervising committee or a representative of this committee shall have access
p.(None): to companies, hospitals, medical practices and other sites that are affected by the implementation of the research project in order to
p.(None): gather information that is required for the carrying out of the committee’s supervision.
p.(None):
p.(None): (3) Buildings or parts of buildings that are used solely for private residence are not covered by (2) above.
p.(None):
p.(None): Obligation to notify adverse reactions and adverse events
p.(None): Section 30
p.(None):
p.(None): (1) The sponsor or the investigator shall immediately inform the supervising committee if during the implementation of a health research
p.(None): project there is any assumption of serious unexpected adverse reactions as a consequence of the project. Unless the research project
p.(None): concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the medicines act, the notification
p.(None): obligation furthermore covers serious adverse events. When serious adverse events are reported, the supervising committee may require
p.(None): any information from the investigator that the committee finds is relevant for its supervision.
p.(None):
p.(None): (2) Once a year throughout the trial period the sponsor or the investigator shall send to the supervising committee a list of all presumed
p.(None): serious unexpected adverse reactions that have occurred during the trial period and provide information on the safety of the trial subjects.
p.(None): Unless the research project concerns clinical trial of medicines covered by the supervision of the Medicines Agency according to the
p.(None): Medicines Act, the notification obligation furthermore covers serious adverse events.
p.(None):
p.(None):
p.(None):
p.(None): Notification on the termination of health research projects
p.(None):
p.(None): Section 31
p.(None):
p.(None): (1) No later than 90 days after the termination of a notifiable health research project the investigator and the sponsor shall jointly inform
p.(None): the supervising committee that the project has been terminated.
p.(None):
p.(None): (2) If a research project is discontinued before its planned termination, the investigator and the sponsor shall jointly inform the
p.(None): supervising committee about the project’s discontinuation no later than 15 days following the decision to discontinue the project. The
p.(None): reasons for discontinuation of the project must be stated. If necessary the supervising committee may require that the investigator and
p.(None): the sponsor submit an explanatory report.
p.(None):
p.(None): Other tasks
p.(None):
p.(None): Section 32
p.(None):
p.(None): (1) The national committee shall coordinate activity in the regional committees, shall lay down recommended guidelines and shall express
p.(None): its opinion on fundamental issues that are not related to the approval of any concrete research project.
p.(None):
p.(None): (2) The national committee may suggest to the Minister for the Interior and Health that further rules are laid down as provided for in the
p.(None): present act.
p.(None):
p.(None): Section 33
p.(None):
p.(None): (1) The committees shall follow development within health care research and try to promote understanding of the ethical issues that this
p.(None): development may lead to in relation to the health care services and health research environments.
p.(None):
p.(None): (2) The committee system shall actively cooperate with and coordinate tasks with relevant national and international authorities and
p.(None): organisations etc.
p.(None):
p.(None): (3) The committee system shall secure quality development, quality assurance and learning processes within the committee system. The
p.(None): Minister for the Interior and Health may lay down further rules in this regard.
p.(None):
p.(None): Section 34
p.(None):
p.(None): (1) The regional committees and the national committee shall submit a joint annual report with details on the activity and practice of the
p.(None): committees during the previous year.
p.(None):
p.(None): (2) The annual report, which is to be published, shall include a list of all notified projects and shall describe
p.(None):
p.(None): 1) general tendencies in the development of the activity of the committee system including cooperation according to Section 33 (2) and
p.(None): activity according to Section 33 (3) in relation to quality development, quality assurance and learning processes within the committee
p.(None): system,
p.(None):
p.(None): 2) general development trends within health research,
p.(None):
p.(None): 3) significant issues of research ethics discussed in the committees, and
p.(None):
p.(None): 4) the reasoning underlying decisions in significant cases.
p.(None):
p.(None): Part 7
p.(None):
p.(None): Establishing of research ethics committees
p.(None):
p.(None): The regional research ethics committees
p.(None):
p.(None): Section 35
p.(None):
p.(None): (1) The regional councils shall set up regional research ethics committees. A regional council may set up one or several committees within
p.(None): its geographical area. A committee may also be set up by several regional councils.
p.(None):
p.(None): (2) The regional councils may agree on a division of received notifications among themselves.
p.(None):
p.(None): Section 36
p.(None):
p.(None): (1) A regional committee shall consist of at least 7 members of which 3 are active within health research. If the regional council finds that
p.(None): considerations for the activity of a regional committee, the number of projects or other reasons indicate this, a committee may consist of 9
p.(None): or 11 members. If there are 9 or 11 members, 4 or 5 members respectively must be active within health research.
p.(None):
p.(None): (2) Members of the regional committees must be affiliated to the region or regions that the committee in question covers. The members
p.(None): active within research shall be appointed following recommendation from relevant research fora, cf (7) below. Recommendations shall, if
p.(None): possible, include an equal number of women and men. On appointment it shall be secured to the extent possible that in the committee
p.(None): one gender outnumbers the other by only one member.
p.(None):
p.(None): (3) The regional committee shall select its chair among the appointed members active within research and a deputy chair among the
p.(None): appointed lay members.
p.(None):
p.(None): (4) The regional committee shall propose rules of procedure that must be approved by the national research ethics committee.
p.(None):
p.(None): (5) Committee members are appointed for 4 years corresponding to the electoral period of the regional councils. Members may be
p.(None): reappointed twice. Alternates may be appointed.
p.(None):
p.(None): (6) The previous committee shall continue its activity until new members have been appointed and the new committee has elected its
p.(None): officers.
p.(None):
p.(None): (7) The Minister for the Interior and Health may lay down further rules on what fora are considered relevant research fora, cf. (2) above.
p.(None):
p.(None): The national research ethics committee
p.(None):
p.(None): Section 37
p.(None):
p.(None): The Minister for the Interior and Health shall set up the national research ethics committee.
p.(None):
p.(None): Section 38
p.(None):
p.(None): (1) The national research ethics committee consists of 13 members to be appointed as follows:
p.(None):
p.(None): 1) The Minister for the Interior and Health shall appoint the chair of the national research ethics committee.
p.(None):
p.(None): 2) 2 members shall be appointed by the Minister for the Interior and Health following joint recommendation from governing boards of
p.(None): the Danish Council for Strategic Research and the Danish Council for Independent Research.
p.(None):
p.(None): 3) 5 members shall be appointed by the Minister for the Interior and Health in consultation with the minister for science, technology and
p.(None): development following open advertisement.
p.(None):
p.(None): 4) 5 members shall be appointed by the Minister for the Interior and Health on the basis of recommendations from the individual
p.(None): regions.
p.(None):
p.(None): (2) To the extent possible an equal number of men and women shall be recommended pursuant to (1) no. 2 above, respectively (1) no. 4
p.(None): above. Recommendations pursuant to (1) no. 4 shall include as many lay persons as persons who are active within health research.
p.(None):
p.(None): (3) In connection with appointment it shall be secured that the committee is constituted such as to cover a broad range of members who
p.(None): are active within health research and lay members. On appointment it shall be secured to the extent possible that in the committee one
p.(None): gender outnumbers the other by only one member.
p.(None):
p.(None): (4) The chair shall represent state research interests as well as interests pertaining to general education, research ethics, general culture or
p.(None): social considerations that are significant to the activity of the national committee.
p.(None):
p.(None): (5) Members appointed according to (1) nos. 2 and 3 above shall represent research interests as well as interests pertaining to general
p.(None): education, research ethics, general culture or social considerations that are significant to the activity of the national committee.
p.(None):
p.(None): (6) The chair and the members appointed according to (1) nos. 2 and 3 above may not be members of the Folketing or of regional or
p.(None): municipal councils.
p.(None):
p.(None): (7) The committee selects its deputy chair among the members appointed.
p.(None):
p.(None): (8) The committee shall draw up a proposal for rules of procedure to be approved by the Minister for the Interior and Health.
p.(None):
p.(None): (9) Committee members are appointed for 4 years corresponding to the electoral period of the regional councils. Members may be
p.(None): reappointed twice. Alternates may be appointed.
p.(None):
p.(None): (10) The previous committee shall continue its activity until new members have been appointed and the new committee has elected its
p.(None): officers.
p.(None): Part 8
p.(None):
p.(None): Financing
p.(None):
p.(None): Section 39
p.(None):
p.(None): (1)The costs of the regional committees shall be borne by the relevant regional council.
p.(None):
p.(None): (2) Research institutions etc. and private companies and hospitals shall pay a fee per project or amendment of a project that is notified to
p.(None): the region in question in order to cover part of the cost. The Minister for the Interior and Health shall lay down rules on the amount of such
p.(None): fees and their collection.
p.(None):
p.(None): (3) Members of the regional committees and any alternates shall receive reimbursement of expenditure according to the provision of
p.(None): Section 11 of the act on the regions.
p.(None):
p.(None): (4) The Minister for the Interior and Health shall lay down further rules on access for the regions to provide supplementing reimbursement
p.(None): for members of the regional committees and any alternates.
p.(None):
p.(None): Section 40
p.(None):
p.(None): (1) The costs of the national research ethics committee shall be borne by the Ministry for the Interior and Health. The Minister for the
p.(None): Interior and Health provides the required administrative assistance for the national committee.
p.(None):
p.(None): (2) In order to partially cover the cost of processing notifications concerning especially complex areas, cf. Section 15 (1), research
p.(None): institutions etc. and private companies and hospitals shall pay a fee per project or amendment that is notified to the national research
p.(None): ethics committee. The Minister for the Interior and Health shall lay down rules on the amount of such fees and their collection.
p.(None):
p.(None): (3) The chair and the deputy chair of the national research ethics committee and the 7 members appointed according to Section 38 (1)
p.(None): nos. 2 and 3 and any alternates are paid according to agreement with the Minister for the Interior and Health who shall also bear the cost.
p.(None):
p.(None): (4) Members of the national research ethics committee appointed according to Section 38 (1) no. 4 and any alternates shall be paid
p.(None): subsistence allowances, compensation for lost earnings and reimbursement of expenditure according to Section 16a in the act on
p.(None): municipal governance. The costs shall be borne by the regional council that has recommended the member in question as member of the
p.(None): committee.
p.(None):
p.(None): Part 9
p.(None):
p.(None): Penalties and compensation
p.(None):
p.(None): Section 41
p.(None):
p.(None): (1) Unless a more severe punishment is deserved according to other legislation, a fine or up to 4 months of imprisonment is incurred by
p.(None): anyone who
p.(None):
p.(None): 1) commences a project in contravention of Sections 13, 14 or 27 or commences a project in contravention of the conditions provided for
p.(None): in the permission given, cf. Section 17 (2),
p.(None):
p.(None): 2) fails to comply with the notification obligation according to Section 30,
p.(None):
p.(None): 3) fails to comply with an injunction or disclosure obligation provided for in Section 28 (3) or Section 29 (1),
p.(None):
p.(None): 4) acts in contravention of injunctions issued according to Section 28 (3), or
p.(None):
p.(None): 5) denies access of the supervisory authority according to Section 29 (2).
p.(None):
p.(None): (2) Rules laid down pursuant to this act may include provisions on punishment in the form of penalties for contravention of provisions
p.(None): contained in these rules.
p.(None):
p.(None): (3) Companies etc. (legal persons) may incur criminal liability according to Part 5 of the penal code.
p.(None):
p.(None): Section 42
p.(None):
p.(None): (1) The sponsor or, if the sponsor does not belong under Danish jurisdiction, the investigator, shall pay a compensation of DKK 1350 to
p.(None): persons who have participated in a project commenced in contravention of Sections 13, 14 or 27 or who have not given informed consent
p.(None): or when proxy consent has not been obtained, cf. Sections 3 to 5 and Section 12 unless the investigator or the sponsor are able to
p.(None): substantiate that this contravention is not caused by any error on the part of the investigator or the sponsor.
p.(None):
p.(None): (2) The amount of this compensation shall be regulated annually as of January 1 by 2 per cent to which shall be added the adjustment
p.(None): percentage for the fiscal year in question, cf. act on rate adjustment. The resulting amounts shall be rounded up to a figure divisible by an
p.(None): amount of DKK 50. Adjustment shall be undertaken on the basis of the amounts applicable at the time of adjustment prior to rounding up.
p.(None):
p.(None): (3) Compensation shall be fixed on the basis of the amounts applicable at the time when the trial subject took part in the project.
p.(None):
p.(None): (4) The provision of (1) above shall be without prejudice to an individual’s access to or the amount of any indemnity according to general
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| accessXtoXinformation | Access to information |
| age | Age |
| authority | Relationship to Authority |
| control group | participants in a control group |
| criminal | criminal |
| education | education |
| emergency | Public Emergency |
| gender | gender |
| incapacitated | Incapacitated |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| single | Marital Status |
| stem cells | stem cells |
| student | Student |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
capacity
consent
ethics
harm
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input