79C3C34C52B45572883A05D425EB0F82
Act on Scientific Research in the Health Sector No. 44/2014
https://leaux.net/URLS/General/Iceland-_Act_on_Scientific_Research_in_the_Health_Sector_No._442014.pdf
http://leaux.net/URLS/ConvertAPI Text Files/32017DA7F5C2F4373608DDAF0D4D8079.en.txt
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This file was generated: 2020-12-01 05:55:58
| 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 / vulnerable
Searching for indicator vulnerable:
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p.000004:
p.000004: Article 14
p.000004: Procedure and appeal.
p.000004: The procedure of the National Bioethics Committee and institutional review boards is subject to the
p.000004: provisions of the Administrative Procedures Act.
p.000004: Decisions of review boards appointed under Article 11 may be appealed to the National Bioethics Committee.
p.000004: Decisions of the National Bioethics Committee may be appealed to the Minister. A judgement by the National
p.000004: Bioethics Committee under sentence 2 of paragraph 1 of Article 12 is not liable to review by the Minister.
p.000004:
p.000004: SECTION IV
p.000004: General provisions on scientific research on human subjects.
p.000004: Article 15
p.000004: Scientific research on human subjects.
p.000004: Scientific studies which entail intervention may not be carried out on human subjects if it is deemed likely that
p.000004: the same or a comparable objective can be attained without human participation.
p.000004: Before a scientific study on human subjects is approved, the National Bioethics Committee or an institutional review
p.000004: board shall evaluate potential risk and burden on the one hand, and benefits for the participants or others on the
p.000004: other hand. In research on the effectiveness of a new treatment, with or without placebo, it shall be ensured
p.000004: that patients receive approved treatment. Should it transpire that the risk outweighs the potential
p.000004: benefit, the National Bioethics Committee or an institutional review board will halt the study.
p.000004: Special care shall be taken when recruiting individuals from vulnerable social groups, i.e. individuals who for some
p.000004: reason are not in a position to make an informed or free decision.
p.000004:
p.000004: Article 16
p.000004: Acquisition, use and delivery of health information materials for scientific research.
p.000004: The acquisition, use and delivery of health information materials for use in scientific studies shall be in
p.000004: accord with the objective of the study and with the approval granted by the National Bioethics Committee or an
p.000004: institutional review board.
p.000004:
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p.000005: Article 17
p.000005: Duty to report unforeseen incidents.
p.000005: The principal investigator of a study shall immediately submit to the monitoring body under paragraphs 2
p.000005: and 3 of Article 29, and to the Data Protection Authority if applicable, written notification of unforeseen
p.000005: incidents which have, or could have, adversely affected participants, and are believed to be attributable to the
p.000005: study.
p.000005: The principal investigator, other investigators and staff shall, on their own initiative, disclose to
p.000005: monitoring bodies information on factors which could pose a risk to the security of participants in the study. An
p.000005: unforeseen death shall immediately be notified to the police in accord with the provisions of the Act on Death
p.000005: Certificates, Autopsies etc.
p.000005:
p.000005: SECTION V
p.000005: Consent for scientific research on human subjects.
p.000005: Article 18
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Health / Mentally Disabled
Searching for indicator disability:
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p.000006: or mental causes, consent is subject to Article 23.
p.000006:
p.000006: Article 23
p.000006: Conditions for participation by individuals not competent to grant consent.
p.000006: A study on human subjects with participants who are not competent to grant consent is permissible only
p.000006: where all the following conditions are met:
p.000006: a. there is reason to believe that the findings of the study may lead to enhancement of the participants’ health,
p.000006: b. research of comparable effectiveness cannot be carried out on individuals competent to give consent,
p.000006: c. the individuals in question have been informed about the study in so far as that is possible, and
p.000006: are not opposed to participation,
p.000006: d. the guardian of a child, the guardian of an individual who has been deprived of legal competence, or the next of
p.000006: kin of an individual under paragraph 2 of Article 22, has granted consent which meets the conditions of this Act.
p.000006: A study may be approved, although the research findings are not deemed likely to produce results of direct benefit
p.000006: to the health of the person concerned, provided that the aim is significantly to increase scientific
p.000006: understanding of the individual’s condition, disease or disability, for the benefit of persons in the same age
p.000006: category, having a similar disability, or suffering from the same disease. Such studies shall meet the conditions
p.000006: stated in items b, c and d of paragraph 1, and must entail only minor risk and burden.
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p.000007:
p.000007: Article 24
p.000007: Consent for research in an emergency situation.
p.000007: In an emergency situation, when a patient is unable to grant consent and when it is not possible to
p.000007: elicit the consent of the next of kin, a study which is not part of treatment is permissible only if:
p.000007: a. the patient’s risk and burden are minor,
p.000007: b. the patient is not opposed to participation and there is no reason to suppose that he/she would be opposed to
p.000007: participation if he/she were competent to grant consent,
p.000007: c. similar results cannot be achieved by research on individuals able to grant consent,
p.000007: d. the study is indisputably justified with regard to the potential for its findings being beneficial
p.000007: for the individual in question or individuals with the same disease, or promoting important preventive
p.000007: measure, diagnoses or cures, and
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.000006: paragraphs 2 and 3 of Article 12. The National Bioethics Committee or an institutional review board which approved the
p.000006: research protocol shall determine whether it is necessary to elicit renewed consent from participants under Article 18.
p.000006:
p.000006: Article 21
p.000006: Withdrawal of consent.
p.000006: Participants in a scientific study may withdraw their consent at any time. The same applies to consent for the
p.000006: retention of biological samples or health data for use in subsequent studies under Article 19.
p.000006: Should consent be withdrawn, research on the relevant participant’s biological samples or health data shall cease.
p.000006: Participants may require their biological samples and health data to be destroyed.
p.000006: It is not possible, however, to require destruction under paragraph 2 if the biological sample or health
p.000006: data is/are anonymised, if the biological sample has been subsumed into other material, or if data already
p.000006: comprise part of the findings of a study.
p.000006:
p.000006: Article 22
p.000006: Competence to consent.
p.000006: Those who are of age under the provisions of the Act on legal competence are competent to consent to participation in a
p.000006: scientific study.
p.000006: Should a person who is of age be evidently incapable of understanding information on a scientific study due to physical
p.000006: or mental causes, consent is subject to Article 23.
p.000006:
p.000006: Article 23
p.000006: Conditions for participation by individuals not competent to grant consent.
p.000006: A study on human subjects with participants who are not competent to grant consent is permissible only
p.000006: where all the following conditions are met:
p.000006: a. there is reason to believe that the findings of the study may lead to enhancement of the participants’ health,
p.000006: b. research of comparable effectiveness cannot be carried out on individuals competent to give consent,
p.000006: c. the individuals in question have been informed about the study in so far as that is possible, and
p.000006: are not opposed to participation,
p.000006: d. the guardian of a child, the guardian of an individual who has been deprived of legal competence, or the next of
p.000006: kin of an individual under paragraph 2 of Article 22, has granted consent which meets the conditions of this Act.
p.000006: A study may be approved, although the research findings are not deemed likely to produce results of direct benefit
p.000006: to the health of the person concerned, provided that the aim is significantly to increase scientific
p.000006: understanding of the individual’s condition, disease or disability, for the benefit of persons in the same age
...
Health / patients in emergency situations
Searching for indicator emergency situation:
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p.000006: b. research of comparable effectiveness cannot be carried out on individuals competent to give consent,
p.000006: c. the individuals in question have been informed about the study in so far as that is possible, and
p.000006: are not opposed to participation,
p.000006: d. the guardian of a child, the guardian of an individual who has been deprived of legal competence, or the next of
p.000006: kin of an individual under paragraph 2 of Article 22, has granted consent which meets the conditions of this Act.
p.000006: A study may be approved, although the research findings are not deemed likely to produce results of direct benefit
p.000006: to the health of the person concerned, provided that the aim is significantly to increase scientific
p.000006: understanding of the individual’s condition, disease or disability, for the benefit of persons in the same age
p.000006: category, having a similar disability, or suffering from the same disease. Such studies shall meet the conditions
p.000006: stated in items b, c and d of paragraph 1, and must entail only minor risk and burden.
p.000006:
p.000006:
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p.000007: 7
p.000007:
p.000007: Article 24
p.000007: Consent for research in an emergency situation.
p.000007: In an emergency situation, when a patient is unable to grant consent and when it is not possible to
p.000007: elicit the consent of the next of kin, a study which is not part of treatment is permissible only if:
p.000007: a. the patient’s risk and burden are minor,
p.000007: b. the patient is not opposed to participation and there is no reason to suppose that he/she would be opposed to
p.000007: participation if he/she were competent to grant consent,
p.000007: c. similar results cannot be achieved by research on individuals able to grant consent,
p.000007: d. the study is indisputably justified with regard to the potential for its findings being beneficial
p.000007: for the individual in question or individuals with the same disease, or promoting important preventive
p.000007: measure, diagnoses or cures, and
p.000007: e. a study in emergency situations has been specifically approved by the National Bioethics Committee or
p.000007: an institutional review board.
p.000007: The individual in question, or his/her next of kin, shall be provided with information on the study as soon as
p.000007: possible, and the appropriate consent shall be elicited for continuation of the study.
p.000007:
p.000007: SECTION VI
p.000007: General provisions on retrospective studies.
p.000007: Article 25
p.000007: Retrospective studies.
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Social / Access to Social Goods
Searching for indicator access:
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p.000001:
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p.000001:
p.000001:
p.000001: Act on Scientific Research in the Health Sector No. 44/2014.
p.000001:
p.000001: SECTION I
p.000001: Objective and scope.
p.000001: Article 1
p.000001: Objective.
p.000001: The objective of this Act is to foster scientific research of a high standard in the health sector, and
p.000001: to safeguard the interests of participants.
p.000001:
p.000001: Article 2
p.000001: Scope and oversight.
p.000001: This Act applies to scientific research in the health sector. It applies to scientific studies carried out, in whole or
p.000001: in part, in Iceland. The provisions of Sections IV and V apply only to research on human subjects, and the provisions
p.000001: of Section VI only to retrospective studies.
p.000001: Clinical trials of medicinal products are in addition subject to the provisions of the Medicinal Products
p.000001: Act and of regulations issued on the basis of that Act. In addition, clinical trials of medical equipment are subject
p.000001: to the provisions of the Act on Medical Devices and of regulations issued on the basis of that Act.
p.000001: The Data Protection Act applies in so far as other provisions are not made under this Act. Access to health registers
p.000001: kept by the Medical Director of Health is subject to the Medical Director of Health and Public Health Act. Access to
p.000001: biological samples stored in biobanks is subject to the Biobanks and Health Databanks Act. Access to data in
p.000001: health databanks is subject to the Biobanks and Health Databanks Act. The use of human gametes and embryos for
p.000001: stem-cell research is subject to the provisions of the Act on Artificial Fertilisation and use of Human Gametes and
p.000001: Embryos for Stem-Cell Research. Matters for which the above- mentioned legislation makes no provision are
p.000001: additionally subject to the provisions of this Act, as applicable.
p.000001: The Minister is responsible for the implementation of this Act.
p.000001:
p.000001: Article 3
p.000001: Definitions.
p.000001: In this Act the following terms have these meanings:
p.000001: 1. Scientific research in the health sector: Research on human subjects, biological samples and health data
p.000001: in which scientific methods are applied in order to enhance knowledge of health and diseases.
p.000001: 2. Scientific research project on human subjects: A study in which the individual takes an active part in
p.000001: scientific research, for instance by undergoing tests, or providing samples or information for the study.
p.000001:
p.000001: 1
p.000001:
p.000001: 3. Intervention: An intervention entails physical intervention, or an intervention which entails a risk to
p.000001: the psychological health of the individual in question.
p.000001: 4. Health data: Information in health records, information and data from biobanks and health databanks, and other
p.000001: information on medical history and health.
p.000001: 5. Biological sample: Organic material from a human being, alive or deceased, which may provide biological
p.000001: information about him/her.
p.000001: 6. Health information materials: Health data and biological samples.
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p.000001: protocol which has been approved by the National Bioethics Committee or an institutional review board.
p.000001: 11. Health databank: Databank which has been licensed by the Minister to store health data which are
p.000001: acquired for scientific research, or which arise from such research.
p.000001:
p.000001: SECTION II
p.000001: Requirements for scientific research in the health sector.
p.000001: Article 4
p.000001: Fundamental requirements.
p.000001: Scientific research in the health sector shall be founded upon respect for the human dignity of the participants. Human
p.000001: rights shall not be sacrificed in favour of the interests of science or society.
p.000001: The design and implementation of a scientific research project in the health sector shall be of such a nature that
p.000001: ethical and scientific principles are honoured, and personal privacy safeguarded.
p.000001:
p.000001: Article 5
p.000001: Requirements for design of scientific research projects.
p.000001: Scientific research projects in the health sector shall be based upon a research protocol which provides
p.000001: information on the study and its principal investigator. In the application submitted to the National
p.000001: Bioethics Committee or to an institutional review board, cf. Article 12, circumstances which might lead to a conflict
p.000001: of interest shall be declared.
p.000001: The Minister shall make more detailed provisions in a regulation for the design of scientific research
p.000001: projects in the health sector, including research protocol, internal monitoring and the
p.000001: responsibilities of the principal investigator.
p.000001:
p.000001: Article 6
p.000001: Confidentiality.
p.000001: Those who are granted access to identifiable health information materials or other personal data in the implementation
p.000001: or monitoring of a study are subject to a duty of confidentiality.
p.000001: The duty of confidentiality does not prevent data being provided to those who are entitled to access under the
p.000001: provisions of this Act or other legislation.
p.000001:
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p.000002: 2
p.000002:
p.000002: Article 7
p.000002: Retention of health information materials.
p.000002: After a study is completed, health information materials which were acquired for a retrospective study,
p.000002: or which arise from such research, may be retained permanently in a biobank or health databank, if this
p.000002: was stipulated in the research protocol which has been approved by the National Bioethics Committee or an
p.000002: institutional review board.
p.000002: Retention of health information materials acquired for a scientific study on human subjects, or arising from
p.000002: such a study, is contingent upon the consent granted for the study. If health data are to be permanently
p.000002: retained, they shall be stored in a health databank, and biological samples in a biobank.
p.000002: Health data from each scientific study shall be stored separately in a health databank. It is prohibited to link
p.000002: together health data on an individual from different studies while they are stored in a health databank. Access to and
p.000002: utilisation of the data are subject to the provisions of the Biobanks and Health Databanks Act.
p.000002: Should health information materials have been acquired for use in a specific scientific study on human
p.000002: subjects, and should the participants not have granted consent for them to be retained for use in subsequent studies as
p.000002: provided in Article 19, they shall not be retained for any longer than is necessary in order to complete the
p.000002: study. The National Bioethics Committee or an institutional review board may, however, decide, after final
p.000002: findings have been submitted to the committee, that necessary health information materials are to be
p.000002: retained for a specified period, as required in order to evaluate the study. After that time the materials shall be
p.000002: destroyed or anonymised, unless their preservation is obligatory under the National Archives Act or other legislation.
p.000002: Retention of health information materials acquired for clinical trials of medicinal products on human subjects, or
p.000002: arising from such research, is subject to the provisions of the Medicinal Products Act and regulations issued on the
p.000002: basis of that Act. Retention of health information materials acquired for clinical trials of medical equipment, or
p.000002: arising from such research, is subject to the Act on Medical Devices and regulations issued on the basis of that Act.
p.000002:
p.000002: Article 8
p.000002: Transfer of health information materials from Iceland.
p.000002: Transfer of biological samples and health data from Iceland for use in scientific research in the health sector is
p.000002: subject to the provisions of the Data Protection Act.
p.000002:
p.000002: SECTION III
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p.000005: after it commences, without stating any reason. Consent may, as applicable, consist in answering a questionnaire,
p.000005: provided that the provisions of sentences 1 and 2 on the provision of information are fulfilled.
p.000005: The National Bioethics Committee, having received the opinion of the Data Protection Authority, issues rules
p.000005: on how potential participants in scientific research are to be selected and approached, and on the information to be
p.000005: provided before consent is elicited; processing of personal data is subject to the provisions of the Data Protection
p.000005: Act.
p.000005:
p.000005: Article 19
p.000005: Broad consent for retention of materials for use in subsequent studies.
p.000005: Participants’ consent may be elicited to retain biological samples and health data for subsequent use in
p.000005: designated scientific research in the health sector. The National Bioethics Committee or an institutional review board
p.000005: states conditions for the use of broad consent. The committee may also decide that a renewed consent should be
p.000005: elicited, if it deems that necessary.
p.000005: Participants who have given broad consent under paragraph 1 shall have access to information on what
p.000005: research is being carried out by the principal investigator, institution or company. Participants may refuse use of
p.000005: their materials in specified studies, in which case their use is prohibited.
p.000005: Biological samples retained under paragraph 1 shall be permanently stored in a biobank of scientific samples for use
p.000005: under the provisions of the Biobanks and Health Databanks Act. Health data retained under paragraph 1 shall
p.000005: be permanently stored in a health databank for use under the provisions of the Biobanks and Health Databanks
p.000005: Act. Participants must be informed of this.
p.000005: The principal investigator of a study which deposits biological samples in a biobank, or other health data in a
p.000005: health databank, makes an agreement with the management of the bank on arrangements for access to materials for
p.000005: scientific research. It shall be ensured that the use is covered by the participants’ consent under paragraph 1
p.000005: and is consistent with the Data Protection Act.
p.000005:
p.000005:
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p.000006: 6
p.000006:
p.000006: Article 20
p.000006: Alterations to research protocol.
p.000006: With respect to alterations to the research protocol, the principal investigator shall adhere to the provisions of
p.000006: paragraphs 2 and 3 of Article 12. The National Bioethics Committee or an institutional review board which approved the
p.000006: research protocol shall determine whether it is necessary to elicit renewed consent from participants under Article 18.
p.000006:
p.000006: Article 21
p.000006: Withdrawal of consent.
p.000006: Participants in a scientific study may withdraw their consent at any time. The same applies to consent for the
p.000006: retention of biological samples or health data for use in subsequent studies under Article 19.
p.000006: Should consent be withdrawn, research on the relevant participant’s biological samples or health data shall cease.
p.000006: Participants may require their biological samples and health data to be destroyed.
p.000006: It is not possible, however, to require destruction under paragraph 2 if the biological sample or health
p.000006: data is/are anonymised, if the biological sample has been subsumed into other material, or if data already
p.000006: comprise part of the findings of a study.
...
p.000007: for the individual in question or individuals with the same disease, or promoting important preventive
p.000007: measure, diagnoses or cures, and
p.000007: e. a study in emergency situations has been specifically approved by the National Bioethics Committee or
p.000007: an institutional review board.
p.000007: The individual in question, or his/her next of kin, shall be provided with information on the study as soon as
p.000007: possible, and the appropriate consent shall be elicited for continuation of the study.
p.000007:
p.000007: SECTION VI
p.000007: General provisions on retrospective studies.
p.000007: Article 25
p.000007: Retrospective studies.
p.000007: Retrospective studies are subject to the provisions of Sections I–III and VI–IX. The design and implementation of
p.000007: retrospective studies, and scientific evaluation of them, are subject to the provisions of Sections I–III.
p.000007:
p.000007: Article 26
p.000007: Principle regarding use of health information materials.
p.000007: The use of health information materials in research shall be in accord with a research protocol which
p.000007: has been approved by the National Bioethics Committee or an institutional review board under the
p.000007: provisions of Section III. Such use shall be in conformity with the declared objective of the study and
p.000007: with the Data Protection Act. The materials shall be adequate and pertinent and not exceed what is necessary in
p.000007: order to attain the objective of the study.
p.000007:
p.000007: Article 27
p.000007: Access to health information materials.
p.000007: The National Bioethics Committee or an institutional review board authorises access to health information
p.000007: materials for scientific studies which have been approved by the National Bioethics Committee or an institutional
p.000007: review board.
p.000007: The National Bioethics Committee or an institutional review board may state conditions for this use. Access is
p.000007: subject to the consent of the body responsible for the materials. It shall be ensured that access to biological samples
p.000007: and health data is provided on an equitable basis. In access to health information materials, account shall be taken of
p.000007: the fact that they contain confidential information.
p.000007: On every occasion that a medical record is examined for a scientific study, that shall be noted in the record. Should
p.000007: data from the records of a company or institution be examined for a scientific study, that fact shall also be noted in
p.000007: the record.
p.000007:
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p.000008: 8
p.000008:
p.000008: Access to biological samples shall be in conformity with the provisions of the Biobanks and Health Databanks Act with
p.000008: respect to the right of biological sample donors to withdraw consent, and access to medical records shall
p.000008: conform with the provisions of the Health Records Act.
p.000008: The National Bioethics Committee shall issue rules of procedure regarding the handling of applications for access to
p.000008: health information materials.
p.000008:
p.000008: Article 28
p.000008: Health databanks.
p.000008: Health databanks are subject to the provisions of the Biobanks and Health Databanks Act.
p.000008:
p.000008: SECTION VII
p.000008: Monitoring.
p.000008: Article 29
p.000008: Monitoring of scientific research.
p.000008: The National Bioethics Committee and institutional review boards monitor scientific research in the health
p.000008: sector.
p.000008: The Icelandic Medicines Agency monitors clinical trials of medicinal products under the Medicinal Products Act and
p.000008: clinical trials of medical devices under the Act on Medical Devices.
p.000008: The National Bioethics Committee and institutional review boards shall monitor the implementation of studies
p.000008: they have approved. The principal investigator of the study must submit necessary data to them.
p.000008: Should the National Bioethics Committee or an institutional review board be of the view that the implementation of
p.000008: the study is not consistent with the research protocol and data submitted, or that it no longer meets the
p.000008: provisions of legislation and regulations on scientific research in the health sector, it shall instruct the principal
p.000008: investigator to make rectifications.
p.000008: Should the instructions for rectification not be complied with, or in the case of a grave violation, the
p.000008: National Bioethics Committee or institutional review board may revoke its approval of the study. Should
p.000008: approval be revoked, the study shall cease immediately.
p.000008:
p.000008: Article 30
p.000008: Data Protection Authority monitoring.
p.000008: The Data Protection Authority monitors the processing of personal data in scientific research.
p.000008:
p.000008: Article 31
p.000008: Duty of disclosure to monitoring bodies.
p.000008: The principal investigator and others involved in the implementation of a study shall grant monitoring bodies access
p.000008: to the research premises and shall, notwithstanding the duty of confidentiality, provide them with all
p.000008: information and data which they deem necessary in order to fulfil their duty of monitoring under this Act.
p.000008:
p.000008: Article 32
p.000008: Confidentiality of monitoring bodies.
p.000008: Monitoring bodies and those working for them are subject to the duty of confidentiality under Article 6.
p.000008:
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p.000009: SECTION VIII
p.000009: Penalties. Article 33 Penalties.
p.000009: Infringement of this Act or, as applicable, rules issued on the basis of this Act, entails fines or imprisonment for up
p.000009: to three years, if the violation does not entail more severe penalties under other legislation:
p.000009: 1. Articles 6 and 32 on confidentiality.
p.000009: 2. Article 7 on retention of health information materials.
p.000009: 3. Article 12 on approval by the National Bioethics Committee or an institutional review board for a scientific
p.000009: research project in the health sector.
p.000009: 4. Article 17 on duty of reporting of unexpected events.
p.000009: 5. Section V on consent for a scientific study on human subjects.
p.000009: 6. Article 20 on alterations to a research protocol.
p.000009: 7. Art 31 on the duty to grant monitoring bodies information, data and access to premises.
p.000009: The same penalties apply if a study is not halted on revocation of a approval for a scientific study by the National
p.000009: Bioethics Committee an institutional review board, cf. paragraph 5 of Article 29.
p.000009: Complicity in such an offence is punishable as provided in the General Penal Code, unless more severe penalties are
p.000009: entailed by other legislation.
p.000009: In the case of an offence committed in the activities of a legal entity, the legal entity may be fined under the
p.000009: provisions of Section II of the General Penal Code.
p.000009:
p.000009: SECTION IX
p.000009: Various provisions.
p.000009: Article 34
p.000009: Authority for issue of regulations.
p.000009: The Minister may make more detailed provision in regulations for the implementation of this Act, inter alia regarding
p.000009: in what cases, and how, a participant in a scientific study is to be informed of important factors revealed by the
p.000009: study which relate to his/her health.
p.000009:
p.000009: Article 35
p.000009: Entry into force.
p.000009: This Act takes effect on 1 January 2015. Temporary Provisions I, however, take effect immediately.
p.000009:
p.000009: Article 36
p.000009: Amendments to other legislation.
p.000009: …
p.000009:
p.000009: Temporary provisions I.
p.000009: Before this Act takes effect the Minister shall appoint a new National Bioethics Committee under Article 9 which shall
p.000009: operate from 1 January 2015. The Minister may also, before this Act takes effect, establish by regulations
p.000009: institutional review boards as authorised in Article 11.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: II.
p.000010: Approval for a scientific research project in the health sector for which an application is received before this Act
...
Social / Age
Searching for indicator age:
(return to top)
p.000005: and is consistent with the Data Protection Act.
p.000005:
p.000005:
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: Article 20
p.000006: Alterations to research protocol.
p.000006: With respect to alterations to the research protocol, the principal investigator shall adhere to the provisions of
p.000006: paragraphs 2 and 3 of Article 12. The National Bioethics Committee or an institutional review board which approved the
p.000006: research protocol shall determine whether it is necessary to elicit renewed consent from participants under Article 18.
p.000006:
p.000006: Article 21
p.000006: Withdrawal of consent.
p.000006: Participants in a scientific study may withdraw their consent at any time. The same applies to consent for the
p.000006: retention of biological samples or health data for use in subsequent studies under Article 19.
p.000006: Should consent be withdrawn, research on the relevant participant’s biological samples or health data shall cease.
p.000006: Participants may require their biological samples and health data to be destroyed.
p.000006: It is not possible, however, to require destruction under paragraph 2 if the biological sample or health
p.000006: data is/are anonymised, if the biological sample has been subsumed into other material, or if data already
p.000006: comprise part of the findings of a study.
p.000006:
p.000006: Article 22
p.000006: Competence to consent.
p.000006: Those who are of age under the provisions of the Act on legal competence are competent to consent to participation in a
p.000006: scientific study.
p.000006: Should a person who is of age be evidently incapable of understanding information on a scientific study due to physical
p.000006: or mental causes, consent is subject to Article 23.
p.000006:
p.000006: Article 23
p.000006: Conditions for participation by individuals not competent to grant consent.
p.000006: A study on human subjects with participants who are not competent to grant consent is permissible only
p.000006: where all the following conditions are met:
p.000006: a. there is reason to believe that the findings of the study may lead to enhancement of the participants’ health,
p.000006: b. research of comparable effectiveness cannot be carried out on individuals competent to give consent,
p.000006: c. the individuals in question have been informed about the study in so far as that is possible, and
p.000006: are not opposed to participation,
p.000006: d. the guardian of a child, the guardian of an individual who has been deprived of legal competence, or the next of
p.000006: kin of an individual under paragraph 2 of Article 22, has granted consent which meets the conditions of this Act.
p.000006: A study may be approved, although the research findings are not deemed likely to produce results of direct benefit
p.000006: to the health of the person concerned, provided that the aim is significantly to increase scientific
p.000006: understanding of the individual’s condition, disease or disability, for the benefit of persons in the same age
p.000006: category, having a similar disability, or suffering from the same disease. Such studies shall meet the conditions
p.000006: stated in items b, c and d of paragraph 1, and must entail only minor risk and burden.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Article 24
p.000007: Consent for research in an emergency situation.
p.000007: In an emergency situation, when a patient is unable to grant consent and when it is not possible to
p.000007: elicit the consent of the next of kin, a study which is not part of treatment is permissible only if:
p.000007: a. the patient’s risk and burden are minor,
p.000007: b. the patient is not opposed to participation and there is no reason to suppose that he/she would be opposed to
p.000007: participation if he/she were competent to grant consent,
p.000007: c. similar results cannot be achieved by research on individuals able to grant consent,
p.000007: d. the study is indisputably justified with regard to the potential for its findings being beneficial
p.000007: for the individual in question or individuals with the same disease, or promoting important preventive
...
Social / Child
Searching for indicator child:
(return to top)
p.000006: data is/are anonymised, if the biological sample has been subsumed into other material, or if data already
p.000006: comprise part of the findings of a study.
p.000006:
p.000006: Article 22
p.000006: Competence to consent.
p.000006: Those who are of age under the provisions of the Act on legal competence are competent to consent to participation in a
p.000006: scientific study.
p.000006: Should a person who is of age be evidently incapable of understanding information on a scientific study due to physical
p.000006: or mental causes, consent is subject to Article 23.
p.000006:
p.000006: Article 23
p.000006: Conditions for participation by individuals not competent to grant consent.
p.000006: A study on human subjects with participants who are not competent to grant consent is permissible only
p.000006: where all the following conditions are met:
p.000006: a. there is reason to believe that the findings of the study may lead to enhancement of the participants’ health,
p.000006: b. research of comparable effectiveness cannot be carried out on individuals competent to give consent,
p.000006: c. the individuals in question have been informed about the study in so far as that is possible, and
p.000006: are not opposed to participation,
p.000006: d. the guardian of a child, the guardian of an individual who has been deprived of legal competence, or the next of
p.000006: kin of an individual under paragraph 2 of Article 22, has granted consent which meets the conditions of this Act.
p.000006: A study may be approved, although the research findings are not deemed likely to produce results of direct benefit
p.000006: to the health of the person concerned, provided that the aim is significantly to increase scientific
p.000006: understanding of the individual’s condition, disease or disability, for the benefit of persons in the same age
p.000006: category, having a similar disability, or suffering from the same disease. Such studies shall meet the conditions
p.000006: stated in items b, c and d of paragraph 1, and must entail only minor risk and burden.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Article 24
p.000007: Consent for research in an emergency situation.
p.000007: In an emergency situation, when a patient is unable to grant consent and when it is not possible to
p.000007: elicit the consent of the next of kin, a study which is not part of treatment is permissible only if:
...
Social / Police Officer
Searching for indicator police:
(return to top)
p.000004: benefit, the National Bioethics Committee or an institutional review board will halt the study.
p.000004: Special care shall be taken when recruiting individuals from vulnerable social groups, i.e. individuals who for some
p.000004: reason are not in a position to make an informed or free decision.
p.000004:
p.000004: Article 16
p.000004: Acquisition, use and delivery of health information materials for scientific research.
p.000004: The acquisition, use and delivery of health information materials for use in scientific studies shall be in
p.000004: accord with the objective of the study and with the approval granted by the National Bioethics Committee or an
p.000004: institutional review board.
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: Article 17
p.000005: Duty to report unforeseen incidents.
p.000005: The principal investigator of a study shall immediately submit to the monitoring body under paragraphs 2
p.000005: and 3 of Article 29, and to the Data Protection Authority if applicable, written notification of unforeseen
p.000005: incidents which have, or could have, adversely affected participants, and are believed to be attributable to the
p.000005: study.
p.000005: The principal investigator, other investigators and staff shall, on their own initiative, disclose to
p.000005: monitoring bodies information on factors which could pose a risk to the security of participants in the study. An
p.000005: unforeseen death shall immediately be notified to the police in accord with the provisions of the Act on Death
p.000005: Certificates, Autopsies etc.
p.000005:
p.000005: SECTION V
p.000005: Consent for scientific research on human subjects.
p.000005: Article 18
p.000005: Participants’ consent.
p.000005: Consent shall be elicited from participants in a scientific study on human subjects.
p.000005: The consent shall be in writing and freely granted after the participant has been provided with adequate information on
p.000005: the study, risks it may entail, potential benefits, and the nature of the participation. The participant shall be
p.000005: informed that he/she may decline to take part in a scientific study, or withdraw from participation at any time
p.000005: after it commences, without stating any reason. Consent may, as applicable, consist in answering a questionnaire,
p.000005: provided that the provisions of sentences 1 and 2 on the provision of information are fulfilled.
p.000005: The National Bioethics Committee, having received the opinion of the Data Protection Authority, issues rules
p.000005: on how potential participants in scientific research are to be selected and approached, and on the information to be
p.000005: provided before consent is elicited; processing of personal data is subject to the provisions of the Data Protection
p.000005: Act.
p.000005:
p.000005: Article 19
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000003:
p.000003: Article 11
p.000003: Institutional review boards.
p.000003: The Minister may establish by regulations1) an institutional review board within a specific healthcare institution,
p.000003: having elicited the opinion of the National Bioethics Committee. The regulations shall provide inter alia for
p.000003: appointment to and tasks of the institutional review board. Such a review board evaluates only scientific
p.000003: research projects carried out within the relevant institution, or jointly with educational bodies with which it
p.000003: collaborates.
p.000003: 1) Regulation No. 1186/2014.
p.000003:
p.000003: Article 12
p.000003: Approval by National Bioethics Committee or an institutional review board.
p.000003: A scientific research project in the health sector may not be commenced unless it has been approved by the National
p.000003: Bioethics Committee or an institutional review board. The National Bioethics Committee or institutional review
p.000003: board shall evaluate the research protocol of a scientific study from the perspectives of science, ethics
p.000003: and human rights. The National Bioethics Committee and institutional review boards may attach certain
p.000003: conditions to their approval of a study.
p.000003: No alterations to the nature or scope of a scientific study, nor any other major alteration, may be made unless
p.000003: previously approved by the National Bioethics Committee or an institutional review board which approved the
p.000003: original research protocol.
p.000003: The National Bioethics Committee may determine that minor changes to a scientific study are subject only to the duty to
p.000003: notify the National Bioethics Committee or institutional review board, under rules to be issued by the National
p.000003: Bioethics Committee.
p.000003:
p.000003: Article 13
p.000003: Consideration by the Data Protection Authority.
p.000003: The National Bioethics Committee and institutional review boards shall submit to the Data Protection Authority a
p.000003: summary of each application for a scientific study. This shall be done
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: as soon as possible. The summary shall provide information on the applicants, and describe the processing of personal
p.000004: data to be carried out for the study in question.
p.000004: Having received the summary under paragraph 1, the Data Protection Authority decides whether it will consider
p.000004: the case further. The National Bioethics Committee or institutional review board may grant approval ten working days
p.000004: after receipt of the summary by the Data Protection Authority, unless the Authority has within that time notified the
p.000004: relevant committee otherwise. Should the Data Protection Authority do so, the committee may not grant approval until
...
p.000006: A study on human subjects with participants who are not competent to grant consent is permissible only
p.000006: where all the following conditions are met:
p.000006: a. there is reason to believe that the findings of the study may lead to enhancement of the participants’ health,
p.000006: b. research of comparable effectiveness cannot be carried out on individuals competent to give consent,
p.000006: c. the individuals in question have been informed about the study in so far as that is possible, and
p.000006: are not opposed to participation,
p.000006: d. the guardian of a child, the guardian of an individual who has been deprived of legal competence, or the next of
p.000006: kin of an individual under paragraph 2 of Article 22, has granted consent which meets the conditions of this Act.
p.000006: A study may be approved, although the research findings are not deemed likely to produce results of direct benefit
p.000006: to the health of the person concerned, provided that the aim is significantly to increase scientific
p.000006: understanding of the individual’s condition, disease or disability, for the benefit of persons in the same age
p.000006: category, having a similar disability, or suffering from the same disease. Such studies shall meet the conditions
p.000006: stated in items b, c and d of paragraph 1, and must entail only minor risk and burden.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Article 24
p.000007: Consent for research in an emergency situation.
p.000007: In an emergency situation, when a patient is unable to grant consent and when it is not possible to
p.000007: elicit the consent of the next of kin, a study which is not part of treatment is permissible only if:
p.000007: a. the patient’s risk and burden are minor,
p.000007: b. the patient is not opposed to participation and there is no reason to suppose that he/she would be opposed to
p.000007: participation if he/she were competent to grant consent,
p.000007: c. similar results cannot be achieved by research on individuals able to grant consent,
p.000007: d. the study is indisputably justified with regard to the potential for its findings being beneficial
p.000007: for the individual in question or individuals with the same disease, or promoting important preventive
p.000007: measure, diagnoses or cures, and
p.000007: e. a study in emergency situations has been specifically approved by the National Bioethics Committee or
p.000007: an institutional review board.
p.000007: The individual in question, or his/her next of kin, shall be provided with information on the study as soon as
p.000007: possible, and the appropriate consent shall be elicited for continuation of the study.
p.000007:
p.000007: SECTION VI
p.000007: General provisions on retrospective studies.
p.000007: Article 25
p.000007: Retrospective studies.
p.000007: Retrospective studies are subject to the provisions of Sections I–III and VI–IX. The design and implementation of
p.000007: retrospective studies, and scientific evaluation of them, are subject to the provisions of Sections I–III.
p.000007:
p.000007: Article 26
p.000007: Principle regarding use of health information materials.
p.000007: The use of health information materials in research shall be in accord with a research protocol which
p.000007: has been approved by the National Bioethics Committee or an institutional review board under the
...
Social / education
Searching for indicator educational:
(return to top)
p.000003: Bioethics Committee rules on that matter.
p.000003: The National Bioethics Committee shall evaluate collaborative projects, multinational projects, clinical
p.000003: trials of medicinal products and other scientific research protocols in the health sector which do not fall
p.000003: within the terms of reference of an institutional review board under Article 11.
p.000003: The National Bioethics Committee shall participate in public and academic debate in the field of bioethics, provide
p.000003: advice and promulgate advisory opinions on subjects within the field of the committee.
p.000003: Further provision shall be made in regulations for the tasks of the National Bioethics Committee,
p.000003: including the Committee’s authority to draw up its own rules of procedure. The National Bioethics Committee’s rules
p.000003: of procedure are subject to confirmation by the Minister.
p.000003: Rules of procedure drawn up by the National Bioethics Committee on the basis of this Act or regulations based on the
p.000003: Act apply also to the work institutional review boards appointed under this Act.
p.000003:
p.000003: Article 11
p.000003: Institutional review boards.
p.000003: The Minister may establish by regulations1) an institutional review board within a specific healthcare institution,
p.000003: having elicited the opinion of the National Bioethics Committee. The regulations shall provide inter alia for
p.000003: appointment to and tasks of the institutional review board. Such a review board evaluates only scientific
p.000003: research projects carried out within the relevant institution, or jointly with educational bodies with which it
p.000003: collaborates.
p.000003: 1) Regulation No. 1186/2014.
p.000003:
p.000003: Article 12
p.000003: Approval by National Bioethics Committee or an institutional review board.
p.000003: A scientific research project in the health sector may not be commenced unless it has been approved by the National
p.000003: Bioethics Committee or an institutional review board. The National Bioethics Committee or institutional review
p.000003: board shall evaluate the research protocol of a scientific study from the perspectives of science, ethics
p.000003: and human rights. The National Bioethics Committee and institutional review boards may attach certain
p.000003: conditions to their approval of a study.
p.000003: No alterations to the nature or scope of a scientific study, nor any other major alteration, may be made unless
p.000003: previously approved by the National Bioethics Committee or an institutional review board which approved the
p.000003: original research protocol.
p.000003: The National Bioethics Committee may determine that minor changes to a scientific study are subject only to the duty to
p.000003: notify the National Bioethics Committee or institutional review board, under rules to be issued by the National
p.000003: Bioethics Committee.
p.000003:
p.000003: Article 13
p.000003: Consideration by the Data Protection Authority.
p.000003: The National Bioethics Committee and institutional review boards shall submit to the Data Protection Authority a
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000003: The role of the National Bioethics Committee.
p.000003: The National Bioethics Committee has the role of evaluating scientific research projects in the health sector with
p.000003: the objective of ensuring that they are consistent with scientific and ethical principles. In the case
p.000003: of doubt as to whether a project is to be deemed scientific research in the health sector, the National
p.000003: Bioethics Committee rules on that matter.
p.000003: The National Bioethics Committee shall evaluate collaborative projects, multinational projects, clinical
p.000003: trials of medicinal products and other scientific research protocols in the health sector which do not fall
p.000003: within the terms of reference of an institutional review board under Article 11.
p.000003: The National Bioethics Committee shall participate in public and academic debate in the field of bioethics, provide
p.000003: advice and promulgate advisory opinions on subjects within the field of the committee.
p.000003: Further provision shall be made in regulations for the tasks of the National Bioethics Committee,
p.000003: including the Committee’s authority to draw up its own rules of procedure. The National Bioethics Committee’s rules
p.000003: of procedure are subject to confirmation by the Minister.
p.000003: Rules of procedure drawn up by the National Bioethics Committee on the basis of this Act or regulations based on the
p.000003: Act apply also to the work institutional review boards appointed under this Act.
p.000003:
p.000003: Article 11
p.000003: Institutional review boards.
p.000003: The Minister may establish by regulations1) an institutional review board within a specific healthcare institution,
p.000003: having elicited the opinion of the National Bioethics Committee. The regulations shall provide inter alia for
p.000003: appointment to and tasks of the institutional review board. Such a review board evaluates only scientific
p.000003: research projects carried out within the relevant institution, or jointly with educational bodies with which it
p.000003: collaborates.
p.000003: 1) Regulation No. 1186/2014.
p.000003:
p.000003: Article 12
p.000003: Approval by National Bioethics Committee or an institutional review board.
p.000003: A scientific research project in the health sector may not be commenced unless it has been approved by the National
p.000003: Bioethics Committee or an institutional review board. The National Bioethics Committee or institutional review
p.000003: board shall evaluate the research protocol of a scientific study from the perspectives of science, ethics
p.000003: and human rights. The National Bioethics Committee and institutional review boards may attach certain
p.000003: conditions to their approval of a study.
p.000003: No alterations to the nature or scope of a scientific study, nor any other major alteration, may be made unless
p.000003: previously approved by the National Bioethics Committee or an institutional review board which approved the
p.000003: original research protocol.
p.000003: The National Bioethics Committee may determine that minor changes to a scientific study are subject only to the duty to
p.000003: notify the National Bioethics Committee or institutional review board, under rules to be issued by the National
p.000003: Bioethics Committee.
p.000003:
p.000003: Article 13
...
p.000005: incidents which have, or could have, adversely affected participants, and are believed to be attributable to the
p.000005: study.
p.000005: The principal investigator, other investigators and staff shall, on their own initiative, disclose to
p.000005: monitoring bodies information on factors which could pose a risk to the security of participants in the study. An
p.000005: unforeseen death shall immediately be notified to the police in accord with the provisions of the Act on Death
p.000005: Certificates, Autopsies etc.
p.000005:
p.000005: SECTION V
p.000005: Consent for scientific research on human subjects.
p.000005: Article 18
p.000005: Participants’ consent.
p.000005: Consent shall be elicited from participants in a scientific study on human subjects.
p.000005: The consent shall be in writing and freely granted after the participant has been provided with adequate information on
p.000005: the study, risks it may entail, potential benefits, and the nature of the participation. The participant shall be
p.000005: informed that he/she may decline to take part in a scientific study, or withdraw from participation at any time
p.000005: after it commences, without stating any reason. Consent may, as applicable, consist in answering a questionnaire,
p.000005: provided that the provisions of sentences 1 and 2 on the provision of information are fulfilled.
p.000005: The National Bioethics Committee, having received the opinion of the Data Protection Authority, issues rules
p.000005: on how potential participants in scientific research are to be selected and approached, and on the information to be
p.000005: provided before consent is elicited; processing of personal data is subject to the provisions of the Data Protection
p.000005: Act.
p.000005:
p.000005: Article 19
p.000005: Broad consent for retention of materials for use in subsequent studies.
p.000005: Participants’ consent may be elicited to retain biological samples and health data for subsequent use in
p.000005: designated scientific research in the health sector. The National Bioethics Committee or an institutional review board
p.000005: states conditions for the use of broad consent. The committee may also decide that a renewed consent should be
p.000005: elicited, if it deems that necessary.
p.000005: Participants who have given broad consent under paragraph 1 shall have access to information on what
p.000005: research is being carried out by the principal investigator, institution or company. Participants may refuse use of
p.000005: their materials in specified studies, in which case their use is prohibited.
p.000005: Biological samples retained under paragraph 1 shall be permanently stored in a biobank of scientific samples for use
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.000006: stated in items b, c and d of paragraph 1, and must entail only minor risk and burden.
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Article 24
p.000007: Consent for research in an emergency situation.
p.000007: In an emergency situation, when a patient is unable to grant consent and when it is not possible to
p.000007: elicit the consent of the next of kin, a study which is not part of treatment is permissible only if:
p.000007: a. the patient’s risk and burden are minor,
p.000007: b. the patient is not opposed to participation and there is no reason to suppose that he/she would be opposed to
p.000007: participation if he/she were competent to grant consent,
p.000007: c. similar results cannot be achieved by research on individuals able to grant consent,
p.000007: d. the study is indisputably justified with regard to the potential for its findings being beneficial
p.000007: for the individual in question or individuals with the same disease, or promoting important preventive
p.000007: measure, diagnoses or cures, and
p.000007: e. a study in emergency situations has been specifically approved by the National Bioethics Committee or
p.000007: an institutional review board.
p.000007: The individual in question, or his/her next of kin, shall be provided with information on the study as soon as
p.000007: possible, and the appropriate consent shall be elicited for continuation of the study.
p.000007:
p.000007: SECTION VI
p.000007: General provisions on retrospective studies.
p.000007: Article 25
p.000007: Retrospective studies.
p.000007: Retrospective studies are subject to the provisions of Sections I–III and VI–IX. The design and implementation of
p.000007: retrospective studies, and scientific evaluation of them, are subject to the provisions of Sections I–III.
p.000007:
p.000007: Article 26
p.000007: Principle regarding use of health information materials.
p.000007: The use of health information materials in research shall be in accord with a research protocol which
p.000007: has been approved by the National Bioethics Committee or an institutional review board under the
p.000007: provisions of Section III. Such use shall be in conformity with the declared objective of the study and
p.000007: with the Data Protection Act. The materials shall be adequate and pertinent and not exceed what is necessary in
p.000007: order to attain the objective of the study.
p.000007:
p.000007: Article 27
p.000007: Access to health information materials.
p.000007: The National Bioethics Committee or an institutional review board authorises access to health information
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000002: appointed by the Minister without nomination. The Minister appoints a chair from among the members. The committee
p.000002: elects a deputy chair from among its members. Substitutes shall be appointed in the same manner. It shall be ensured
p.000002: that the committee includes individuals with expertise in the methodology of health sciences, ethics, law and data
p.000002: protection.
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Article 10
p.000003: The role of the National Bioethics Committee.
p.000003: The National Bioethics Committee has the role of evaluating scientific research projects in the health sector with
p.000003: the objective of ensuring that they are consistent with scientific and ethical principles. In the case
p.000003: of doubt as to whether a project is to be deemed scientific research in the health sector, the National
p.000003: Bioethics Committee rules on that matter.
p.000003: The National Bioethics Committee shall evaluate collaborative projects, multinational projects, clinical
p.000003: trials of medicinal products and other scientific research protocols in the health sector which do not fall
p.000003: within the terms of reference of an institutional review board under Article 11.
p.000003: The National Bioethics Committee shall participate in public and academic debate in the field of bioethics, provide
p.000003: advice and promulgate advisory opinions on subjects within the field of the committee.
p.000003: Further provision shall be made in regulations for the tasks of the National Bioethics Committee,
p.000003: including the Committee’s authority to draw up its own rules of procedure. The National Bioethics Committee’s rules
p.000003: of procedure are subject to confirmation by the Minister.
p.000003: Rules of procedure drawn up by the National Bioethics Committee on the basis of this Act or regulations based on the
p.000003: Act apply also to the work institutional review boards appointed under this Act.
p.000003:
p.000003: Article 11
p.000003: Institutional review boards.
p.000003: The Minister may establish by regulations1) an institutional review board within a specific healthcare institution,
p.000003: having elicited the opinion of the National Bioethics Committee. The regulations shall provide inter alia for
p.000003: appointment to and tasks of the institutional review board. Such a review board evaluates only scientific
p.000003: research projects carried out within the relevant institution, or jointly with educational bodies with which it
p.000003: collaborates.
p.000003: 1) Regulation No. 1186/2014.
p.000003:
p.000003: Article 12
p.000003: Approval by National Bioethics Committee or an institutional review board.
p.000003: A scientific research project in the health sector may not be commenced unless it has been approved by the National
p.000003: Bioethics Committee or an institutional review board. The National Bioethics Committee or institutional review
p.000003: board shall evaluate the research protocol of a scientific study from the perspectives of science, ethics
p.000003: and human rights. The National Bioethics Committee and institutional review boards may attach certain
p.000003: conditions to their approval of a study.
p.000003: No alterations to the nature or scope of a scientific study, nor any other major alteration, may be made unless
p.000003: previously approved by the National Bioethics Committee or an institutional review board which approved the
p.000003: original research protocol.
p.000003: The National Bioethics Committee may determine that minor changes to a scientific study are subject only to the duty to
p.000003: notify the National Bioethics Committee or institutional review board, under rules to be issued by the National
p.000003: Bioethics Committee.
p.000003:
p.000003: Article 13
p.000003: Consideration by the Data Protection Authority.
p.000003: The National Bioethics Committee and institutional review boards shall submit to the Data Protection Authority a
p.000003: summary of each application for a scientific study. This shall be done
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: as soon as possible. The summary shall provide information on the applicants, and describe the processing of personal
p.000004: data to be carried out for the study in question.
p.000004: Having received the summary under paragraph 1, the Data Protection Authority decides whether it will consider
p.000004: the case further. The National Bioethics Committee or institutional review board may grant approval ten working days
p.000004: after receipt of the summary by the Data Protection Authority, unless the Authority has within that time notified the
p.000004: relevant committee otherwise. Should the Data Protection Authority do so, the committee may not grant approval until
p.000004: the Authority has reached a finding, in accord with the provisions of the Data Protection Act. The Authority may inter
p.000004: alia require security measures to be applied to the handling of personal data. Should the Data Protection Authority
p.000004: judge that the handling of personal data contravenes the Data Protection Act, approval shall not be granted for the
p.000004: study.
p.000004: The Data Protection Authority may issue rules on security of personal data in the implementation of
p.000004: scientific research in the health sector. The Minister may make further provision in regulations1) for
p.000004: interaction with the Data Protection Authority under this Article, following consultation with the National
p.000004: Bioethics Committee and the Data Protection Authority.
p.000004: 1) Regulation No. 1187/2014.
p.000004:
p.000004: Article 14
p.000004: Procedure and appeal.
p.000004: The procedure of the National Bioethics Committee and institutional review boards is subject to the
p.000004: provisions of the Administrative Procedures Act.
p.000004: Decisions of review boards appointed under Article 11 may be appealed to the National Bioethics Committee.
p.000004: Decisions of the National Bioethics Committee may be appealed to the Minister. A judgement by the National
p.000004: Bioethics Committee under sentence 2 of paragraph 1 of Article 12 is not liable to review by the Minister.
p.000004:
p.000004: SECTION IV
p.000004: General provisions on scientific research on human subjects.
p.000004: Article 15
p.000004: Scientific research on human subjects.
p.000004: Scientific studies which entail intervention may not be carried out on human subjects if it is deemed likely that
p.000004: the same or a comparable objective can be attained without human participation.
p.000004: Before a scientific study on human subjects is approved, the National Bioethics Committee or an institutional review
p.000004: board shall evaluate potential risk and burden on the one hand, and benefits for the participants or others on the
p.000004: other hand. In research on the effectiveness of a new treatment, with or without placebo, it shall be ensured
p.000004: that patients receive approved treatment. Should it transpire that the risk outweighs the potential
p.000004: benefit, the National Bioethics Committee or an institutional review board will halt the study.
p.000004: Special care shall be taken when recruiting individuals from vulnerable social groups, i.e. individuals who for some
p.000004: reason are not in a position to make an informed or free decision.
p.000004:
p.000004: Article 16
p.000004: Acquisition, use and delivery of health information materials for scientific research.
p.000004: The acquisition, use and delivery of health information materials for use in scientific studies shall be in
p.000004: accord with the objective of the study and with the approval granted by the National Bioethics Committee or an
p.000004: institutional review board.
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: Article 17
p.000005: Duty to report unforeseen incidents.
p.000005: The principal investigator of a study shall immediately submit to the monitoring body under paragraphs 2
p.000005: and 3 of Article 29, and to the Data Protection Authority if applicable, written notification of unforeseen
p.000005: incidents which have, or could have, adversely affected participants, and are believed to be attributable to the
p.000005: study.
p.000005: The principal investigator, other investigators and staff shall, on their own initiative, disclose to
p.000005: monitoring bodies information on factors which could pose a risk to the security of participants in the study. An
p.000005: unforeseen death shall immediately be notified to the police in accord with the provisions of the Act on Death
p.000005: Certificates, Autopsies etc.
p.000005:
p.000005: SECTION V
p.000005: Consent for scientific research on human subjects.
p.000005: Article 18
p.000005: Participants’ consent.
p.000005: Consent shall be elicited from participants in a scientific study on human subjects.
p.000005: The consent shall be in writing and freely granted after the participant has been provided with adequate information on
p.000005: the study, risks it may entail, potential benefits, and the nature of the participation. The participant shall be
p.000005: informed that he/she may decline to take part in a scientific study, or withdraw from participation at any time
p.000005: after it commences, without stating any reason. Consent may, as applicable, consist in answering a questionnaire,
p.000005: provided that the provisions of sentences 1 and 2 on the provision of information are fulfilled.
p.000005: The National Bioethics Committee, having received the opinion of the Data Protection Authority, issues rules
p.000005: on how potential participants in scientific research are to be selected and approached, and on the information to be
p.000005: provided before consent is elicited; processing of personal data is subject to the provisions of the Data Protection
p.000005: Act.
p.000005:
p.000005: Article 19
p.000005: Broad consent for retention of materials for use in subsequent studies.
p.000005: Participants’ consent may be elicited to retain biological samples and health data for subsequent use in
p.000005: designated scientific research in the health sector. The National Bioethics Committee or an institutional review board
p.000005: states conditions for the use of broad consent. The committee may also decide that a renewed consent should be
p.000005: elicited, if it deems that necessary.
p.000005: Participants who have given broad consent under paragraph 1 shall have access to information on what
p.000005: research is being carried out by the principal investigator, institution or company. Participants may refuse use of
p.000005: their materials in specified studies, in which case their use is prohibited.
p.000005: Biological samples retained under paragraph 1 shall be permanently stored in a biobank of scientific samples for use
p.000005: under the provisions of the Biobanks and Health Databanks Act. Health data retained under paragraph 1 shall
...
p.000008: health information materials.
p.000008:
p.000008: Article 28
p.000008: Health databanks.
p.000008: Health databanks are subject to the provisions of the Biobanks and Health Databanks Act.
p.000008:
p.000008: SECTION VII
p.000008: Monitoring.
p.000008: Article 29
p.000008: Monitoring of scientific research.
p.000008: The National Bioethics Committee and institutional review boards monitor scientific research in the health
p.000008: sector.
p.000008: The Icelandic Medicines Agency monitors clinical trials of medicinal products under the Medicinal Products Act and
p.000008: clinical trials of medical devices under the Act on Medical Devices.
p.000008: The National Bioethics Committee and institutional review boards shall monitor the implementation of studies
p.000008: they have approved. The principal investigator of the study must submit necessary data to them.
p.000008: Should the National Bioethics Committee or an institutional review board be of the view that the implementation of
p.000008: the study is not consistent with the research protocol and data submitted, or that it no longer meets the
p.000008: provisions of legislation and regulations on scientific research in the health sector, it shall instruct the principal
p.000008: investigator to make rectifications.
p.000008: Should the instructions for rectification not be complied with, or in the case of a grave violation, the
p.000008: National Bioethics Committee or institutional review board may revoke its approval of the study. Should
p.000008: approval be revoked, the study shall cease immediately.
p.000008:
p.000008: Article 30
p.000008: Data Protection Authority monitoring.
p.000008: The Data Protection Authority monitors the processing of personal data in scientific research.
p.000008:
p.000008: Article 31
p.000008: Duty of disclosure to monitoring bodies.
p.000008: The principal investigator and others involved in the implementation of a study shall grant monitoring bodies access
p.000008: to the research premises and shall, notwithstanding the duty of confidentiality, provide them with all
p.000008: information and data which they deem necessary in order to fulfil their duty of monitoring under this Act.
p.000008:
p.000008: Article 32
p.000008: Confidentiality of monitoring bodies.
p.000008: Monitoring bodies and those working for them are subject to the duty of confidentiality under Article 6.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: SECTION VIII
p.000009: Penalties. Article 33 Penalties.
p.000009: Infringement of this Act or, as applicable, rules issued on the basis of this Act, entails fines or imprisonment for up
p.000009: to three years, if the violation does not entail more severe penalties under other legislation:
p.000009: 1. Articles 6 and 32 on confidentiality.
p.000009: 2. Article 7 on retention of health information materials.
p.000009: 3. Article 12 on approval by the National Bioethics Committee or an institutional review board for a scientific
p.000009: research project in the health sector.
p.000009: 4. Article 17 on duty of reporting of unexpected events.
p.000009: 5. Section V on consent for a scientific study on human subjects.
p.000009: 6. Article 20 on alterations to a research protocol.
p.000009: 7. Art 31 on the duty to grant monitoring bodies information, data and access to premises.
p.000009: The same penalties apply if a study is not halted on revocation of a approval for a scientific study by the National
p.000009: Bioethics Committee an institutional review board, cf. paragraph 5 of Article 29.
p.000009: Complicity in such an offence is punishable as provided in the General Penal Code, unless more severe penalties are
p.000009: entailed by other legislation.
p.000009: In the case of an offence committed in the activities of a legal entity, the legal entity may be fined under the
p.000009: provisions of Section II of the General Penal Code.
p.000009:
p.000009: SECTION IX
p.000009: Various provisions.
p.000009: Article 34
p.000009: Authority for issue of regulations.
p.000009: The Minister may make more detailed provision in regulations for the implementation of this Act, inter alia regarding
p.000009: in what cases, and how, a participant in a scientific study is to be informed of important factors revealed by the
p.000009: study which relate to his/her health.
p.000009:
p.000009: Article 35
p.000009: Entry into force.
p.000009: This Act takes effect on 1 January 2015. Temporary Provisions I, however, take effect immediately.
p.000009:
p.000009: Article 36
p.000009: Amendments to other legislation.
p.000009: …
p.000009:
p.000009: Temporary provisions I.
p.000009: Before this Act takes effect the Minister shall appoint a new National Bioethics Committee under Article 9 which shall
p.000009: operate from 1 January 2015. The Minister may also, before this Act takes effect, establish by regulations
p.000009: institutional review boards as authorised in Article 11.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: II.
p.000010: Approval for a scientific research project in the health sector for which an application is received before this Act
p.000010: takes effect is subject to the provisions of the prior Act and regulations. From the entry into force of
p.000010: this Act, all scientific research projects in the health sector are subject to this Act, including those approved on
p.000010: the basis of previous legislation and regulations, which have not been concluded.
p.000010:
p.000010:
p.000010: [This translation is published for information only. The original Icelandic text is published in the Law Gazette.
p.000010: In case of a possible discrepancy, the original Icelandic text applies.]
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
...
General/Other / participants in a control group
Searching for indicator placebo:
(return to top)
p.000004: interaction with the Data Protection Authority under this Article, following consultation with the National
p.000004: Bioethics Committee and the Data Protection Authority.
p.000004: 1) Regulation No. 1187/2014.
p.000004:
p.000004: Article 14
p.000004: Procedure and appeal.
p.000004: The procedure of the National Bioethics Committee and institutional review boards is subject to the
p.000004: provisions of the Administrative Procedures Act.
p.000004: Decisions of review boards appointed under Article 11 may be appealed to the National Bioethics Committee.
p.000004: Decisions of the National Bioethics Committee may be appealed to the Minister. A judgement by the National
p.000004: Bioethics Committee under sentence 2 of paragraph 1 of Article 12 is not liable to review by the Minister.
p.000004:
p.000004: SECTION IV
p.000004: General provisions on scientific research on human subjects.
p.000004: Article 15
p.000004: Scientific research on human subjects.
p.000004: Scientific studies which entail intervention may not be carried out on human subjects if it is deemed likely that
p.000004: the same or a comparable objective can be attained without human participation.
p.000004: Before a scientific study on human subjects is approved, the National Bioethics Committee or an institutional review
p.000004: board shall evaluate potential risk and burden on the one hand, and benefits for the participants or others on the
p.000004: other hand. In research on the effectiveness of a new treatment, with or without placebo, it shall be ensured
p.000004: that patients receive approved treatment. Should it transpire that the risk outweighs the potential
p.000004: benefit, the National Bioethics Committee or an institutional review board will halt the study.
p.000004: Special care shall be taken when recruiting individuals from vulnerable social groups, i.e. individuals who for some
p.000004: reason are not in a position to make an informed or free decision.
p.000004:
p.000004: Article 16
p.000004: Acquisition, use and delivery of health information materials for scientific research.
p.000004: The acquisition, use and delivery of health information materials for use in scientific studies shall be in
p.000004: accord with the objective of the study and with the approval granted by the National Bioethics Committee or an
p.000004: institutional review board.
p.000004:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: Article 17
p.000005: Duty to report unforeseen incidents.
p.000005: The principal investigator of a study shall immediately submit to the monitoring body under paragraphs 2
p.000005: and 3 of Article 29, and to the Data Protection Authority if applicable, written notification of unforeseen
p.000005: incidents which have, or could have, adversely affected participants, and are believed to be attributable to the
p.000005: study.
p.000005: The principal investigator, other investigators and staff shall, on their own initiative, disclose to
p.000005: monitoring bodies information on factors which could pose a risk to the security of participants in the study. An
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| authority | Relationship to Authority |
| child | Child |
| disability | Mentally Disabled |
| educational | education |
| emergency | Public Emergency |
| emergency situation | patients in emergency situations |
| incapable | Mentally Incapacitated |
| minor | Youth/Minors |
| opinion | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| police | Police Officer |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input