79C3C34C52B45572883A05D425EB0F82
NBC Informed Consent
http://www.vsn.is/en/content/informed-consent
http://leaux.net/URLS/ConvertAPI Text Files/DC2CA855B3090B584CE09D99FD22C219.en.txt
Examining the file media/Synopses/DC2CA855B3090B584CE09D99FD22C219.html:
This file was generated: 2020-12-01 05:57:43
| 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.(None): of broad consent. The committee concerned may also decide that a renewed consent should be elicited, if it deems necessary.
p.(None):
p.(None): Participants who have given broad consent shall have access to information on what research is being carried out by the principal investigator,
p.(None): institution or company. Participants may refuse use of their materials in specified studies, in which case their use is prohibited.
p.(None):
p.(None): Biological samples retained shall be permanently stored in a biobank of scientific samples for use under the provisions of the Biobanks and Health
p.(None): Databanks Act No 110/2000, as amended i.a. 2014.
p.(None):
p.(None): Health data retained shall be permanently stored in a health databank for use under the provisions of the Biobanks and Health Databanks Act.
p.(None): Participants must be informed of this.
p.(None):
p.(None): The principal investigator of a study which deposits biological samples in a biobank, or other health data in a health databank, makes an agreement
p.(None): with the management of the bank on arrangements for access to materials for scientific research. It shall be ensured that the use is covered by the
p.(None): participants’ consent under para. 1 and is consistent with the Data Protection Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Vulnerable Groups including Children
p.(None): Do I need a Research Permit?
p.(None): International context
p.(None): Informed consent
p.(None): Withdrawal of Consent
p.(None): Access to and use of health data and bio-samples.
p.(None): Biobanks
p.(None): Duty to report unexpected events
p.(None): Advertising to recruit participants
p.(None):
p.(None):
p.(None): Dagatal
p.(None):
p.(None):
p.(None): « March 2020 »
p.(None):
p.(None):
p.(None):
p.(None): S M T W T F S
p.(None): 1 2 3 4 5 6 7
p.(None): 8 9 10 11 12 13 14
p.(None): 15 16 17 18 19 20 21
p.(None): 22 23 24 25 26 27 28
p.(None): 29 30 31
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Members of the NBC
p.(None):
p.(None): The National Bioethics Committee, Iceland 1 January 2015 - 31 December 2018
p.(None):
p.(None): Ordinary members and deputy members:
p.(None):
p.(None): Sunna Snædal, MD, Ph.D, Chairman
p.(None): dep. Reynir Tómas Geirsson, Prof. Emer. Obstetrics
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): for participating in a subsequent studies.
p.(None):
p.(None): B) Participants’ consent may be elicited to retain biological samples and health data for subsequent use in designated scientific research in the
p.(None): health sector (broad consent). The NBC or HREC have to approve further use of samples and linked information and may state conditions for the use
p.(None): of broad consent. The committee concerned may also decide that a renewed consent should be elicited, if it deems necessary.
p.(None):
p.(None): Participants who have given broad consent shall have access to information on what research is being carried out by the principal investigator,
p.(None): institution or company. Participants may refuse use of their materials in specified studies, in which case their use is prohibited.
p.(None):
p.(None): Biological samples retained shall be permanently stored in a biobank of scientific samples for use under the provisions of the Biobanks and Health
p.(None): Databanks Act No 110/2000, as amended i.a. 2014.
p.(None):
p.(None): Health data retained shall be permanently stored in a health databank for use under the provisions of the Biobanks and Health Databanks Act.
p.(None): Participants must be informed of this.
p.(None):
p.(None): The principal investigator of a study which deposits biological samples in a biobank, or other health data in a health databank, makes an agreement
p.(None): with the management of the bank on arrangements for access to materials for scientific research. It shall be ensured that the use is covered by the
p.(None): participants’ consent under para. 1 and is consistent with the Data Protection Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Vulnerable Groups including Children
p.(None): Do I need a Research Permit?
p.(None): International context
p.(None): Informed consent
p.(None): Withdrawal of Consent
p.(None): Access to and use of health data and bio-samples.
p.(None): Biobanks
p.(None): Duty to report unexpected events
p.(None): Advertising to recruit participants
p.(None):
p.(None):
p.(None): Dagatal
p.(None):
p.(None):
p.(None): « March 2020 »
p.(None):
p.(None):
p.(None):
p.(None): S M T W T F S
p.(None): 1 2 3 4 5 6 7
p.(None): 8 9 10 11 12 13 14
p.(None): 15 16 17 18 19 20 21
p.(None): 22 23 24 25 26 27 28
p.(None): 29 30 31
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Members of the NBC
p.(None):
p.(None): The National Bioethics Committee, Iceland 1 January 2015 - 31 December 2018
p.(None):
p.(None): Ordinary members and deputy members:
p.(None):
p.(None): Sunna Snædal, MD, Ph.D, Chairman
p.(None): dep. Reynir Tómas Geirsson, Prof. Emer. Obstetrics
p.(None): Rögnvaldur G. Gunnarsson, MJur, Philosophy
p.(None): dep. Hafrún Kristjánsdóttir, Ph.D. Psychology
p.(None): Una Strand Viðarsdóttir, Ph.D. Anatomist
p.(None): dep. Stefán Baldursson, Ph.D, Pedagogy
p.(None): Flóki Ásgeirsson, LL.M., Law
p.(None): dep Svala Ísfeld Ólafsdóttir, MA Law
p.(None): Védís Helga Eiríksdóttir, PhD, Public Health
...
Searching for indicator access to information:
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p.(None): 3. Respect the autonomy of participants concernig the decision to participate or not participate in a biomedical study.
p.(None): 4. Respect for the participants right to determine the use, destruction or retention of all research data concerning her person person, incl
p.(None): biological samples.
p.(None):
p.(None): Consent may, as applicable, consist in answering a questionnaire, provided that the provisions of clauses 1 and 2 on the provision of information are
p.(None): fulfilled.
p.(None):
p.(None): There are two types of consent:
p.(None):
p.(None): A) A limited/narrow consent for participation in a single study without allowing health data or biological samples to be retained or to be called upon
p.(None): for participating in a subsequent studies.
p.(None):
p.(None): B) Participants’ consent may be elicited to retain biological samples and health data for subsequent use in designated scientific research in the
p.(None): health sector (broad consent). The NBC or HREC have to approve further use of samples and linked information and may state conditions for the use
p.(None): of broad consent. The committee concerned may also decide that a renewed consent should be elicited, if it deems necessary.
p.(None):
p.(None): Participants who have given broad consent shall have access to information on what research is being carried out by the principal investigator,
p.(None): institution or company. Participants may refuse use of their materials in specified studies, in which case their use is prohibited.
p.(None):
p.(None): Biological samples retained shall be permanently stored in a biobank of scientific samples for use under the provisions of the Biobanks and Health
p.(None): Databanks Act No 110/2000, as amended i.a. 2014.
p.(None):
p.(None): Health data retained shall be permanently stored in a health databank for use under the provisions of the Biobanks and Health Databanks Act.
p.(None): Participants must be informed of this.
p.(None):
p.(None): The principal investigator of a study which deposits biological samples in a biobank, or other health data in a health databank, makes an agreement
p.(None): with the management of the bank on arrangements for access to materials for scientific research. It shall be ensured that the use is covered by the
p.(None): participants’ consent under para. 1 and is consistent with the Data Protection Act.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Vulnerable Groups including Children
p.(None): Do I need a Research Permit?
p.(None): International context
p.(None): Informed consent
p.(None): Withdrawal of Consent
p.(None): Access to and use of health data and bio-samples.
p.(None): Biobanks
p.(None): Duty to report unexpected events
p.(None): Advertising to recruit participants
p.(None):
p.(None):
p.(None): Dagatal
p.(None):
p.(None):
...
Social / Marital Status
Searching for indicator single:
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p.(None): after it commences, without stating any reason.
p.(None):
p.(None): The objective of obtaining informed consent from participanits in a scientific study within the health sector is to secure and protect their rights and
p.(None): interests:
p.(None):
p.(None): 1. Respect for their dignity - people shall not be enrolled in a scientific study within the healts sector withour due reason and participants shall
p.(None): enjoy respect in every sense.
p.(None): 2. Care for their health and wellbeing - inconvenience and risk due to participation shall at all times be to an acceptable minimum and the
p.(None): objective must be to find ways to diagnose or treat diseases, understand their mechanisims and to imptove health and wellbeing.
p.(None): 3. Respect the autonomy of participants concernig the decision to participate or not participate in a biomedical study.
p.(None): 4. Respect for the participants right to determine the use, destruction or retention of all research data concerning her person person, incl
p.(None): biological samples.
p.(None):
p.(None): Consent may, as applicable, consist in answering a questionnaire, provided that the provisions of clauses 1 and 2 on the provision of information are
p.(None): fulfilled.
p.(None):
p.(None): There are two types of consent:
p.(None):
p.(None): A) A limited/narrow consent for participation in a single study without allowing health data or biological samples to be retained or to be called upon
p.(None): for participating in a subsequent studies.
p.(None):
p.(None): B) Participants’ consent may be elicited to retain biological samples and health data for subsequent use in designated scientific research in the
p.(None): health sector (broad consent). The NBC or HREC have to approve further use of samples and linked information and may state conditions for the use
p.(None): of broad consent. The committee concerned may also decide that a renewed consent should be elicited, if it deems necessary.
p.(None):
p.(None): Participants who have given broad consent shall have access to information on what research is being carried out by the principal investigator,
p.(None): institution or company. Participants may refuse use of their materials in specified studies, in which case their use is prohibited.
p.(None):
p.(None): Biological samples retained shall be permanently stored in a biobank of scientific samples for use under the provisions of the Biobanks and Health
p.(None): Databanks Act No 110/2000, as amended i.a. 2014.
p.(None):
p.(None): Health data retained shall be permanently stored in a health databank for use under the provisions of the Biobanks and Health Databanks Act.
p.(None): Participants must be informed of this.
p.(None):
p.(None): The principal investigator of a study which deposits biological samples in a biobank, or other health data in a health databank, makes an agreement
...
Social / philosophical differences/differences of opinion
Searching for indicator philosophy:
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p.(None): Do I need a Research Permit?
p.(None): International context
p.(None): Informed consent
p.(None): Withdrawal of Consent
p.(None): Access to and use of health data and bio-samples.
p.(None): Biobanks
p.(None): Duty to report unexpected events
p.(None): Advertising to recruit participants
p.(None):
p.(None):
p.(None): Dagatal
p.(None):
p.(None):
p.(None): « March 2020 »
p.(None):
p.(None):
p.(None):
p.(None): S M T W T F S
p.(None): 1 2 3 4 5 6 7
p.(None): 8 9 10 11 12 13 14
p.(None): 15 16 17 18 19 20 21
p.(None): 22 23 24 25 26 27 28
p.(None): 29 30 31
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Members of the NBC
p.(None):
p.(None): The National Bioethics Committee, Iceland 1 January 2015 - 31 December 2018
p.(None):
p.(None): Ordinary members and deputy members:
p.(None):
p.(None): Sunna Snædal, MD, Ph.D, Chairman
p.(None): dep. Reynir Tómas Geirsson, Prof. Emer. Obstetrics
p.(None): Rögnvaldur G. Gunnarsson, MJur, Philosophy
p.(None): dep. Hafrún Kristjánsdóttir, Ph.D. Psychology
p.(None): Una Strand Viðarsdóttir, Ph.D. Anatomist
p.(None): dep. Stefán Baldursson, Ph.D, Pedagogy
p.(None): Flóki Ásgeirsson, LL.M., Law
p.(None): dep Svala Ísfeld Ólafsdóttir, MA Law
p.(None): Védís Helga Eiríksdóttir, PhD, Public Health
p.(None): dep, Elías Freyr Guðmundsson, M.Sc., biology epidemiology
p.(None): Sigurður Guðmundsson, MD, Ph.D
p.(None): dep. Guðrún V. Skúladóttir, Ph.D Physiology,
p.(None): Henry A. Henrysson, PhD, Philosophy, Ethics
p.(None): dep. Helga Þorbergsdóttir, RN., Community Nursing
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Vísindasiðanefnd | Borgartún 21- 4. hæð, 105 Reykjavík | vsn@vsn.is | Sími: +354 5517100 |
p.(None): Kennitala: 680800-2510
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
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p.(None):
p.(None):
p.(None):
p.(None): HOME NEWS THE BIOETHICS COMMITTEE SYSTEM CRITERIA GENERAL STUDIES CLINICAL TRIALS LINKS
p.(None):
p.(None):
p.(None):
p.(None): Home » Criteria
p.(None):
p.(None):
p.(None):
p.(None): Informed consent
p.(None): Consent shall be elicited from participants in a scientific study on human subjects. The consent shall be in writing and freely granted after the
p.(None): participant has been provided with adequate information on the study, risks that participation may entail, potential benefits, and the nature of the
p.(None): participation. The participant shall be informed that he/she may decline to take part in a scientific study, or withdraw from participation at any time
p.(None): after it commences, without stating any reason.
p.(None):
p.(None): The objective of obtaining informed consent from participanits in a scientific study within the health sector is to secure and protect their rights and
p.(None): interests:
p.(None):
p.(None): 1. Respect for their dignity - people shall not be enrolled in a scientific study within the healts sector withour due reason and participants shall
p.(None): enjoy respect in every sense.
p.(None): 2. Care for their health and wellbeing - inconvenience and risk due to participation shall at all times be to an acceptable minimum and the
p.(None): objective must be to find ways to diagnose or treat diseases, understand their mechanisims and to imptove health and wellbeing.
p.(None): 3. Respect the autonomy of participants concernig the decision to participate or not participate in a biomedical study.
p.(None): 4. Respect for the participants right to determine the use, destruction or retention of all research data concerning her person person, incl
p.(None): biological samples.
p.(None):
p.(None): Consent may, as applicable, consist in answering a questionnaire, provided that the provisions of clauses 1 and 2 on the provision of information are
p.(None): fulfilled.
p.(None):
p.(None): There are two types of consent:
p.(None):
p.(None): A) A limited/narrow consent for participation in a single study without allowing health data or biological samples to be retained or to be called upon
p.(None): for participating in a subsequent studies.
p.(None):
p.(None): B) Participants’ consent may be elicited to retain biological samples and health data for subsequent use in designated scientific research in the
p.(None): health sector (broad consent). The NBC or HREC have to approve further use of samples and linked information and may state conditions for the use
p.(None): of broad consent. The committee concerned may also decide that a renewed consent should be elicited, if it deems necessary.
p.(None):
p.(None): Participants who have given broad consent shall have access to information on what research is being carried out by the principal investigator,
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| access to information | Access to information |
| autonomy | Impaired Autonomy |
| philosophy | philosophical differences/differences of opinion |
| single | Marital Status |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protect
protection
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input