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Informed consent
Consent shall be elicited from participants in a scientific study on human subjects. The consent shall be in writing and freely granted after the
participant has been provided with adequate information on the study, risks that participation may entail, potential benefits, and the nature of the
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
after it commences, without stating any reason.

The objective of obtaining informed consent from participanits in a scientific study within the health sector is to secure and protect their rights and
interests:

    1. Respect for their dignity - people shall not be enrolled in a scientific study within the healts sector withour due reason and participants shall
       enjoy respect in every sense.
    2. Care for their health and wellbeing - inconvenience and risk due to participation shall at all times be to an acceptable minimum and the
       objective must be to find ways to diagnose or treat diseases, understand their mechanisims and to imptove health and wellbeing.
    3. Respect the autonomy of participants concernig the decision to participate or not participate in a biomedical study.
    4. Respect for the participants right to determine the use, destruction or retention of all research data concerning her person person, incl
       biological samples.

Consent may, as applicable, consist in answering a questionnaire, provided that the provisions of clauses 1 and 2 on the provision of information are
fulfilled.

There are two types of consent:

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
for participating in a subsequent studies.

B) Participants’ consent may be elicited to retain biological samples and health data for subsequent use in designated scientific research in the
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
of broad consent. The committee concerned may also decide that a renewed consent should be elicited, if it deems necessary.

Participants who have given broad consent shall have access to information on what research is being carried out by the principal investigator,
institution or company. Participants may refuse use of their materials in specified studies, in which case their use is prohibited.

Biological samples retained shall be permanently stored in a biobank of scientific samples for use under the provisions of the Biobanks and Health
Databanks Act No 110/2000, as amended i.a. 2014.

Health data retained shall be permanently stored in a health databank for use under the provisions of the Biobanks and Health Databanks Act.
Participants must be informed of this.

The principal investigator of a study which deposits biological samples in a biobank, or other health data in a health databank, makes an agreement
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
participants’ consent under para. 1 and is consistent with the Data Protection Act.




Vulnerable Groups including Children
Do I need a Research Permit?
International context
Informed consent
Withdrawal of Consent
Access to and use of health data and bio-samples.
Biobanks
Duty to report unexpected events
Advertising to recruit participants


Dagatal


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Members of the NBC

The National Bioethics Committee, Iceland 1 January 2015 - 31 December 2018

Ordinary members and deputy members:

      Sunna Snædal, MD, Ph.D, Chairman
      dep. Reynir Tómas Geirsson, Prof. Emer. Obstetrics
      Rögnvaldur G. Gunnarsson, MJur, Philosophy
      dep. Hafrún Kristjánsdóttir, Ph.D. Psychology
      Una Strand Viðarsdóttir, Ph.D. Anatomist
      dep. Stefán Baldursson, Ph.D, Pedagogy
      Flóki Ásgeirsson, LL.M., Law
      dep Svala Ísfeld Ólafsdóttir, MA Law
      Védís Helga Eiríksdóttir, PhD, Public Health
      dep, Elías Freyr Guðmundsson, M.Sc., biology epidemiology
      Sigurður Guðmundsson, MD, Ph.D
      dep. Guðrún V. Skúladóttir, Ph.D Physiology,
      Henry A. Henrysson, PhD, Philosophy, Ethics
      dep. Helga Þorbergsdóttir, RN., Community Nursing




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