Children's rights in clinical research.
OBJECTIVE
To address the use of children and children's genetic information in research, analyze Icelandic laws as an example, review existing literature on children in clinical research, and describe nurses' actions as children's advocates.


METHODS
An integrated literature review was conducted using theoretical and empirical literature on children as human subjects in clinical research. Five Icelandic laws were analyzed.


RESULTS
Legal protection of children as human subjects is an international issue and is lacking in Icelandic legislation. In spite of an identified need to protect children as human subjects, research on children's rights in clinical research is scarce. Nurses have not taken an active stance in protecting children as human subjects.


CONCLUSIONS
The recently passed Bill on Health Sector Database in Iceland raises questions about protection of human subjects regardless of age and stature. The effects of this Icelandic case could have international implications regarding centralized health care databases, ownership of data, and related ethical and legal decisions.
Bragadóttir
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University of Iowa College of Nursing, Iowa City 52241-1121, USA. helga-bragadottir@uiowa.edu
D000293:Adolescent; D002648:Child; D002669:Child Welfare; D004992:Ethics, Medical; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D006801:Humans; D007055:Iceland; D007258:Informed Consent; D007391:International Cooperation; D010344:Patient Advocacy / Q000331:legislation & jurisprudence; D011640:Public Policy