Comparison of participant information and informed consent forms of five European studies in genetic isolated populations View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2009-10-14

AUTHORS

Deborah Mascalzoni, A Cecile JW Janssens, Alison Stewart, Peter Pramstaller, Ulf Gyllensten, Igor Rudan, Cornelia M van Duijn, James F Wilson, Harry Campbell, Ruth Mc Quillan,

ABSTRACT

Family-based research in genetically isolated populations is an effective approach for identifying loci influencing variation in disease traits. In common with all studies in humans, those in genetically isolated populations need ethical approval; however, existing ethical frameworks may be inadequate to protect participant privacy and confidentiality and to address participants’ information needs in such populations. Using the ethical–legal guidelines of the Council for International Organizations of Medical Sciences (CIOMS) as a template, we compared the participant information leaflets and consent forms of studies in five European genetically isolated populations to identify additional information that should be incorporated into information leaflets and consent forms to guarantee satisfactorily informed consent. We highlight the additional information that participants require on the research purpose and the reasons why their population was chosen; on the potential risks and benefits of participation; on the opportunities for benefit sharing; on privacy; on the withdrawal of consent and on the disclosure of genetic data. This research raises some important issues that should be addressed properly and identifies relevant types of information that should be incorporated into information leaflets for this type of study. More... »

PAGES

296-302

References to SciGraph publications

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  • 2007-06-28. The UNESCO Universal Declaration on Bioethics and Human Rights: Perspectives from Kenya and South Africa in HEALTH CARE ANALYSIS
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  • 2000-08. Genetic homogeneity of Icelanders: fact or fiction? in NATURE GENETICS
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/ejhg.2009.155

    DOI

    http://dx.doi.org/10.1038/ejhg.2009.155

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1012352309

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/19826451


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    39 schema:description Family-based research in genetically isolated populations is an effective approach for identifying loci influencing variation in disease traits. In common with all studies in humans, those in genetically isolated populations need ethical approval; however, existing ethical frameworks may be inadequate to protect participant privacy and confidentiality and to address participants’ information needs in such populations. Using the ethical–legal guidelines of the Council for International Organizations of Medical Sciences (CIOMS) as a template, we compared the participant information leaflets and consent forms of studies in five European genetically isolated populations to identify additional information that should be incorporated into information leaflets and consent forms to guarantee satisfactorily informed consent. We highlight the additional information that participants require on the research purpose and the reasons why their population was chosen; on the potential risks and benefits of participation; on the opportunities for benefit sharing; on privacy; on the withdrawal of consent and on the disclosure of genetic data. This research raises some important issues that should be addressed properly and identifies relevant types of information that should be incorporated into information leaflets for this type of study.
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