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From: steven perkins <>
Subject: [DNA] Article: Comparison of participant information and informedconsent forms of five European studies in genetic isolatedpopulations
Date: Thu, 18 Feb 2010 12:04:25 -0500


Article

European Journal of Human Genetics (2010) 18, 296–302;
doi:10.1038/ejhg.2009.155; published online 14 October 2009

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

Deborah Mascalzoni1, A Cecile JW Janssens2, Alison Stewart3, Peter
Pramstaller1, Ulf Gyllensten4, Igor Rudan5,6, Cornelia M van Duijn2,
James F Wilson6, Harry Campbell6 and Ruth Mc Quillan6 on behalf of the
EUROSPAN consortium

1. 1Institute of Genetic Medicine, European Academy Bozen/Bolzano
(EURAC), Bolzano, Italy
2. 2Department of Epidemiology, Erasmus MC, University Medical
Center Rotterdam, Rotterdam, The Netherlands
3. 3PHG Foundation, Worts Causeway, Cambridge, UK
4. 4Department of Genetics and Pathology, Rudbeck Laboratory,
Uppsala University, Uppsala, Sweden
5. 5Faculty of Medicine, Croatian Centre for Global Health,
University of Split, Split, Croatia
6. 6Centre for Population Health Sciences, Medical School,
University of Edinburgh, Edinburgh, UK

Correspondence: Dr D Mascalzoni, Institute of Genetic Medicine, EURAC
Research, Viale Druso 1, Bolzano I-39100, Italy. Tel: +39 471 055513;
Fax: +39 471 055599; E-mail:

Received 15 December 2008; Revised 24 August 2009; Accepted 28 August
2009; Published online 14 October 2009.
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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.

Keywords:

informed consent, isolates, participation, EUROSPAN, information
leaflets, ethics


--
Steven C. Perkins
http://stevencperkins.com/
Online Journal of Genetics and Genealogy
http://jgg-online.blogspot.com/
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http://stevencperkins.com/genealogy.html
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http://scpgen.blogspot.com/


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