title: Comparison of participant information and informed consent forms of five European studies in genetic isolated populations.
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.
authors.affiliation: Institute of Genetic Medicine, European Academy Bozen/Bolzano (EURAC), Bolzano, Italy. deborah.mascalzoni@eurac.edu
authors.forename: Deborah
authors.initials: D
authors.lastname: Mascalzoni
authors.forename: A Cecile J W
authors.initials: AC
authors.lastname: Janssens
authors.forename: Alison
authors.initials: A
authors.lastname: Stewart
authors.forename: Peter
authors.initials: P
authors.lastname: Pramstaller
authors.forename: Ulf
authors.initials: U
authors.lastname: Gyllensten
authors.forename: Igor
authors.initials: I
authors.lastname: Rudan
authors.forename: Cornelia M
authors.initials: CM
authors.lastname: van Duijn
authors.forename: James F
authors.initials: JF
authors.lastname: Wilson
authors.forename: Harry
authors.initials: H
authors.lastname: Campbell
authors.forename: Ruth M C
authors.initials: RM
authors.lastname: Quillan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D032962:Consent Forms / Q000941:ethics*; D005006:Ethnicity / Q000235:genetics* / Q000331:legislation & jurisprudence*; D005060:Europe; D006801:Humans; D008875:Middle Aged; D010358:Patient Participation / Q000331:legislation & jurisprudence*; D018579:Patient Selection / Q000941:ethics; D017410:Practice Guidelines as Topic; D012955:Societies, Medical; D055815:Young Adult