title: Informed consent form challenges for genetic research in a developing Arab country with high risk for genetic disease.
abstract: The prevalence of genetic disease is high in the Middle East, particularly in the United Arab Emirates. Our study assesses the information provided in, and the readability ease of, informed consent forms (ICF) for genetic research studies. A multicenter retrospective cross-sectional review of 54 ICFs was conducted to assess compliance by comparing them with standard good clinical practice guidelines for developing consent forms. Readability of the forms was determined using the Flesch-Kincaid scale. Overall Good Clinical Practice compliance for the ICFs averaged at 63 %. Information regarding privacy, confidentiality, specimen collection and storage were absent from the majority of the ICFs. Readability ease score was low (36.7 ± 4.6) and required college-level (11.8 ± 1.4) reading skills to understand the information. Our study highlights the need to improve the readability and information contained in the ICFs for genetic research studies in our setting. Our findings may be generalized to similar cultures in the Middle East and Asia.
authors.affiliation: Department of Academic Affairs, Medical Affairs, Tawam Hospital-In Affiliation with Johns Hopkins Medicine (USA), Post Box 15258, Al Ain, United Arab Emirates, schandra@tawamhospital.ae.
authors.forename: Satish Chandrasekhar
authors.initials: SC
authors.lastname: Nair
authors.forename: Halah
authors.initials: H
authors.lastname: Ibrahim
mesh_terms: D032882:Comprehension; D032962:Consent Forms; D003430:Cross-Sectional Studies; D003906:Developing Countries; D036281:Genetic Research; D006801:Humans; D011932:Reading; D012189:Retrospective Studies; D014479:United Arab Emirates