title: Informed consent documents for BRCA1 and BRCA2 screening: how large is the readability gap?
abstract: The decision to undergo testing for the BRCA1 and BRCA2 mutations, which are associated with an increased risk of breast and ovarian cancer, can have long-term consequences on women's lives. Women who decide to undergo such testing are required to sign informed consent documents, which indicate that they understand the test and its risks and benefits. These documents are generally written for advanced-level readers. However, the reading abilities of many women are substantially lower than the level of the consent forms, resulting in a 'readability gap'. This disparity suggests that women may not fully understand the documents they are asked to sign. The 'readability gap' poses the serious issues about informed consent, raising questions about institutional review boards and the effectiveness of the documents that are currently in use.
authors.affiliation: Program in Health and Behavior Measurement, Research Triangle Institute, Washington, DC 20036, USA. jgribble@rti.org
authors.forename: J N
authors.initials: JN
authors.lastname: Gribble
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019313:BRCA1 Protein / Q000235:genetics*; D024682:BRCA2 Protein; D001943:Breast Neoplasms / Q000235:genetics / Q000517:prevention & control*; D004282:Documentation / Q000592:standards*; D004522:Educational Status; D005260:Female; D005820:Genetic Testing / Q000523:psychology*; D006801:Humans; D007258:Informed Consent; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000235:genetics*; D011932:Reading; D014157:Transcription Factors / Q000235:genetics*; D014481:United States
chemical_list: D019313:BRCA1 Protein; D024682:BRCA2 Protein; D009363:Neoplasm Proteins; D014157:Transcription Factors