Details:

Alternative Title:
J Empir Res Hum Res Ethics
Personal Author:
Bailey, Donald B. ; Raspa, Melissa ; Wheeler, Anne C. ; Edwards, Anne ; Bishop, Ellen ; ... More +
Bailey, Donald B. ; Raspa, Melissa ; Wheeler, Anne C. ; Edwards, Anne ; Bishop, Ellen ; Bann, Carla ; Borasky, David ; Appelbaum, Paul S. Less -
Description:
Advances in understanding neurobiology and intellectual disabilities have led to clinical trials testing new medications. This study assessed parents' perceptions of the ability of their son or daughter with fragile X syndrome (FXS), an inherited form of intellectual disability, to participate in the consent process for clinical trials. Four hundred twenty-two families participated in a survey that included six items assessing various aspects of the ability to provide consent. A rank ordering of decisional tasks was found. The easiest task was to understand that the medication was different from his or her medical treatment; the most difficult was the ability to understand and weigh the potential benefits and risks of study participation. Factor analysis suggested that despite the range in difficulty, the six items were best summarized by a single decisional ability score. Parents of 29% of males reported that their son was not at all capable of participating, but the remainder exhibited a range of decisional skills. Factors associated with this variability include age and parents' willingness to enroll their child in clinical trials. We conclude that many individuals with FXS appear to be able to participate at some level in the consent or assent process, but will likely need individualized support to maximize effective participation.
Subjects:
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Adult Clinical Trials As Topic Comprehension Decision Making Disabled Persons Ethics, Research Family Female Fragile X Syndrome Humans Informed Consent Male Middle Aged Parents Perception Research Subjects Surveys And Questionnaires
Source:
J Empir Res Hum Res Ethics. 9(3):18-28.
Pubmed ID:
25422596
Pubmed Central ID:
PMC4240639
Document Type:
Journal Article
Funding:
R01 HD071987/HD/NICHD NIH HHS/United States ; U01 DD000231/DD/NCBDD CDC HHS/United States ; R01HD071987/HD/NICHD NIH HHS/United States ; U01DD000231/DD/NCBDD CDC HHS/United States
R01 HD071987/HD/NICHD NIH HHS/United States ; U01 DD000231/DD/NCBDD CDC HHS/United States ; R01HD071987/HD/NICHD NIH HHS/United States ; U01DD000231/DD/NCBDD CDC HHS/United States Less -
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:c91dc7c790ad994c761e0e879c70df31922cbfff422d071ca9ea59784f0776f3
Download URL:
https://stacks.cdc.gov/view/cdc/32695/cdc_32695_DS1.pdf
File Type:

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