Parent Ratings of Ability to Consent for Clinical Trials in Fragile X Syndrome
Bibliographic Data
| ID | 12807350 |
|---|---|
| Authors | Donald B Bailey (0000-0002-0513-9330, RTI International, corresponding author), Melissa Raspa (0000-0003-3791-3367, RTI International), Anne Wheeler (0000-0003-2693-5616, RTI International), Anne Edwards (0000-0001-6014-1655, RTI International), Ellen Bishop (0000-0002-0768-5909, RTI International), Carla Bann (0000-0001-9305-8305, RTI International), David Borasky (University of North Carolina at Chapel Hill), Peter Appelbaum (0000-0002-1940-0042, Columbia University) |
| Year | 2014 |
| Volume | 9 |
| Issue | 3 |
| Pages | 18-28 |
| Publication date | 2014-07-01 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Journal of Empirical Research on Human Research Ethics (JOURNAL) |
| Journal identifiers | ISSN: 1556-2646 • E-ISSN: 1556-2654 |
| Publisher | SAGE Publishing (PUBLISHER • US) |
| DOI | 10.1177/1556264614540591 |
| PMID | 25422596 |
| PMCID | PMC4240639 |
| OpenAlex | W2342167652 |
| Language | EN |
| Citations received | 3 |
| References cited | 48 |
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
Alternative medicine · Clinical trial · Daughter · Developmental psychology · Fragile X syndrome · Informed consent · Intellectual disability · Perception · Psychiatry · Autism Spectrum Disorder Research · Clinical Psychology · Ethics and Legal Issues in Pediatric Healthcare · Genetics and Neurodevelopmental Disorders · Medicine · Psychology
| Citations per year | 0.25 |
|---|---|
| Citation span | 2014 - 2020 (7) |
| Highly cited | No |