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| Content Provider | Springer Nature : BioMed Central |
|---|---|
| Author | Shepherd, Victoria Wood, Fiona Griffith, Richard Sheehan, Mark Hood, Kerenza |
| Abstract | Background Research involving adults who lack the capacity to provide informed consent can be challenging. In England and Wales there are legal provisions for consulting with others who know the person with impaired capacity. The role of the ‘proxy’ (or ‘surrogate’) is to advise researchers about the person’s wishes and feelings or to provide consent on the person’s behalf for a clinical trial of a medicine. Information about the study is usually provided to the proxy; however, little information is available to proxies about their role, or the appropriate legal and ethical basis for their decision, to help inform their decision-making. The aim of this study was to analyse the written information that is provided to consultees and legal representatives. Methods Studies including adults lacking capacity to consent which utilised consultees or legal representatives were identified using the UK Clinical Trials Gateway database. A representative sample (n = 30) were randomly selected. Information sheets and other study documents provided to proxies were obtained, and relevant content was extracted. Content analysis was conducted through four stages: decontextualisation of the unit of analysis, recontextualisation, categorisation, and compilation. The data were summarised narratively according to each theme and category. Results Considerable variation was found in the written information sheets provided to proxies. Most directed proxies to consider the wishes and feelings of the person who lacked capacity and to consult with others during the decision-making process. However, a small number of studies extended the scope of the proxy’s role to consider the person’s suitability or eligibility for the study. Particular discrepancies were found in information provided to those acting as consultees or legal representatives in a professional, as opposed to a personal, capacity. Incorrect uses of terminology were frequently found, and a small number of studies inaccurately interpreted the law. Conclusions Despite undergoing ethical review, study documents lacked essential information, incorrectly used terminology, and conflated professionals’ clinical and representation roles. Future recommendations include ensuring proxies are provided with adequate and accurate information which complies with the legal frameworks. Further research is needed to explore the information and decision-making needs of those acting as consultees and legal representatives. |
| Related Links | https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-019-3340-5.pdf |
| Ending Page | 12 |
| Page Count | 12 |
| Starting Page | 1 |
| File Format | HTM / HTML |
| ISSN | 17456215 |
| DOI | 10.1186/s13063-019-3340-5 |
| Journal | Trials |
| Issue Number | 1 |
| Volume Number | 20 |
| Language | English |
| Publisher | BioMed Central |
| Publisher Date | 2019-04-25 |
| Access Restriction | Open |
| Subject Keyword | Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Informed consent mental capacity proxy content analysis participant information sheets randomised controlled trials Medicine/Public Health |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine Pharmacology (medical) |
| Journal Impact Factor | 2/2023 |
| 5-Year Journal Impact Factor | 2.1/2023 |
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