An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent
BACKGROUND: There is increasing international recognition that populations included in trials should adequately represent the population treated in clinical practice; however, adults who lack the capacity to provide informed consent are frequently excluded from trials. Addressing the under-represent...
Autor principal: | |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7257506/ https://www.ncbi.nlm.nih.gov/pubmed/32471488 http://dx.doi.org/10.1186/s13063-020-04406-y |
_version_ | 1783540064810172416 |
---|---|
author | Shepherd, Victoria |
author_facet | Shepherd, Victoria |
author_sort | Shepherd, Victoria |
collection | PubMed |
description | BACKGROUND: There is increasing international recognition that populations included in trials should adequately represent the population treated in clinical practice; however, adults who lack the capacity to provide informed consent are frequently excluded from trials. Addressing the under-representation of groups such as those with impaired capacity to consent is essential to develop effective interventions and provide these groups with the opportunity to benefit from evidence-based care. While the spotlight has been on ensuring only appropriate and justifiable exclusion criteria are used in trials, barriers to the inclusion of adults lacking capacity are multifactorial and complex, and addressing their under-representation will require more than merely widening eligibility criteria. This commentary draws on the literature exploring the inclusion of adults lacking the capacity to consent in research and a number of recent studies to describe the methodological, structural, and systemic factors that have been identified. MAIN TEXT: A number of potentially modifiable factors contributing to the under-representation of adults lacking the capacity to consent in trials have been identified. In addition to restrictive eligibility criteria, methodological issues include developing appropriate interventions and outcome measures for populations with impaired capacity. Structurally determined factors include the resource-intensive nature of these trials, the requirement for more appropriate research infrastructure, and a lack of interventions to inform and support proxy decision-makers. Systemic factors include the complexities of the legal frameworks, the challenges of ethical review processes, and paternalistic attitudes towards protecting adults with incapacity from the perceived harms of research. CONCLUSIONS: Measures needed to address under-representation include greater scrutiny of exclusion criteria by those reviewing study proposals, providing education and training for personnel who design, conduct, and review research, ensuring greater consistency in the reviews undertaken by research ethics committees, and extending processes for advance planning to include prospectively appointing a proxy for research and documenting preferences about research participation. Negative societal and professional attitudes towards the inclusion of adults with impaired capacity in research should also be addressed, and the development of trials that are more person-centred should be encouraged. Further work to conceptualise under-representation in trials for such populations may also be helpful. |
format | Online Article Text |
id | pubmed-7257506 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-72575062020-06-07 An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent Shepherd, Victoria Trials Commentary BACKGROUND: There is increasing international recognition that populations included in trials should adequately represent the population treated in clinical practice; however, adults who lack the capacity to provide informed consent are frequently excluded from trials. Addressing the under-representation of groups such as those with impaired capacity to consent is essential to develop effective interventions and provide these groups with the opportunity to benefit from evidence-based care. While the spotlight has been on ensuring only appropriate and justifiable exclusion criteria are used in trials, barriers to the inclusion of adults lacking capacity are multifactorial and complex, and addressing their under-representation will require more than merely widening eligibility criteria. This commentary draws on the literature exploring the inclusion of adults lacking the capacity to consent in research and a number of recent studies to describe the methodological, structural, and systemic factors that have been identified. MAIN TEXT: A number of potentially modifiable factors contributing to the under-representation of adults lacking the capacity to consent in trials have been identified. In addition to restrictive eligibility criteria, methodological issues include developing appropriate interventions and outcome measures for populations with impaired capacity. Structurally determined factors include the resource-intensive nature of these trials, the requirement for more appropriate research infrastructure, and a lack of interventions to inform and support proxy decision-makers. Systemic factors include the complexities of the legal frameworks, the challenges of ethical review processes, and paternalistic attitudes towards protecting adults with incapacity from the perceived harms of research. CONCLUSIONS: Measures needed to address under-representation include greater scrutiny of exclusion criteria by those reviewing study proposals, providing education and training for personnel who design, conduct, and review research, ensuring greater consistency in the reviews undertaken by research ethics committees, and extending processes for advance planning to include prospectively appointing a proxy for research and documenting preferences about research participation. Negative societal and professional attitudes towards the inclusion of adults with impaired capacity in research should also be addressed, and the development of trials that are more person-centred should be encouraged. Further work to conceptualise under-representation in trials for such populations may also be helpful. BioMed Central 2020-05-29 /pmc/articles/PMC7257506/ /pubmed/32471488 http://dx.doi.org/10.1186/s13063-020-04406-y Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Commentary Shepherd, Victoria An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent |
title | An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent |
title_full | An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent |
title_fullStr | An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent |
title_full_unstemmed | An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent |
title_short | An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent |
title_sort | under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent |
topic | Commentary |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7257506/ https://www.ncbi.nlm.nih.gov/pubmed/32471488 http://dx.doi.org/10.1186/s13063-020-04406-y |
work_keys_str_mv | AT shepherdvictoria anunderrepresentedandunderservedpopulationintrialsmethodologicalstructuralandsystemicbarrierstotheinclusionofadultslackingcapacitytoconsent AT shepherdvictoria underrepresentedandunderservedpopulationintrialsmethodologicalstructuralandsystemicbarrierstotheinclusionofadultslackingcapacitytoconsent |