Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

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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.

Electronic supplementary material

The online version of this article (10.1186/s13063-019-3340-5) contains supplementary material, which is available to authorized users.

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Most cited references 15

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The disappearing subject: exclusion of people with cognitive impairment and dementia from geriatrics research.

Soo Borson, S. Demers, Susan S. Taylor … (2012)

To evaluate exclusion of persons with cognitive impairment from research in geriatrics by determining its frequency, method, and rationale and treatment in the resulting publications. All original research articles published in 2008 and 2009 in the Journal of the American Geriatrics Society (n = 434) were reviewed using a structured data collection tool. The Journal of the American Geriatrics Society. There were no participants in this study. Data captured included recruitment method, explicit criterion for exclusion of persons with cognitive impairment, justification of exclusion criterion, reason given for exclusion, percentage of individuals excluded, and mention of exclusion as a possible limitation. Of 434 articles examined, 16% used recruitment methods likely to reduce participation by persons with cognitive impairment. At least 29% of studies (n = 127) employed explicit exclusion criteria. Half used the Folstein Mini-Mental State Examination (MMSE), with variable cut points (10, 12, 17, 18, 23, 26), and 19% excluded individuals for "having dementia" without specifying how this was determined. Few (6%) provided any justification for exclusion criteria used, only 43% gave any reason for exclusion, and only 14% discussed exclusion as a possible limitation. Persons with cognitive impairment are frequently excluded from research, often without rationale or mention of exclusion as a limitation or any discussion of its potential effect on the evidence base in geriatrics. When necessary, exclusion should be done thoughtfully and with awareness that this may reduce the clinical utility of study findings. © 2012, Copyright the Authors Journal compilation © 2012, The American Geriatrics Society.

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Participant Comprehension of Research for Which They Volunteer: A Systematic Review

Wanda Montalvo, Elaine Larson (2014)

Evidence indicates that research participants often do not fully understand the studies for which they have volunteered. The aim of this systematic review was to examine the relationship between the process of obtaining informed consent for research and participant comprehension and satisfaction with the research.

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Research involving adults lacking capacity to consent: the impact of research regulation on ‘evidence biased’ medicine

Victoria Shepherd (2016)

Background Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals’ exclusion from research as a result of such regulation risks condemning such populations to poor quality care as a result of ‘evidence biased’ medicine. Main Text This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use (Clinical Trials) Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs. Conclusion The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented.

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Author and article information

Contributors

Victoria Shepherd:

ORCID: http://orcid.org/0000-0002-7687-0817

ShepherdVL1@cardiff.ac.uk

Fiona Wood: Wood@cardiff.ac.uk

Richard Griffith: Richard.griffith@swansea.ac.uk

Mark Sheehan: mark.sheehan@ethocx.ox.ac.uk

Kerenza Hood: Hood1@cardiff.ac.uk

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 25 April 2019

Publication date PMC-release: 25 April 2019

Publication date Collection: 2019

Volume: 20

Electronic Location Identifier: 233

Affiliations

[1 ]ISNI 0000 0001 0807 5670, GRID grid.5600.3, Division of Population Medicine, , Cardiff University, ; Heath Park, Cardiff, CF14 4YS UK

[2 ]ISNI 0000 0001 0807 5670, GRID grid.5600.3, Centre for Trials Research, Cardiff University, ; Heath Park, Cardiff, CF14 4YS UK

[3 ]ISNI 0000 0001 0658 8800, GRID grid.4827.9, College of Human and Health Studies, , Swansea University, ; Singleton Park, Swansea, SA2 8PP UK

[4 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Ethox Centre, University of Oxford, Big Data Institute, ; Old Road Campus, Oxford, OX3 7LF UK

Author information

Victoria Shepherd http://orcid.org/0000-0002-7687-0817

Article

Publisher ID: 3340

DOI: 10.1186/s13063-019-3340-5

PMC ID: 6482489

PubMed ID: 31023383

SO-VID: 554ecf11-624b-4291-bc9d-c1a1bad9587b

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.

History

Date received : 3 March 2018

Date accepted : 2 April 2019

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100012068, Health and Care Research Wales;

Award ID: NIHR-FS-2016

Award Recipient : Victoria Shepherd

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: informed consent,mental capacity,proxy,content analysis,participant information sheets,randomised controlled trials

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ScienceOpen disciplines: Medicine

Keywords: informed consent, mental capacity, proxy, content analysis, participant information sheets, randomised controlled trials

Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales

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Most cited references 15

The disappearing subject: exclusion of people with cognitive impairment and dementia from geriatrics research.

Participant Comprehension of Research for Which They Volunteer: A Systematic Review

Research involving adults lacking capacity to consent: the impact of research regulation on ‘evidence biased’ medicine

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