Young People Consenting to Medical Research

Fliss G Davies; Harri Fisher; Giles M Birchley

doi:10.1136/archdischild-2023-325692

Young People Consenting to Medical Research

Fliss G Davies^*, Harri Fisher, Giles M Birchley^*

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

1 Citation (Scopus)

68 Downloads (Pure)

Abstract

The regulations and guidance regarding young people’s consent to participate in medical research are complex.1 Current regulations divide medical research into two types: research that involves the trial of a medication and research that does not (figure 1). Trials of medications are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004,2 whereas other forms of medical research operate without statutory guidance. The statute states that anyone aged 16 years or older can consent to participate in a clinical trial. Those under the age of 16 cannot consent, and consent must be provided by a parent or guardian. This age-based approach is in keeping with other legislation surrounding a young person’s decision-making, such as age limits on learning to drive or buying a lottery ticket. This approach is pragmatic, as it is straightforward to identify which young people can consent for themselves.

Original language	English
Pages (from-to)	349-350
Number of pages	2
Journal	Archives of Disease in Childhood
Volume	109
Issue number	4
Early online date	28 Jun 2023
DOIs	https://doi.org/10.1136/archdischild-2023-325692
Publication status	Published - 19 Mar 2024

Bibliographical note

Funding Information:
GB’s research was funded in whole, or in part, by the Wellcome Trust (grant no 209841/Z/17/Z). For the purpose of Open Access, the authors have applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. FD is an academic foundation doctor with research time funded by the Health Education Authority.

Funding Information:
HF acknowledges the support from the National Institute for Health Research (NIHR) Health Protection Research Unit in Behavioural Science and Evaluation at the University of Bristol. The Health Protection Research Unit in Behavioural Science and Evaluation at the University of Bristol is part of the NIHR and a partnership between University of Bristol and the UK Health Security Agency, in collaboration with the MRC Biostatistics Unit at the University of Cambridge and the University of the West of England.

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This is the accepted author manuscript (AAM). The final published version (version of record) is available online via the BMJ Publishing Group at http://dx.doi.org/10.1136/archdischild-2023-325692. Please refer to any applicable terms of use of the publisher.
Accepted author manuscript, 175 KBLicence: CC BY

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Balancing Best Interests in Health Care, Ethics and Law (BABEL)
Huxtable, R. (Principal Investigator), Laing, J. M. (Co-Investigator), Ives, J. C. S. (Co-Investigator), McGuinness, S. (Collaborator), Birchley, G. M. (Researcher), Valenti, E. (Researcher), Guilloud, S. J. (Researcher) & Finnerty, A. M. (Researcher)
1/09/18 → 31/08/23
Project: Research

Cite this

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title = "Young People Consenting to Medical Research",

abstract = "The regulations and guidance regarding young people{\textquoteright}s consent to participate in medical research are complex.1 Current regulations divide medical research into two types: research that involves the trial of a medication and research that does not (figure 1). Trials of medications are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004,2 whereas other forms of medical research operate without statutory guidance. The statute states that anyone aged 16 years or older can consent to participate in a clinical trial. Those under the age of 16 cannot consent, and consent must be provided by a parent or guardian. This age-based approach is in keeping with other legislation surrounding a young person{\textquoteright}s decision-making, such as age limits on learning to drive or buying a lottery ticket. This approach is pragmatic, as it is straightforward to identify which young people can consent for themselves.",

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note = "Funding Information: GB{\textquoteright}s research was funded in whole, or in part, by the Wellcome Trust (grant no 209841/Z/17/Z). For the purpose of Open Access, the authors have applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. FD is an academic foundation doctor with research time funded by the Health Education Authority. Funding Information: HF acknowledges the support from the National Institute for Health Research (NIHR) Health Protection Research Unit in Behavioural Science and Evaluation at the University of Bristol. The Health Protection Research Unit in Behavioural Science and Evaluation at the University of Bristol is part of the NIHR and a partnership between University of Bristol and the UK Health Security Agency, in collaboration with the MRC Biostatistics Unit at the University of Cambridge and the University of the West of England. ",

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AB - The regulations and guidance regarding young people’s consent to participate in medical research are complex.1 Current regulations divide medical research into two types: research that involves the trial of a medication and research that does not (figure 1). Trials of medications are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004,2 whereas other forms of medical research operate without statutory guidance. The statute states that anyone aged 16 years or older can consent to participate in a clinical trial. Those under the age of 16 cannot consent, and consent must be provided by a parent or guardian. This age-based approach is in keeping with other legislation surrounding a young person’s decision-making, such as age limits on learning to drive or buying a lottery ticket. This approach is pragmatic, as it is straightforward to identify which young people can consent for themselves.

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Young People Consenting to Medical Research

Abstract

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Balancing Best Interests in Health Care, Ethics and Law (BABEL)

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