生物库与研究同意：英格兰东北部年轻人观点的定性主题分析。

Biobanking and consenting to research: a qualitative thematic analysis of young people's perspectives in the North East of England.

机构信息

Paediatric Immunology, Infectious Diseases & Allergy, Great North Children's Hospital, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.

Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, UK.

出版信息

BMC Med Ethics. 2023 Jul 5;24(1):47. doi: 10.1186/s12910-023-00925-w.

DOI:10.1186/s12910-023-00925-w

PMID:37407992

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10324191/

Abstract

BACKGROUND

Biobanking biospecimens and consent are common practice in paediatric research. We need to explore children and young people's (CYP) knowledge and perspectives around the use of and consent to biobanking. This will ensure meaningful informed consent can be obtained and improve current consent procedures.

METHODS

We designed a survey, in co-production with CYP, collecting demographic data, views on biobanking, and consent using three scenarios: 1) prospective consent, 2) deferred consent, and 3) reconsent and assent at age of capacity. The survey was disseminated via the Young Person's Advisory Group North England (YPAGne) and participating CYP's secondary schools. Data were analysed using a qualitative thematic approach by three independent reviewers (including CYP) to identify common themes. Data triangulation occurred independently by a fourth reviewer.

RESULTS

One hundred two CYP completed the survey. Most were between 16-18 years (63.7%, N = 65) and female (66.7%, N = 68). 72.3% had no prior knowledge of biobanking (N = 73). Acceptability of prospective consent for biobanking was high (91.2%, N = 93) with common themes: 'altruism', 'potential benefits outweigh individual risk', 'frugality', and '(in)convenience'. Deferred consent was also deemed acceptable in the large majority (84.3%, N = 86), with common themes: 'altruism', 'body integrity' and 'sample frugality'. 76.5% preferred to reconsent when cognitively mature enough to give assent (N = 78), even if parental consent was previously in place. 79.2% wanted to be informed if their biobanked biospecimen is reused (N = 80).

CONCLUSION

Prospective and deferred consent acceptability for biobanking is high among CYP in the UK. Altruism, frugality, body integrity, and privacy are the most important themes. Clear communication and justification are paramount to obtain consent. Any CYP with capacity should be part of the consenting procedure, if possible.

摘要

背景

生物银行采集生物样本和获得同意是儿科研究中的常见做法。我们需要探讨儿童和青少年（CYP）对生物银行的使用和同意的认识和看法。这将确保能够获得有意义的知情同意，并改进当前的同意程序。

方法

我们与 CYP 共同设计了一项调查，收集人口统计学数据、对生物银行的看法以及使用三种情况（1）前瞻性同意、2）延期同意和 3）达到能力年龄时重新同意和同意的同意，使用三种情况进行同意。该调查通过英格兰北部青年顾问小组（YPAGne）和参与 CYP 的中学进行了传播。数据由三名独立评审员（包括 CYP）使用定性主题方法进行分析，以确定共同主题。数据由第四名评审员独立进行三角剖分。

结果

共有 102 名 CYP 完成了调查。大多数人在 16-18 岁之间（63.7%，N=65），女性（66.7%，N=68）。72.3%（N=73）对生物银行一无所知。前瞻性同意生物银行的接受度很高（91.2%，N=93），常见主题包括：“利他主义”、“潜在利益超过个人风险”、“节俭”和“（不）方便”。在绝大多数情况下（84.3%，N=86），延期同意也被认为是可以接受的，常见主题包括：“利他主义”、“身体完整性”和“样本节俭”。76.5%（N=78）希望在认知成熟到足以给予同意时重新同意，即使之前已经获得了父母的同意。79.2%（N=80）希望在其生物银行生物样本被重新使用时得到通知。