英国OFH项目泛知情同意实践及对我国的启示.pdfVIP

医学科研伦理

医学与哲学2025

年12

月第46

卷第

23

期总第778期

英国OFH项目泛知情同意实践

及对我国的启示*

黄媛媛刘辉11

摘要：在大数据与人工智能迅猛发展的背景下，传统的具体知情同意模式正面临严峻挑战。以英国“我们未来的健康”（Our

Future

Health）项目为例，探讨了其在泛知情同意模式下的实践及治理体系。该项目能够获得较高的公众信任，主要得益于其完

善的泛知情同意流程、高度透明的信息披露、广泛的公众参与，以及健全的治理结构与制度框架。分析了其面临的争议，如

宣传误导、招募过程的潜在不平等效应、风险披露不足以及退出机制的不完善。在结合我国国情基础上，提出应构建和明确

泛知情同意合法性依据，完善泛知情同意流程，加强数据治理体系建设，提升透明度，并积极促进公众参与。

关键词：泛知情同意，数据治理，透明度，公众参与

中图分类号：R-05文献标识码：A文章编号：1002-0772(2025)23-0025-06

DOI：10.12014/j.issn.1002-0772.2025.23.05

ThePracticeofBroadInformedConsentintheUKOurFutureHealthProjectandItsImplicationsforChinaHUANG

11

Yuanyuan,

LIUHui．1.

InstituteofMedicalInformation,ChineseAcademyofMedicalSciences,Beijing100020,China

Abstract：The

rapid

advancements

in

big

data

and

artificial

intelligence

have

posed

challenges

to

the

traditional

model

of

specific

informed

consent.

This

paper

examines

the

practices

and

governance

framework

of

the

UK

Our

Future

Health

project,

which

operates

under

a

broad

consent

model.

The

project

has

garnered

a

relatively

high

level

of

public

trust,

largely

due

to

its

well-established

broad

informed

consent

procedures,

transparent

information

disclosure,

extensive

public

engagement,

and

robust

governance

structures

and

institutional

framework.

However,

the

paper

also

scrutinizes

the

controversies

it

has

faced,

such

as

potential

misleading

publicity,

inequalities

in

the

recruitment

p