UK NSC stakeholder event 2017 Prof Roger Brownsword ethics presentation

Ethics in Screening: the Role of
the UK NSC Ethics Sub-Group
Prof Roger Brownsword
Public Health England leads the NHS Screening Programmes

Background
Reviews
• Independent review of UK NSC structure (2015)
• Government response (Cm 8999: 2015) to the HC Science and Technology
Committee’s report on ‘National Health Screening’ (HC 244: 2014)
Findings and recommendations
• Confirmation of the UK NSC robust ‘evidence base’ for UK NSC
recommendations
• Evolution of human genetics > > more engagement with and judgements on
ethical, legal and social issues (ELSI)
• The process for reflecting these issues within recommendations needs to be
rigorous, transparent and consistent
2 Ethics in Screening: the Role of the UK NSC Ethics Sub-Group

Recommendations
Review of UK NSC in 2015 identified specific recommendations:
• Training of committee members on ethical, legal and social issues
• Seeking expert ethical, legal and social input from established advisory
groups OR
• Setting up a standing reference group in the future
• Being explicit on process and expertise used when drawing conclusions on
ethical issues
• Inclusion of additional members with ethical and socio-legal expertise

The Sub-group
• These matters have been discussed at meetings of the UK NSC; and there
have been some ethics training sessions
• In Summer 2017, it was agreed that an Ethics Task Group should be set up
to take this work forward

Questions about the UK NSC and Ethics
• Does the UK NSC take ethics seriously? Does it have a checklist?
• Is the UK NSC committed to the right kind of (substantive) ethics?
• Does the UK NSC follow the right kind of ethical processes?
• Are the UK NSC’s ethical commitments and its approach to ethical
questions communicated clearly and transparently?
• Does the UK NSC approach and communicate ethical considerations with
rigour, transparency and consistency?

Taking Ethics Seriously 1
• UK NSC has 20 criteria for appraising the viability, effectiveness and
appropriateness of a screening programme, including:
• the condition
• the test
• the intervention
• the screening programme
• implementation criteria
• No overarching ‘ethics’ headings
• No ethics ‘checklist’

Criterion 12:
There should be evidence that the complete screening programme (test,
diagnostic procedures, treatment/intervention) is clinically, socially and
ethically acceptable to health professionals and the public.
Criterion 13:
The benefit gained by individuals from the screening programme should
outweigh any harms, for example from overdiagnosis, overtreatment, false
positives, false reassurance, uncertain findings and complications.
Ethical commitment > > offering screening programmes that have overall
utility (benefit over harm) and that are ‘acceptable’.

• The standard objection to utilitarian ethics is that the pursuit of the collective
good might be to the detriment of individual rights
• The UK NSC is committed to the importance of individual informed consent.
Screening programmes are not mandatory
• Criterion 11deals specifically with screening that aims to provide informed
choice for those offered screening
• Criterion 19 discusses the information available to assist informed choice on
participation in screening

Is the UK NSC committed to the right kind
of (substantive) ethics?
• UK NSC mission underpinned by utilitarian ethic: improving the general
state of public health
• Individuals invited and individual’s participation is on a free and informed
basis
• However…. other factors for the UK NSC to consider, including:
(i) the case of genetic screening
(ii) reproductive decision making in the fetal anomaly screening programme
and the impact of NIPT.
(iii) the risk of killing the apparently healthy (AAA)

Review of the UK NSC June 2015: the
case of genetic screening
Genetic screening and technologies produce new and complex challenges,
including:
• consent and autonomy
• discrimination and stigmatisation
• issues around reproductive choice
• privacy and confidentiality
• data ownership, storage and sharing
Issues to be considered in an expert and explicit way alongside scientific and
clinical evidence

Nuffield Council on Bioethics (NCOB) Review- NIPT1
• FASP aim is ‘not to promote unlimited choice’
• FASP aims to promote ‘informed choice relating to information about
significant medical conditions and impairments’ (2.87)
• Unintended consequences of providing choice…, including ‘a reduction in
the number of people living with the condition’ (2.89)
• Relative to Criterion 12, ‘assessing the ethical and social issues is
particularly important for prenatal screening programmes’; but this is:
• likely to be ‘challenging’;
• ‘a consensus is not likely to be possible’; and
• ‘a majority judgment is unlikely to be acceptable to everyone’ (2.92)
• The potential effects on people with the condition being screened for and on
future persons (particularly with genetic tests) need to be taken into account
(2.93)

The NCOB and NIPT 2
• Key NCOB question is whether UK NSC FASP recommendations give
proper consideration to the values of ‘equality, fairness and inclusion’
• Three principles to guide an ethical approach (Ch 5):
• policy should consider the wider societal environment in which NIPT is provided
and developed
• where appropriate, access to NIPT should be within an environment that enables
autonomous and informed choices
• efforts should be made to reduce any risks of significant harms posed by the
growing use and development of NIPT

NCOB’s recommendation
‘We recommend that the UK NSC takes better consideration of the particular
psychological, ethical and social consequences, some of which will be
unintended, of any prenatal screening programme where termination of a
pregnancy is an option.’ (6.33)

AAAand theApparently Well
• Large AAA are 5.5cm or more
• About 0.1% of men screened have a large AAA
• Untreated large AAAs have the highest risk of bursting
• Large AAAs are referred to a specialist surgeon within two weeks to talk
about your treatment options
• Most men with large AAA are advised to have surgery to treat
• Risk of serious complications from surgery are generally smaller than risk of
untreated large AAA

Data for the year 2015-2016
• Nearly 250,000 men screened
• Found more than 3,000 aneurysms
• Referred 723 men with large AAA for surgery
• 568 men underwent surgery
• 155 declined surgery, were not fit to undergo surgery or were
inappropriately referred
• Sadly, 8 men died following surgery, a mortality rate of 1.4%
• 9 screened men died from ruptured (burst) aneurysms – 7 of them were
men who were unfit for surgery after being referred
Is this ethically acceptable?
Roger Brownsword and Jonothan Earnshaw, “Controversy: The Ethics of Screening for
Abdominal Aortic Aneurysm” (2010) 36 Journal of Medical Ethics 827-830

The Question of Process 1
• The Integrity of the ethical review process is critical where there is no
consensus on whether a screening programme is ethically acceptable
• UK NSC Ethics Task Group met for the first time in September 2017
Initially, the focus of the Group is on:
(i) a checklist of ethical considerations
(ii) methodology:
• how, in principle, ‘to do ethics’ and
• how to integrate ethical deliberation into the UK NSC process
(iii) scenarios where UK NSC screening proposals might raise novel ethical
issues

The Question of Process 2
• The UK NSC is committed to a reflexive deliberative process
• Recommendations are made but are open to review
• New evidence can be taken into consideration
• Same should apply to ethical acceptability judgments when reviewing
proposed or recommended programmes
• To this extent, the UK NSC’s open and inclusive practice already fits the
model of ‘deliberative democracy’

The Question of Communication
• Do the UK NSC ethical deliberations meet desired standards of rigour,
transparency and consistency?
• Most recommendations made by the UK NSC do not hinge on ethical
considerations
• However, recommendations that hinge on ethical considerations need to
provide:
• a reasoned and rigorous justification for the decision and
• a clear account of how that decision was made
• An ad hoc response to ethical issues might be reasoned and rigorous but
would lack the expected procedural process
• Development of a non-tick box framework

Concluding remarks 1
• The UK NSC is recognised as a world-leader in advancing public health
• Current and future recommendations for screening are more likely to attract
ethical scrutiny
• To continue to be a role model in the screening community, the UK NSC
needs to be more explicit in its ethical deliberations
• There is no question that the UK NSC takes ethics seriously, but that is not
sufficient
.

Concluding Remarks 2
The challenges for the Ethics Task Group are:
• to identify relevant ethical considerations (when they are deeply contested)
• to figure out when and how to engage with ethical issues and
• having transparent, practical guidance and proportionate operating
procedures while ensuring meaningful engagement
This will enable the UK NSC to give reasoned ethical justifications within a
rigorous, transparent and consistent process.

UK NSC stakeholder event 2017 Prof Roger Brownsword ethics presentation