By Edward Dove
On 16 October 2017, the UK Health Research Authority (‘HRA’),
a statutory Non Departmental Public Body established in 2011 to promote and
protect the interests of patients, streamline regulation, and promote
transparency in health and social care research, published a new UK Policy Framework for
Health and Social Care Research (‘Policy Framework’). This Policy Framework was
published in accordance with the Care Act 2014, which requires the HRA to
‘publish guidance’ on ‘principles of good practice in the management and
conduct of health and social care research’.[1]
Symbolising the efforts of the HRA to harmonise the health research regulatory
environment across the UK, the Policy Framework replaces separate Research Governance Frameworks (‘RGFs’)
that were previously published in each of the four nations. Indeed, as an
exercise in joint policy-making and public engagement, the Policy Framework was
developed by the HRA and the Health Departments in Northern Ireland, Scotland
and Wales,[2]
following public consultation.
The
principles-based Policy Framework applies to health and social care research
that is within the responsibility of the HRA or the Devolved Administration’s
Health Departments, e.g. health and social care research involving NHS patients,
service users or their relatives or carers. This includes research involving
them indirectly, such as using information that the NHS or social care services
have collected about them. The Policy Framework is targeted primarily to
individuals and organisations with responsibilities for the management and
conduct of health and social care research.
In
this blog, I highlight the key aspects of the Policy Framework, as well as a
couple areas that may raise questions about the effectiveness of governance of
health and social care research.
Key aspects of the Policy
Framework
The RGFs provided a framework for the governance of research in health and
social care through principles, requirements, and standards
of good practice. In large part, the second editions of the RGFs (published in
2005-6) were drafted in response to the Medicines for Human Use (Clinical
Trials) Regulations 2004, and sought to clarify specific legal duties of
sponsors, investigators and others in clinical trials. Unhelpfully, the RGFs
did not tease out the distinction between principles, requirements, and
standards; moreover, the RGFs were seen to suffer from ambiguity and to present
more obstacles than solutions to conducting research (as indeed has been the criticism of the Clinical
Trials Regulations 2004). The Policy Framework aims to overcome this by
focussing on charting
high-level ‘principles of good practice in the management and conduct of health
and social care research’.
As the HRA
itself notes, since the previous RGFs were issued over ten years ago, the
environment for health and social care research has changed considerably. Both
technological developments and shifts in societal attitudes signalled the need
for a revised framework that would set out, at a high level, principles and
responsibilities that took account of legal requirements and professional
standards.
The Policy Framework does indeed reflect an appropriately
updated, high-level governance document for the management and conduct of health and social care
research. Key aspects of the Policy Framework include the following:
- An important titular change from a ‘governance framework’ to a ‘policy framework’. Much more than a rudimentary semantic modification, ‘governance’ entails a complex (and full) array of principles, requirements and standards, not to mention mechanisms to deliver them, including monitoring and assessment arrangements. Unsurprisingly, such a governance framework can easily suffer from perplexity. ‘Policy’, on the other hand, tends to be a system of principles that is solution-orientated; generally, it avoids operational details. Consequently, the Policy Framework is more explicitly high level than the RGFs (though, it should be noted, no shorter in length). This is reflected in the document’s structure, which removes the headings ‘Standards’ and ‘Responsibilities and Accountability’ that was in the RGFs and replaces them with ‘Principles’ and ‘Responsibilities’. Helpfully, there is now an introductory ‘Context’ section (the equivalent of a preamble), which explains the environment that the HRA and the UK Health Departments are committed to achieving.
- Unlike the RGFs, the Policy Framework is placed on firm legal footing, at least in England. The Policy Framework constitutes ‘statutory guidance’ to which local authorities, NHS trusts and NHS foundation trusts in England ‘must have regard’.[3] In contrast, while the Policy Framework has equal application in Northern Ireland, Scotland and Wales, there is no legal obligation per se for local authorities or health boards to have regard to it.
- The Policy Framework lists 19 principles of good practice in research for those who manage and conduct health and social research in the UK, including Safety, Competence, Respect for Privacy, and Duty of Care. Arguably, this is too many principles for a high-level document.
- There is an explicit focus on encouraging patients, service users, and the public to become more involved where appropriate in the design, management and conduct of research. For example, Principle 4 (‘Patient, Service User and Public Involvement’) actively encourages these actors in the ‘design, management, conduct, and dissemination of research, unless otherwise justified’.
- As with the RGFs, the Policy Framework charts responsibilities for key actors in health and social care research, including chief investigators, research teams, funders, sponsors, regulators of professions, and employers.
- All health and social care research, not just clinical trials, is encouraged to be registered, and research findings are encouraged to be published and summarised for those who took part in them and made publicly available.
- The principle of proportionality colours the entire Policy Framework. In part, this is due to the HRA’s role, which is to ensure that ‘the regulation of health and social care research is proportionate, so that research that is clearly lower-risk gets processed accordingly’ (para 9.19 of the Policy Framework). The previous RGFs made only a passing reference to proportionality and its link to risk-based assessments (e.g. ‘If there are any risks to participants, the risks must be in proportion to the potential benefit’; independent expert review ‘must be proportionate to the scale and complexity of each research proposal’.) By contrast, the Policy Framework injects the principle of proportionality throughout the framework, emphasising that research regulation should be proportionate to the level of risk to which the participants are exposed. It also defines proportionality as ‘having an approach to mitigating risks that gives at least the same consideration to the risks that arise if the research does not take place as to those that arise if it does, and the same consideration to their likelihood as to their impact. The risk appetite should favour the research taking place. The prevailing focus should be on the risks to the potential participants and the target population, not on the reputational risks.’ Proportionality is seen, for example, in para 2.1 of the Policy Framework, which sets out the document’s purpose: ‘These principles protect and promote the interests of patients, service users and the public in health and social care research, by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high-quality research in the UK that has the confidence of patients, service users and the public.’
- Connected with the injection of proportionality, the Policy Framework seeks to create an environment that ‘remove[s] unnecessary bureaucracy for researchers, both in what the framework expects of them directly and what it expects of others that then affects them’. Thus, it does not intend to add another layer of work to researchers or others with responsibilities under the Policy Framework. Rather, it intends to set out high-level principles and responsibilities, driven by aims of proportionality, efficiency, and straightforwardness that will be met through operational arrangements, supported by detailed operational guidance.
Critical questions
In reading through the 40-page Policy Framework, a few
sections jump out to me in terms of interest and possible controversy. In the
interest of space, I address two.
First, Principle 1 (Safety) offers a twist to a classic
principle in research ethics. It reads: ‘The safety and well-being of the
individual prevail over the interests of science and society.’ Compare this to
the Declaration of Helsinki (2013), which reads at Paragraph 8: ‘While the
primary purpose of medical research is to generate new knowledge, this goal can
never take precedence over the rights and interests of individual research
subjects.’ Compare this also to the CIOMS Guidelines (2016) at Guideline 1:
‘All research with humans must be carried out in ways that show respect and
concern for the rights and welfare of individual participants and the
communities in which research is carried out.’ One wonders why the Policy
Framework excludes explicit mention of rights and interests here. Is this a new
twist to an old principle that heralds a turn away from rights-based discourse
in research governance frameworks and towards a focus on participant safety and
wellbeing only? Does it suggest that individual interests should not hold
absolute sway over the interests of science and society? Or, might this new
phrasing reflect a more pragmatic position that 1) tacitly recognises that
collective interests may sometimes hold sway over individual interests, and 2) focuses
on safety and well-being as particular manifestations of ‘rights’, rather than reiterating
an amorphous obligation to respect rights which already exist and sit above the
Policy Framework and are covered by ‘hard law’ in any event?
Second, the Policy Framework’s focus on proportionality and
risk reflects a desire by the HRA (and other bodies, such as the Academy
of Medical Sciences) to ensure that research that presents ‘lower risk’ is
processed accordingly, i.e. faces less regulatory burden. Much of the HRA’s
recent work has been on developing tools that lessen the workload for
researchers, sponsors and others; see e.g. the proportionate
consent guidance). While arguably laudable as a regulatory principle, the
connection of proportionality to risk remains under-defined. The HRA, working
alongside ground-level actors (researchers and sponsors in particular, but also
participants), should craft careful and transparent operational guidance under
the umbrella of this Policy Framework to help stakeholders undertake adequate
risk assessment and management and achieve the aim of proportionate – and responsible
– regulation. Key questions to consider should include: what risks will be
evaluated (and conversely, which will be ignored) and what risks will be mitigated
through regulatory means? Will the methods of risk assessment be open to
periodic revision in light of changing circumstances (e.g. new risks and
changes in risk profiles)?
Overall, the HRA should be commended for navigating what was
undoubtedly a difficult political process of negotiation and compromise with
the Devolved Administrations. The Policy Framework brings consistency across
the UK regarding principles of good practice in health and social care research.
It also puts the UK on solid footing for the governance of health and social
care research in an era marked by internationally collaborative, data-driven
research, and participant and patient engagement. This era, of course, is also
marked by increasing uncertainty in light of Brexit and the putative decoupling
of the UK from the EU’s regulatory reach. In time, we will learn whether the
Policy Framework achieves its aim of helping to ‘make the UK an even better
place to do research’ through its increasing emphasis on proportionate,
risk-based regulation.[4]
It may well drive regulatory harmonisation. However, due to the legal basis of the
Policy Framework, where England is statutorily required to ‘have regard’ to it but
the other countries are not, it may also drive (or create opportunity for)
different attitudes and cultures towards interpretation and implementation.
[1]
Care Act 2014, s 111(6).
[2]
Department of Health (Northern Ireland), Scottish Governance Health and Social
Care Directorates (Scotland), Department for Health and Social Services
(Wales).
[3]
Care Act 2014, s 111(7).
[4]
HRA, ‘Draft UK policy framework for health and social care research: for
comment: Summary of responses’ (2015), available at: http://www.hra.nhs.uk/documents/2015/11/draft-uk-policy-framework-health-social-care-research-summary-responses-v1-2.pdf.