UK policy framework for health and social care research:
call for comments
Please send your comments to policyframework@nhs.net by 1st May 2015. The
HRA would find it particularly helpful to receive comments on the following issues:
1. Is there anything more the policy framework should say in order to meet the
ambitions set out in the “Purpose” section?
☒ Yes
☐ No
☐ Undecided
Please provide details:
The purpose section outlines some laudable aims including quick decision-making
on research applications and a focus on using money from funders in conducting
the research rather than getting through ‘unnecessary hoops’ before it starts.
Given these aims, it would be helpful if more detail could be provided on the way
the framework may help to streamline processes, and hence achieve those aims.
2. The policy framework will be implemented by operational arrangements that
reflect and embed the principles it sets out (e.g. in England, guidance for HRA
Approval, which will be made available later). Is the level of detail in the policy
framework sufficient for it to be implemented? If not, how could this be
rectified?
☒ Yes
☐ No
☐ Undecided
Please provide details:
Regarding item 2.2 and footnote 5 on page 3: it would be useful if HRA could
elaborate on this to clarify the meaning and its expectations of institutions if poor
quality research is identified. Universities will generally have codes of conduct and
policies relating to research governance and integrity along with specific policies
and processes for handling research misconduct, particularly in the context of the
Concordat to Support Research Integrity. Might this be referenced as good
practice, and should similar expectations be placed on other organisations?
3. Are there any issues (e.g. obstacles to research) that the policy framework
does not address? If so, what are they and how could they be addressed?
☒ Yes
☐ No
☐ Undecided
Please specify:
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The University has identified the following issues:
(1) Throughout the document there is no mention of monitoring, oversight or audit
requirements, especially from the perspective of a sponsor. The 2005 (2 nd)
edition of the Research Governance Framework stated: “Satisfying itself that
arrangements are kept in place for good practice in conducting the study, and
for monitoring and reporting, including prompt reporting of suspected
unexpected serious adverse events or reactions.” The draft policy omits
expectations around monitoring, reporting adverse events or a requirement for
sponsor oversight. As a sponsor of research the University is keen to
understand if oversight will remain a requirement although the policy does not
acknowledge this explicitly. If so, how is that communicated to sponsors so
that their responsibilities are clear; for example, will there be a guide to
accompany it?
(2) The University would welcome further clarification about whether 'indirect
research' projects (2.1) require ethical approval. We note that we are
encouraged by the increased emphasis on using previously collected data.
(3) The University would appreciate clarification (2.) that the framework also
covers organisations that are providing services for health and social care
organisations. The requirement for 'research sites' to be aware of their capacity
and capability to host research (8.19) can be a concern when the potential
research site is a small local provider / charity, or indeed whether such small
organisations would be able to undertake the other responsibilities of 'research
sites'.
(4) Given some attempts by researchers to claim their research is an "audit" (2.2)
(thereby avoiding NHS ethics processes) when it is not, the University would
welcome further clarity about audits based entirely on existing data, and
suggests that anything involving systematic collection of new data not routinely
collected should be considered research.
4. Do you think the principles that apply to all health and social care research
are right?
☒ Yes
☐ No
☐ Undecided
Please provide details:
The University is pleased to see the additions in item 1.1 relating to retention of
data or tissue for future analysis. The University is encouraging researchers to
maximise the value of data and tissue and our researchers are advised to seek
consent for future unspecified (but appropriate) uses, particularly in clinical
research where the collection of samples takes place.
The University was also pleased to see that the summarisation to research
participants of research findings is encouraged. Patient and public involvement, by
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engaging with research outputs, maximises the value of research as the public are
the ultimate beneficiaries of our research.
The University agrees with item 5.2, which clarifies expectations of compliance
with commissioned health and social care providers.
Regarding item 7.11, it is surprising that voluntary participation is not framed as
the normative expectation – as currently phrased it implies that voluntary
participation is necessary only when required. This contrasts with the ESRC
Framework for Research Ethics (FRE) (2015), which has as its first principle
voluntary participation, free from coercion and undue influence – unless exception
can be justified. This would seem to be a more robust starting point for research in
health and social care, given the power relationships and potential vulnerabilities
for service user and professional participants.
5. Do you think the principles that apply to interventional health and social
care research are right?
☒ Yes
☐ No
☐ Undecided
Please provide details:
Regarding these principles, and those for all health and social care research, it
would be helpful to include an explicit statement that these principles are intended
to apply to all those who take part in research under the policy framework,
including children and adults who lack capacity to consent. Researchers should be
expected to adapt as appropriate to ensure, for example, that children are
appropriately informed, given the opportunity to consent (or not), and given
information about study findings. It may also be useful to have access to the
exploratory work that the University (with others) conducted for the Nuffield
Council on Bioethics, on children’s views of research ethics, which addresses
these considerations:
http://nuffieldbioethics.org/project/children-research/films-young-peoplesperspectives-clinical-ethics-reviews
6. Do you think the policy framework adequately addresses the needs of social
care research? If not, what needs to be covered?
☐ Yes
☒ No
☐ Undecided
Please provide details:
There is continued ambiguity about the status of evaluation studies within the
definition of research. Much evaluation is conducted that specifically aims to
provide an evidence base for (continuing, expanding or revising) service provision
and in this sense is quite clearly intended to provide generalizable or transferrable
knowledge beyond the bounds of the study itself. Evaluation and other research
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which does not meet the criterion of generalizability (which invokes a particular
research paradigm, rather than necessarily being an indicator of quality) may
nevertheless incur significant ethical issues which governance systems (and
requirements for scrutiny of research ethics) need to address.
Footnote 7, p4, needs to highlight the potential for identification through data
linkage, e.g. across datasets.
7. Do you agree with the responsibilities stated for chief investigators?
☒ Yes
☐ No
☐ Undecided
Are there any responsibilities that you think should be added or removed? Please
provide details:
The University agrees that students should not normally take on the role of chief
investigator at any level of study, for all research requiring a Sponsor; though PhD
students may act as the principal investigator (but not the chief investigator).
Footnote 14, p8, stated that ‘exceptions may be made’ for doctoral researchers
under certain circumstances. It would be helpful if this statement was amended to
allow definite exceptions (and the proposed exceptions seem appropriate), given
potential ambiguity about how, and by whom, exceptions would be made. If this
has to be done by the REC, for example, it could cause significant delays to a
project. If necessary, the supervisor could act as formal Co-Investigator as an
additional safeguard for these doctoral projects.
Additionally, we note that Fellowships are not normally associated with students,
but with staff at postdoctoral level and above.
The University ensures appropriate and adequate supervision is provided to a
student. The University disagrees with the expectation expressed in 8.3, as the
student should be allowed to lead a project under supervision as part of learning
and training to become an established researcher, particularly for post graduate
research students.
With respect to items 8.4 and 8.5, p8, the description of research protocols (here
or elsewhere in the document) needs to recognise that research involving
methodological approaches such as ethnography, or other forms of participatory
and qualitative research, may not operate under procedural protocols of the kind
envisaged in this description. The policy framework must be explicit that the
proposal or protocol provides detailed information appropriate to the
methodological approach of the research, otherwise there is a risk that the
framework assumes and privileges certain methodologies.
8. Do you agree with the responsibilities stated for research teams?
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☐ Yes
☒ No
☐ Undecided
Are there any responsibilities that you think should be added or removed? Please
provide details:
The University queries whether it is appropriate for research teams to be
responsible for ensuring participants’ welfare (item 8.6c) – this implies a broader
responsibility than may be appropriate given their remit and expertise. This could
be more specifically phrased to indicate that they are responsible for taking
appropriate steps to ensure that participants are not exposed to risk of harm
associated with their participation in the study, beyond such risks that have been
justified and approved by an ethics committee.
In item 8.7 there is an assumption that an information sheet (and the simple
provision of this) is enough to ensure appropriately informed consent, and this is
likely to be problematic in creating an expectation that providing a highly detailed
information sheet is adequate to fulfil researchers’ responsibilities in relation to
voluntary participation and appropriately informed consent. Either this section
needs to give more detail of appropriate forms of information and consent
recording (e.g. DVDs, web resources, audio-recorded consent), or it should be
less specific and focus on the principles of the researchers’ responsibilities – for
example, to ensure sufficient information delivered in an appropriate way that
participants can keep, adequate time to decide and ask questions, appropriate
recording of consent. Again, the ESRC FRE provides a useful example of this.
9. Do you agree with the responsibilities stated for funders?
☒ Yes
☐ No
☐ Undecided
Are there any responsibilities that you think should be added or removed? Please
provide details:
No comments.
10. Do you agree with the responsibilities stated for sponsors?
☐ Yes
☐ No
☒ Undecided
Are there any responsibilities that you think should be added or removed? Please
provide details:
This section was particularly pertinent to the University, and the following
responses are identified:
(1) Throughout the document there is no mention of monitoring, oversight or audit
requirements, especially from the perspective of a sponsor. The 2005 (2nd)
edition of the Research Governance Framework stated: “Satisfying itself that
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arrangements are kept in place for good practice in conducting the study, and
for monitoring and reporting, including prompt reporting of suspected
unexpected serious adverse events or reactions.” The draft policy omits
expectations around monitoring, reporting adverse events or a requirement for
sponsor oversight. As a sponsor of research the University is keen to
understand if oversight will remain a requirement although the policy does not
acknowledge this explicitly. If so how is that communicated to sponsors so
that their responsibilities are clear; for example, will there be a guide to
accompany it?
(2) Regarding item 8.7, autonomy, the right to withdraw and informed consent are
key to good research practice. However, in some research environments and
research paradigms alternative approaches may be appropriate in terms of the
cohort, e.g. low literacy or research naive communities, or the chosen
methodology, e.g. deception and debrief.
(3) Regarding item 8.10, footnote 15, “the employer or funder is not automatically
the sponsor” clarification about the meaning of this point would be appreciated.
(4) Item 8.10c that the sponsor is responsible for establishing mechanisms to
identify and address poorly planned research / poor quality research proposals
and applications is noted as a new sponsor requirement. The ethical review
procedure does include looking at validity of research and research objectives,
however guidance on what an appropriate mechanism would be to address
poorly planned research would be appreciated.
(5) Item 8.10f that the CI has made appropriate arrangements for making
information about the study available is noted as a new sponsor requirement
but is in line with the University practice in terms of open access, research
data management and encouraging tissue and data to be used for future
unspecified purposes, providing there is consent to do this from the research
participants.
(6) Regarding item 8.12, universities should accept the role of sponsor for all
educational research conducted by their own students, unless the student’s
employment mean it is more appropriate for a health or social care provider to
do so: this is problematic for students intending to undertake research in an
NHS Trust.
i.
ii.
The University has agreed with its local acute NHS Trust partner that
research involving the Trust’s patients should be sponsored by the
Trust. The new requirement thus undermines the strong working
relationship between us and our partner Trust. We imagine this will be
the same of many such partnerships. We also believe that many Trusts
will prefer to be sponsor for studies involving their patients.
The term “conducted by” is rather ambiguous in this context. Currently,
where undergraduate students have a role in designing research
involving NHS patients, this is undertaken in conjunction with an
appropriately experienced member of staff, in the (usually NHS)
healthcare organisation who may or may not have an academic
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iii.
contract. The NHS member of staff initiates the topic by proposing it as
an option for students to choose from, and this process, including
approvals, is supported by the Medical School in close partnership with
the NHS Trust. In these circumstances, we believe that the NHS Trust
should accept the role of sponsor.
We also consider that it is good practice in supporting an understanding
of the context, and conducive to research governance, for a member of
NHS staff to have an active advisory role in all educational research.
Where there is such involvement, University considers that it is
appropriate for the academic and NHS organisation to agree which of
the two is best placed to sponsor and to ensure the obligations of
sponsorship are fulfilled.
(7) Regarding item 8.13, we support this statement. In addition to "encouraging
an awareness of research", should this specify that students should be
encouraged to develop an awareness of the importance of ethical issues in
research"?
(8) The importance of supervisors developing research projects to which students
can contribute may be applicable at Undergraduate, Masters and Doctoral
levels.
(9) Regarding item 8.14, we agree with this proposal, but further explanation of
what is meant by batching may be useful; for example, to what extent do the
projects have to be similar? There also needs to be clarity and good
communication on REC requirements for updating the participation of different
“generations” of named students, without undue bureaucracy.
(10) With respect to 8.15, we agree that Undergraduate students should not
normally lead such projects. There does, however, need to be scope for
exceptions. For example, it is important that more graduate medical students
(some of whom come from another health profession) can make the most of
their research experience from a more mature perspective.
(11) Regarding 8.16, non-health related courses, there is ambiguity about what
might constitute a ‘health-related’ course, and also what might comprise
appropriate expertise for a Co-Supervisor. There are significant workload
implications for university staff in this requirement, and it could function as a
barrier to research training for important health-related work in interdisciplinary
contexts.
11. Do you agree with the responsibilities stated for research sites?
☒ Yes
☐ No
☐ Undecided
Are there any responsibilities that you think should be added or removed? Please
provide details:
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Regarding item 8.19f, it would be useful for the HRA to suggest how to undertake
expedited review where there is an urgent need to ensure the correct permissions
/ approvals are sought and to show due process and diligence around the project
in a very short timeframe. A university will require processes to undertake this kind
of urgent review. How does HRA anticipate universities doing this and
simultaneously demonstrating due diligence and process?
12. Do you agree with the responsibilities stated for professional bodies?
☒ Yes
☐ No
☐ Undecided
Are there any responsibilities that you think should be added or removed? Please
provide details:
Regarding item 8.20, in cases where there is the potential of both research
misconduct and professional misconduct, HRA advice on the communication that
should take place between employers, professional bodies, etc. would be helpful.
13. Do you agree with the responsibilities stated for regulators?
☒ Yes
☐ No
☐ Undecided
Are there any responsibilities that you think should be added or removed? Please
provide details:
No comments.
14. Do you agree with the responsibilities stated for employers?
☒ Yes
☐ No
☐ Undecided
Are there any responsibilities that you think should be added or removed? Please
provide details:
No comments.
15. Do you agree with the responsibilities stated for health and social care
providers?
☒ Yes
☐ No
☐ Undecided
Are there any responsibilities that you think should be added or removed? Please
provide details:
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No comments.
16. Do you think the policy framework will help make the UK a better place to
do research?
☒ Yes
☐ No
☐ Undecided
Please provide details:
The current Research Governance Framework has been a significant step forward
in identifying and implementing standards of research. Whilst evolution is
necessary, it needs to ensure that it is positive, and that current progress is not
undermined. The move to make the Framework UK-wide is positive and
welcomed. Consistency across the UK is essential.
The overarching opening statement about the importance of research and the
need to ensure that research governance systems do not act as a barrier to
research is very welcome. However, there is a need to do more to ensure that the
policy framework is appropriate for the diversity of research in health and social
care, including different participant populations and disciplinary and
methodological approaches.
The continued omission of evaluation research from the framework, while
expedient, neglects the fact that evaluation commonly involves research
methodologies, and hence needs to address common issues in terms of ethics
and quality. In addition, the nature of evaluation research incurs additional ethical
concerns relating to over-research and risk of coercion with vulnerable groups of
service users. Whilst evaluation studies are scrutinised within the University REC
system, regardless of the DH/HRA policy framework, it is of significant concern
that this activity could go ahead without ethics scrutiny in other organisations.
17. Is there anything more it could say in order to achieve this?
☐ Yes
☒ No
☐ Undecided
Please provide details:
No comments.
18. Do you have any suggestions about how to measure the policy
framework’s contribution to achievement of the ambitions set out in the
“Purpose” section?
Please provide details:
No comments.
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19. Do you have any other comments?
The University wishes to make the following final points:
(1) The University welcomes the commitment to involve potential participants in
research design, management and conduct or as members of research
approval bodies such as research ethics committees (1.2 and 7.4). This may
have training implications for researchers and students and for recruitment of
lay members of RECs.
(2) Item 7.2 “Research must be designed, reviewed, managed and made public in
a way that ensures integrity, quality and transparency.” Might also include
confidentiality.
(3) The commitment to provide information about research projects (7.10) is
welcome, and is already a feature of good research applications but needs to
be standard for all. This is a training issue and organisations’ forms may need
to be amended so that it is explicitly covered.
(4) With respect to 8.7, should the default setting be that consent is required, with
a list of possible exceptions then given?
About you
Where are you based?
☒ England
☐ Wales
☐ Crown Dependency
☐ Scotland
☐ EU outside UK
☐ Northern Ireland
☐ Outside EU Please specify:
What will we do with your response?
The HRA has a commitment to transparency. We will analyse the comments we
receive, and publish a report on our website which summarises them and explains
how we will address the themes raised. We will use the comments received to inform
the next version of the policy document which will be sent out as part of a formal
consultation later in the year.
Organisational responses: In the interest of transparency, all comments made on
behalf of an organisation may normally be published and attributed unless an
explanation is provided with your response as to why you consider the information
should not be. (Please note the Confidentiality of Information section below.).
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Individual responses: We will aim to summarise individual responses in such a way
that does not identify individual respondents unless we have your permission to
identify you.
If we receive comments without this form we will adopt the position that
organisational responses are attributed and individual responses anonymised.
Are you responding in an organisational or personal capacity?
☒ Organisational
☐ Individual
If you are replying in an organisational capacity, please note that your
response may be published and quoted in the final report.
☐ If you do not wish your organisational response, and any quotes used from it, to
be identified in any report on this call for comments and any future HRA publications,
or published once the comments period has ended, please explain why below:
Individual responses
I am responding primarily as a:
☐ Researcher/research team member
☐ Research support staff
☐ Member of the public
☐ Patient
☐ REC member
☐ HRA staff
☐ NHS/Social Care/HSC R&D management community
☐ Other NHS/Social Care/HSC staff
☐ Industry (mainly or only phase I)
☐ Industry (other)
☐ Regulatory body
☐ Academic
☐ Other
Please write in below:
☐ I am willing for my response, and any quotes used from it, to be made
identifiable in the report on this call for comments and any future HRA
publications.
☐ I do not wish my response, or any quotes used from it, to be identified in
the report on this call for comments, future HRA publications, or published
once the comments period has ended.
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All responses
☒ I am willing to be contacted by the HRA for further information in relation
to this call for comments or future consultations.
If you have checked the box above please provide your contact details
below. By providing these contact details, you are giving your consent for a
member of HRA staff to contact you about calls for comments and
consultations. The HRA takes data protection very seriously. We promise
we will not pass your details on to any other organisations or use them for
any other purposes.
Contact name: Isla-Kate Morris
Email: i.morris@sussex.ac.uk
Confidentiality of information
The HRA will process your personal data in accordance with the DPA and in most
circumstances this will mean that your personal data will not be disclosed to third
parties without your permission or unless required by law.
Information we receive, including personal information, may be published or
disclosed in accordance with the access to information regimes (primarily the
Freedom of Information Act 2000 (FOIA), the Data Protection Act 1998 (DPA) and
the Environmental Information Regulations 2004).
If you want the information that you provide to be treated as confidential, please be
aware that, under the FOIA, there is a statutory Code of Practice with which public
authorities must comply and which deals, amongst other things, with obligations of
confidence. In view of this it would be helpful if you could explain to us why you
regard the information you have provided as confidential. If we receive a request for
disclosure of the information we will take full account of your explanation, but we
cannot give an assurance that confidentiality can be maintained in all circumstances.
An automatic confidentiality disclaimer generated by your IT system will not, of itself,
be regarded as binding on the HRA.
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