Research Governance
On this page you will find:
Research Governance Frameworks
The Research Governance Framework
for Health and Social Care sets out the broad principles of good
research governance. The first English edition was issued in March
2001. The second edition was issued in April 2005.
Similar Frameworks exist also for
Wales, Scotland and Northern Ireland.
The English version is available
on the
Department of Health Website from which there is also a link to
those for Wales, Scotland and Northern Ireland. These
frameworks cover all research undertaken within the Department of
Health and the NHS and research undertaken by local authority
social care organisations.
An amendment to Edition 2 of the
Research Governance Framework for England was been made by the
Department of Health in November 2006 to correct some detailed
information about multinational clinical trials.
Footnote 21 (PDF) at the bottom of Page
34 now states "The Regulations require a sponsor to be established,
or have a legal representative, in the European Community.
Neither of them need be established in the United Kingdom."
See also the Frequently Asked Questions
(FAQ) word
document on the NHS R&D Forum web site.
Purpose of
Research Governance
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To ensure that health and social
care research is conducted to high scientific and ethical
standards.
See also the PCRTA (Primary Care Research Team
Assessment) pages which give details of the scheme run by the
College's Research Group to ensure best practice in the conduct of
research in the practice setting and which relates to the standards
promulgated by the Research Governance Framework.
To whom does it
apply?
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Everyone involved in research in
a health or social care setting using NHS resources or involving
NHS patients.
A useful guide and checklist for
researchers can be found on the
RDDirect site which offers a
research process flowchart. This maps the different stages of
research, including the research governance elements, and provides
hints, tips and checklists for researchers at all levels.
What is
covered by the
Framework?
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There are five key areas:
ethics, science, information, health and safety, and
finance and intellectual property.
Within these areas, the key
points are as follows:-
- Shared responsibility for effective
research. All practitioners and staff are
responsible at some level for ensuring that the procedures for
obtaining informed consent from patients/participants in studies
and maintaining confidentiality are respected, and that information
collected is real and accurate. Examples might include taking
responsibility for discussing with the research team a patient’s
concern about how their consent was gained; spending energy on
understanding the detailed procedures and rationale for a study
when you could have ‘taken it as read’; or at worst acting on a
suspicion that fictitious records of data collection are being
compiled by a colleague. These parallel the responsibilities of
clinical governance.
- The need for clear systems for hosting and
conducting research. Any research in which a
practitioner or practice has agreed to take part by a) recruiting
patients, b) gathering data, or c) allowing researchers to conduct
research within the practice, requires tight recording systems that
include evidence of ethics committee consent, research protocols,
and the named lead and sponsor of the project.
- Audit trails. There is an
undoubted need for clear system as there is now the likelihood that
projects and researchers will be targeted for audit from time to
time. It needs to be remembered that the Framework rests on
the assumption that the quality standards set out in it can be
shown to be delivered by those involved in research at any
level.
‘Own account
research’
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The Framework document flags up
the issue of the setting where research is being conducted on one’s
own patients, sometimes by a single individual. This is seen as
particularly open to abuse because of the lack of colleagues acting
as ‘checks and balances’. We suggest that in this setting, evidence
of ethics approval, full procedural details, and a system within
one’s own practice to host your studies as if they were being
introduced by an outside agency would be good practice; and would
act as a self - protection to the independent researcher.
See also Indemnity for Independent
Contractors.
You will need to consider who might be in a position to be your
Research Sponsor. There are a number of organisations you could
approach including a local academic department or the research
representative at your local Primary Care Group/Trust.
Small-scale
research
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For example, that funded
with "soft" money or small grants from say a pharmaceutical company
or a small charity. In such cases the funder may well not be
prepared to act as the Research Sponsor as it is unlikely that they
will have the systems in place to fulfil this role or the resources
available to provide such systems.
Research in
training
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Novice researchers, including
students and registrars, are probably an ‘at risk’ group, due to
inexperience and some short deadlines where procedural details may
be rushed. Any institution requesting that students do a ‘research’
project while they are with them should provide a supervisor, a
means of vetting and ensuring ethical approval is obtained for such
studies where this is deemed necessary by the local research ethics
committee, and a link for trouble shooting to advise the practice
based staff. If you are the supervisor for some projects, it may be
valuable to press colleagues responsible for the training scheme or
students to provide a ‘framework’ within which such studies are to
be undertaken.
Such studies also require a
Research Sponsor and many institutions will require institutional
sponsorship of such research in line with other research projects
being undertaken within the institution. The position with
regard to this will need to be ascertained within each
institution.
Research ethics committee
approval
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All research within the NHS which
involves individuals, their organs, tissue or data must have the
prior approval of a research ethics committee. Multi-centre
studies will need local ratification in addition to the approval
obtained from one of the Multi-centre Research Ethics Committees in
the UK.
Disclosure
of incentives for participating in research
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The Research Group has prepared some guidance on this issue,
which is set out below. When you are doing research in your
practice which involves recruiting patients you must disclose to
each patient any material incentive or benefit the practice
receives in respect of the patient’s involvement.
The College
has members who both host and lead research. There has been concern
about doctors receiving undisclosed payments for helping with
research, and this is not seen to be in keeping with a transparent
and ethical practice. The public expect to be fully informed
about the basis on which research is carried out, and the RCGP
feels that this includes any reimbursement or incentives offered to
practitioners who assist with research studies.
The College believes that practices should not be out of pocket
because of their participation, and that they should be reimbursed
for any additional expenditure they may incur. It is not uncommon
for practices to be offered some sort of incentive to help with
research, e.g. being given additional money for staff time,
actually being given a researcher to help work in the practice in
order to do the study, or being given some financial reimbursement
to cover the cost of identifying patients who might be suitable
recruits for a study. However, we do advise members to ensure that
if such arrangements are made for a particular research study that
members of the public being invited to participate are aware of the
incentives involved.
Incentives offered to practices should be at an appropriate level,
and should not be of an amount that could be regarded as an
improper inducement to recruit patients to a study or to retain
them, once recruited, within a study.
When you are doing research in your practice which involves
recruiting patients you must disclose to each patient any material
incentive or benefit the practice receives in respect of the
patient’s involvement. We therefore hope that if and
when you are doing research in your practice, and especially when
recruiting patients, that you will be open and honest and ensure
that the information leaflet has a clear and appropriate statement
about financial or other resources that are being given to the
practice to support the research being undertaken.
Primary Care Organisation
approval
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All studies need to have approval
from the host organisation or organisations covering the area(s)
where the research will be the undertaken. A list of
R&D contacts
in Primary Care Trusts in England is available on the NHS
R&D Forum Web Site.
Research governance requires all
NHS research to have a Research Sponsor. The Sponsor is the
individual or institution that takes responsibility for the
initiation and financing (or arranging the financing) of the
study. The Sponsor satisfies itself that the study meets
the relevant standards and ensures that arrangements are put and
kept in place for management, monitoring and reporting.
Primary Care Organisations have
legal powers to engage in and facilitate research and like other
institutions which are legal entities, can act as Sponsors
providing they are in a position to undertake the role of
Sponsor. In England, PCTs (RM&G) should normally be well
placed to take on the role of Sponsor. PCTs can become Sponsors of
research undertaken by their own staff, independent contractors or
of research undertaken by third parties on patients for whom the
PCT has a duty of care.
Although Independent Contractor
may become Research Sponsors they should be aware of the scope of
responsibility involved. Should such a step be being
contemplated they should, first of all, contact their professional
body and their mutual indemnity society, to ensure that the
appropriate safeguards for indemnity are in place.
More information on Research
Sponsors and their role this can be downloaded at the
NHS R&D
Forum web site together with a useful listing of
frequently asked question.
Honorary Research Contracts and the Research
Passport
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The NHS R&D Forum has been
working on clarifying the requirements for honorary research
contracts and the Greater Manchester Strategic Health Authority has
also been piloting a Research Passport system. The Passport
system pilot has now been reviewed and the R&D Forum and
Greater Manchester Strategic Health Authority are now working in
partnership with the UK Clinical Research Collaboration (UKCRC) to
produce guidance documents that will enable a consistent approach
to issuing honorary research contracts.
Independent contractors are not
covered by NHS indemnity. For further information on
indemnity arrangements in primary care download the NHS R&D
Forum's
Primary Care Working Party's position statement on
indemnity.
Intellectual
Property
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The NHS plan highlights the need
for the NHS to become an innovative organisation and to ensure that
innovations are identified and developed in the interests of
patients and society as a whole. The Department of Health
published a Framework and Guidance on the Management of
Intellectual Property in the NHS in 2002.
NHS Innovations has been set
up to support Primary Care Trusts in this area and
Regional Innovation Hubs are being established across
England. There is also a
hub in
Scotland. See also the
NHS R&D Forum's web site.
Other
documents and web sites relevant to Research
Governance
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A wide range of documents and
other information relating to Research Governance have been
produced - and are constantly being added to.
A good
guide to research governance documentation and information has
been prepared by the Trent Research Development and Support Unit
and can be found on the NHS R&D Forum's web site.
The
NHS R&D Forum's web site
provides a useful source of information on all issues relating to
research governance and management. Its What's New page
contains information on latest developments and links to relevant
sites. See also its Toolkit for PCTs RM&G (Primary Care
Trusts Research Management and Governance) which, although designed
primarily for PCTs contains useful information for researchers as
well.
The NHS R&D Forum also
produce a regular electronic
newsletter.
This contains information on latest developments, new guidance and
publications and courses.
Members of the Forum are able to receive emailed copies of the
newsletter. Membership of the Forum is free. See the
Forum's web site for information on how to join.
Ethical approval from an NHS
Research Ethics Committee is required for any research proposal
involving:
- Patients and users of the NHS, whether past or present,
including NHS patients who may be being treated under contract with
private sector healthcare providers.
- People who are to be invited to participate in a study because
they are a carer or relative of a patient or user of the NHS.
Access to data, organs or other bodily material of past and present
NHS patients.
- Use of, or potential access to, NHS premises or
facilities.
- NHS staff if they are recruited to a study by virtue of their
professional role.
- Foetal material and IVF involving NHS patients
- Recently deceased in NHS premises.
The Central Office for Research
Ethics Committees (COREC) co-ordinates the
development of operational systems for local and multi-centre
Research Ethics Committees (LRECs and MRECs), on behalf of the
National Health Service in England. It also works closely
with colleagues from Northern Ireland, Scotland and Wales who have
similar responsibilities. Their web site provides access to
comprehensive and up-to-date information on the research ethics
committee (REC) system in the UK, including the application form
and guidance necessary to apply for an ethical review, the meeting
dates for RECs and their contact details.
Details of your local
research ethics committee, how to contact them, when they meet can
all be found on the Central Office for Research Ethics Committees
(COREC) website.
If your study will be taking
place in more than 3 Primary Care Organisations, ethical approval
will need to be obtained from one of the Multi-Centre Research
Ethics Committees (MREC). Consult the COREC site for more
information about this and how to apply for MREC approval.
COREC's
frequently asked questions may be of interest/assistance.
Research Governance and Clinical
trials
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The
Medicines for
Human Use (Clinical Trials) Regulations (SI2004/1031) came
into force on 1
st May 2004. All European clinical trials
will have to be designed, conducted and reported in accordance with
the principles of Good Clinical Practice. Researchers are
required to report all serious adverse reactions
to the
Medicines Healthcare and Regulatory Authority (MHRA), who
use this information to monitor and, if necessary, stop trials if
they present a risk to volunteers. The MHRA site contains
information on a wide range of topics including and it is
worthwhile keeping an eye on its What's New page.
As at November 2005, the MHRA is
consulting on revisions to the Clinical Trials Regulations in order
to implement the European Commission's Directive on Good Clinical
Practice. The 2004 UK Clinical Trials Regulations implemented
the original 2001 EU Clinical Trials Directive but this has now
been added to by 2005 Good Clinical Practice (GCP) Directive.
A revised set of Regulations is now needed to reflect the
provisions of the new Directive. Information on the proposals
is available on the
MHRA website and consultation will close on 7th February
2006.
The European Medicines Evaluation Agency has a guide to
Good Clinical
Practice (GCP) (PDF) - an international ethical and scientific
quality standard for designing conducting, recording and reporting
trials that involve the participation of human subjects.
There
is a
DH guide
to GCP (PDF) and also the
Medical Research Council's
guide (PDF) to GCP.
From the 1st May 2004 all clinical trials must have an
EUDRACT number and be included on
a database (EudraCT) of all clinical trials taking place within the
EU. More information on this is available at the
European Medicines Evaluation Agency
(EMEA) site and from the
EudraCT site.
Comprehensive information on the
Clinical Trials Regulations and related issues is provided on
the NHS R&D
Forum's web site and it is also worth keeping an eye on this
site for latest updates.
Another useful site is that of
the
Institute of Clinical
Research which offers a range of information and resources for
those engaged in clinical trials