Michael Clark PhD
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Both involve answering specific questions
which relate to the quality of care.
They can both be carried out either
prospectively or retrospectively.
It is also true that both audit and research
involve careful sampling, questionnaire
design principles, and data collection and
analysis
What is the difference?
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http://www.leedsth.nhs.uk/sites/research_and_development/quick.php
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A structured activity which is intended to
provide new knowledge which is
generalisable (i.e. of value to others in a
similar situation) and intended for wider
dissemination
Department of Health 2002
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A quality improvement process that seeks to
improve patient care and outcomes through
systematic review of care against explicit criteria
and the implementation of change. Aspects of
the structure, processes and outcomes of care
are selected and systematically evaluated against
explicit criteria. Where indicated, changes are
implemented at an individual, team, or service
level and further monitoring is used to confirm
improvement in healthcare delivery
Principles for Best Practice in Clinical Audit, NICE,
2002
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Research is about creating new knowledge,
about whether new treatments work or
whether some treatments are better than
others. It determines what is best practice
Clinical audit is a way of finding out if we are
doing what we should be doing. Are we
following guidelines, and are we using best
practice?
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Both audit and research involve answering a
specific question relating to quality of care
Both can be carried out either prospectively
or retrospectively
Both involve careful sampling, questionnaire
design and analysis of findings
Both activities should be professionally led
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Research creates new knowledge about what works
and what is best; clinical audit tells us if we are
following best practice.
Research is based on a hypothesis; clinical audit
measures against standards.
Research can involve patients trying an untested
treatment method; clinical audit never involves
patients trying new treatment methods.
Research may involve a degree of experimentation on
patients; clinical audit never involves anything
happening to the patient which is different to their
normal treatment.
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Research may involve allocating patients to different
treatment groups; clinical audit never involves
allocating patients to different treatment groups.
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Research may be based on a scientifically valid
sample size; clinical audit sample sizes don't need to
be scientifically valid.
Research may involve some detailed statistical
analysis of the collected data; clinical audit requires
only basic statistic analyses
The results from research are generalisable; clinical
audit results are applicable within local settings only.
Research findings can have a wide reaching influence
on clinical practice; clinical audit has a local influence
on clinical practice but can be shared widely
Research involving NHS staff, patients, their tissue or
data, or facilities and equipment requires ethics
committee approval; clinical audit rarely requires
ethics approval
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Research can't survive without audit as we
wouldn't know whether best practice was
being carried out, and audit can't survive
without research as without research we
wouldn't know what best practice was
Research identifies areas for clinical audit and
clinical audit identifies areas for research
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Answer these three questions –
Is the aim of your project to improve the
quality of care for a particular patient group
in the local setting (i.e. within the Trust)? YES
Will the project involve measuring practice
against a set of standards? YES
Does your project involve anything being
done to patients which is beyond what can be
described as normal clinical management?
NO
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Where do you start?
Research governance framework for health and social care:
Second edition
http://www.dh.gov.uk/en/publicationsandstatistics/publications
/publicationspolicyandguidance/dh_4108962
Research is essential to the successful promotion and protection
of health and wellbeing, and also to modern, effective health and
social care services.
At the same time, research can involve an element of risk, both
in terms of return on investment and sometimes for the safety
and wellbeing of the research participants.
Proper governance of research is essential to ensure that the
public can have confidence in, and benefit from, quality research
in health and social care. The public has a right to expect high
scientific, ethical and financial standards, transparent decision
making processes, clear allocation of responsibilities and robust
monitoring arrangements
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The framework is of direct relevance to all
those who host, conduct, participate in, fund
and manage health and social care research.
It is not just for investigators, managers or
any one professional group. All service and
academic staff, no matter how senior or
junior, have a role to play in the conduct of
research.
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The framework aims to forestall poor
performance, adverse incidents, research
misconduct and fraud, and to ensure that
lessons are learned and shared when poor
practice is identified. Learning from adverse
events will promote good practice, enhance
the ethical and scientific quality of research,
and safeguard the public
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Standards across five domains
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Ethics
Science
Information
Health, safety and employment
Finance and intellectual property
◦ Read framework and its appendices for current
standards and legislation
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All existing sources of evidence, especially
systematic reviews, must be considered
carefully before undertaking research.
Research which duplicates other work
unnecessarily, or which is not of sufficient
quality to contribute something useful to
existing knowledge, is unethical
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Every proposal for health and social care research
must be subjected to (scientific) review by
experts in the relevant fields able to offer
independent advice on its quality .
Arrangements for peer review should be in
proportion to the scale of the research and the
risks involved
NHS R&D committees
Data collected in the course of research must be
retained for an appropriate period, to allow
further analysis by the original or other research
teams subject to consent, and to support
monitoring by regulatory and other authorities
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No research study within the NHS involving
individuals, their organs, tissue or data may
begin until it has a favourable opinion from a
research ethics committee
Integrated Research Application System
https://www.myresearchproject.org.uk/
Answer questions that compile both the
ethics committee application and the NHS
R&D application
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The principles of Good Clinical Practice apply to all research
involving patients, not just clinical trials.
GCP is an international ethical and scientific quality standard for
the design, conduct and record of research involving humans.
Comprised of 13 core principles, GCP applies to all clinical
investigations that could affect the safety and well-being of
human participants (in particular, clinical trials of medicinal
products).
GCP was developed by the regulatory authorities of the EU, Japan
and US in a steering group termed the Tripartite International
Conference on Harmonisation (ICH) and provides international
assurance that:
◦ Data and reported results of clinical investigations are credible and
accurate, and
◦ Rights, safety and confidentiality of participants in clinical research are
respected and protected
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Research should be conducted in accordance with the ethical principles
that have their origin in the Declaration of Helsinki, and that are consistent
with GCP and the applicable regulatory requirement(s).
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Before research is initiated, foreseeable risks and inconveniences should
be weighed against the anticipated benefit for the individual research
participant and society. Research should be initiated and continued only if
the anticipated benefits justify the risks.
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The rights, safety, and well-being of the research participants are the most
important considerations and should prevail over interests of science and
society.
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The available nonclinical and clinical information on an investigational
product should be adequate to support the proposed research.
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Research should be scientifically sound, and
described in a clear, detailed protocol.
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Research should be conducted in compliance with the
protocol that has received prior institutional review
board (IRB)/independent ethics committee (IEC)
approval/favourable opinion.
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The medical care given to, and medical decisions
made on behalf of, subjects should always be the
responsibility of a qualified physician or, when
appropriate, of a qualified dentist.
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Each individual involved in conducting research should be qualified by education, training,
and experience to perform his or her respective task(s).
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Freely given informed consent should be obtained from every subject prior to research
participation.
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All research information should be recorded, handled, and stored in a way that allows its
accurate reporting, interpretation and verification.
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The confidentiality of records that could identify subjects should be protected, respecting
the privacy and confidentiality rules in accordance with the applicable regulatory
requirement(s).
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Investigational products should be manufactured, handled, and stored in accordance with
applicable good manufacturing practice (GMP). They should be used in accordance with
the approved protocol.
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Systems with procedures that assure the quality of every aspect of the research should be
implemented.
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All those conducting health and social care research
must open their work to critical review through the
accepted scientific and professional channels. Once
established, findings must be made accessible to
those participating and to all those who could benefit
from them. This may be through publication and/or
other means appropriate to the type of research
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Successful commercial development often depends
upon the protection of intellectual property or
commercial confidentiality at critical points in the
innovation process. The timing of the publication of
research findings needs to take account of this.
If we don’t want to be Dr Frankenstein or
Igor what do we have to watch out for?
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Most academic research today is carried out
with multi-professional teamwork with little
scope for single investigators
Educational research – MSc/PhD guidance and
support with academic supervisors – USE
THEM!
Other likely areas of activity relate to
commercial supported research of medical
devices (beds, dressings, TNP, electrostimulation - anything that isn’t a medicine).
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What questions to ask?
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Is it research or audit? Clinical audit never involves patients trying
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new treatment methods.
Look at the protocol.
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Study title and chief investigator, sponsor
Introduction
Study methods and materials
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Protocol modifications
Subject selection
Interventions to be administered
Adverse events
Monitoring
Quality control and quality assurance
Ethics
Data handling and record keeping
Final report
Records, reports and retention requirements
Design, objectives, sample size, study population, inclusion and exclusion criteria,
primary and secondary outcomes, study materials and labelling, study duration,
study termination/withdrawal, end of study, data storage
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3. Write a protocol – chief investigator. Each
individual involved in conducting research should
be qualified by education, training, and experience
to perform his or her respective task(s). Research
governance framework sets out responsibilities for
chief investigators, investigators and researchers.
Work within your competency.
4. Check intervention has a CE mark. If no CE
mark the research must be submitted for approval
to the Medicines and Healthcare Products
Regulatory Agency by the company.
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5. Submission to ethics and NHS R&D. Who is to
undertake this? Submissions need to be signed by
someone who can commit the trust to undertaking
the study.
6. Financial agreements. For commercial research in
secondary care, agreements will be between the
commercial sponsor and each NHS body accountable
for the care of NHS patients participating in the trial.
In primary care, these contracts will normally be
between the commercial sponsor and General
Practitioners or Practices.
Agreements not with the individual. Protect valuable
resources – ‘know how’ of NHS staff, access to NHS
patients.
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7. Agreement to publish or present the
results must be in the agreement.
8. Are the timescales realistic? Human
nature to be over optimistic regarding how
many subjects are available and can be
recruited.
9. Always bear in mind throughout the study
Each individual involved in conducting research
should be qualified by education, training, and
experience to perform his or her respective task(s)
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Research can be differentiated from audit
Research is governed by a substantial
framework protecting patients and staff.
Work through the key steps when starting a
new project. Be clear about your role and
responsibilities – am I competent to do this?
Research is fun.