An Introduction to Research Governance
Dr Gillian Gatenby
Research Governance Manager
Trust R&D
Newcastle Joint Research Office
November 2011
Overview of Presentation
2

Research Governance – What is it? Why does it exist?

Good Clinical Practice

The regulatory background and the legislation which
impacts on clinical research in the UK

Defining Research, Audit & Service Evaluation

Gaining the necessary approvals to carry out clinical
research in the NHS
What is Research Governance?
Research Governance is essentially a term covering the principles and
processes by which standards are set in research. According to the
Department of Health (DH), Research Governance improves research and
safeguards the public by:




enhancing ethical awareness and scientific quality
promoting good practice
reducing adverse incidents and ensuring lessons are learned
forestalling poor performance and misconduct
Research Governance is for all managers and staff, in all professional
groups, no matter how senior or junior working in all health and social care
research environments who:






design research studies
participate in research
host research in their organisation
fund research proposals or infrastructure
manage research
undertake research
The Research Governance Framework
The Research Governance Framework (RGF) was developed by the DH to
set out the principles, requirements and standards expected for the conduct
of clinical and non clinical research in the UK covering:
• Ethics (The dignity, rights, safety & wellbeing of participants must be the
primary consideration in any research study)
• Science (must ensure only high quality, valid research is conducted as
determined by independent scientific review of research proposals)
• Health & Safety (research can use potentially dangerous equipment,
substances or organisms so patient and researcher safety is paramount)
• Information (allow public access to information on research being conducted
and the findings from research)
• Finance (financial probity, consideration of adequate insurance cover for
research, arrangements for intellectual property, contracting)
• Quality Research Culture (promotion of excellence in research in the UK)
Good Clinical Practice (GCP)
GCP is an international ethical and scientific quality standard
for the design, conduct, recording and reporting of trials that
involve the participation of human subjects. Its purpose is to:


ensure the protection of the rights and well being of
research participants
ensure that results of research are accurate and credible
The principles of Good Clinical Practice have their origin in
the Declaration of Helsinki and apply to ALL research, not
just clinical trials of medicinal products!
5
Why Have Research Governance & GCP?
Episodes in history have shaped the regulation of research involving human
subjects & led to the introduction of GCP & tight regulations & governance
procedures for research. Some examples:
Elixir of sulphanilamide disaster in the USA in 1937
(improperly prepared medicine led to mass poisoning and in response the
1938 Food, Drug & Cosmetic Act was created to ensure all drugs safety
tested before marketing)
•
World War II & Nuremberg Trials
(Led to the creation of the Declaration of Helsinki in 1946 - the foundation of
the ethical principles on which GCP was built)
•
Tuskegee Syphilis Experiment
(US public health study conducted for 40 years to study the progression of
syphilis led to changes in the law governing protection of participants in
clinical research)
•
Use of Thalidomide in the 1950s/1960s
(changes to legislation worldwide to ensure stricter testing for drugs prior to
licensing)
•
Regulations & Legislation in the UK
The following are the key guidance documents, legislation and regulations
which govern the conduct of research in the UK:
7

DH Research governance framework for health and social care (2nd
Edition Sept 2005)

EU Clinical Trials Directive transposed into UK law through the
Medicines for Human Use (Clinical Trials) Regulations 2004

EU Medical Devices Directives implemented in the UK through the
Medical Devices Regulations 2002

Human Tissue Act 2004 (fully implemented Sept 2006)

Mental Capacity Act 2005 (fully implemented Oct 2007)

Data Protection Act 1998 and Freedom of Information Act 2000

Governance arrangements for NHS Research Ethics Committees
(GAfREC)
Research/Audit/Service Evaluation
8

Not all clinical projects conducted in the NHS are research.
Your study may be RESEARCH, an AUDIT or a SERVICE
EVALUATION

However, it is often difficult to differentiate between these three
types of study

Helpful guidance is provided by the National Research Ethics
Services (NRES) Guidance page –
http://www.nres.nhs.uk/applications/is-your-project-research/
What is Research?

Research attempts to derive generalizable, new knowledge

Quantitative research is designed to test a hypothesis. Quantitative research
may involve evaluating or comparing interventions, particularly new ones.

Qualitative research identifies/explores themes following established
methodology. Qualitative research usually involves studying how interventions
and relationships are experienced

Research addresses clearly defined questions, aims and objectives

Research usually involves collecting data that are additional to those for routine
care but may include data collected routinely. May involve treatments, samples
or investigations additional to routine care

Research may involve randomisation

Research normally requires Research Ethics Committee (REC) review. Refer
to: www.nres.npsa.nhs.uk/applications/apply/
What is Service Evaluation?

Designed & conducted solely to define or judge current care

Designed to answer: “What standard does this service achieve?”

Measures current service without reference to a standard

Involves an intervention in use only. The choice of treatment is that of the
clinician and patient according to guidance, professional standards
and/or patient preference.

Usually involves analysis of existing data but may include administration
of interview or questionnaire.

No allocation to intervention

No randomisation

Does not require REC review
What is Audit?

Designed & conducted to produce information to inform delivery of best
care

Designed to answer: “Does this service reach a predetermined standard?”

Involves an intervention in use only. Choice of treatment is that of the
clinician & patient according to guidance, professional standards and/or
patient preference

Usually involves analysis of existing data but may include administration of
simple interview or questionnaire.

No allocation to intervention
o
No randomisation

Does not require REC review
Undertaking Research in the NHS
Having determined you wish to undertake a clinical research project in
the NHS you need to:
12

Be aware of how clinical research is governed in the UK and the approvals
that must be in place before the research begins

Obtain permission to conduct the research from NHS R&D. All research
conducted in the NHS requires NHS permission at each NHS Trust where
the research is to run

Prepare your submission to the REC which is now completed through a
system known as IRAS (Integrated Research Application System)

For certain research projects (those hoping for adoption onto the NIHR
Portfolio) a new centralised system for NHS approval is used known as
NIHR CSP: NHIR Co-ordinated System for gaining NHS Permission (more
about CSP later)
Governance Checks & Risk Assessment
In accordance with the Research Governance Framework, NHS
organisations are responsible for ensuring that the research they
host meets the necessary standards – this is achieved through
research proposals undergoing governance checks & risk
assessment prior to commencing
In Newcastle upon Tyne Hospitals NHS Foundation Trust, the Trust
R&D team in the Joint Research Office are responsible for carrying
out the governance checks & risk assessment for every research
project which runs in the Trust.
Governance Checks & Risk Assessment
For all research conducted in the Trust the R&D team assesses:
14

Organisational risk: Sponsorship, insurance & indemnity, duty of care to
research participants

Patient safety: e.g. review of informed consent procedures, review by an
appropriate ethics committee, appropriate review by regulatory authorities
controlling drugs, approval for exposure to radiation where required etc

Risks to the Investigator and other research staff

Arrangements for data collection and storage and maintenance of
confidentiality of participants and use of data

Scientific risk: ensuring scientific quality of the research through good design
and independent review

Financial risk: ensuring financial probity and appropriate use of NHS
resources, contracting, insurance
Organisational Risk - Sponsorship
All research conducted in the NHS must have an identified Sponsor.
The sponsor is the individual or organisation which takes responsibility
for the initiation, management and financing of the research project. The
Sponsor must ensure that:
15

The research team hold the necessary contracts with the Trust and
are appropriately qualified to conduct the research

Arrangements are in place locally to deliver the research as
proposed in the research protocol

Through independent peer review the scientific quality of the
research is assured

All necessary approvals are obtained prior to the research
commencing (REC approval, MHRA approval, all local approvals etc)

Responsibilities for the management, monitoring and reporting of the
research are delegated appropriately
Determining a Research Sponsor
16

For non-commercial research involving NHS patients it is usual for NHS
Trust to act as Research Governance Sponsor as the duty of care for the
patients participating in research and the staff conducting the research
resides with the NHS Trust

The Sponsor is usually the lead Trust where study is initiated and where
the Chief Investigator is employed

Some Trusts/Universities have co-sponsorship arrangements in place

Universities tend not to sponsor research projects which involve patients
and are interventional in nature. It is common however for Universities to
sponsor non interventional research (e.g. research involving existing
collections of tissue samples held in a university research tissue bank or
a healthy volunteer study where there is no NHS Trust involvement)

For commercial research the Sponsor is usually the commercial
organisation leading the research

In all cases R&D requires evidence of Sponsorship
The Research Team
17

The Chief Investigator (CI) is the person designated to take overall
responsibility for the design, conduct and reporting of a study

For multi-centre studies it is common to have the CI located at the main
research site and local Principal Investigators (PI) identified at participating
research sites

Honorary Research Contracts (HRCs) are required for non-NHS staff
conducing research where they will have direct contact with patients or staff
and/or direct bearing on quality of care for patients. Letters of
permission/access are required for those working with data or tissue only

A Research Passport scheme now operates for non NHS staff who require
access to multiple NHS Trusts as part of their research

A full HRC provides NHS indemnity. The Trust indemnifies for negligent harm
under the Clinical Negligence Scheme for Trusts (CNST).

This Trust expects all those conducting research projects to have undertaken
training in GCP
Scientific Risk: Independent Peer Review
The Research Governance Framework states that all projects should be
independently peer reviewed – this is the responsibility of the Sponsor:
18

If research has been funded by a commercial organisation, DH or an
established charitable body for example, it is generally the case that
these organisations will have conducted a rigorous peer review prior
to funding a study

If a study is designed in house by the research team and has not
been funded by a known funding body or another Trust or University,
the R&D office would need to arrange an independent peer review of
the research proposal in house

R&D must see evidence of a favourable peer review for a research
proposal before R&D approval will be granted
Research Ethics
•
Research Ethics Committees (RECs) safeguard the rights, safety,
dignity and well-being of people participating in research in the
NHS. They review applications for research and give an opinion
about the proposed participant involvement and whether the
research is ethical.
•
RECs are entirely independent of research Sponsors and
investigators.
•
Each year, RECs in the UK review around 6,000 research
applications. On average, they give an opinion after 35 days: well
within the maximum allowance of 60 days.
Research Ethics
Broadly speaking, legislation requires REC review of research involving:








20
people who lack (or lose) capacity to give informed consent to take
part (or to keep taking part) in the research;
processing of confidential patient information without consent where
this would otherwise breach confidentiality;
material consisting of or including human cells, which has been taken
from the living or the deceased
patients who are cared for in private and voluntary sector nursing
homes (in England, Wales and Northern Ireland) and/or residents of
residential care homes (in Northern Ireland only);
exposure to ionising radiation;
medical devices that are not CE-marked (i.e. not compliant with
European Directives) or CE-marked medical devices that have been
modified or are being used for a new purpose;
investigational medicinal products;
protected information from the Human Fertilisation and Embryology
Authority
Applying for Ethical Approval
21

REC review via NHS RECs is under the control of the National
Research Ethics Service (NRES)

The application form for the REC is completed online through
IRAS (integrated research application system)

The application to the REC is signed by the CI and the Sponsor
for the research – this can be done electronically but the form
must be authorised before submission to the REC

Now have ‘main REC’ for each study
 A favourable opinion for a study must be obtained by the CI
from the main REC
 If a multi-centre study, each site must have a Site Specific
Assessment conducted as part of Trust R&D approval at that
site
Data Protection/Caldicott in Research
Caldicott refers to a review commissioned by the Chief Medical Officer.
Information Management Principles were created to improve how the NHS
handles and protects person identifiable information. Think of the following
when designing your research:
•
•
•
•
•
•
Justify the purpose of why you are using confidential information in your research
Only use confidential information when necessary
Use the minimum information that is required
Access to information should be restricted to only those who need to access it
All those handling confidential information must understand their responsibilities
Understand & comply with law (Data Protection & Freedom of Information Acts)
In this Trust, Caldicott approval is required for research collecting and
transferring person identifiable data. The approval process for Caldicott & Data
Protection is combined and requires submission of a single form to the Trust
Caldicott Guardian.
Databases storing identifiable patient/staff information must be registered with
the Trust and held on Trust servers.
22
Insurance & Indemnity in Research
o
Indemnity is the “promise” of insurance cover, not the insurance itself.
o
In the NHS indemnity is provided by the NHS Litigation Authority under the
Clinical Negligence Scheme for Trusts (CNST).
o
The NHS is legally liable for the negligent acts or omissions of its employees
o
Those substantively employed by the NHS and those holding honorary
contracts with the NHS are covered by CNST whilst working in the Trust.
o
The NHS only covers claims of negligent harm. Non negligent harm is not
covered by NHS Indemnity.
o
University employees conducting research in the NHS need to inform their
organisation’s insurance Department as it may be necessary to obtain a
certificate of insurance for your research.
o
For some research projects using a device or medicinal product, product
liability may apply – this is usually provided by the product manufacturer
o
R&D requires confirmation of insurance arrangements for research
Financial Risk
24

Projects must be fully costed and funded before the research can
be approved to commence in the NHS – seek advice from Trust
R&D as to the requirements for costing for your study

For externally-funded, non-commercial research involving the
NHS see the “Attributing revenue costs of externally funded noncommercial research in the NHS (ARCO)” guidelines produced by
DH to assist with costing your research proposal. You will need to
consider not only the research costs but also potential service
support costs and excess treatment costs.

Commercial projects would be expected to be fully costed and
funded by the company sponsoring the research with all
appropriate overheads and all necessary set-up fees (e.g., R&D,
Pharmacy, Clinical Research Facility etc) included in the fees for
conducting the research
Clinical Trials of Investigational Medicinal Products
(ctIMPs)
The EU Clinical Trials Directive
25

The EU Directive 2001/20/EC was transposed into the legislation of all EU
member states from 1 May 2004

The Medicines for Human Use (Clinical Trials) Regulations 2004 (the
Regulations) regulate clinical trials in the UK since they came into force
on the 1 May 2004

The aims of the Directive and the subsequent regulations were to
harmonise the regulation of clinical trials, improve the rights, privacy and
protection of research participants in accordance with Good Clinical
Practice (GCP)

The Directive applies to any clinical trial of an Investigational Medicinal
Product (IMP)

Recently Trust R&D has received applications for approval of trials
involving ATMPs (Advances Therapy Medicinal Products) as well as
CTIMPs
MHRA

UK Competent Authority is the Medicines and Healthcare products
Regulatory Agency (MHRA)

The MHRA has the power to inspect organisations conducting clinical
trials of IMPs/ATMPs and devices in the UK and indeed elsewhere in the
world

There have been various amendments to the Medicines for Human Use
(Clinical Trials) Regulations 2004 as listed below:




26
The Medicines for Human Use (Clinical Trials) Amendment (No.1)
Regulations SI (2006/1928) provide a legal basis on which the MHRA can
inspect clinical trials and transposes into UK Law the EU Directive
(2005/28/EC) on Good Clinical Practice
The Medicines for Human Use (Clinical Trials) Amendment (No.2)
Regulations SI (2006/2984) make provisions relating to trials involving
incapacitated adults in emergency situations
The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality
(Amendment) Regulations 2008 SI (2008/941) make additional provision
relating to trials involving minors in emergency situations
The Medicines for Human Use (Miscellaneous Amendments) Regulations
2009 SI (2009/1164)
Good Clinical Practice in ctIMPs
(Amendment Regulations 2006)
Summary of main GCP Responsibilities:












27
Trial documents: Master Trial Files/Investigator site file must be maintained
Adequate resources must be available (time, facilities, staff, training, potential to
recruit)
Recorded evidence of investigators qualifications (signed CV), GCP training etc
Rights/well-being of trial subjects (ethical approval and medical care ensured)
Compliance with protocol as set out in initial application to MHRA/REC or
amendments as approved by MHRA & Ethics (non adherance to the protocol is
a serious breach of GCP)
IMPs to be stored, labelled and used in accordance with protocol
Data recorded & stored appropriately (eg changes to case report forms must be
dated and initialled (no tippex!)
Informed consent essential - patient MUST sign and DATE informed consent
form as per protocol and ethics approval – MUST show that all staff taking
consent are trained in obtaining consent
Regular monitoring – establishing data monitoring committees and evidence of
decisions made (minutes)
Progress reports to Ethics and MHRA (copy to sponsor) – yearly and end of trial
Safety reporting – very specific for ctIMPs regarding reporting of Serious
Adverse Events (guidance available regarding legal requirements)
Records retention and archiving – patient confidentiality issues/integrity of the
record of the trial to be maintained
Permissions Needed for ctIMPs

All ctIMPs must be registered with the European clinical trials database
to obtain unique EudraCT number to be used on all correspondence with
the MHRA

The investigator must obtain a Clinical Trial Authorisation (CTA) from
Medicines and Healthcare Products Regulatory Agency (MHRA) prior to
commencing the trial

For ctIMPs the is a requirement in the Trust that the trial will be regularly
monitored (ideally by a registered Clinical Trial Unit or a Contract
Research Organisation) to ensure that the trial is running safely and is
GCP compliant at all times


28
For commercial studies the commercial sponsor arranges monitoring
For non-commercial trials, monitoring should be arranged through an
accredited clinical trials unit
EU Medical Devices Directive
The Medical Devices directive defines a medical device as:
Any instrument, apparatus, appliance, material or other article, whether used
alone or in combination, including the software necessary for its proper
application intended by the manufacturer to be used for human beings for the
purpose of:





29
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap,
investigation, replacement or modification of the anatomy or of a
physiological process,
control of conception,
and which does not achieve its principle intended action in or on the
human body by pharmacological, immunological or metabolic means,
but may be assisted in its function by such means.
Permissions Needed for Device Trials
30

Devices are regulated in the UK by the Medicines and Healthcare
products Regulatory Agency (MHRA)

The legislation covers the placing on the market and putting into service
of medical devices

This enables the device to obtain a CE mark – manufacturer's claim that
the device satisfies the relevant Essential Requirements in the Directives
and is fit for its intended purpose

If using CE marked devices in research then no need to register with
MHRA

Clinical devices developed and used within an NHS setting only (eg,
made by and used in Medical Physics) do not fall under the regulations –
CE mark not necessary unless placing on the market

GREY areas – does it cross-over into medicinal products legislation (eg,
device administers a medicinal product)
Human Tissue Act 2004
31

Implemented Sept 2006 the HT Act is regulated in the UK by The Human
Tissue Authority (HTA) for the removal, storage, use and disposal of human
bodies, organs and tissue from the living and deceased.

Consent is the fundamental principle of the Act
Under the Act, consent is broadly required to store and use relevant material
from the living for a number of ‘scheduled purposes’, including ‘research in
connection with disorders, or the functioning of, the human body’. Consent is
also required to remove, store and use relevant material from a deceased
person. This consent must be both appropriate and valid.

The HTA has the authority to inspect organisations that store and use tissues
for the purposes covered by the HT Act.

What does the Act do?
 Identifies the range of activities for which a licence will be required
(the Trust and the University hold licences from the HTA)
 Prohibits the conduct of certain activities without a licence
 Establishes penalties (including custodial sentences)
 Prohibits commercial dealing in human material
Definition of Relevant Material
The material that the HT Act covers is called ‘relevant material’,
which is material that consists of or includes human cells (even a
single cell!).
‘Relevant material’ includes blood, tissues and organs.
It does not include:
• Material which contains no cells e.g. serum.
• Gametes (ova and sperm).
• Material created outside of the body e.g. embryos, cell lines.
Information about relevant material can be found on the HTA website
and supplementary list of relevant materials:
http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/defini
tionofrelevantmaterial.cfm
32
Using Human Tissue Samples in Research

Consent



Ethics review from an NHS REC


A licence is required for storage of tissue for research purposes only if
you are storing licensable tissue (relevant material) for unspecified
research purposes
Transfer of tissue

33
Ethical approval from an NHS REC can be project specific or generic if it
is obtained for the initiation of a Research Tissue Bank (RTB)
HTA Licence


Need consent to collect and use tissue in research in most cases
(exceptions if held before 01 Sept 2006, ‘surplus’ tissue if anonymised
and research approved by an NHS REC, 100 year rule)
Consent can be for use of tissue samples in a specific research project or
generic to allow for use of samples in future unspecified research
Material Transfer Agreements (MTA) are required for the transfer of tissue
to or from an RTB or other organisation
Mental Capacity Act 2005
34

Became law in Oct 2007

The Mental Capacity Act 2005 (MCA) provides a statutory
framework to empower and protect vulnerable people who are
not able to make their own decisions.

It makes clear who can take decisions, in which situations, and
how they should go about this.

It enables people to plan ahead for a time when they may lose
capacity.
Five Key Principles of the MCA
35

A presumption of capacity

The right for individuals to be supported to make their own
decisions

That individuals must retain the right to make what might be
seen as eccentric or unwise decisions

Anything done for or on behalf of people without capacity
must be in their best interests

Least restrictive intervention of the person’s basic rights and
freedoms
Research and the MCA
36

The Act sets out a single clear test for assessing whether a person lacks
capacity to make a particular decision at a particular time

The Act sets out clear parameters for research:

Research involving, or in relation to, a person lacking capacity may be
lawfully carried out if an ‘appropriate body’ (a Research Ethics
Committee designated to review MCA applications) agrees that the
research is safe, relates to the person’s condition and cannot be done
as effectively using people who have mental capacity.

Carers or nominated third parties must be consulted and agree that
the person would want to join an approved research project

A personal consultee is identified in the case of loss of capacity
during research

Nominated consultee if no personal consultee available – see
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/Publica
tionsPolicyAndGuidance/DH_083131 for guidance
Research Involving Radiation
IRMER: The Ionising Radiation (Medical Exposure) Regulations 2000 as
amended by the Ionising Radiation (Medical Exposure) (Amendment)
Regulations 2006
Scope of IRMER
IRMER governs the exposure to ionising radiation of patients or other
persons voluntarily participating in medical or biomedical, diagnostic or
therapeutic research programmes. The research provisions of IRMER
apply to any research exposure involving ionising radiation, not only to
exposures that are additional to routine care
Procedures involving ionising radiation include:
 Diagnostic X-rays, CT scans or DXA scans
 Radiotherapy
 Radionuclide imaging (including diagnostic imaging)
 NB: Magnetic Resonance Imaging (MRI) or ultrasound does not
involve ionising radiation.
R&D requires evidence of IRMER review if studies involve ionising radiation
Research Involving Radiation
ARSAC: The Administration of Radioactive Substances Advisory
Committee
•
The administration of radioactive substances is governed by the
Medicines (Administration of Radioactive Substances) Regulations 1978
(MARS) as well as by IRMER. Regulation 2 of MARS requires that any
doctor or dentist wishing to administer radioactive medicinal products to
humans should hold a certificate issued by Health Ministers.
•
In the case of research involving administration of radioactive
substances (nuclear medicine), preparatory work may include
application for a research ARSAC certificate from the Department of
Health in order to comply with MARS
•
R&D requires a copy of the ARSAC certificate where research involves
the administration of radioactive substance to a research participant
Clinical Trial Agreements
It is sometimes necessary to execute an agreement to cover the
financial arrangements and division of responsibilities between
Parties for the conduct of a project:
•
For commercially sponsored and funded trials the ABPI model
Clinical Trial Agreement (mCTA) is generally used.
•
For non commercially sponsored research there is the national
model agreement for non commercial research (mNCA)
•
Where a project involves the transfer of tissues between
organisation a Material Transfer Agreement (MTA) may be
necessary.
Integrated Research Application System
(IRAS)

Web based system at www.myresearchproject.org.uk

A single system for applying for the permissions and approvals for
health and social care / community care research in the UK

Enables you to enter the information about your project once
instead of duplicating information in separate application forms

Uses filters to ensure that the data collected and collated is
appropriate to the type of study, and consequently the permissions
and approvals required

Helps you to meet regulatory and governance requirements
Integrated Research Application System
(IRAS)
IRAS captures the information needed for the relevant approvals
from the following review bodies:









41
Administration of Radioactive Substances Advisory Committee
(ARSAC)
Gene Therapy Advisory Committee (GTAC)
Medicines and Healthcare products Regulatory Agency (MHRA)
Ministry of Justice
NHS / HSC R&D offices
NRES/ NHS / HSC Research Ethics Committees
National Information Governance Board (NIGB)
National Offender Management Service (NOMS)
Social Care Research Ethics Committee
Entry page for IRAS
42
When to Apply for Approvals
It can be confusing as to when to apply for certain approvals…
43

It is now a requirement of final R&D approval that there is
evidence of other approvals having been granted before giving
final R&D approval

Ideally you should apply for ethics, MHRA, other approvals (eg
Caldicott) at the same time as applying for R&D approval so the
applications can be processed in parallel – you should NOT wait
for R&D approval before applying for ethics, MHRA etc (integrated
application process)

The new CSP system helps with order of approvals

You CANNOT begin your research in an NHS Trust without the
final letter of approval from that organisation
The NIHR Portfolio
The goal of the National Institute for Health Research (NIHR) is to create a health
research system in which the NHS supports outstanding individuals, working in
world class facilities, conducting leading edge research focused on the needs of
patients and the public
The Institute manages its activities through four main work strands:




NIHR Faculty: supporting the individuals carrying out and participating in
research
NIHR Research: commissioning and funding research (e.g. NIHR programme
grants, RfPB etc)
NIHR Infrastructure: providing the facilities for a thriving research environment
(e.g. BRUs & BRCs)
NIHR Systems: creating unified, streamlined and simple knowledge
management systems (RDMIS CSP Module)
The National Institute for Health Research Clinical Research Network (NIHR
CRN) Portfolio is a database of high-quality clinical research studies that are
eligible for support from the NIHR Clinical Research Network in England.
Applying for Portfolio Adoption
The NIHR Coordinated System for gaining NHS Permission (NIHR CSP) is the entry
point for non-commercial studies applying for portfolio adoption and Clinical Research
Network (CRN) support.
Studies automatically eligible for consideration for NIHR CRN support are those that:

Have some of their research funding provided by the NIHR, other areas of central
Government and NIHR non-commercial Partners; and

Fulfil the Eligibility Criteria definition of a ‘research study’ which is "the attempt to
derive generalisable (i.e. of value to others in a similar situation) new knowledge
by addressing clearly defined questions with systematic and rigorous methods".
Studies potentially eligible for consideration for NIHR CRN support are those that are:

Commercially funded and commercially sponsored (i.e. commercial contract
research)

Non-commercial studies
o Investigator initiated trials (i.e. commercial collaborative research)
o Funded by overseas Governments
o Funded by overseas charities
NHS REC approval and NHS permission are prerequisites for research to be
supported via the CRN.
Clinical Research Networks in the UK
Studies on the NIHR Portfolio have the following support:

Access to local network of dedicated research support staff including research
nurses and other allied health professionals, who can help identify eligible patients,
arrange consent to participate in the study and monitor patients as they progress
through the study

Support to ensure your study can be successfully undertaken in the NHS including
pharmacy, imaging and pathology services and the possibility of securing
protected time for NHS staff to conduct research

Access to experienced RM&G staff that can advise on governance aspects of
undertaking research in the NHS and facilitate rapid approval of your study
through the NIHR Coordinated System for gaining NHS Permission (NIHR CSP).
Although the CRN operates as one organisation, it is made up of a number of parts:

Six “Topic” Research Networks (covering Cancer, Dementia and Neurodegenerative Diseases, Diabetes, Medicines for Children, Mental Health & Stroke)

A Primary Care Research Network

A Comprehensive Clinical Research Network, which covers all other areas. Our
researchers are supported by Northumbria Tyne & Wear Comprehensive Local
Research Network (NTW CLRN), one of 25 CLRNs in England.
Research Design Service

National Institute for Health Research Research Design
Services' (NIHR RDSs) aim is to increase the volume and quality
of successful grant applications for NIHR funding

In Newcastle RDS North East provides expert advice to help
local researchers to develop and design high quality research
proposals for submission to national, peer-reviewed funding
competitions for applied health or social care research

The RDS is part of the NIHR infrastructure and is a national
service regionally delivered working to the maxim "consistency
where possible, flexibility where appropriate".

The support is provided free of charge
To recap…
You need to:
48

Register your research with Trust R&D & obtain R&D approval from each
research site, including all local approvals required from Support Depts
(Pharmacy, Labs, Imaging, etc Finance etc)

Obtain favourable ethical opinion from an NHS REC (where the NHS is
involved in the research) or a UREC (if applicable)

Honorary Research Contracts/ necessary permissions for non NHS staff

Obtain Data protection/Caldicott approval

Obtain MHRA approval for ctIMPs or device trials

Agree arrangements for collection, use & storage of tissue samples

Other certificates/approvals as appropriate (eg, GTAC – for gene therapy;
ARSAC – radiation; NIGB if accessing clinical information without consent)

Signed agreements where required (mCTA/mNCA, MTAs etc)
List of Common Acronyms in Research

















49

ARSAC: Administration of Radioactive Substances Advisory Committee
ATMP: Advanced Therapy Medicinal Products
NIHR CSP: Coordinated System for gaining NHS Permission
ctIMP: clinical trial of an Investigational Medicinal Product
EudraCT: European Union Drug Regulating Authorities Clinical Trials
GAfREC: Governance Arrangements for Research Ethics Committees
GTAC: Gene Therapy Advisory Committee
IRAS: Integrated Research Application System
IRMER: The Ionising Radiation (Medical Exposure) Regulations 2000
mCTA: model Clinical Trial Agreement
mNCA: model agreement for non commercial research
MHRA: Medicines and Healthcare product Regulatory Agency
MTA: Material Transfer Agreement
NIGB: National Information Governance Board
NIHR: National Institute for Health Research
NPSA: National Patient Safety Agency
NRES: National Research Ethics Service
PIAG: Patient Information Advisory Group
Useful Websites
50

Department of Health – Research Governance Framework
http://www.dh.gov.uk/en/Policyandguidance/Researchanddevelopment/AZ/Researchgovernance/index.htm

NRES http://www.nres.npsa.nhs.uk/

IRAS https://www.myresearchproject.org.uk/

MHRA for trials of Medical Devices and Medicinal Products
http://www.mhra.gov.uk/index.htm

EudraCT for registering a ctIMP http://eudract.emea.europa.eu/

Clinical Trials Toolkit http://www.ct-toolkit.ac.uk/
Useful Websites
51

Mental Capacity Act information – Department of Health
http://www.dh.gov.uk/en/SocialCare/Deliveringsocialcare/Me
ntalCapacity/MentalCapacityAct2005/index.htm

Information about Research Passports
http://www.nihr.ac.uk/systems_research_passports.aspx

NIHR Portfolio information:
http://www.crncc.nihr.ac.uk/about_us/processes/portfolio

NIHR Portfolio information for Commercial projects
http://www.crncc.nihr.ac.uk/Life+sciences+industry

Human Tissue Authority http://www.hta.gov.uk/
ANY QUESTIONS?
Contact Details
Dr Gillian Gatenby
Research Governance Manager
Joint Research Office
6th Floor, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
Trust R&D main office: 0191 2825959
53