RESEARCH & DEVELOPMENT (R&D) POLICY

POLICY/PROCEDURE NUMBER:

CLP19

VERSION NUMBER:

REPLACES SEPT DOCUMENT

RESEARCH CONDUCT &

PROCESSES POLICY

REPLACES NEP DOCUMENT

RESEARCH & DEVELOPMENT

POLICY

AUTHOR:

Research Manager

CONSULTATION GROUPS:

Research Lead, Executive

Medical Director, R&D Staff,

R&D Group

IMPLEMENTATION DATE:

April 2018

AMENDMENT DATE(S):

LAST REVIEW DATE:

NEXT REVIEW DATE:

April 2021

APPROVAL BY

RATIFICATION BY QUALITY COMMITTEE

April 2018

POLICY SUMMARY

This policy and associated guidance sets out the Trust policy for the development,

conduct and management of research within the organisation in accordance with

the key legal, quality, ethical and safety frameworks underpinning research in the

NHS in order to ensure the rights, privacy and dignity of all who are recruited as

participants in a research study. Detailed processes for conduct and management

of research are set out in R&D Standard Operating Procedures (SOPs).

The Trust monitors the implementation of and compliance with this policy in

the following ways;

Monitoring of implementation and compliance with this policy and associated

procedures will be undertaken by the Executive Medical Director, Research

manager, Research lead, and R&D group.

Services

Applicable

Comments

Trust-wide



The Director responsible for monitoring and reviewing this policy is the Executive

Medical Director

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ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST

RESEARCH & DEVELOPMENT (R&D) POLICY

CONTENTS

THIS IS AN INTERACTIVE CONTENTS PAGE, BY CLICKING ON THE TITLES

BELOW YOU WILL BE TAKEN TO THE SECTION THAT YOU WANT.

1.0 INTRODUCTION

2.0 DEFINITIONS

3.0 BACKGROUND

4.0 SCOPE

5.0 DUTIES

6.0 STANDARD OPERATING PROCEDURES

7.0 IMPLEMENTATION

8.0 RESEARCH PRIORITIES

APPENDICES

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ESSEX PARTNERSHIP UNIVERSITY NHS FOUNDATION TRUST

RESEARCH & DEVELOPMENT (R&D) POLICY

1.0 INTRODUCTION

1.1 The purpose of this policy is to put in place a framework to communicate the

principles, legal requirements and standards for all research conducted in the

Trust.

1.2 This policy also puts in place the delivery mechanisms to ensure that these

standards are met and arrangements to monitor quality and adherence to

these standards, ensuring compliance with the UK Policy Framework for

Health and Social Research (2017) and compliance with other regulatory and

statutory requirements.

2.0 DEFINITIONS

2.1 Research has been defined as “research is defined as the attempt to derive

generalisable or transferable new knowledge to answer or refine relevant

questions with scientifically sound methods” (UK Policy Framework for Health

and Social Care Research, DH, 2017). The Health Research Authority (HRA)

provides a decision tool to help understand if a study would be considered

research by the NHS: http://www.hra-decisiontools.org.uk/research/. One or

more of the following criteria must be true for the study to be considered

research:

 The study involves randomisation

 The protocol demands changing treatment / patient care from accepted

standards for any of the patients involved

 The findings will be generalisable

Generalisable in this context means the extent to which the findings of a

clinical study can be reliably extrapolated from the subjects who participated

in the study to a broader patient population and a broader range of clinical

settings.

If, having consulted the HRA decision tool, there is still doubt, then applicants

are advised to consult the R&D office. A HRA email address has also been

set up in case of ambiguity - [email protected]

Note that the following are not research and therefore not subject to the

research governance process:

Clinical Audit is 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

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service level and further monitoring is used to confirm improvement in

healthcare delivery.

Service Evaluation can be seen as a set of procedures to judge a pilot's

merit by providing a systematic assessment of its aims, objectives, activities,

outputs, outcomes, and costs. Evaluation provides practical information to

help decide whether a development or service should be continued or not.

Evaluation also involves making judgements about the value of what is being

evaluated.

2.2 Research activity may include observational or interventional designs (such

as clinical trials) which may be externally funded or undertaken within existing

resources. A range of methodologies and tools may be employed in the

design of the projects, including quantitative or qualitative methods,

randomization, blinding and cohort designs.

3.0 BACKGROUND

3.1 This policy and the related procedural guideline are based upon the UK Policy

Framework for Health and Social Care Research 2017. All NHS studies need

to be conducted according to this framework. Clinical Trials of Investigational

Medicinal Products (CTIMPs) are subject to additional regulation and must be

conducted according to International Conference on Harmonisation – Good

Clinical Practice (ICH-GCP) standards.

3.2 All research in the NHS must be conducted ethically. Research involving

service users, or service user data that is not fully anonymised, requires

formal approval from an independent Research Ethics Committee (REC).

Formal REC approval is not required for studies involving staff only.

3.3 All research in the NHS requires centralised HRA approval to verify the

proposed study is compliant from a legal and governance perspective. To

meet legal requirements, additional approvals may be required depending on

the study setting, use of data, investigational medicinal products, gene

therapy or administration of radioactive substances. Applications for HRA,

REC and a range of other research approvals are made via the online

Integrated Research Application System (IRAS). Researchers are advised to

contact the R&D office as early as possible for advice on setting up a new

study. As a final step, new studies generally require “Confirmation of Capacity

and Capability” from the Trust (detailed in a Trust Standard Operating

Procedure). This involves R&D office led local assessment of feasibility,

putting into place practical arrangements for study delivery and, if appropriate,

issuing of a final email to confirm the study can go ahead at EPUT.

3.4 This policy aims to ensure sound research governance arrangements are in

place for the conduct of research in the Trust in order to ensure the rights,

privacy and dignity of all who are recruited as participants in a research

Study, to ensure service users are informed of opportunities to take part in

research relevant to them and to contribute to generation of new knowledge

with potential to improve care.

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3.5 This Trust promotes and encourages a culture of high quality research within

the organisation working with its research partners including but not limited to

other NHS organisations, academic institutes and commercial partners. The

Trust aims to secure R&D capability to improve services and bring benefits to

service users.

3.6 The National Institute for Health Research (NIHR) and its operational

organisations, the Clinical Research Networks (CRNs) informs the research

agenda in terms of research management and funding processes. EPUT is a

member of the NIHR Clinical Research Network: North Thames (CRN: North

Thames).

3.7 The NIHR Portfolio is made up of high quality clinical research studies across

a range of specialities. Studies adopted to the NIHR portfolio are eligible for

the NIHR Study Support Service. NIHR Portfolio studies may also be eligible

for support from CRN funded R&D staff employed by EPUT who can assist

with study set-up, co-ordination, conducting assessments and recruiting

participants. Studies are automatically eligible for the Portfolio if funded by

NIHR or NIHR non-commercial partners. Organisations are more likely to be

accepted as a NIHR non-commercial partner, if funding is awarded via open

competition across England. Commercially funded studies are a “high priority

for NIHR portfolio adoption”. Other non-commercial studies may be eligible,

based on potential value to the NHS. Researchers are advised to contact the

R&D office to explore whether a proposed study may be eligible for NIHR

adoption as CRN support is often invaluable to the success of a project.

Further detail is available on the NIHR site: https://www.nihr.ac.uk/funding-

and-support/study-support-service/eligibility-for-nihr-support/

3.8 Studies with both a Commercial Sponsor and Commercial Funder are not

subsidised by the NHS and all activity must be paid for by the company

involved. Cost attribution for non-commercial studies in the NHS is more

complex and worked out through the “Attributing the costs of health and social

care research (AcoRD) framework (DH, 2012-2015). In summary, AcoRD

considers 3 costs of research:

 Research Costs - the costs of the R&D itself that end when the

research ends. They relate to activities that are being undertaken to

answer the research questions. (usually met by grant funders, though

some specific research activities may be met by Department of Health

– see Annex A and Annex B costs)

 NHS Treatment Costs - the patient care costs, which would continue

to be incurred if the patient care service in question continued to be

provided after the R&D study had stopped (met by NHS)

 NHS support costs - the additional patient care costs associated with

the research, which would end once the R&D study in question had

stopped, even if the patient care involved continued to be provided

(met by CRN if on NIHR portfolio, otherwise by Sponsor or Funder)

Further details on AcoRD are available from the DH:

https://www.gov.uk/government/publications/guidance-on-attributing-the-

costs-of-health-and-social-care-research

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4.0 SCOPE

4.1 This policy applies to clinical and non-clinical research undertaken by all staff

in all disciplines wanting to undertake a research study in the Trust. It also

applies to all researchers from external organisations who may apply to the

Trust to conduct research in this organisation.

5.0 DUTIES

5.1 The Trust Board of Directors is responsible for:

 ensuring that the principles of this policy, related standard operating

procedures and other associated policies are implemented across the

organisation;

 ensuring that necessary financial resources are available.

5.2 The Executive Medical Director will ensure:

 The delegated responsibilities to the R&D group are met, monitored and

effective.

 This policy and related standard operating procedures are embedded within

clinical and research practice.

 This policy and related standard operating procedures are reviewed and

updated regularly in accordance with best practice and national guidance.

 Learning derived from quality monitoring and review of local and national best

practice guidance is incorporated into clinical and research practice.

5.3 The Trust R&D Lead is responsible for:

 Providing advice to the Trust Board and Trust Management on all matters

relating to R&D, and their implications for service delivery and development.

 Representing the Trust’s research interest to external organisations, both

locally and regionally, in both academic and healthcare sectors.

 Representing the Trust as a member of the Clinical Research Network: North

Thames Partnership Group.

 Ensuring that research taking place in the Trust is actively promoted, both

internally and externally.

5.4 The Chief Pharmacist will ensure:

 Pharmacy standard operating procedures are in place for the receipt, handling

and issue of IMPs

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 Capacity and capability to participate in individual CTIMPs is considered from

a pharmaceutical perspective

 The safe and secure handling of IMPs

5.5 Responsibilities of the Research & Development Department:

 Developing and establishing systems for the management of research

involving EPUT.

 Developing and maintaining the EPUT study feasibility process to meet the

requirements of applicable laws and regulations.

 Conducting effective feasibility checks on new studies and ensuring that

appropriate assessment and approvals are in place before commencement of

research within EPUT.

 Maintaining a record of all research being conducted within EPUT.

 Assessing applications for EPUT to act as a sponsor for individual studies or

to support grant applications

 Arranging for written agreements to be put in place where required for studies

involving an external partner, funder and/or sponsor, including agreements

with universities or other employers in relation to student supervision and

arrangements for sub-contracting.

 Ensuring that adequate payment is obtained for participation in commercial

clinical research, which is not subsidised by the NHS, and that such payment

flows to departments supporting the study.

 In relation to commercial research, in partnership with the finance department:

costing commercial research studies, negotiating contracts, developing and

establishing systems to ensure financial probity.

 Permitting and assisting with any monitoring, auditing or inspection required

by relevant authorities and conducting internal monitoring as appropriate.

 Contributing to development of the EPUT R&D Strategy with the R&D Lead in

consultation with researchers and the R&D Group.

 Promoting dissemination of research findings.

 Promote awareness of the Trust Intellectual Property Policy and the

identification, management and exploitation of intellectual property generated

from research.

 Compiling and submitting R&D reports and returns as required by national

and regional bodies and the Executive Medical Director.

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 To develop research opportunities and experience with within the Trust by

fostering a research culture.

 Ensure that research taking place in the Trust is actively promoted, both

internally and externally.

 Meeting internal and external performance targets.

 Monitoring and reporting on implementation of this policy on an ongoing basis.

 Ensuring the R&D department and research within the Trust operates in line

with national standards and Trust policies including data protection, health

and safety requirements, monitoring of misconduct and fraud and financial

probity.

 the identification, management and exploitation of intellectual property

generated from research in the Trust through promotion and raising

awareness of the Trust Intellectual Property Policy (CP45)

 the health, safety, dignity and well-being of those involved in research through

monitoring of policy and procedural adherence including reporting

requirements in accordance with SOPs and Trust policy and monitoring of

ongoing studies.

6.0 STANDARD OPERATING PROCEDURES

6.1 Standard Operating Procedures (SOPs) are detailed written instructions to

achieve uniformity and set out the way practice and procedures must (i.e.

mandatory) or should (i.e. advisory) be performed. SOPs are written

instructions and records of procedures agreed and adopted by the

Researchers following consultation and discussion as appropriate.

In many cases, external Sponsors will provide study-specific SOPs. With

agreement of the Trust PI, these will generally be preferred to the generic

SOPs below, to ensure uniformity across the study.

Note that while some SOPs are specifically for CTIMPs, they may be used as

a reference for best practice for other study types.

6.2 SOPs applicable to all studies:

 Amendments to Research Projects

 Confirming Capacity and Capability

 Generating and Submitting REC annual progress reports

 Performing and Documenting Training for Research Staff

 Preparation, Approval, Review and Implementation of Research SOPs

 The Process of Obtaining Informed Consent for a Research Study

 Identification of Potential Research Participants

 Staff Exiting Procedure

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 Use of Centrifuges and Handling of Bodily Fluids for Centrifuging in Research

SOPs for CTIMPs only:

 Archiving and Destroying Documents

 Audit and Inspection

 Case Record Form Completion

 Definition of Responsibilities for Externally Sponsored Clinical Trials

 Externally Sponsored Study Close Down

 Initiation Visit

 Study Files and Filing for Externally Sponsored Clinical Trials

 Monitoring Visit

 Notification of Serious Breaches of GCP in Clinical Trials

 Safety Reporting in Externally Sponsored Clinical Trials

7.0 OTHER RELEVANT POLICIES AND GUIDANCE

7.1 Other relevant Trust policies and procedures include:

 Adverse Incident (Including Serious Incidents) policy and procedure CP3 and

CPG3

 Trust Standard Financial Instructions

 Management of Trust Intellectual Property policy CP45

 Mental Capacity Act 2005 policy and procedure MCP 1 and MCPG1

 Information Governance and Security Policy CP50 and CPG50

 Information Risk Policy & Procedure CP57 and CPG57

 Information Sharing & Consent Policy and Procedure CP60 and CPG 60

 Corporate Health & Safety Policy RM01

 Disciplinary (Conduct) Policy HR27

 Safe and Secure Handling of Medicine CLPG13

7.2 Other relevant national policies and guidance include:

 NIHR Research in the NHS: Human Resource (HR) Good Practice Resource

Pack

 ICH (International Conference on Harmonisation of Technical Requirements

for Registration of Pharmaceuticals for Human Use) – GCP (Good Clinical

Practice)

 HRA guidance documentation

 UK Policy Framework for Health and Social Care Research 2017

 Caldicott principles

 Attributing the costs of health and social care research (DH, 2012)

8.0 RESEARCH PRIORITIES

8.1

The Trust will contribute to research in national priority areas as set out by

the Department of Health. The current priorities for the Trust are as

follows:

 Mental Health

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 Older people

 Reducing inequalities

 Improving the patient experience

 Building capacity to deliver health and social care

 Progressive, degenerative mental conditions (e.g. dementias)

 Community research

8.2

The Trust will encourage contribution to research projects in national

priority areas of other NHS Trusts and academic and clinical institutions.

8.3

The Trust will work with and foster strong collaborative links with academic

institutions.

8.4

The Trust will work collaboratively with academic institutions to seek

external research funding and will liaise closely on the appropriate

management of research grants and contract arrangements.

END