RESEARCH GOVERNANCE POLICY

Policy Title / Research Governance Policy
Version: / V5
Approved by: / Research Education and Training Sub-Committee
Date of approval: / April 2018
Policy supersedes: / Research Governance Policy v4 June 2015
Lead Board Director: / Dr Yvette Oade
Policy Lead (and author if different): / Dr Jacqueline Andrews
Name of responsible committee/group: / University of Leeds/Leeds Teaching Hospitals Joint Research Governance Committee
Date issued: / April 2018
Review date: / April 2020
Target audience: / Researchers, research support staff, CSU management teams.
Keywords / Research & Innovation, research governance.

Contents

Paragraph / Page
Staff Summary / 3
1 / Purpose / 4
2 / Background/Context / 5
3 / Definitions / 6
4 / Policy Effect: Processes under the Policy / 7
5 / Roles and Responsibilities / 13
6 / Equality Analysis / 18
7 / Consultation and Review Process / 19
8 / Standards / 21
9 / Process for Monitoring Compliance and Effectiveness / 22
10 / References / 24

Appendix 1 University of Leeds/Leeds Teaching Hospitals Joint Research Governance Framework diagram

STAFF SUMMARY

The Trust’s ambition is to be a global leader in research and innovation,delivering benefit to patients at pace and scale to make a real and lasting difference to the quality of care provided by the Trust. We must ensure that research that we undertake is carried out safely and to the highest quality standards.

This policy sets out the requirements for the management and conduct of research within the Trust to ensure that research activity complies with the principles of the UK Policy Framework for Health and Social Care Research (Health Research Authority (HRA), 2017). It provides a framework for research to ensure good practice in research.

Research governance is needed to:

  • safeguard participants in research
  • protect researchers / investigators (by providing a clear framework within which to work)
  • enhance ethical and scientific quality
  • mitigate risk
  • monitor practice and performance
  • promote good practice and ensure that lessons are learned.

The policy is relevant to all staff who undertake, support or manage clinical research including chief and principal investigators, care professionals, researchers,research nurses, managers and support staff.

The policy applies to research activity where 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, HRA, 2017)

The policy applies to all research activity involving the Trust including:

•Research where the Trust is the sponsor

•Research where the Trust is a participating site in research

•Research where participants are patients, carers, service users, volunteers and members of Truststaff

•Research using patient tissue, organs or data

•Research taking place on Trust premises

•Research involving Trust resources

•Research that is non-clinical or laboratory based

•Research being undertaken as part of an educational qualification

The implementation of the policy builds on an existing partnership with the University of Leeds, and where possible, is pursued jointly.

The policy does not apply to audit or service evaluations. For guidance on the differentiation between research, audit and service evaluation see: For requirements for clinical audit see the Trust’s Clinical Audit Policy:

1 PURPOSE

This policy provides a framework of standards and requirements for the conduct and management of research in the Trust to ensure that all research activity complies with the principles of the UK policy framework for health and social care research (HRA, 2017).

Failure to follow this policy could result in the instigation of disciplinary procedures.

2BACKGROUND/CONTEXT

The Leeds Teaching Hospitals NHS Trust recognises the importance of research to the promotion and protection of the health and wellbeing of its patients.Sound governance of research is essential to ensure that the patients, service users and the public can have confidence in, and benefit from, quality health research.

The UK policy framework for health and social care research (HRA, 2017) sets out the high level principles and standards for the conduct and management of health and social careresearch. These principles protect and promote the interests of patients, service users and the public in health and social care research by describing ethical conduct and proportionate, assurance-based management of health and social care research, so as to support and facilitate high quality research in the UK that has the confidence of patients, service users and the public. The frameworkwas developed by the Health Research Authority (HRA) and applies to health and social care research that is within the responsibility of the HRA or the Devolved Administrations’ Health Departments.

The policy framework reflects the relevant legislation in the UK and is consistent with recognised ethical standards and with models of good practice as they apply to particular types of research involving human participants. In reflecting these, the policy framework recognises the value of their proportionate application to different types of research.

The policy framework is statutory guidance in accordance with the Care Act 2014 to which NHS trusts must have regard. It is expected that organisations and individuals will follow the principles and standards set out in the framework which are supported by national operational policies and guidance, standard operating procedures (SOPs) and operational platforms.

3DEFINITIONS

Chief investigator (CI):The overall lead researcher for a research project. Has responsibility for its overall conduct. (HRA 2017).

Principal investigator (PI):The lead researcher for a research project at a particular site. Has responsibility for the conduct of the project at that site. (HRA 2017).

Research team: The people involved in the conduct of a research project. There may be different research teams for the project at different sites. (HRA 2017).

Research site: The organisation with day-to-day responsibility for the location where a research project is carried out. (HRA 2017)

Research sponsor:The organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project. (HRA 2017)

Funder: The body or bodies that fund a research project. (HRA 2017)

Employer: The body or bodies that employ the investigators and research teams for a research project. (HRA 2017)

Public: The general public. Includes carers, relatives of patients and service users and healthy volunteers. (HRA 2017)

Health Research Authority (HRA): The HRA is a Non Departmental Public Body with the remit to protect and promote the interests of patients and the public in health and social care research.It does this by supporting and promoting a robust and efficient regulatory and governance framework in the UK.
4POLICY EFFECT

Health Research Authority approval

All project-based research that involves NHS organisations in England must have HRA approval. It brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with independent ethical opinion by a Research Ethics Committee (REC). The needs of patients and participants with protected characteristics are considered as part of this review process which ensures that research is accessible to all. For further guidance on applying to HRA see:

Evidence of HRA approval (which incorporates full favourable opinion from an NHS REC) is required before the Trust will issue confirmation of capacity and capability.

Research sponsorship

All research must have an identifiedsponsor. The sponsor is the organisation or partnership that takes on overall responsibility for proportionate, effective arrangements being in place to set up, run and report a research project (HRA 2017). The Trust and the University of Leeds have agreed that the research sponsor organisation should be the substantive employer of the chief investigator of the study. For commercially initiated research, the commercial company would be expected to act as research sponsor. Evidence of research sponsorship will be required before Trust confirmation of capacity and capabiity is granted.

Trust confirmation of capacity and capability

All research taking place within the Trust must have Trust confirmation of capacity and capability before any research activity begins. The Trust will only extend NHS indemnity cover (for negligent harm) to its employees taking part in research studies that have been registered and where confirmation of capacity and capability has been issued by the R&I department. The Trust will not accept liability for research that has not been registered and confirmed. For further guidance on the R&I confirmation of capacity and capability process see:

Scientific review

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. Each proposal or protocol must be subjected to review by relevant experts who are able to offer independent advice on its quality. It is the research sponsor’s responsibility to ensure adequate peer review is in place which is proportional to the scale of the research. For externally funded research, for example from a research council or a charity, it is expected that peer review would have been undertaken as part of the application for funding process. For commercially sponsored projects, itis the responsibility of the commercial sponsor to arrange peer review. For student projects, peer review by the individual’s supervisor should normally be adequate. For self-funded research, peer review must be undertaken/arranged by the CSU R&I Leador Clinical Director. For further guidance please see:

Study design

The design and procedure of the research must be clearly described and justified in a research proposal or protocol. For further guidance and template protocol please see:

Finance

Financial probity and compliance with the law and with the rules set out by HM Treasury for the use of public funds are as important in research as in any other area. There must be transparency and accountability of all research income and expenditure.

The Attributing the Costs of Health and Social Care Research and Development (AcoRD, DH, 2012) provides a framework for the NHS and its partners to identify, attribute and recover the various costs associated with research in the NHS in a transparent, robust and consistent manger.

When considering a study, the R&I accountant must be satisfied that all costs for the research are fully covered. For all commercial research within the Trust there is also a non-refundable R&I Fee.

Conducting clinical trials of investigational medicinal products (CTIMPs)

There is a strict legal framework within which clinical trials of investigational medicinal products (CTIMPs) must be conducted. The EU Clinical Trials Directive and GCP Directive (transposed in UK Law through the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) and subsequent amendments, state that clinical trials must be carried out according to the principles of Good Clinical Practice (GCP). GCP is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting CTIMPs that involve the participation of human subjects. Compliance with GCP provides assurance that the rights, safety and well-being of trial subjects are protected and that the results of CTIMPs are credible and accurate.

This legislation states that it is against the law to start or conduct, or to recruit participants to a clinical trial involving a medicinal product until there is a favourable opinion from a research ethics committee and a clinical trials authorisation from the licensing authority, the Medicines and Healthcare products Regulatory Agency (MHRA).

The Trust/University Sponsor Quality Assurance Team (based within the Trust Research & Innovation Department) will help and advise on the design, set up and ongoing management of Trust and University of Leeds sponsored CTIMPs,including how to report safety events, manage the study drug/s and provide assurance on the quality of the clinical trial.

Training

All staff working on research studies should be qualified by education, training and experience, or otherwise competent under the supervision of a suitably qualified person.

It is mandatory for all staff working on clinical trials of investigational medicinal products (CTIMPs) at LTHT (ie named on the delegation log) to undergo full GCP training. The training covers key legislation and provides guidance on conducting research for all members of the research team. Staff must complete a comprehensive introductory course either on line or face to face and thereafter must complete refresher training every 2 years. Training is provided by the NIHR Clinical Research Network Yorkshire & Humber (CRN Y&H).

Information about GCP training and othercourses is available via the R&I website at

Use of patient data

Data and information collected in the course of research must be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification to ensure data integrity. Furthermore, the appropriate use and protection of patient data should be paramount and particular attention must be given to systems for ensuring confidentiality of personal information.

The handling of personal information in research must be compliant with Trust policies in relation to the Data Protection Act 1998 and any data/confidentiality breaches must be reported using the Trust’s data protection policyat

All use ofpatient data for research purposes requires the consent of the patient. There are some exceptions where patient data can be used without consent under Section 251of the NHS Act 2006. Requests for this use are made through the Confidentiality and Advisory Group (CAG).

Use of human tissue

Research which involves tissue or organs should be handled in line with the requirements of the Human Tissue Act 2004. The Act states that tissue classified as ‘relevant material’ that is to be stored for future, yet unspecified, research purposes must be stored in a facility which holds a research sector Human Tissue Authority licence. To use donated tissue, researchers must obtain NHS research ethics committee approval and ensure that appropriate consent is in place for the intended use (unless a consent exemption exists, as specified in the Act). Please see the Trust and University of Leeds human tissue storage and use policy at

Further information is also available from the Human Tissue Authority at

Health, safety and employment

The safety of research participants and research staff must be given priority at all times. health and safety regulations and Trust policies or employing organisation’s health and safety policies must be strictly observed during the course of the research. This is particularly important if the research involves the use of potentially dangerous or harmful equipment, substances or organisms.

Appropriate employment arrangements must also be in place for research staff. For NHS staff, evidence of their employment status will be required. Researchers not employed by any NHS organisation who interact with research participants in a way that has a direct bearing on the quality of their care should hold an NHS honorary research contract. Other arrangements will be made for non-NHS staff where their research does not have a bearing on the quality of patient care.

It is the responsibility of the chief investigator or principal investigator at each site to ensure staff have the necessary contracts or letters of access in place before staff begin research work within the Trust. For further information see

Intellectual property

NHSorganisations are required to manage the intellectual property (IP) arising from their activities. Ideas arising out of routine work as well asresearch may lead to improvements in patient care through new innovations and financial benefits to the inventor or the NHS.

All staff should be aware of and abide by Trust IP policy which can be accessed at

Monitoring and audit

Organisations and individuals involved in research are expected to be able to demonstrate compliance with the requirements of the UK Policy Framework for Health and Social Care Research (HRA 2017) and the Medicines for Human Use (Clinical Trials) Regulations 2004. It is a statutory requirement that CTIMPs are conducted in accordance with the principles of GCP. Working to GCP principles involves meeting stringent criteria in respect of study documentation, safety monitoring and reporting, data capture and management, study monitoring, training of study personnel and study conduct in general. A risk-based monitoring programme for CTIMPs is in place in the Trust conducted by the Sponsor QA Team. If a study has a commercial sponsor, then it would be expected that the commercial company (or a delegated clinical research organisation) would conduct and monitor the CTIMP in accordance with GCP requirements.

Agreements/contracts

Before a research study can start, sponsors and host institutions need to have appropriate agreements in place which set out the responsibilities of the parties involved in the research.

Commercial research studies

For commercial CTIMPs the Trust expects that commercial companies will use the national model Clinical Trial Agreement (mCTA or CRO mCTA) for pharmaceutical companies working with the NHS.

For commercial studies involving medical devices, the Trust expects that commercial companies will use the national model Clinical InvestigationAgreement (mCIA or CRO mCIA)

Non-commercial research studies

For non-commercial studies the Trust expects that other non-commercial partners will use the national model Non-Commercial Agreement (mNCA).

The model agreements can be found at

Indemnity

The Trust participates in the NHS risk pooling scheme administered by the NHS Litigation Authority “Clinical Negligence Scheme for NHS Trusts” for:

-medical professional and/or medical malpractice liability, and

-general liability

NHS indemnity for negligent harm is extended to researchers with an employment contract (substantive or honorary) with the Trust. The Trust only accepts liability for research activity where confirmation of capacity and capability has been issued by the R&I Department.