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Resources to understand health research in the NHS

Information from the following organisations and documents will help innovators to understand the background to health research in the NHS.

 

1.       Strategic Context

 

Best research for best health: a national health research strategy (2006)

This publication sets out the goals for research and development which remain relevant today.  It demonstrates the commitment to creating a vibrant research environment that contributes to the health and wealth of England. 

https://www.gov.uk/government/publications/best-research-for-best-health-a-new-national-health-research-strategy

 

Research governance framework for health and social care: second edition (2005)

This document sets out the broad principles of good research management for health and social care.

https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition

 

Faster easier clinical research

The National Institute for Health Research (NIHR) is striving to make research faster and easier in the NHS. To achieve this objectivethe NIHR is working with partners including the DH and the HRA to simplify and streamline administrative and regulatory procedures governing research studies to improve research initiation and delivery.

http://www.nihr.ac.uk/systems/Pages/faster_easier_clinical_research.aspx

 

NIHR briefing paper 5.1

This document sets out how the NIHR works to promote faster, easier clinical research to high standards through effective management support within the regulatory context.

http://www.nihr.ac.uk/about/Pages/Briefingdocuments.aspx

 

2. Organisations and Partners

 

The National Institute for Health Research (NIHR)

The NIHRprovides the framework through which the Department of Health can position, maintain and manage the research, research staff and research infrastructure of the NHS in England as a national research facility. The NIHR’s vision is to improve the health and wealth of the nation through research.

www.nihr.ac.uk

NIHR briefing documents set out the aims and measures the NIHR has in place to achieve its vision. http://www.nihr.ac.uk/about/Pages/Briefingdocuments.aspx

 

The NIHR Clinical Research Network (NIHR CRN)

The NIHR CRN helps to provide the infrastructure that allows high quality clinical research to take place in the NHS, so that patients can benefit from new and better treatments, and we can learn how to improve NHS healthcare for the future.

 

Although the NIHR CRN operates as one organisation, it is made up of a number of different parts: 6 topic research networks (covering cancer, dementia and neurodegenerative diseases, diabetes, medicines for children, mental health and stroke); a primary care research network; a comprehensive clinical research network, which covers all other disease areas.

http://www.crncc.nihr.ac.uk/

 

The NIHR Clinical Research Network is changing its structure. From April 2014 the NIHR CRN will comprise 15 NIHR Local Clinical Research Networks. The boundaries of these NIHR Local Clinical Research Networks will be based on the geographical footprint of the Academic Health Science Networks.   Each NIHR Local Clinical Research Network will provide support for all therapy areas or clinical “themes” and will cover both commercial and non-commercial research.

http://www.crncc.nihr.ac.uk/evolving_the_network/transition_programme_homepage

 

The NIHR Clinical Research Network Portfolio

The 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.

http://www.crncc.nihr.ac.uk/about_us/processes/portfolio

 

Health Research Authority (HRA)

The Health Research Authority (HRA) protects and promotes the interests of patients and the public in health research. The HRA works closely with other bodies, including the Medicines and Healthcare products Regulatory Authority (MHRA) and the NIHR to create a unified approval process and to promote proportionate standards for compliance and inspection within a consistent national system of research governance. 

http://www.hra.nhs.uk/

 

The National Research Ethics Service (NRES)

The National Research Ethics Service (NRES) exists to facilitate ethical research that is of potential benefit to participants, science and society. NRES provides robust, ethical review of proposed research via Research Ethics Committees (RECs). These independent committees put the rights, safety, dignity and well-being of research participants at the centre of their decision making.  NRES sits within the core of the Health Research Authority.

http://www.hra.nhs.uk/

 

Medicines and Healthcare Products Regulatory Agency (MHRA)

The MHRA is responsible for ensuring that medicines and medical devices work, and are acceptably safe. All drug and device trials need to be registered and approved by the MHRA.

http://www.mhra.gov.uk/Aboutus/index.htm

 

The UK Clinical Research Collaboration (UKCRC)

The UKCRC Partners’ goal is to establish the UK as a world leader in clinical research. It provides a forum that enables all partners to work together to transform the clinical research environment in the UK. The forum promotes a strategic approach to the identification of opportunities and obstacles to clinical research and their resolution. In so doing the UKCRC aims to benefit the public and patients by improving national health and increasing national wealth.

http://www.ukcrc.org/

 

3. Industry Research

 

The NHS and pharmaceutical industry share a common purpose to improve patient care outcomes through high quality and cost effective treatment and management.  Effective engagement and efficient collaboration is a key factor.

Joint working handbook:

http://www.abpi.org.uk/_layouts/download.aspx?SourceUrl=/our-work/library/guidelines/Documents/Joint Working handbook.pdf

 

Guidance on the collaboration between healthcare professionals and the pharmaceutical industry.

The Ethical Standards in Health & Life Sciences Group (ESHLSG) has published guidance on collaboration between healthcare professionals and the pharmaceutical industry. The guidance is currently under review (May 2013).

http://www.eshlsg.org/our-

 

Supporting Research Projects & Managing Delivery

 

The following links will help anyone wishing to undertake research in the NHS to navigate the research study process from design to completion.

 

4. Developing new studies

 

NIHR Research Design Service

The NIHR Research Design Service (RDS) supports researchers to develop and design high quality research proposals for submission to NIHR and other national, peer-reviewed funding competitions for applied health or social care research.

http://www.nihr.ac.uk/research/Pages/ResearchDesignService.aspx

 

NIHR CRN support for study planning

The Clinical Research Network can help researchers ensure their study is deliverable in the NHS.

http://www.crncc.nihr.ac.uk/researchers/planning_your_study/index

 

Coordinated network support – set up and delivery

NIHR CRN provides researchers with the practical support they need to make clinical studies happen in the NHS, so that more research takes place across England, and more patients can take part.

http://www.crncc.nihr.ac.uk/researchers/study-setup-support/index

 

5. Local Decisions, Capacity and Capability

 

HRA Decision Tools

Not all of the projects undertaken within the NHS are research. Under the Research Governance Framework for Health and Social Care (second edition 2005)projects not classified as research are not managed as research within the NHS.  In the first instance you should refer to the HRA Decision Tool:  http://www.nres.nhs.uk/applications/is-your-project-research/

 

The Integrated Research Application System (IRAS)

IRAS is a single system for applying for the permissions and approvals for health and social care /community care research in the UK. It enables the applicant to enter the information about their project once instead of duplicating information in separate application forms.

https://www.myresearchproject.org.uk/Help/Information.aspx

 

IRAS Training module

A training module is available to support the use of IRAS (suitable for anyone doing health and community care research).

https://www.myresearchproject.org.uk/ELearning/IRAS_E_learning.htm

 

National Institute for Health Research Coordinated System for gaining NHS permission (NIHR CSP)

When research involving human participants (or their organs, tissue or data) is hosted in or through the NHS, written permission on behalf of the NHS organisation providing care must be in place before the research can begin.  NIHR CSP standardises and streamlines the process of gaining NHS Permission for commercial and non-commercial clinical research studies in England.

http://www.crncc.nihr.ac.uk/about_us/processes/csp

 

Gaining NHS Permission for clinical research – CSP operating manual

http://www.crncc.nihr.ac.uk/about_us/processes/csp/resources/

 

Revised process for handling amendments to NIHR CSP studies:

http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/CSP/Documents/Amendments%20Guidance%20for%20Researchers_1.0.pdf

 

Email link for any queries about the NRES application process.

nres.queries@nhs.net

 

6. Model Agreements

 

Before a piece of research can start, sponsors and host institutions need to have appropriate agreements in place. Considerable time and effort can be required to draft different versions of such agreements for the various research scenarios. To simplify this process, the UKCRC partners and stakeholders have developed a suite of model agreements which can be used "off the shelf", without modification.

http://www.crncc.nihr.ac.uk/about_us/ccrn/gm/industry/research-contracts/model-agreements-research

 

7. Research funding and financial management

 

NHS R&D costs

Information on how the NIHR CRN can provide funding can be found through the following links:

http://www.crncc.nihr.ac.uk/researchers/planning_your_study/funding

 

Eligibility Criteria for NIHR Clinical Research Network Support

http://www.crncc.nihr.ac.uk/about_us/processes/portfolio/p_eligibility/

 

Attributing the costs of health & social care Research & Development (AcoRD):

This guidance is applicable for studies where full application for funding submitted after 1 October 2012:

https://www.gov.uk/government/publications/guidance-on-attributing-the-costs-of-health-and-social-care-research

 

NIHR Industry costing guidance and template

The national industry costing templates are used for generating commercial study costs to provide cost transparency and predictability when negotiating local site budgets and prevent delays during study set-up.

http://www.crncc.nihr.ac.uk/Life+sciences+industry/tools/costing

 

 

NIHR grants

The NIHR commissions and funds NHS, social care and public health research.

http://www.nihr.ac.uk/research/Pages/programmes_research_programmes.aspx

 

RDinfo

RDinfo is a research funding database with information on grants, charities and institutions.

http://www.rdinfo.org.uk/Welcome.aspx

 

Understanding Good Practice

 

These links provide useful information to help understand what constitutes good practice in the management and conduct of research.

 

8. R&D functions, roles and responsibilities

 

NIHR Research Support Services (RSS) Framework

The NIHR RSS Framework is a set of tools and guidelines to support a consistent and streamlined approach to managing health research studies in the NHS including: an operational capability statement,  study planning tools,  local standard operating procedures (SOPs) and a framework of competencies for R&D staff. They support the objectives of faster easier research.

 

http://www.nihr.ac.uk/systems/Pages/Research_Support_Services.aspx

http://www.nihr.ac.uk/systems/Pages/OperationalCapabilityStatements.aspx

 

9 Research management and Good Clinical Practice

 

Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (World Medical Association)

The declaration sets out the ethical principles for medical research involving human subjects, including research on identifiable human material and data- worldwide.

Between April and June 2013, the World Medical Association consulted on proposed changes to the declaration. 

http://www.wma.net/en/30publications/10policies/b3/index.html

 

Research governance framework for health and social care: second edition (Department of Health, 2005)

This document sets out the broad principle of good research management for health and social care.

https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition

 

The Research Passport and streamlined human resources arrangements

The ‘Research in the NHS: Human Resource (HR) Good Practice Resource Pack’ describes the process for handling HR arrangements for researchers and provides a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS. 

 

The resource pack includes details of:

•A Research Passport system for issuing honorary research contracts (HRCs) or letters of access to HEI researchers who need to undertake their research within the NHS.  The research passport provides evidence of the pre-engagement checks undertaken on the researcher in line with NHS Employment Check Standards; and

•NHS to NHS arrangements for sharing and accepting pre-engagement checks between NHS organisations when NHS staff wish to undertake research within the NHS outside of their employing Trust.

http://www.nihr.ac.uk/systems/Pages/systems_research_passports.aspx

 

Medicines and Healthcare Products Regulatory Agency (MHRA)

The MHRA is responsible for ensuring that medicines and medical devices work, and are acceptably safe. All drug and device trials need to be registered and approved by the MHRA.

http://www.mhra.gov.uk/Aboutus/index.htm

 

The Medicines for Human Use Act (Clinical Trials) Regulations (2004)

The Medicines for Human Use (Clinical Trials) Regulations regulate trials of

medicines on people.

http://www.legislation.gov.uk/uksi/2004/1031/made/data.pdf

 

Good Clinical Practice (GCP) in clinical trials of medicinal products

Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials of medicines that involve the participation of human subjects.  Compliance with this good practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate.

 

The principles of GCP apply to all researchinvolving patients, not just clinical trials.

For research, training should be appropriate and proportionate to the type of research undertaken, and should cover the responsibilities of researchers set out in relevant legislation and standards.  There is no set requirement for the frequency of such training. Researchers are expected to maintain awareness of current standards through reference to published guidance and relevant policies.  Training should be updated when legislation has changed, new policies or practice have been implemented, different research activities are to be undertaken, or a significant period of time has elapsed since research activities have been conducted. 

 

For research involving a Clinical Trial of an Investigational Medicinal Product (CTIMP), there is a requirement for GCP training.  However, the timing of this training is not specified in legislation or guidance but should be appropriate and proportionate.  See the HRA and MHRA website for further details.

http://www.hra.nhs.uk/

http://www.mhra.gov.uk/

 

The NIHR CRN providesGCP training which is free of charge for staff working on a clinical trial or study which has been accepted onto the NIHR CRN Portfolio of studies and if you work directly with an NIHR Clinical Research Network, including patient and public representatives.  NIHR CRN works with the MHRA to ensure that the training meets recognised standards and regulatory requirements.

http://www.crncc.nihr.ac.uk/workforce_development/courses/faqs#Booking%20Questions

 

Safety Reporting (Pharmacovigilance)

Safety reporting is an essential aspect of the conduct of every clinical trial of an investigational medicinal product (CTIMP) and it is important that to understand both the issues involved and the legal requirements of this.  Before a CTIMP is approved the REC and the MHRA need to be satisfied that there is a plan to record and report all adverse events (AEs) that occur in a proportionate and timely manner.

http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Safetyreporting-SUSARsandASRs/index.htm
http://www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodPharmacovigilancePractice/index.htm

 

Mental Capacity Act 2005

This act covers who can provide consent or be consulted and what type of research is appropriate to be conducted with people who lack capacity.

http://www.legislation.gov.uk/ukpga/2005/9/contents

 

Data Protection Act 1998

The nature of research means that there is a large amount of paper and electronic data held about research subjects. Research staff has a responsibility to their research subjects and their employer regarding data protection.

http://www.legislation.gov.uk/ukpga/1998/29/contents

 

The Human Tissue Act 2004

This Act was introduced to regulate the removal, storage and use of Human Organs and Tissue.

http://www.legislation.gov.uk/ukpga/2004/30/contents

 

The Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER)

These regulations control the exposure of people to radiation for medical purposes, including diagnosis, therapy and research.  Local IRMER practitioner review and sign off of studies involving ionising radiation is required to ensure research participants do not receive higher than is safe dosages of ionising radiation.

2000: http://www.legislation.gov.uk/uksi/2000/1059/contents/made

2006 Amendment: http://www.legislation.gov.uk/uksi/2006/2523/contents/made

 

The Administration of Radioactive Substances Advisory Committee (ARSAC)

An ARSAC certificate is required, at present, by the person administering radioactive substances as part of a research project. The certificate is applied for by each site where the substance will be administered.

http://www.arsac.org.uk/

 

Medical Devices Regulations 2002

These regulations implement the EC Medical Devices Directives into UK law. They place obligations on manufacturers to ensure that their devices are safe and fit for their intended purpose before they are CE marked and placed on the market in any EC member state.

 

Full guidance on medical devices regulations can be found at: http://www.mhra.gov.uk/Howweregulate/Devices/index.htm

 

10. Research Management and Governance Systems

 

NIHR Portal

The NIHR Portal is a business intelligence and knowledge management platform for all NIHR or Department of Health Policy Research Program (PRP) funded organisations and health research professionals.

https://portal.nihr.ac.uk/Pages/default.aspx

 

The Integrated Research Application System (IRAS) (see also section 5 above)

IRAS is a single system for applying for the permissions and approvals for health and social care /community care research in the UK. It enables the applicant to enter the information about their project once instead of duplicating information in separate application forms.

https://www.myresearchproject.org.uk/Help/Information.aspx

 

CSP Module

The CSP Module is the system used by staff across NHS organisations and the Clinical Research Network to support the NIHR Coordinated System for gaining NHS Permission (CSP).Log on using your NIHR Portal login.

http://owc.cspmodule.nihr.ac.uk/webcenter

 

CSP Operating Manual

http://www.crncc.nihr.ac.uk/about_us/processes/csp/resources

 

 

11. Toolkits

 

Clinical Trials Toolkit

This provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive route map, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials.

http://www.ct-toolkit.ac.uk/

 

Experimental Medicine Toolkit

This Toolkit has been designed to support investigators, research managers and ethics committees in assessing the risks involved in experimental medicine studies and devising risk proportionate management and monitoring strategies.

http://www.em-toolkit.ac.uk/home.cfm

 

Data and Tissues Toolkit

Practical help with the legislative and good practice requirements relating to the use of personal information and human tissue samples in healthcare research in the UK

www.dt-toolkit.ac.uk/

 

Stem Cell Toolkit

A regulatory tool for those conducting human stem cell research in the UK

www.sc-toolkit.ac.uk/

 

12. Patient and Public Involvement

 

Patient & Public Awareness

Involving patients and members of the public in research can lead to better research, clearer outcomes, and faster uptake of new evidence.  The NIHR encourages patients and the public to be actively involved in all NIHR-funded health and social care research.

http://www.nihr.ac.uk/awareness/Pages/default.aspx

 

INVOLVE

INVOLVE is a national advisory group that supports greater patient and public involvement in NHS, public health and social care research and shares knowledge and learning on public involvement in research.

http://www.invo.org.uk/

 

It's OK to ask: The NIHR's patient empowerment campaign

This is the NIHR campaign to empower patients and encourage engagement in clinical research.  Patients are often unaware of clinical research opportunities unless they are asked to take part by a clinician. Whilst the clinician-initiated approach to recruitment has been very successful, the NIHR also wants to empower patients to start conversations about research if they want to. This could have a positive impact on the speed of recruitment to studies and the general research culture across healthcare providers, which would be beneficial to researchers.

Resources are available to help promote the campaign at www.crncc.nihr.ac.uk/oktoask

International Clinical Trials Day: 20 May

International Clinical Trials Day is celebrated around the world on or near the 20 May each year, to commemorate the day that James Lind started his famous trial on the deadly disease scurvy. It provides a focal point to raise awareness of the importance of research to health care, and highlights how partnerships between patients and healthcare practitioners are vital to high-quality, relevant research.

http://www.nihr.ac.uk/Pages/InternationalClinicalTrialsDay.aspx

 

13. Research Misconduct

 

Research Integrity Concordat. Universities UK, with funders of research, government departments and other stakeholders developed a concordat to support research integrity. It sets out five commitments that all those involved with research should make. The Concordat protects and promotes research good conduct so that it continues to command public confidence, safeguards participants and maintains the UK’s reputation for excellent research.
http://www.universitiesuk.ac.uk/highereducation/Documents/2012/TheConcordatToSupportResearchIntegrity.pdf

 

The UK Research Integrity Office (UKRIO) promotes good research practice. It is an independent body, which provides a comprehensive service in support of research integrity to the research community. The UKRIO publishes guidance on good research practice and the investigation of alleged misconduct and provides a confidential advisory service.
http://www.ukrio.org/home/

 

 

If you read and understand all of the above - you won't go far wrong! If however you want some expert advice then contact the MedTECH Centre incubator.

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