The West Yorkshire R&D Team is here to help at every stage of the research process. We can help with the development of ideas, provide support and advice during the research governance process and enable knowledge dissemination. We can provide guidance on all aspects of research and assist with defining whether a project is research, service evaluation or audit.

We are responsible for research taking place in GP practices across West Yorkshire and in practices in the Harrogate and Rural District CCG area. This may involve practices identifying patients or conducting further research activity. Our responsibility is advising researchers and health care professionals in setting up studies, accessing primary care and assessing and arranging capacity and capability of practices to take part in studies. We may also audit ongoing studies. After a study is completed we help to disseminate research findings and get these adopted in practice. 

What is research?

Research as defined by the National Research Ethics Service (NRES) is: ‘The attempt to derive generalizable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them.’

Research can sometimes be mistaken for service evaluation or audit and vice versa, but the we are able to advise on which category each project falls into and what review is necessary in each case.

What do I need to do?

If you are interested in developing or starting a study in primary care in West Yorkshire and/or Harrogate, we can help. The tabs below cover the different stages of the research process. Please use these to read further information about research across West Yorkshire and Harrogate or contact the team with your questions. If you are looking to undertake a study in a different area, or within a secondary or community care setting, please see here for information on which NHS R&D office you can contact for advice, or read more about NHS research below.

If you are a student looking to carry out a student research project you can follow the advice found in the section 'Developing an idea, consulting with others' (below) when developing your idea. Advice specifically for students who are submitting an application for governance checks can be found in the student section of the ‘Ready to write and submit your application for governance checks' tab.

Please follow this link for practical ways in which we can help you access GP practices in an attempt to increase study recruitment, or this link for ways that we can help you to disseminate your research findings. 

Developing an idea, consulting with others
Ready to write and submit your application for governance checks
Finding sites, recruiting patients
Disseminating the results of your research

 

Is it research?

The Health Research Authority (HRA) definition of research is: “the attempt to derive generalisable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them”. You can check whether your project is research by using the HRA decision tool.

If you need further advice or would like us to provide written confirmation that your study is not research, please contact research@bradford.nhs.uk

If your study is research, you need to go through the governance process but if it is service evaluation, audit or surveillance, you will not need to go through this process. We are able to issue a letter confirming whether your study is service evaluation or audit if you would find this useful (contact us with your protocol if you would like a letter). Or alternatively you can contact the HRA for advice HRA.Queries@nhs.net. Please note the West Yorkshire R&D Team will only be able to provide advice upon receipt of a version-controlled protocol.

Developing your idea

So you've got an idea and are ready to start developing it into a proposal. What do you need to consider?

You need:

  • To define your research question (you can find some advice plus further links here)

  • To consider PICO

  • To check whether your project is research

  • To write a protocol detailing what you intend to do

  • To identify and obtain funding (see here for further advice)

  • To determine who will be the Chief Investigator and any local Principal Investigators and get their agreement for the roles

  • To identify a sponsor and get their agreement to sign off your application 

  • To consider your sites - what sites do you need? Are they NHS sites? Have you liaised with sites to make sure they have the capacity to participate?

  • To consider feasibility - will you be able to recruit the patients you need? (If a study treatment has negative side effects or the research is burdensome, it may be difficult to get people to participate. Alternatively if you have chosen a rare condition you may need to widen your study geographical area to reach sufficient patients.)

  • To consider research data management and what will happen to your collected data during and after your research project

  • To consult with patients, colleagues, R&D and other groups to gain support for advice on your research

Writing your protocol

The protocol is a key document which explains what you are going to do in your research study. It is a useful document for pulling together information and describing your study to members of the research team, to research sites and regulatory bodies. It forms a part of your IRAS application. Your protocol may need to be updated over the course of your study to ensure it is always an accurate record of what is taking place.

Writing a good protocol which clearly describes the study is important and some advice can be found at the following links:

You can also contact the Research Design Service for help.

Applications must include a plain English summary. Advice from the NIHR’s ‘Make it Clear’ campaign can be found here.

Consulting with others

Your study will benefit from collaborating with and taking on feedback from others; this is something that funders will deem essential. Consider:

  • Colleagues who can provide input into your study or your application. If you have colleagues who have done similar projects or successfully applied for the funding stream you are interested in, you may benefit from their experience.

  • Experts from other institutions, either academic or practitioner. They may be able to input into the study, be interested in helping with the study, or be able to help you to establish a research site in their area.

  • Clinicians can be valuable in identifying possible issues in running the study in practice, or in recruiting patients. They may offer insights into the patient group, size of the patient population, and previous experience with the patient group or treatment. This may inform your research.

  • Statisticians can advise on sample sizes, power calculations and advising on statistical analysis which you may wish to undertake. This is important for quantitative research as it will ensure that your research is sufficiently powered to obtain a meaningful result. 

  • Patient groups can help to inform whether your study is looking at issues that are important to patients. They may be able to identify possible recruitment issues by highlighting techniques that may influence patients to take part, or barriers that may discourage patients from taking part.

  • The general public provide another perspective and useful insights – this group may also contribute as controls for your study.

You can read more about patient and public involvement here. The HRA considers patient and public involvement to be essential and has increased focus on this in recent years. Public involvement should be meaningful and real - so consider what you can involve patients and the public with and how their perspectives could be used to influence and guide your study. If you are conducting a study involving young people you can consult with Young Dynamos to gain insight.

Research design expertise is provided by the Research Design Service which advises how to put together a feasible research project. This can help to avoid having to re-submit or submit amendments if some issues have not been considered before application.

NHS R&D offices can advise on the local area, practices which may wish to be involved in the study and have the required staff, facilities and equipment. They can also help with generating a research proposal and applying through the IRAS system.

Advice or help finding collaborators

Collaborators from academia, healthcare and patient groups can add value to your study. Collaborating sites will be necessary for recruiting participants and for conducting the research. If you are interested in identifying collaborators from the West Yorkshire universities we have a number of contacts and can help to put you in touch with others with similar interests.

You can also contact us if you are looking for collaborators from local NHS primary care sites; we maintain contact with local GPs and practices specialising in, or with a particular interest in, various topic areas. We can help you to identify local collaborators from primary care, including identifying practices to carry out your study. Contact us for information.

A webinar about working together with sites can be found here.

Looking for collaborators?

If you have a piece of research (or have an idea you wish to develop further), you may wish to identify collaborators. We have links with academics and health professionals across West Yorkshire, and may be able to help you to find someone who can help you to develop a proposal or can help you to bring your study to a new area. We can also offer advice on patient involvement. We can help you to identify:

  • An academic collaborator with specific subject expertise

  • A GP practice or group of practices which you could use to recruit

  • A GP practice or group of practices where you could carry out my study

  • A GP who would be interested to work with you as local collaborator/Principal Investigator

  • A health professional with particular expertise

  • A population with suitable demographics for your study

  • A patient group to advise or collaborate with

Please contact us with your requirements.

For more information on finding partners, the EU provides some guidance and services. These can be particularly helpful if wanting to identify collaborators outside of the UK and outside of healthcare/academia.

The CORDIS partner service allows you to search for partners or register yourself to be found by other potential partners. 

The Innovative Medicines Initiative (IMI) partner search focuses on IMI projects specifically. Again you can share your details or search for partners. 

You can find advice on seeking collaborators on the EU participant portal at  http://ec.europa.eu/research/participants/portal/desktop/en/funding/index.html (see Step 2).

If your institution is a member of UKRO (UK Research Office) you can gain access to a portal through which you can identify partners as well as gaining useful information on applying for funding.

Funding including advice on current funding opportunities

Below are some of the many ways of finding funding streams appropriate to your research; remember, it can take months to pull together a funding application so factor that into this process.

Remember to consider:

  • What are funders looking for?

  • Does your application fit the funding call?

  • Is your application in the required format with the required information?

  • Have you involved patients/the public in your proposal? It is becoming more and more important for funders to see evidence that you have consulted with patients to ensure the relevance of your proposal (are you asking a question of importance to patients?), to ensure you have considered specific features of your target population (do you know how to reach them, how to attract them to take part in the study, what they may or may not be willing to do, what their language or other accessibility requirements are?) and to ensure you have considered disseminating information to patients after the study. You can get advice on patient and public involvement from INVOLVE which has produced a series of briefing documents or from www.peopleinresearch.org. You can get advice on your institution engaging with the public here.

  • Have you considered all the financial elements, including a full costing, an understanding of where you may need to apply for excess treatment costs, and what service support costs you will need from the CRN?

  • When is the deadline? Make sure you submit on time – remembering that applications can take a long time to pull together, make sure you start early!

General opportunities

For a list of current opportunities please click here.

Some of the key funding streams are:

European Union

EU funding is still available and UK partners are still able to apply up until the date the UK leaves the EU. 

The European Union has two major programmes appropriate to health research. These are:

  • Horizon 2020 - Horizon 2020 is the main EU funding programme running from 2014 to 2020, with nearly €80bn total funding.

  • 3rd Health Programme - The EU’s specific health programme (health and health-related projects are also incorporated in Horizon 2020) is focused on EU health strategy. There are annual work plans and funding actions released. The total budget is nearly €450m.

NIHR (National Institute for Health Research) which includes:

  • RfPB Research for Patient Benefit - RfPB is a national, response-mode programme inspired by patients and practice to generate high quality research for the benefit of users of the NHS in England. Its main purpose is to realise, through evidence, the huge potential for improving, expanding and strengthening the way that healthcare is delivered for patients, the public and the NHS.

  • PGfAR - Programme Grants aim to produce independent research findings that will have practical application for the benefit of patients and the NHS in the relatively near future. Programme Development Grants are a complementary scheme to allow investigators to undertake preparatory research that will position them to submit a competitive Programme Grant application. 

  • I4i Invention for Innovation - Invention for Innovation (i4i) is a translational funding scheme to advance healthcare technologies and interventions for increased patient benefit in areas of existing or emerging clinical need.

  • HSDR Health Services and Delivery Research - The NIHR Health Services and Delivery Research (HS&DR) Programme funds research to produce evidence on the quality, accessibility and organisation of health services. This includes evaluations of how the NHS might improve delivery of services.

  • PHR Public Health Research - The PHR Programme funds research to generate evidence to inform the delivery of non-NHS interventions intended to improve the health of the public and reduce inequalities in health. The scope is multi-disciplinary and broad, covering a wide range of interventions that improve public health.

  • HTA Health Technology Assessment - The HTA Programme is the largest of the NIHR programmes. It funds independent research about the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS. The term ‘health technology’ covers a range of methods used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.

  • EME Efficiency and Mechanism Evaluation (co-funded with the MRC) - The EME Programme funds clinical efficacy studies.  The studies it supports usually test if an intervention works as expected in a well-defined population or group of patients.  The Programme also provides an opportunity to use clinical studies to understand disease or treatment mechanisms, which may in turn lead to improvements in health and patient care.

Medical Research Council (MRC) which includes:

Subject-specific funding opportunities

AMRC - (the Association of Medical Research Charities) is a good place to look for very specific disease areas or patient groups. You can search the member directory for your topic area.

Funding Opportunities RSS feed

Local funding opportunities

Research Capability Funding (RCF)

To enable the continuance of research within the NHS the research arm of the Department of Health, the National Institute for Health Research (NIHR), funds a number of research programmes and initiatives to ensure that patients and the public benefit from the most up-to-date and cost effective health interventions and treatments. One such programme is Research Capability Funding (RCF) which is financial support provided by the NIHR to NHS organisations to enable them to maintain and develop research capacity. The aim is a quality-driven fund that allows for local discretion and management of people to support and develop patient and people driven research.

The allocation of funding is primarily targeted at:

  • Supporting NHS organisations to act flexibly and strategically in the maintenance of research capacity and capability, ensuring that staff can have dedicated time to support the development of grants that could lead to future research and or portfolio delivery;

  • Sustaining the appointment, development and retention of key staff undertaking or supporting people based research;

  • Contributing towards the costs of hosting NIHR funded or ‘adopted’ research that are currently not fully covered across the NIHR programmes and are not met in other ways.

Research Capability Funding (RCF) is allocated by the NIHR to research-active NHS bodies or NHS health care providers, if they either:  

  • Received sufficient NIHR income to reach a threshold to trigger an RCF allocation of at least £20k;

  • Recruited at least 500 individuals to non-commercial studies, conducted through the NIHR-Clinical Research Network, during the previous RCF year reporting period.

The NIHR has stringent rules on the exact definitions of what RCF monies can and cannot be spent on and as such must have a robust and transparent process for allocating out the monies. The WY R&D team holds a decision making panel with representatives from the West Yorkshire CCGs and public health reviewing each application for RCF before collectively agreeing which applications will be granted funding. 

The deadline to apply for funding from 2018/19’s RCF allocation has now passed. If you would like to be contacted directly to be made aware when the competition is next open then please contact the research team: research@bradford.nhs.uk. For further information please contact the team or visit the NIHR website.

Further advice

For further advice on gaining research funding, please see the following links

 

The governance process

The governance process ensures that all research that takes place within the NHS is ethical, well thought out, properly financed, safe for patients and in keeping with the aims of the NHS. It also ensures that the people conducting research are properly trained and vetted, again to ensure robust research and patient safety.

The governance process applies to research studies as defined by the UK Policy Framework for Health and Social Care Research 2017. Service evaluation, audit and surveillance projects do not require the process, but we are also able to advise on whether a project fits the criteria for research or one of the other project types (see “is it research”). Contact us for advice on this - however please note we are not able to provide confirmation of whether a project is research or service evaluation without a version-controlled protocol.

Please note that, as of 1st April 2016, all studies taking place in the NHS in England need to go through the Health Research Authority (HRA) for approval. This replaces the previous submissions to REC and NHS R&D and is a slightly different process. Submissions are still completed through the IRAS form. Any studies taking place in Scotland, Wales and/or Northern Ireland will also require separate permission for these countries, but this should not require multiple applications and will be coordinated through the lead country. 

Application is via the IRAS system. To complete your IRAS application, visit www.myresearchproject.org.uk. You will need to attach all the study documentation to your application, including participant documents (invitations, information sheets and consent forms), evidence of insurance, study protocol, and Statement of Activities and Schedule of Events which detail what activities you are planning to carry out at each site. Most studies require approval from an NHS Research Ethics Committee (REC) which needs to be booked via the central booking service. The application to REC is also via the IRAS form. See this guide to find out whether you need review by a REC. Studies which do not require approval from an NHS REC need to contact central booking (see above) to get a 'dummy' REC number to include in the IRAS form.

For a guide to using IRAS click here.

Before you start the IRAS process, consult with your University to find out whether they need their own ethics committee to review the study first. Sometimes Universities have a separate application form for this process, where others use the IRAS form.

To conduct a research study in the NHS, which means either recruiting patients or staff through their role in the NHS, or using patient or staff data, or taking place on NHS premises, you will need to consult with the NHS organisation where you intend to conduct the research, which will need to confirm capability and capacity of the organisation to take part in the study. For research in primary care each GP practice you want to use as a research site or Participant Identification Centre (PIC) has to sign off to say they have capability and capacity. If your study is taking place in primary care in West Yorkshire or Harrogate and Rural District you also need to liaise with us and we will issue an advisory email to GP practices regarding capability and capacity and confirming that a study has liaised with R&D. A webinar explaining how sponsors should work together with sites can be found here. You can also find information in your HRA approval letter about how you will be expected to get confirmation of capacity and capability.

HRA approval is only issued after all required regulatory approvals are completed - these can also include specialist approvals if your study involves certain elements. You will be issued an HRA approval letter which confirms that final approval has been received. 

We can help you to identify sites. Please contact us for information. For other areas or for secondary or community care organisations please also see the RD Forum to identify which NHS organisation will be able to offer you support.

You may need to undertake GCP (Good Clinical Practice) training (see here for guidance) or obtain a research passport or letter of access (see here for guidance) before undertaking your research. Letters of access are required for accessing NHS sites. Research passports and letters of access for West Yorkshire CCGs and Harrogate and Rural District CCG and all GP practices in these CCG areas are managed by the West Yorkshire R&D team. Please contact us: research@bradford.nhs.uk

If you need advice, please contact research@bradford.nhs.uk or for technical queries helpdesk@myresearchproject.org.uk 

Before you apply - checklist

If you are a student please see here for guidance on applying for regulatory approvals.

You need:

  • To define your research question (you can find some advice plus further links here)

  • To consider PICO

  • To check whether your project is research

  • To write a protocol detailing what you intend to do

  • To identify and obtain funding (see here for further advice)

  • To determine who will be the Chief Investigator and any local Principal Investigators and get their agreement for the roles

  • To identify a sponsor and get their agreement to sign off your application

  • To check whether your project is eligible for HRA approval 

  • To check whether any other regulatory approvals are necessary 

  • To consider whether you want to apply to be included in the CRN portfolio

  • To identify whether your project has any Excess Treatment Costs (ETCs). You will need to apply for ETCs to be funded by the Trusts or CCGs hosting the research. See below for further guidance

  • To complete an IRAS form, get the appropriate electronic signatures and submit it along with all of the study documentation

  • To complete a statement and schedule of activities for each site type and submit it along with the IRAS form. When you liaise with sites you should send these documents, along with the Local Information Pack, for the sites to confirm their capability and capacity to undertake the research. Please also copy in the NHS R&D contact which performs an advisory and oversight role. If you need help identifying sites, the NHS R&D contact can also help with this.

To conduct a research study in the NHS, which means either recruiting patients or staff through their role in the NHS, or using patient or staff data, or taking place on NHS premises, you will need to consult with the NHS organisation, which will need to confirm capability and capacity of the organisation to take part in the study. For research in primary care each GP practice you want to use as a research site or Participant Identification Centre (PIC) has to sign off to say they have capability and capacity. If your study is taking place in primary care in West Yorkshire or Harrogate and Rural District you also need to liaise with us, the West Yorkshire R&D Team. We can advise practices on their side of the research process. We can also help you to identify sites. For other areas or for secondary or community care organisations please also see the RD Forum to identify which NHS organisation will be able to offer you support.

If you are accessing NHS sites or patient records to undertake the research, you will probably need to apply for a Research Passport in order to get a Letter of Access which assures the NHS sites that you are appropriately checked and qualified. To get the application form or to find out more see the NIHR guide or contact research@bradford.nhs.uk.

For further useful links please see below.

Throughout the study

Any amendments, both substantial and non-substantial, should be notified by the researchers to us and to the HRA. Substantial amendments requiring REC review have to be sent to REC which approved your study originally. For non-substantial amendments or amendments for studies where REC review is not required, these should be sent to the HRA: hra.amendments@nhs.net. If your study was processed under the old, pre-HRA system, amendments still need to go through the HRA. To add a site you need to email the HRA to bring the study under their approval. To do this, you should email hra.amendments@nhs.net with the title “IRAS XXXXXX – request for pre-HRA approval study to come under HRA approval”. The full approved document set should also be sent, and for non-commercial studies adding new sites, you should also complete and attach a Statement of Activities and Schedule of Events.

Once an amendment receives approval from the HRA and REC where applicable, the document set should be updated to all participating sites. Please read carefully the HRA amendment approval letter and REC favourable opinion which will inform you of any additional steps you need to take. For amendments where the HRA confirms that sites should confirm capability and capacity, sites will have to sign the updated Statement of Activities and Schedule of Events to confirm they are able to implement the amendment.

Research teams should provide all sites with a contact who will be able to help sites/patients with any queries. They should also provide a procedure for reporting any adverse events. Audits can be conducted by sponsors, by any of the applicable regulatory bodies or by our team. These will involve checking of your documents and processes. Authorities such as the MHRA (Medicines and Healthcare products Regulatory Authority) can require paper copies of all relevant documents so you should make sure sites hold all documents in paper form.

After the study

After the study research teams usually ‘close down’ the participating sites to confirm the end of the study. Documents relating to the study should be kept throughout the study and follow up, and for as long as the study data is kept. Studies keep research data for some time after the completion of a study in case of audit, queries or long-term side effects. How long they keep data for is dependent on the nature of the study and the policies of the organisations involved and/or funders.

If you are a student

Student research (defined as ‘solely for educational purposes’) is currently handled slightly differently to other research.

Currently, student research is only required to go through the HRA Approval process if it:

My study meets the criteria for HRA approval My study does not meet the criteria for HRA approval

 

West Yorkshire Universities – Research contacts

University of Leeds – Clare Skinner or Jean Uniake: governance-ethics@leeds.ac.uk

Leeds Beckett University – (School of Clinical and Applied Sciences) Rob Brooks R.B.Brooks@leedsbeckett.ac.uk, (Carnegie School of Sport) Karen Hind K.Hind@leedsbeckett.ac.uk, (School of Health and Community Studies), Claire Surr C.A.Surr@leedsbeckett.ac.uk.

University of Bradford – Tamsin Holt: T.L.Holt@bradford.ac.uk or Deborah Hodgson: D.Hodgson1@bradford.ac.uk

University of Huddersfield (the School of Human and Heath Sciences) –  the School Research Ethics Panel - Warren Gillibrand: W.P.Gillibrand@hud.ac.uk, Rachel Armitage: R.A.Armitage@hud.ac.uk or Dawn Leeming: d.leeming@hud.ac.uk  

University of Huddersfield (the School of Applied Sciences, the School of Business and the School of Education and Professional Development): Professor Liz Towns-Andrews, Director of the Research and Enterprise: L.Towns-Andrews@hud.ac.uk

If your University is not listed here, please ask your academic supervisor for assistance.

Guide to letters

You may be issued with different letters when you apply for approvals. Here’s our guide explaining what these letters are for.

HRA initial assessment letter

This letter indicates that your application has been received and it is intended that you start to liaise with sites and NHS R&D once this is received. You can also liaise with sites and NHS R&D prior to this.

This letter doesn’t mean that assessment is complete. The letter gives a list of documents received and may also include some questions which the assessor needs further clarification on.

The letter will also confirm:

  • Whether formal confirmation of capacity and capability will be required by each site

  • Whether you need to appoint a Principal investigator at each site

  • Whether GCP training will be required

  • Whether letters of access will be required

  • Whether the study will be applying to be included in the CRN portfolio.

You should read through the letter carefully, answer any questions and follow the instructions given in the letter. You should also check that the document list includes all documents.

REC valid application letter

This letter indicates that a study has been accepted for REC review and confirms details of the meeting where the study will be discussed. It will also confirm the REC reference number. It confirms the list of documents to be reviewed – again these should be checked to ensure all documents are included.

The letter discusses site arrangements, as RECs now assess non-NHS sites. You should read the detail to find out what you need to do, and what will be done, to assess sites.

REC approval letter

REC letters will all confirm that a study summary will be published on the HRA website. The letter will confirm the opinion given by the REC but should also indicate that you need to wait until final HRA approval is issued before you can proceed any further. The letter will describe the discussion around the study which took place at the meeting.

All REC letters will give a list of approved documents and the versions approved – these should be the documents you go on to use and if any changes are made to these then an amendment will be required.

When a study has REC approval, any amendments submitted also need to be submitted to the REC, and the REC will also issue an opinion to confirm or reject an amendment.

Sometimes the REC gives favourable opinion (which is approval), however sometimes the REC gives one the following opinions:

  • Unfavourable - The letter confirms that REC favourable opinion has not been given and you are not able to proceed with your study. The study requires some fundamental changes which mean that you will need to make a new application. The letter will explain the reasoning behind the decision and what the future options are.

  • Favourable with conditions - This indicates that the favourable opinion is subject to some conditions, which will be outlined in the letter. This opinion does not allow you to proceed until the conditions have been met and a further letter issued to confirm acceptance. You may need to go back to the REC to submit the conditions.

  • Provisional opinion - This indicates that the REC gives a favourable opinion on the condition that some minor changes are made. This would not normally require you to go back to the REC but could require changes to be submitted in correspondence. Again this opinion does not allow you to proceed until the changes are made and a further letter issued to confirm acceptance.

HRA approval letter

This letter confirms final HRA approval. You may have liaised with the HRA during the assessment process and detail of this should be included and confirmed in this letter. You should read the letter carefully as it will detail what you need to do next. There will be another document attached “After HRA approval – guidance for sponsors and investigators” which you should also read.

The lead R&D contact listed on your IRAS form should be sent a copy of this letter (details of who is sent copies is below the signature) – but all other R&D offices and sites will need to be informed of the HRA’s decision and sent this letter.

The sections:

  • HRA assessment criteria - This describes how the different parts of the HRA assessment have been carried out and is worth reading through in case any further information is provided

  • Participating NHS organisations in England - This gives more detail about working with NHS sites in England and what you should do

  • Confirmation of capacity and capability - This details whether sites will be expected to give a formal confirmation of capacity and capability, how you will be expected to liaise with sites, and links to other documents which may be useful to advise you

  • Principal investigator suitability - This confirms whether you need to appoint a principal investigator at each site and whether you need to undertake GCP training

  • HR good practice resource pack expectations - This describes whether you need to obtain letters of access, research passports, or honorary research contracts to undertake your research. The HR good practice resource pack which tells you more about the requirements can be found here: https://www.nihr.ac.uk/about-us/CCF/policy-and-standards/research-passports.htm)

  • Other information to aid study set-up - This describes anything else you may need to consider and also confirms whether you intend to apply for the study to be included in the CRN portfolio.

CAG approval

Final outcome letter

Where approval has been sought from CAG, a letter will be received to confirm whether this has been agreed, specifying any conditions which you must adhere to when processing data which falls under the CAG requirements.

For research studies,CAG approval is only a part of the approval process and you will also need to receive a letter of HRA approval.

More useful links

HRA e-learning (please note that you can access this training without registering by clicking on ‘log in as guest’).

Other regulatory bodies

Please click here to read more about the main regulatory approvals which may be required.

Please see below for further information about all of the regulatory bodies you may need to consider.

See also

https://www.hra.nhs.uk/planning-and-improving-research/learning/

www.bradfordresearch.nhs.uk/for-researchers-and-staff/new-to-research/step-by-step-guide

Excess treatment costs ETCs

If your study involves a different treatment from standard care, which costs more or less than standard care, then it may involve an excess treatment cost or excess treatment saving. These are separate from research costs or study support costs, which should be funded through the research funding or through the local Clinical Research Network (CRN).

Excess treatment costs are applied for as part of a study application and should be flagged up to the relevant CCG(s) (all CCG commissioning sites where the research is taking place) as early as possible in the application process. This allows the CCG(s) time to consider the application. If there is an excess treatment saving, i.e. the study treatment costs less than the standard treatment would have, this should also be reported to the CCG(s).

For further information on excess treatment costs please click here, or for queries please contact us research@bradford.nhs.uk.

Please note that there is a forthcoming change to the excess treatment cost application process, and further information will be available about this soon. Before you apply please contact research@bradford.nhs.uk to discuss.

During and after your study

As your study progresses the study team is responsible for:

During

You can now start recruiting participants. Alongside your recruitment and study activity you must ensure that the following are carried out:

  • Ensuring the study is carried out in accordance with the protocol and the latest approved documents are used. In addition, clinical trials must be carried out in accordance with the Declaration of Helsinki.

  • Ensuring records and documents are up to date and the relevant bodies informed. If there are any changes to the study these must be submitted to the HRA for approval. First the sponsor must categorise the amendment as substantial or non-substantial. Substantial amendments need to be approved by the REC if the study type requires REC review. Non-substantial amendments should be submitted to the HRA (hra.amendments@nhs.net). Amendments then need to be agreed by all applicable sites. Sites have 35 days to respond and if they do not respond within that time, the amendment may be implemented at that site. There are templates for amendment notifications which can be found on the IRAS site. You may also need to notify other bodies, such as MHRA, if these were involved in the original approval. All applicable NHS R&D offices also need to be informed of any amendments. For further information please click here or consult this flowchart.

  • Communicating with research sites. Sites should be kept updated and have a point of contact in the study team for any queries.

  • Ensuring site files are up to date. Sites must each hold a paper site file which includes a full and up to date set of documents including the delegation log; training log; CVs of all involved staff at the site; all current versions of study documents; documentation about regulatory approvals; study protocol; information about procedures taking place at the site and correspondence.

  • Ensuring staff have the relevant training. This means the training, education and/or experience to allow involved staff to conduct the research. So for example if a member of the team is taking blood samples they must be trained to do so. This training may include Good Clinical Practice training – your HRA approval letter should confirm whether this is required. All staff involved in research may find this training useful.

  • Reporting serious adverse events. There should be a procedure in place for reporting these which needs to be communicated to each site, and all events must be responded to appropriately and reported to the relevant bodies.

  • Documenting consent forms. Consent forms should be kept in a safe place and data protection complied with.

  • Ensuring data and samples handled appropriately. Consider who has access, where any paper records are kept, who is given smart card access to NHS systems, how samples are transported and by whom.

  • Ensuring current Letters of Access for any study staff accessing NHS premises. Any staff member who will be accessing an NHS site for research purposes should have a letter of access (for details see here), and these should be current to reflect required access. To apply for a letter of access please contact research@bradford.nhs.uk.

  • Updating recruitment onto CRN database. Number of study recruits should be updated monthly onto the Central Portfolio Management System (CPMS) for portfolio studies. Please see here for further information.

  • Annual progress reports. Please see here for templates. These should be submitted to the REC, HRA and any other applicable bodies.

After

After completion of a study consideration should be given to:

  • Patients and their experience of the study. Please see here for details.

  • End of study reports should be submitted to the REC within 90 days of the end of the study and copies sent to NHS R&D. If the study was not REC approved the end of study report should be sent to the HRA with your IRAS ID and contact details. If the study was a CTIMP the end of study form should be sent to MHRA within 90 days of the end of the study. See here for templates. If your study was with the Confidentiality Advisory Group the Confidentiality Advice Team should be notified of the end of the study in writing to hra.cag@nhs.net.

  • The final research report should be sent to REC and MHRA (for CTIMPS) within 12 months of the end of the study.

  • Study outputs should be shared with participants and research sites if possible. We can also share these on our site so please send these to research@bradford.nhs.uk.

  • Study site files and documents should be kept as documented in the original application, and sites should be communicated with to let them know how long they need to keep information for and how.

  • Dissemination events can be useful for getting your message out to the community. We can help you to promote any events, so please contact research@bradford.nhs.uk for advice.

 

Please see the 'How we can help' section below for practical ways in which we can help you access GP practices in an attempt to increase study recruitment, or read the below information and then do contact us if you've any further questions about finding sites and recruiting patients.

Finding sites

Identifying the sites where your research will take place is essential, and it is recommended you start to approach sites early where possible to get them on board with your study. Sites will each have to agree that they have the capability and capacity to take part in the research and a separate agreement or signed statement of activities is required to formalise this arrangement.

If your study requires any specialist equipment or skills this may affect which practices can participate in your study. You may also be looking for a specific demographic. In these instances, for portfolio studies, the NIHR CRN (National Institute for Health Research – Clinical Research Network) can help. For commercial studies, please see here for details.

For help from the CRN with study setup please see here.

For help identifying GP practices which may be interested in your research area, please contact us.

Recruiting participants

Your study will not be able to take place without participants so there are a number of considerations to be taken into account when developing your study, such as how many participants you need to take part in your study, and how many you can feasibly recruit. 

A statistician may be able to advise you on how many participants you will need to take part in your study to obtain a meaningful result. You can read more here.

You also need to consider what may make participants (either staff, patients or the general public) want to take part in your study. You must offer potential participants a free choice and must not coerce them into participating, but consider:

  • How you will get their attention?

  • How can you reach them? Where can you reach them?

  • How should you communicate with them and make the study understandable to them? Are there any specific considerations e.g. language, easy read information, child participants?

  • Should you reward them or reimburse their travel costs?

If your study asks participants to do something difficult or unpleasant, you may find it difficult to recruit as many as you would like. After all, your participants give up their time and more to participate in your study. If this is not pleasant, or is risky, or takes up a lot of time, participants may be more likely to decline to take part, or withdraw during the study. This is another very good reason for involving patients and the general public as early as possible, to identify what parts of the study may be off-putting and how best to communicate about the study with your participants.

In these instances, or if you are approaching a group which may be difficult to reach, for example GP practice staff who may struggle to find the time to participate in your study, or patients who may be difficult to find or approach, this doesn’t mean you should be put off from your study aim. You may, however, need to approach more people, allow more time, or cast the net more widely in more areas in order to reach your recruitment target.

Some research areas may have a database of people interested in participating in certain types of research. One good example of this is Join Dementia Research.

Please see 'How we can help' for practical ways in which we can help you access GP practices in an attempt to increase study recruitment

For further advice on recruiting patients to portfolio studies you can contact your local CRN Research Delivery Manager or speak with a member of our team. For advice about non-portfolio studies please contact us.

How we can help

We can help you to raise awareness about your research study. Please contact our Research Engagement Officer if you would like to discuss research engagement and knowledge transfer opportunities in further detail. Some of these opportunities include:

Newsletters

We feed into various newsletters, including those received directly by commissioners and health professionals. Please contact us if you would like to increase awareness of and recruitment to a research study by contributing to these newsletters. 

We also produce our own twice yearly newsletters aimed at anyone with an interest in NHS research. If you would like to contribute to these please contact the team. If you would like to receive these then please join our mailing list.

Events

We frequently hold stands at various events across the region (e.g. practice protected time sessions) sharing information about research taking place across the area. If you would like us to share information about your study please do get in touch to discuss whether there are any upcoming events at which it might be appropriate for us to do so.

Research Network Meetings

Research network meetings are open to attendance by practice managers, general practitioners and any general practice staff members with an interest in research. These sessions include presentations given by researchers about studies taking place locally. 

The meetings begin with a meet and greet session where research professionals can network over a buffet lunch. This is followed by presentations by academics sharing information about upcoming projects, studies open for recruitment, or research study findings. We aim to provide an opportunity for the discussion of any potential research ideas that you wish to explore, so as to enable the troubleshooting of issues that may arise in relation to the practicalities of delivering a research project in a primary care setting; this feedback can then be taken into account during the early stages of a project's development. The meetings can help you to generate wider awareness of your research study during the recruitment period. They are also a chance for study teams to thank those who have taken part in a study whilst sharing study findings. 

Our colleagues from the Clinical Research Network: Yorkshire & Humber Division 5 are often present at these meetings, providing further opportunities for collaboration between the National Institute for Health Research, commissioners, research academics and health professionals. There is always time set aside for any questions or discussion around the topics presented, where we share our experiences of research in primary care and learn from each other.

To find out more about our network meetings or to register interest in presenting at a future network meeting then please contact us.

Website 

We can share information about your research study during the recruitment period via our website and Twitter.

 

Read about: EventsNewslettersRepository / Research Network Meetings / Website 

It is important that the findings of research are shared, as:

  • Healthcare practice moves forward through the use of research findings;

  • Commissioners use robust research evidence to support their commissioning decisions;

  • Research participants often value receiving the results of research they've been involved in as this recognises the importance of their contribution;

  • Other researchers can use research findings to inform their own research studies;

  • Published research contributes to the growing body of knowledge which can be accessed by academics, clinicians, students, commissioners, or anyone with an interest in research.

It is important to share research findings, even if nothing significant was discovered – not finding anything can also be an interesting result. Publishing or disseminating this sort of finding also ensures that others can see that the research has already been carried out, so that they do not waste time and money attempting to replicate the research.

Dissemination can take many forms. The most traditional is a published journal article. You can use a service like NHS Evidence to identify a suitable publication. Journals will usually have a website which gives instructions on submitting. Many research funders require research findings to be published in an open access publication.

You can also contact the press with any key findings, in particular in ‘hot topic’ areas. For advice on writing a press release see here.

You may want to promote a finding or an article via social media, or via a research specific social media platform e.g. ResearchGate.

Fast Track Impact has offered the following top tips for using Twitter to enhance the impact of your research.

How we can help

We can help you to disseminate your research findings. Please contact Research Engagement Officer Gemma Doran if you would like to discuss research engagement and knowledge transfer opportunities in further detail. Some of these opportunities include:

Events

We hold twice yearly themed evidence events, where research findings are shared directly with health professionals. You can read about our most recent events below:

If you would like to be informed about future events, please contact us.

Our next event will take place in October 2018.

Newsletters

The West Yorkshire R&D Team feed into various newsletters, including those received directly by commissioners and health professionals. Please contact us if you would like to contribute information to these newsletters, for example if you need to: raise awareness of a research related event or training opportunity; increase awareness of and recruitment to a research study; disseminate results and learning from research; or generally raise awareness about research related activity. To disseminate information this way in the area please contact Gemma to discuss.

Alongside these pre-existing newsletters the WY R&D team are in the process of developing a quarterly newsletter aimed at anyone with an interest in NHS research who signs up to our mailing list:

If you would like to contribute to these please contact the team. If you would like to receive these then please join our mailing list.

Repository

The West Yorkshire R&D Team can publish or link to articles in our repository.

Research Network Meetings

The West Yorkshire R&D Team hold research network meetings. These are open to attendance by practice managers, general practitioners and any general practice staff members with an interest in research. These sessions include presentations given by researchers about studies taking place across locally. 

These meetings begin with a meet and greet session where research professionals can network over a buffet lunch. This is followed by presentations by academics sharing information about upcoming projects, studies open for recruitment, or research study findings. We aim to provide an opportunity for the discussion of any potential research ideas that you wish to explore, so as to enable the troubleshooting of issues that may arise in relation to the practicalities of delivering a research project in a primary care setting; this feedback can then be taken into account during the early stages of a project's development. These meetings are also a chance for study teams to thank those who have taken part in a study whilst sharing study findings. 

Our colleagues from the Clinical Research Network: Yorkshire & Humber Division 5 are often present at these meetings, providing further opportunities for collaboration between the National Institute for Health Research, commissioners, research academics and healthcare professionals. There is always time set aside for any questions or discussion around the topics presented, where we share our experiences of research in primary care and learn from each other.

To register interest in presenting your research findings at a future network meeting then please contact Gemma.

Website 

We can share information about your research findings via our website and Twitter.

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