Information for Health Researchers

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 and Wales need to go through the Health Research Authority (HRA)/Health and Care Research Wales (HCRW) 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 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 for all of the UK nations 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 Organisation information document which detail what activities you are planning to carry out at each site (NB: the Organisation information document replaced the statement of activities and schedule of events in England and Wales, as well as the SSI form in other UK nations, from 5th June 2019). Most studies require approval from an NHS Research Ethics Committee (REC) which needs to be booked via the online booking service via the e-submission tab of your IRAS form. See this guide to find out whether you need review by a REC and this toolkit to determine whether you can apply for proportional review by 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 (some PIC sites with very small involvement, e.g. advertising the study via a poster, do not need to go through a sign-off process, as long as they are HRA-approved). If your study is taking place in primary care in West Yorkshire 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. You can 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 a 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 NHS R&D 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 all GP practices in West Yorkshire are managed by the West Yorkshire R&D team.  

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

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 and whether it classes as a Clinical Trial of an Investigational Medicinal Product (CTIMP)

• 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 which is done through the Clinical Research Network. 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 an local information pack 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 Organisational Information Document, 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 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 R&D 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 IRAS 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 an Organisation information document.

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. Sites are not required to confirm acceptance of an amendment, but if they do not wish to implement it, they should notify the study sponsor immediately. It may help the sponsor if the site confirms receipt of an amendment - otherwise this can be implemented after 35 days.

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 Medicines and Healthcare products Regulatory Authority (MHRA) 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.

New eligibility criteria for student research has been in place since 1st September 2021:

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

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:

• Requires review by an NHS Research Ethics Committee (REC) (check whether NHS REC is required), or

• Is taking place across more than one NHS organisation, or

• Is adopted onto the CRN Portfolio

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) Nicola Kine: N.Kine@leedsbeckett.ac.uk, (School of Health and Community Studies) Claire Surr: C.A.Surr@leedsbeckett.ac.uk.

University of Bradford – Nazreen Akhtar: N.Akhtar67@bradford.ac.uk

University of Huddersfield (the School of Human and Heath Sciences) – the School Research Ethics Panel - Michael Concannon: m.j.concannon@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.

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

HRA/HCRW 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/HCRW approval letter

This letter confirms final HRA/HCRW 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 and Wales - This gives more detail about working with NHS sites in England and Wales 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.myresearchproject.org.uk/help/hlphrgoodpractice.aspx

• 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.

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.

• Gene Therapy Advisory Committee (GTAC) for gene therapy clinical trials – this is now incorporated into HRA approval. Please note that applications need to be booked for review by GTAC.

• Confidentiality Advisory Group (CAG) - this is now incorporated into HRA approval. Please note that applications need to be booked for review by CAG. You can also apply separately to CAG as some studies may need CAG approval but not HRA approval.

• Research Ethics Committee (REC) – this is now incorporated into HRA approval. Please note that applications still need to be booked for review by the REC. There are also separate Research Ethics Committees for social care studies, for studies sponsored or funded by the Ministry of Defence, and within Higher Education Institutions. Click on the links to find out more if you think these may be appropriate for your study.

• Medicines and Healthcare products Regulatory Agency (MHRA) – Medicines - this is required for any Clinical Trials of Investigational Medicinal Products (CTIMPS) 

• Medicines and Healthcare products Regulatory Agency (MHRA) – Devices - this is required for clinical investigations of medical devices. 

• Administration of Radioactive Substances Advisory Committee (ARSAC)

• National Offender Management Service (NOMS) – required for any studies with prisons (including YOIs) or probation trusts. 

• Human Fertilisation and Embryology Authority (HFEA) for research involving human embryos and gametes.

• Human Tissue Authority (HTA) which approves organisations which store human tissue for research.

See also

• Health Research Authority (HRA) - e-learning

• Bradford Institute for Health Research - information for researchers 

Since 1st October 2018 the NIHR Clinical Research Network (CRN) has managed national operational oversight of Excess Treatment Costs (ETCs). Our regional NIHR Yorkshire and Humber Clinical Research Network (Y&H CRN) manages this process across Yorkshire and Humber, meaning that any applications for ETCs within Yorkshire and Humber should be applied for under this system via the Schedule of Events Cost Attribution Template (SoECAT), liaising with the local AcoRD specialists who can be contacted via the CRN’s study support services.

The following link provides guidance on how to complete the SoECAT:

• SoECAT guidance

When there is an ETC incurred at a general practice, the practice needs to pay out the cost first and it will be reimbursed. ETCs are reimbursed to practices at Q2 if they meet a minimum threshold of £100, or at Q4 if they do not reach the threshold.

You can read more about ETCs online: https://www.nihr.ac.uk/researchers/collaborations-services-and-support-for-your-research/run-your-study/excess-treatment-costs.htm

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.

• 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.

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 National Institute for Health and Care Research – Clinical Research Network (NIHR CRN) 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.

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 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 Agile Research Team or speak with a member of our team. For advice about non-portfolio studies please contact us.

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

As well as contacting practices directly, we can also feed into various newsletters, including those received 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. 

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.

Website 

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