Frequently Asked Questions

What do the Research Compliance team do?

Ensure the correct regulatory approvals are in place to undertake the research at this Trust, ensure the services involved understand what is being asked of them and that they have capability and capacity to support the study.  Ensure both financial and contractual arrangements are in place before signing off the Trust’s Capability and capacity to support.  Monitoring and auditing of studies.  Approving amendments, signing off research passports and generating letters of access.  Also performance related issues.

What do the Research Support and Training team do?

They provide support in developing and running research studies and service evaluations. The level of involvement depends on what is required and can involve undertaking and collaborating on service evaluations and literature reviews. They run feasibility searches in the CRIS system and are the approved researchers for work involving access to forensic data in CRIS. They offer advice on training opportunities to support staff to get involved in research and service evaluation. They also support the research clinics and the SERPs.

What do the Research Delivery team do?

The Research Delivery Team work on a range of studies adopted by the National Institute for Health and Care Research Clinical Research Network. They include research nurses and research delivery officers and are based at the Institute of Mental Health.

What are research clinics?

A half-hour MS Teams call with team members from the different functions of the R&E Dept. These are available for anyone – it may be that you just have an idea and are not sure where to get started. We can give advice on all aspects of research and service evaluation. You are welcome to attend with other project members. We encourage anyone wanting to do a service evaluation to book on to a research clinic before you apply so that we can support you with your application. Dates, times and booking details are on our website.

What are SERPs?

A Service Evaluation Review Panel (SERP) is arranged following the submission of a SE1 form (service evaluation application). SERPs are an MS Teams call with staff from the R&E Dept to discuss your application and answer any queries based on the initial governance review. These were set up to help clarify and resolve things faster than to-ing and fro-ing by email. The SERP will be led by one of our Research Compliance Facilitators. Booking on to a research clinic before you apply to do a service evaluation should reduce the need for a SERP, as many queries can be resolved at this meeting

What effect has Covid-19 had on research in the Trust?

Covid-19 has had several effects. The R&E Dept worked successfully from home during the first lockdown and have largely retained home working. The use of MS Teams has meant we are easily accessible to all in the Trust. 

The HRA and NIHR provided guidance. Urgent public health studies were prioritised. Many studies were paused until they were safe to continue, often with revised methodologies so they could adhere to the regulations. Other studies were abandoned to reduce the demands on clinical services. It was also likely that had service evaluations continued, they would not have given a true reflection of the service. The HRA stopped reviewing individual undergraduate and master’s student research projects and advised on other ways in which students could gain experience of health and social care research.

Where can I find out more information?

 Please contact research@nottshc.nhs.uk if you can’t find the information you are looking for on our website.

How can I tell if my project is research or service evaluation?

Please complete the HRA decision tool to see whether your project is ‘research’. If not, it may be service evaluation or audit. A service evaluation will seek to answer, “What standard does this service achieve?”. A clinical audit is about finding out if we are doing what we should be doing e.g., does the service meets a predefined standard?

I’d like to do a service evaluation. What do I need to do?

Discuss with your service if this is of benefit to them, complete the SE1 form available on our website, and book on to one of our research clinics to talk through your form prior to submission to ensure you have everything in place. There is also guidance built into the form and a separate guidance document.

Do I need to consider ethics as part of my service evaluation?

Yes. Unlike research, your application will not be reviewed by a Research Ethics Committee. However, it should still be ethical, and it will be reviewed by our Research Compliance Team.  

If you are a student undertaking a service evaluation as part of your course, you may be required to submit the project to your University’s Research Ethics Committee – your course supervisor will be able to provide guidance. We recommend contacting us about your project prior to sending it to university ethics; we sometimes receive applications which have been approved by the university but are not compatible with our Trust processes and data protection regulations.

Do I need to get consent?

It is likely that you will need to obtain consent if you want to use person identifiable information during your research project or service evaluation.  To comply with the law, consent must be explicit and fully informed; it can be given verbally or in writing.  We have developed a template participant information sheet and consent form to cover different scenarios which you can adapt for your research project or service evaluation to ensure you meet the legal requirements relating to consent. 

There are times when it’s not feasible, or even possible, to obtain consent.  If you believe that this applies to your project or evaluation, please discuss this with the Research and Evidence Team who will be able to provide guidance in relation to satisfying the legal requirements.  

Do you have examples of service evaluations?

Trust staff can access final reports on our intranet, Connect. Some service evaluations are published externally and are available via the East Midland’s Evidence Repository. 

How can I access routinely collected data?

The law says that if personal data has been collected for a particular purpose, it can’t be used for another purpose that isn’t connected with or reasonably incidental to the original purpose.  This means that if information has been collected to allow the Trust to deliver healthcare, it can’t be used for a ‘secondary purpose’ without certain legal obligations being met.

Furthermore, personal information which has been given with the expectation that it will be held in confidence – for example, medical information shared by a patient with their clinician – can’t be shared with anyone else without the patient’s consent unless very specific criteria apply.  

It’s important to note that the UK GDPR and the Data Protection Act (2018) only apply to identifiable data – this includes pseudonymised information.  If you only need fully anonymised or aggregate data for your research project or service evaluation, you will be able to use that data without restriction.

 

I’ve already collected data. Can I use it?

This depends on several different factors including what the data contains, why it was initially collected and who has a legal right to access it.  

Person identifiable information which was provided or collected to allow the Trust to deliver care cannot be used for another purpose that isn’t directly connected with or reasonably incidental to delivery of care without certain legal requirements being met.  These legal requirements include the need to satisfy the Common Law Duty of Confidentiality which will always apply to health-related data.  This means that unless very specific circumstances apply, information which was shared with the expectation that it would be held in confidence cannot be shared with or used by anyone else without consent.  It is not possible to rely on implied consent to use person identifiable data from medical records for research projects or service evaluations.  

 

Can I take data out of the Trust?

This will depend on several factors including what the data contains, where you want to transfer the data to and who you would like to share the data with.

Data which has been fully anonymised to the standard required by the Information Commissioner’s Office (ICO) can be transferred out of the Trust without limitations.  More details about the ICO definition of anonymised data can be found here: Anonymisation: managing data protection risk code of practice.

Restrictions must be applied to data which is pseudonymised or fully identifiable.  These include ensuring that the data will be at least as secure as if it remained within the Trust’s IT infrastructure.  Consideration will also need to be given to how you intend to transfer the data and who will be able to access it once it’s transferred.  The Research and Evidence Team can provide advice about transferring data during the research clinic or SERP.

The Trust do not recommend transferring person identifiable data (which includes pseudonymised data) outside of the UK / EU.

 

Do I need a Data Protection Impact Assessment (DPIA)?

The need for a DPIA will be determined by factors such as what type of data you intend to use, what you plan to do with the data and how you will process the data.  

A DPIA will need to be completed for every research project sponsored by the Trust.  

 

What is CRIS? Can we use it?

CRIS stands for Clinical Records Interactive Search. Its official name is CRIS Powered by Akrivia Health. The CRIS system allows research, service evaluations and audit to be carried out on the data held in our RiO electronic health records platforms. The records within the CRIS platform have been deidentified meaning patient names have been masked and key dates like dates of birth have been truncated.  Some records for example, records for patients under the care of the Nottingham Centre for Transgender Health, are not available via the CRIS platform.  Records for individuals who have opted-out of allowing their data to be used for research and planning without their consent are also unavailable. As an additional security measure, records relating to patients in our Forensic Services are only accessible to the Research Assistants in the Research Support and Training team.

You will need to make an application to access the information in CRIS which will be considered by the Trust’s CRIS Oversight Committee.  Please contact our CRIS Coordinator if you would like further details.

 

I’d like to interview people. Where can I get advice on asking the right kind of questions?

Have a look at published work in similar areas to see if suitable interview schedules are already available – this may include contacting the corresponding author to ask for the interview/topic guide. Another useful resource is available at nhsevaluationtoolkit.net. If you need further help, please book on to one of our research clinics and we can advise.

What assistance can you give me with analysis?

You should consider who will do the analyses when planning your project. Funded research projects often require a statistician to be part of the team. For other projects, please contact us to discuss your requirements.  

What software is available? 

• R - is a comprehensive statistical package and is free to use. It has quite a steep learning curve and requires some coding knowledge. Training courses are available. There is an active NHS-R community promoting the use of R in the NHS.  This is used by the Information Analysts in the Trust’s Clinical Development Unit Data Science Team.
• jamovi – is menu driven and built on top of the R statistical language. It can also give you the R code for your analyses which may help in learning R. 
• PSPP – is a free alternative to SPSS. It is menu driven, like SPSS, but is more limited in its functions. 
• Excel – a ‘Data Analysis’ addon is available within the data tab which can be used to do some basic analyses such as t-tests.

R (and R Studio), jamovi, and PSPP should be available to install via the Software Center in the IT Support folder within NottsHC Shortcuts – if not, please contact IT.

Can I do my project in the Trust?

Students regularly undertake research and service evaluation projects in the Trust. These may be for academic or professional qualifications. You will need to consider the type of project and the length of your course to ensure there is time to gain the necessary approvals.  Please see the service evaluation FAQs, speak with your supervisors, and contact the R&E Dept if you need further advice.

 

I need help with the IRAS form. Can you help?

You will use the IRAS form to apply for research projects. It is usual practice for academic institutions to sponsor student research. You should seek help from your academic supervisor and your sponsor in the first instance.

 

Can I analyse my data at my university?

If you are only using fully anonymised data for example, statistical information, you can analyse the data at your university without restrictions.

If you are using pseudonymised and/or fully identifiable data that the Trust is the Data Controller for then you can only analyse the data at your university if data security safeguards in place.  There must also be a Data Processing Agreement in place between your university and the Trust. The Trust currently has Data Processing Agreements in place with the following universities:

• University of Nottingham
• Nottingham Trent University
• University of Lincoln
• University of Manchester (for a sponsored study)
• University of Sheffield
• King's College London (for a sponsored study)

 

Sharing Agreements are in the process of being approved with other universities.  If there isn’t currently an Agreement in place with your university, the Research and Evidence Team can support with development of the necessary paperwork.

The term Data Controller is defined in the UK GDPR; the Trust will be Data Controller for any data processed during a research project that we are sponsoring.  The Trust is also Data Controller for the information in medical records.  If the Trust isn’t the Data Controller for the information you’ll be analysing, please speak to the Research and Evidence Team for advice.

 

I’m doing Forensic Psychology training via the British Psychological Society and am not attached to a university. Who will sponsor my research project?

Research projects are usually sponsored by the student’s university. The Trust will act as sponsor where there is no university involved i.e., qualification via the BPS. Please contact us at the earliest opportunity to discuss your proposed project.