Category / nhs

Research in the NHS – HR Good Practice Resource Pack updated

Guidance, NHS, PG research, Research Ethics, student research

Researchers from BU wishing to conduct their research within NHS premises will require the appropriate documentation. There is plenty of guidance available to guide researchers through these processes.

The Human Resources (HR) Good Practice Resource Pack has been reviewed and updated in light of the Data Protection Act 2018 (DPA 2018) and the General Data Protection Regulation (GDPR) which came into force in the UK on 25 May 2018.

The HR Good Practice Resource Pack describes the process for handling HR arrangements for researchers and provides a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS.

Changes to the document include:

  1. Inclusion of a transparency notice, which informs and clarifies to the applicant the purpose of collecting their personal data, their rights relating to data processing, as well as fulfilling other GDPR transparency requirements.
  2. The data requested in the Research Passport application form has been minimised following discussion with Data Protection and Information Governance Officers and Human Resource experts.
  3. All references to the Data Protection Act 1998 have been updated to DPA 2018.

You can find all the updated documents here along with the RDS workflow here surrounding staffing and delegation.

Remember that there is guidance available at BU with regard to implementing your research in a healthcare setting. Take a look at the Clinical Governance blog for documents, links and training opportunities. You can also get in touch with BU’s Research Ethics team with any queries.

NIHR RDS Residential Research Retreat – 26-28 November 2019

Funding opportunities, NHS

Do you have a great idea for a research project?

Are you planning to apply for research funding?

Do you need a dedicated period of quality time with support to develop your research project?

Dillington House, Somerset. 26 – 28 November 2019.

Applications open on 20 May 2019

The Residential Research Retreat provides protected time with expert coaching and support for you to develop your research proposal to the standard required to be competitive in seeking high quality research funding.

Register your interest with us by filling in the form here

And don’t forget, your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) on the 5th floor of Royal London House. Feel free to pop in and see us, call us on 61939 or send us an email.

NIHR RDS Grant Applications Seminar & Support Event – 2 May 2019

Funding opportunities, NHS

Are you planning to submit a grant application to NIHR?

We are holding a one-day event at the University of Bristol that is aimed at helping you to improve your chances of success.

The morning seminar session is open to anyone to come and hear Simon Goodwin, RfPB Programme Manager for the South West, and RDS advisers give presentations on what makes a good grant proposal. Topics covered will include:

  • what does the NIHR (and in particular RfPB) look for?
  • the application as a marketing document: selling the topic, selling the method, and selling the team
  • the team
  • clarity of description and explanation
  • feasibility issues
  • identifying and avoiding potential pitfalls.

The afternoon support session of one-to-one appointments is for those who would like to discuss their own proposal with an RDS adviser.

This event is FREE and refreshments and lunch will be provided. Places are limited and will be allocated on a ‘first come, first served’ basis. In order to secure your place please register using our online form by 1pm, 24 April 2019. Find out more.

And don’t forget, your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) on the 5th floor of Royal London House. Feel free to pop in and see us, call us on 61939 or send us an email.

Wessex patients report positive experience of research for a second year

Knowledge Exchange, NHS

The National Institute for Health Research (NIHR) Clinical Research Network (CRN) Wessex has recently conducted a survey, distributed amongst the 10 NHS organisations in the Wessex region. This is the second time the CRN Wessex patient research experience survey (PRES) has been conducted, and ran throughout October 2018.

400 responses were received anonymously, and showed that 96% of participants had a good experience of taking part in research. It also showed that 98% of research participants surveyed had all the information that they needed in relation to the study.

Copied from the original article –

‘Many of those surveyed reported that the research staff supporting them were friendly and helpful and that they had a considerable amount of time to spend with them in order to explain the study and answer any questions.

The survey also highlighted that one of the key motivators for taking part in research was a desire to help others, with one participant commenting: “It’s good to know that this research could help future generations of patients.”’

 

The survey will be conducted again in October of this year.

NIHR Valid Informed Consent training dates

NHS, Research Ethics, Training

Before agreeing to participate in your study, your participants should receive all the information they require in order to make an informed decision. Once they wish to participate, then an informed consent form should be completed and filed appropriately.
Although the process sounds complex, there are currently a great training opportunities to help familiarise yourself with the background to, and process of informed consent in clinical research.

The Wessex Clinical Research Network are hosting the following training sessions at University Hospital Southampton and Poole Hospital –

  • Wednesday 8th May, 8:30am – 12:30pm, Seminar Room, Level C, West Wing, NIHR WTCRF, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD;
  • Wednesday 8th May, 1:00pm – 5:00pm, Seminar Room, Level C, West Wing, NIHR WTCRF, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD;
  • Monday 20th May, 8:30am – 1:00pm, Seminar Room 3, Education Centre, Ground Floor, Poole Hospital NHS FT Longfleet Road, Poole, BH15 2JB.

If you’re interested in attending, get in touch with the Wessex CRN to book your place.

Introduction to Good Clinical Practice – 15th May 2019

NHS, Research Ethics, Training

Are you interested in running your own research project within the NHS? Good Clinical Practice, or ‘GCP’, is a requirement for those wishing to work on clinical research projects in a healthcare setting.

GCP is the international ethical, scientific and practical standard to which all clinical research is conducted. By undertaking GCP, you’re able to demonstrate the rights, safety and wellbeing of your research participants are protected, and that the data collected are reliable.

The next GCP full day session is scheduled for Wednesday 15th May, at Bournemouth University, Lansdowne Campus (Bournemouth House) – 8:45am – 4:30pm.

The day will comprise of the following sessions:

  • Introduction to research and the GCP standards;
  • Preparing to deliver your study;
  • Identifying and recruiting participants – eligibility and informed consent;
  • Data collection and ongoing study delivery;
  • Safety reporting;
  • Study closure.

If you’re interested in booking a place, please contact Research Ethics.

Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

Health Research Authority public involvement guidance – third blog post

NHS, Research Ethics

Involving patients and/or the public in your clinical research is a great way to ensure that your study is designed and set-up in a way that will be attractive to participants. By carrying out PPI (patient and public involvement) you can also ensure that your research will be of benefit, not only to individuals but also the wider population and healthcare in general.

In 2018 the Health Research Authority (HRA) released guidance to help applicants better identify where they have involved the public in their research applications, and the difference that it made to their studies.

In addition, in January of this year two HRA blog posts were advertised, following the journey of a Research Fellow at the University of Surrey, who conducted PPI for her research project. The first and second posts can be found on the HRA website alongside other news items.

The HRA have just released the third blog post in which they talk to one of the lay Research Ethics Committee (REC) members who sat on the panel that reviewed the fellow’s study. The post explores the Committee member’s views on how public involvement benefited the research application. You can find it here.

Remember that support is on offer at BU if you are thinking of introducing your research ideas into the NHS, social care or healthcare institutions – email the Research Ethics mailbox, and take a look at the Clinical Governance blog.

REMINDER – Training opportunity: completing and submitting your IRAS application

NHS, Research Ethics, Training

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 102, this Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

Training opportunity – completing and submitting your IRAS application

NHS, Research Ethics, Training

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 102 Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

Training opportunity – completing and submitting your IRAS application

NHS, Research assessment, Research Ethics, Training

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 102 Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

HRA help guides – data and technology

Guidance, NHS, Research Ethics

An updated Code of Conduct for the application of data-driven technologies in the NHS was published on Tuesday of this week – the code ‘sets out what the NHS expects from companies who are developing new technologies for the health system, and what they can expect in return.

In order to assist applicants and researchers, the HRA have created new pages that set out the approvals process for data-driven technology research.

The section incorporates two pages of support –

The help pages will be added to the Clinical Governance section of the blog, for ease of access.

Research transparency – HRA response to the Science and Technology Committee

Knowledge Exchange, NHS, Research Ethics

The House of Commons Science and Technology Committee released a report last year on clinical trials transparency, as it was evident that a nearly half of clinical trials fail to publish their results. In their report, the committee made a number of recommendations to the Health Research Authority in order to rectify the situation.

At the time the HRA issued a response but today have published a further statement which sets out their commitment to research transparency. This is especially pertinent given the article published simultaneously in BMJ Open, which details the numbers of clinical trials that are publicly registered, compared with those that have received favourable opinion (approval) from a UK NHS research ethics committee.

BU has access to the ClinicalTrials.gov system so get in touch if you would like access. This is a great opportunity to register your study and study results in the public domain. It is free to register your study.
Despite the name, the system may be used for other clinical research projects.

NIHR – Making a difference: Improving treatment for advanced prostate cancer

NHS

The NIHR have recently published an article on the STAMPEDE trial which is helping to improve the prognosis and quality of life of those diagnosed with prostate cancer.

This is a research study that’s supported by the NIHR, and has been up and running since 2005, with more than 10,000 men having taken part. 125 UK sites are conducting the research, with local NHS Trusts amongst those 125.

The trial is multi-arm, so compares different treatments amongst the participant group – it is also ‘randomised’, so participants are allocated their treatment at random, reducing any bias in allocation.

The results to date from the trial have also influenced the NHS treatment for men with high risk, locally advanced metastatic prostate cancer. More STAMPEDE related news can be found on their website.

You can read the article here, which contains a testimony from a trial participant whose condition and quality of life have been vastly improved.

NIHR Programme Grants for Applied Research (PGfAR) Roadshow – 10th April 2019

Funding opportunities, NHS

NIHR Programme Grants for Applied Research (PGfAR) Roadshow

We are offering a number of events which offer an opportunity to gain a greater understanding of the NIHR Programme Grants for Applied Research (PGfAR) and Programme Development Grant (PDG) funding streams.

Registration to these events will be FREE and refreshments will be provided.

The next event taking place in the South is in Exeter, Devon. 10 April 2019.

Places are limited and will be allocated on a ‘first come, first served’ basis. In order to secure your place at our South West event in Exeter, please register using our online form by 1pm, 27 March 2019.

Researchers currently developing, or considering developing, a proposal for submission to PGfAR or PDG for funding are also invited to take advantage of a one to one session (subject to availability) with the NIHR Programme team and RDS staff to discuss their proposed study. To access this opportunity please complete the one to one booking form.

And don’t forget, your local branch of the NIHR RDS (Research Design Service) is based within the BU Clinical Research Unit (BUCRU) on the 5th floor of Royal London House. Feel free to pop in and see us, call us on 61939 or send us an email.

Training opportunity – completing and submitting your IRAS application

NHS, Research Ethics, Training

Are you currently in the process of designing, setting up or planning your research study, and would like to extend your project into the NHS?

Yes? Then you may want to take advantage of this training opportunity.

Oliver Hopper (Research & Development Coordinator, Royal Bournemouth and Christchurch Hospital) and Suzy Wignall (Clinical Governance Advisor, RDS)  will be running a training session on how to use, and complete your own application within the IRAS system.

IRAS (Integrated Research Application System) is the system used to gain approvals from the NHS Research Ethics Committee and Health Research Authority, before rolling out your study to NHS Trusts. To support this, the session will include the background to research ethics and the approvals required for NHS research.

The session will also be interactive, and so as participants, you will have the opportunity to go through the form itself and complete the sections, with guidance on what the reviewers are expecting to see in your answers, and tips on how to best use the system.

The training will take place in Studland House – Lansdowne Campus, room 102 Thursday 28th March at 09:30am – 12:30pm.

Get in touch with Research Ethics if you would like to register your interest and book a place.

HRA responds to paper outlining concerns over study set-up delays

NHS, Research assessment, Research Ethics, Research Integritiy

Two researchers from the University of Cambridge recently published an article in which they expressed their concerns over the ethics review and study set-up of a project, that was submitted in 2013.

Their study wished to recruit healthcare staff, which under the current system only requires HRA approval and not NHS Research Ethics Approval. However at the time of this study’s set-up, NHS Research Ethics clearance was a requirement.

Here are a few figures from the article which highlight the inadequacies of the previous system, that researchers had to navigate to undertake NHS-based clinical research.

  • Approx. 89 individuals were involved in the study approvals;
  • 81 named individuals were communicated with regarding ethics and governance approval via email, telephone or in person;
  • 35 of the research participants were healthcare employees, translating to approx. 2 approvers per participant;
  • 491 exhanges took place with the 89 individuals, generating 193 pages of text.

Even though the above are rather off-putting, the Health Research Authority approval system has substantially improved timelines, efficiency and support for researchers and applicants. The new procedure was introduced in April 2016.
Now when you liaise with the HRA and Research Ethics Committee, you have one named contact for each team – a HRA Assessor and the REC Manager.

You can read the HRA’s response here, which signposts the reader to further resources.

Likewise at BU, dedicated support is on offer if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog for guidance, further reading and regular updates.

Medical research: articles/blogs of interest

Knowledge Exchange, NHS, Research Ethics

A medical ethicists explores the need to temper researchers’ enthusiasm when it comes to presenting the benefits of a treatment, and how important it is to distinguish research from a treatment.

Read the full article here.

Six project management tips for a PhD – Whatever kind of large research project you are doing, these tips from the private sector might be of some use.

Read the full article here.

#DataSavesLives—Patient participation ensures data are accurate and useful – In this blog, the author argues that we must not ignore the benefits that sharing patient data can have on quality in healthcare

Read the full blog post here.

New HRA guidance launched for public co-applicants in research

Guidance, NHS

‘Increasing numbers of public contributors are helping to shape and deliver health and social care research, and there has been a rise in the number of public co-applicants joining research teams.

Involving members of the public in research design and development has been shown to have a positive effect on projects by improving the quality and relevance of research. However, until now there has been no guidance, either for researchers or for people involved, about what it means to be a co-applicant.

Now new guidance co-developed by NIHR-INVOVLE, the NHS R&D Forum and the Health Research Authority, has been launched to help support members of the public who are co-applicants on research grants and ensure that their contribution is valuable and rewarding.’

See the HRA’s update here and remember that support is on offer at BU if you are thinking of introducing your own research idea into the NHS – email Research Ethics for advice and take a look at the Clinical Governance blog.