Research and innovation

group shot of research staff

About the department

The team is made up of a group of healthcare professionals who have dedicated their careers to advancing medicine, and improve our healthcare system.

Our research team consists of doctors, nurses, midwives, trial practitioners, scientists and administrators.

The aim and objective of our department is to work with our patients, staff and partners to bring tomorrow’s treatment to the NHS today as we believe research and innvovation is the key to improving our NHS for the future.   

Our team is based at Queen’s Hospital next to Outpatients Team 5 in the Green Zone. We can be contacted on 01708 435 305 and 01708 435 306 or by emailing a specific contact detailed in Our Team.

Our team

Helena Walsh

Associate Director of Research and Innovation
01708 435000 ext 2203
Helena.Walsh@bhrhospitals.nhs.uk

Victoria Darkins
Research and Development Finance and Contracts Lead
01708 435306
victoria.darkins@bhrhospitals.nhs.uk

Rachael Connolly
Research and Development Communications and Data facilitator
01708 435 000 Ext 2944
rachael.connolly@bhrhospitals.nhs.uk

Silvana Farrell
Research and Development Administrator
01708 435000 ext 4956
silvana.farrell@bhrhospitals.nhs.uk

Introduction to our research trials

Research is work that produces new generalisable results. Research starts with a question such as "is this treatment that I am carrying out the most effective available?"

The next step is to examine the existing knowledge; is there information available from experts and published papers? If there is, then apply the research knowledge to changing your practice - this is development. If the knowledge is not available you have a potential research project, discuss it with your manager and contact us.

We currently host almost 200 active research studies, across most of our speciality, ranging from cancer, rheumatology, neuroscience, cardiology to maternity. Last year we have recruited over 6,500 patients into clinical research and aiming to maintain this level of performance. Our research partners include national and international universities which allow us to test the latest theory in medical science. We also work with pharmaceutical companies to fast track next generation drugs to the NHS

Registering a trial

For you to register a project you must fill in the Integrated Research Application System (IRAS) form. IRAS is the only way to apply for ethics approval from an NHS approval for NIHR portfolio studies.

IRAS is a single system for applying for the permissions and approvals for health and social care/community care research in the UK it enables you to enter the information about your project once instead of duplicating information in separate application forms and uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required. It helps you to meet regulatory and governance requirements and retains familiar aspects of the NRES form system.

IRAS captures the information needed for the relevant approvals from the following review bodies:

  • Administration of Radioactive Substances Advisory Committee (ARSAC)
  • Gene Therapy Advisory Committee (GTAC)
  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • Ministry of Justice
  • NHS / HSC R&D offices
  • NRES/ NHS / HSC Research Ethics Committees
  • National Information Governance Board (NIGB)
  • Social Care Research Ethics Committee

 

Research training courses

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct and record of research involving humans.

All of our staff involved in the conduct of a clinical trial of an investigational medicinal product (CTIMP) must receive initial and regular update training in GCP. This is a legal requirement under the UK legislation on clinical trials.

You need to attend GCP training if you are a:

  • Principal Investigator/Co-investigator
  • Research Nurse
  • Trial Coordinator
  • Trial Pharmacist
  • Member of a laboratory involved in data analysis related to the trial

Comprised of 13 core principals, GCP applies to all clinical investigations that could affect the safety and well-being of human participants (in particular, clinical trials of medicinal products).

GCP was developed by the regulatory authorities of the EU, Japan and US in a steering group termed the Tripartite International Conference on Harmonisation (ICH) and provide international assurance that:

  • data and reported results of clinical investigations are credible and accurate
  • rights, safety and confidentiality of participants in clinical research are respected and protected

It was finalised in 1996 and became effective in 1997. When first expounded, it was internationally recognised as best practice, but was not enforceable by law.

However, with the advent of the Medicines for Human Use (Clinical Trials) Regulations 2004 and the recent EU directive on Good Clinical Practice, compliance with GCP is now a legal obligation in the UK/Europe for all trials of investigational medicinal products.

GCP – 13 PRINCIPLES

  1. Clinical trials should be conducted in accordance with the ethical principles that have their original in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s)
  2. Before a trial is initiated, foreseeable risks and inconveniences should be weighted against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks
  3. The rights, safety and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society
  4. The available non-clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial
  5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol
  6. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion
  7. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist
  8. Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s)
  9. Freely given informed consent should be obtained from every subject prior to clinical trial participation
  10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification
  11. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s)
  12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol
  13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.

GCP COURSES

Our one-day GCP course has been accredited by the Royal College of Physicians, London at six CPD points and is open to all Trust staff irrespective of which organisation is sponsoring the trial. A certificate of attendance is issued after completion of the course. GCP certificates are subject to audit and inspection by the regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA).

REFRESHER COURSES

If you attended a GCP course prior to 2009, you need to attend a refresher course to update your GCP Training and to gain knowledge of the amendments to the UK legislation of the Medicines for Human Use (Clinical Trials) Regulations 2004. If your GCP training certificate is now more than two years old, we invite you to attend our GCP refresher course, which lasts approximately half a day, followed by a half hour question and answer session at the end. The course is accredited with two CPD points form the Royal College of Physicians and certificates will be handed out at the end.

@BHRUT_Research