All NHS based research must be approved by a Research Ethics Committees (REC) and must also be approved by the local NHS R&D Department. If the research is a clinical trial involving medicines it will also need approval from the Medicines and Healthcare products Regulatory Agency (MHRA)
Research Governance // Sponsorship // Funding // Protocol Development // Insurance and Indemnity // Obtaining Approval // Standard Operating Procedures // Training // Annual Progress Report // Study Completion // Publication and Final Report
Sponsorship
The Research Governance Framework (2009) requires all studies to have an identified Sponsor within the UK
ABM University Health Board may take on a Sponsorship role for research studies being led by members of staff but exclude those studies taken as part of an educational programme. Potential studies requiring ABM Sponsorship can include studies initiated by clinical academics but which may be inappropriate for the University to Sponsor due to patient care issues and may also include studies which have been funded by a pharmaceutical organisation or other funding body but which is not linked to their own Organisational R&D strategies. However, the majority of clinical research is Sponsored externally by commercial companies and/or or non-commercial charitable organisations.
For more information on Study Sponsorship, please contact the R&D team on 01792 704056.
If you require your study to be Sponsored by ABMU Health Board, please contact the R&D team prior to completing any IRAS REC or R&D forms.
Funding
ABM operates an internal grants scheme, called ‘Own Account’. Approximately £40K is made available each year to support small-scale research projects.
The following criteria is applied each year –
Priority for funding will be awarded to studies that correspond to the Assembly’s strategic priorities for R&D, namely
a. Prevention and early intervention
b. Service organisation and delivery and/or
c. Chronic disease management
Applications should be in typed format and should not exceed three sides of A4. Please include the following:
- RESEARCH TOPIC (no more than 100 words)
- TITLE OF STUDY (no more than 100 words)
- Lay Summary (no more than 200 words)
- METHODOLOGY (no more than 500 words)
- ANTICIPATED OUTCOME (no more than 500 words)
- HOW RESULTS WILL BE USED TO INFLUENCE SERVICE DELIVERY (no more than 500 words)
- AMOUNT OF FUNDING REQUIRED
- BREAKDOWN OF COSTS
Please note:
Pilot studies with the potential to secure subsequent grant from external bodies are encouraged
Applicants who have previously received ‘own account’ funds will have submitted end-of-project reports.
Protocol Development
The research protocol provides a detailed description of the objectives, design, methodology, statistical consideration and management of a research study. All protocols must be peer reviewed for scientific quality and relevance as part of research governance requirements.
Usually as part of the funding process, funders would have undertaken a robust peer review of the protocol, equally external Sponsors are responsible for peer review prior to submitting protocols to R&D for approval. For all in-house Sponsored studies, the Health Board operates a Joint Scientific Review Committee with the College of Medicine , Swansea University
Insurance and Indemnity
Insurance and indemnity is a pre-requisite for all clinical research and is the responsibility of the Sponsor. A clear statement of who is providing cover and under what circumstances should appear in the study protocol, the participant information sheet and ethics application form.
Commercial or other non-commercial Sponsors of research will be responsible for providing indemnity and extending this indemnity to the Health Board.
Obtaining necessary approvals
Ethics Application
The ethics application form can be accessed on the IRAS (previously NRES) site at www.myresearchproject.org.uk. Full guidance on completion is available on the website or advice can be sought from the R&D team on 01792 704056.
For studies involving recruitment of patients from within one of the Health Board Hospitals
From 1st April 2011, a new Centralised Permissions Process will take effect in Wales
Standard Operating Procedures
Good Clinical Practice (GCP) places a responsibility on Sponsors to implement Standard Operating Procedures (SOPs) for every aspect of clinical trial management. This is a legal requirement for clinical trials of an investigational medicinal product but is also recognised good practice for all research studies. ABM University Health Board has worked in partnership with the West Wales Organisation for Rigorous Trials in Health & Social Care (WWORTH) based at Swansea College of Medicine to develop a suite of SOPs for use in internally Sponsored clinical trials. It is strongly recommended therefore that you approach the WWORTH team for formal adoption of your study to enable access and support in the management of the trial, which will include use and access to the prepared SOPs.
Please contact the R&D team on 01792 704056 & we will be happy to provide you with WWORTH contact details.
Training
GCP training is a legal requirement for all staff engaged in clinical trials and is also recommended good practice for staff undertaking other type of clinical research. Staff training records need to document clearly the GCP training dates of all members of the research team, The Research Governance Framework (RGF) requires that each member of the research team, is qualified by education and experience to perform research.
GCP training is available to all ABMU Staff via an annual training day. Further, NHS Wales staff involved in research can also access training via NISCHR CRC. For details of current courses available, please contact the NISCHR team.
Contact details –
NISCHR Clinical Research Centre,
3rd Floor, 12 Cathedral Road
CF11 9LJ
Tel: 02920 196821
email: nischr-crc@wales.nhs.uk
Annual Progress Reports
A progress report should be submitted to the REC that gave a favourable opinion of the research (the 'main REC') 12 months after the date on which the favourable opinion was given. Annual progress reports should be submitted thereafter until the end of the study. Please also send a copy of such reports to R&D. Provision of Annual Progress reports to the R&D Department is a condition for ongoing Health Board Management Approval.
Annual Progress report templates can be accessed via the NRES website - http://www.nres.npsa.nhs.uk/
Early End/Temporary Halt to Study
If the study is terminated early or is temporarily suspended, it is the responsibility of the Chief Investigator (on behalf of the Sponsor) to notify the main REC and MHRA (if a clinical trial of an IMP) within 15 days explaining the reasons for the early closure/temporary suspension. Please inform R&D of any such suspension or early end to a study. The simple way to do this would be to copy any ethics correspondence to R&D.
Study Completion
Study completion or end of a study is normally considered as the date when the last patient has their last visit (of all sites, if a multi-site trial). The Chief Investigator must notify the Main REC, with a copy to R&D. Forms accessible from http://www.nres.npsa.nhs.uk/
Publication and Final Report
The Chief Investigator should also provide a summary of the clinical study within one year of the end of the study to the main REC. The Health Board is sometimes called upon to provide references to recent publications. Please also inform R&D of the reference when your paper is accepted for publication.
For specific guidance on any of the following issues, please contact the R&D team on 01792 704056 –
· R&D Approval
· Ethics Approval & IRAS
· Training
· Patient Information & Consent
· Maintenance of Study files
· Archiving
· Protocol development and Scientific Review
· MHRA Approval
· Medicines for Human Use (Clinical Trials) Regulations 2004
· Safety Reporting requirements of Clinical Research Activity
· Sponsorship
· Human Tissue Act requirements
· Mental Capacity Act issues in research
· Data protection issues and confidentiality issues in research
· Collaboration with WWORTH
· GCP & Study Conduct
· Contracts
ABM University Health Board R&D department wishes to acknowledge thanks to Oxford University and Oxford Radcliffe Hospitals
