Research Management in the Trust
Research management and governance in the Trust is currently overseen by the Joint Research Committee and the Joint Research Governance Committee.
The Joint Research Committee is responsible for promoting, supporting and developing high quality research.
- An important role in this is the development and implementation of the joint research strategy of the Trust and the University of East Anglia, alongside other member organisations on the Norwich Research Park, with a particular focus on growing research at the Trust.
- Other key functions of the Committee are to monitor key performance indicators for research, represent the views of the research community at the Trust and to work closely with other committees and groups in partnership with the University in key areas such as research education and training and business enterprise.
- The Committee has members from across the Trust and the University and meets every two months. It reports to the Trust Executive.
The Joint Research Governance Committee is responsible for the governance of research activities within the Trust in line with the UK Policy Framework for Health and Social Care Research and provides advice on healthcare research to the University of East Anglia.
- The Committee has members from across the Trust and the University and meets monthly. It currently reports to the Clinical Governance Committee.
Individual research studies taking place in the Trust must obtain both local NHS research governance approval (R&D management approval) and a favourable opinion from an NHS Research Ethics Committee. Currently, Trust approval for individual research studies is done in one of two ways:
1. For studies which are NIHR Portfolio Eligible, please submit via the IRAS system where your project will be processed via the central system for permissions (CSP) . Prior to submission, please talk with the relevant research facilitator who will support you through this process.
2. For research which is not portfolio eligible, please contact the R&D office on 01603 289808 or firstname.lastname@example.org for further information and advice. R&D management approval is required for research studies involving the use of any NHS resources (staff, facilities, NHS patients, patient data, patient samples or tissue) within the Trust.
If you are seeking Trust approval for your research we advise that you contact the Joint Research Office as early as possible in the process. When a new study comes into the office for approval, the relevant research facilitator will arrange to have a short meeting with you to undertake a risk planning exercise for your study which allows any potential barriers to approval to be identified and dealt with as soon as possible and to plan with you how this will be done.
Before research studies can be submitted to a Research Ethics Committee they must have written evidence of a scientific peer review. The Joint Research Office can arrange peer review of your research study if this is required. Please speak with the relevant research facilitator supporting your research study.
Once studies have been granted both Research Governance and Research Ethics approval they can begin. Investigators are obliged to submit annual/final reports to the research facilitators as a requirement under the Research Governance Framework. The submission of this annual progress data also forms part of the standard terms and conditions for the approval of research studies within the Trust.
Amendments to research must also be notified to the Joint Research Office, in order to check that these do not affect the original terms of approval for the study. The research facilitators will review the amendments and issue approval.
Individual research studies may be subject to monitoring and audit from the Sponsor during the timeline of the study. Further information on the procedures for individual research studies to follow to ensure compliance with Good Clinical Practice are detailed in the Joint Trust and University of East Anglia Standard Operating Procedures.
Under the UK Framework for Health and Social Care Research all health and social care research projects require a sponsor. The sponsor is the individual, organisation or Partnership that takes on overall responsibility for proportionate, effective arrangements being in place to fund, set up, run and report a research project. The sponsor has overall responsibility for the research and is normally expected to be the employer of the chief investigator in the case of non-commercial research. Where the Trust agrees to be the Study Sponsor we work to our published Sponsorship Policy document and Sponsorship SOP.
Good Clinical Practice
“Good Clinical Practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.” EU Directive 2001/20/EC. Article 1, Clause 2
Good Clinical Practice is fundamental to safeguarding the well-being of participants in research studies and all researchers conducting a research study at the Trust will need to submit evidence that he/she has completed a recent GCP training course. Details of classroom based training .Online training is also available through the Local Clinical Research Network.
If you are unsure about any of the processes for individual research studies, please contact the Trust research office by telephoning 01603 289808 or by sending an email to email@example.com.