“Research is essential to the successful promotion of health and well-being and to modern and effective health and social care services” (Research Governance Framework for Health and Social Care, March 2001).
The R&D Department has a number of functions:
- To advise on designing the study
- Statistical Analysis
- Facilitation of the research process
- Implementation and management of Research Governance
- University Liaison
- Registration of Intellectual Properties
Note to researchers at City Hospitals Sunderland:
- From the 1st April 2009 researchers no longer need to send Site Specific Information forms (SSIs) to the Research Ethics Committee (REC) for Site Specific Assessment (SSA).
- The SSI form should now be submitted directly to the relevant NHS R&D office where site approval is required.
- RECs will rely on the checks undertaken by R&D departments as the checks that form the SSA are already part of standard R&D review.
- The favourable opinion from REC will be conditional upon permission at each of the relevant NHS organisations.
- There is no longer a need to inform REC about the addition of new sites EXCEPT for clinical trials of Investigational Medicinal Products (ctIMPs). For ctIMPs it is still necessary to submit a substantial amendment to MHRA and REC with the main details of the new site and investigator in order to comply with the Clinical Trials Regulations.
- Form SF1 will no longer be used to maintain a complete listing of approved sites.
- Any SSA applications in the REC system on 1st April 2009 will continue to be processed by RECs but no new applications will be accepted after that date.
The SSI form will be populated with signature panels for relevant authorisations. These include signatures from Business Managers, Clinical Directors, Service Support (i.e. Radiology or Pathology) and Finance, when appropriate.
IMPORTANT: ALL applications for NHS Research Ethics Committee (REC) Review should now be made via the Integrated Research Application System (IRAS), which is available at www.myresearchproject.org.uk . IRAS will provide guidance to applicants about the new arrangements.
The Integrated Research Application System (IRAS):
- Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
- Enables you to enter the information about your project once instead of duplicating information in separate application forms
- Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
- Helps you to meet regulatory and governance requirements
- 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
You can download the combined bulletin from National Patient Safety Agency and the NHS Research & Development Forum which provides full details about this change at: http://www.nres.npsa.nhs.uk/news-and-publications/news/bulletin-on-the-site-specific-assessment-transfer/
If you have any queries please contact the R&D department.
For a step by step guide on how to use the IRAS system, please see the Practical IRAS Guide.
NIHR Coordinated System for gaining NHS Permission (NIHR CSP)
The National Institute for Health Research (NIHR) Coordinated System for gaining NHS Permission (CSP) ensures all quality assurance and statutory requirements in respect of clinical research are met, through standardising and streamlining the process for gaining NHS Permission in England. This will reduce both approval times and bureaucracy.
Please see below a link to the National Institute for Health Research (NIHR) website. This NIHR goal is to create a health research system in which the NHS supports outstanding individuals, working in world class facilities, conducting leading edge research focused on the needs of patients and the public. The NHS reputation for international excellence is growing as it gains recognition for being the preferred host for collaborative and multi-centred research in the public interest in partnership with and for industry. This will benefit patients, society, the NHS and all our stakeholders.
* Please note: All documents attached are valid on day of publication only. Documents may be superseded or removed periodically.Please check back for updates.