Information for Researchers
Make early contact with R&D
If you have a research idea, proposal or wish to take part in a research study please contact the R&D Department at the earliest opportunity to avoid delay in starting. Please read through the relevant sections below for information and how to contact the R&D Office.
Is my study research?
Researchers are advised to use the following decision tool provided by the Health Research Authority (HRA): To find out if your study is research – http://www.hra-decisiontools.org.uk/research/
Health Research Authority (HRA) Approval – the new process for the NHS in England
Health Research Authority (HRA) Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent REC opinion provided through the UK research ethics service. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study. Please click on the following link for full guidance:
http://www.hra.nhs.uk/research-community/hra-approval-the-new-process-for-the-nhs-in-england/
Do I need Ethical Opinion for my research?
Check via this link to find out if your study needs NHS research ethics approval:
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.
Both the HRA and the Medicines and Healthcare products Regulatory Agency (MHRA) advocate a proportionate approach to the application of GCP to the conduct of clinical trials and the appropriate training of staff involved, including those seeking consent from potential participants. The HRA and MHRA joint statement clarifies the legal requirements for training in Good Clinical Practice (GCP) in the UK.
For further information please go to: https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/good-clinical-practice/
To access GCP training please click on the following link: https://learn.nihr.ac.uk/ or scan the QR code below.
Good Practice in Research & Consent: GMC Guidance
The guidance sets out the good practice principles that doctors are expected to understand and follow if they are involved in research. It provides more detailed guidance on how the principles of Good Medical Practice and Consent apply in the context of research. Please click here to view the full guidance.
What is a Sponsor?
A sponsor is the organisation that will be legally responsible for the management and organisation of the trial – this is normally an organisation such as a NHS Trust, a University or a commercial company – often the employer of the Chief Investigator of the study. For further guidance please click on the link below:
https://www.hra.nhs.uk/planning-and-improving-research/research-planning/roles-and-responsibilities/
Local Confirmation Assessment of Capacity & Capability
If you have a research study that you wish to open at CHFT then the R&D Department will need to assess, arrange and confirm their capacity and capability to deliver the study at the Trust. This process has several stages and is explained in full in the document R&D Confirmation of Capacity & Capability SOP here.
The Research Passport & Streamlined Human Resources Arrangements
The Research Passport and Streamlined Human Resources Arrangements is the process for handling HR arrangements for researchers by providing a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS.
The Resource Pack includes details of:
- A Research Passport system for issuing honorary research contracts (HRCs) or letters of access to Higher Education Institutions (HEIs) researchers who need to undertake their research within the NHS. The research passport provides evidence of the pre-engagement checks undertaken on the researcher in line with NHS Employment Check Standards; and
- NHS to NHS arrangements for sharing and accepting pre-engagement checks between NHS organisations when NHS staff wish to undertake research within the NHS outside of their employing Trust.
The Department of Health (DH) recommends the Research Passport to the NHS, HEIs and to other research employers working in partnership with the NIHR. The UKCRC Partners endorse the routine use of the Research Passport.
For further guidance and to access the Resource Pack please click on the link below:
https://www.myresearchproject.org.uk/help/hlphrgoodpractice.aspx#Research-Passport
