Research Approval Guidance
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Research Approval Guidance
For all types of research projects [i.e. Academic, Non-funded, NIHR Portfolio Adopted (funded)] that would like to recruit and be carried out in an NHS Trust there is a new approval system in place. This approval is required regardless of the type of participant that will be recruited into the study, i.e. NHS Staff, Service User, Carer.
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.
If you are unsure whether your project is Research, you can follow the guidance of the HRA decision tool found here
Applying for Permission to Carryout your Research in Lancashire Care NHS Foundation Trust
Before applying for Trust R&D Permission (referred to as Capacity and Capability Confirmation) to undertake your project in the Trust you MUST gain HRA Approval (see the link above to the HRA web pages, which gives you all the information you require about how to apply for HRA Approval and if your participants are NHS Service Users and/or Carers how to apply for Research Ehics Committee (REC) Approval. Your study may also require other regulatory approvals, such as Medicines and Healthcare Products Regulatory Authortity (MHRA), Prisons and all this information can be found on these pages).
Once you have submitted for HRA Approval, your submission is valid and you have received a valid assessment letter from the HRA you can then contact the Research Department (contact details below) to check the feasibility of carrying out your project in the Trust and other inital discussions prior to HRA Approval letter being granted (there may be contracts/agreements that need to be discussed/ agreed at this point and research passports that need to be arranged).
You will need to send the study documents that receive HRA Approval to the Research Department, along with the Statement of Activities and Schedule of Events so that this department can carry out the Capacity and Capability checks and if deemed acceptable, an email to confirm this will be granted. Following receipt of the email of Capacity and Capability you can then begin your project in the Trust.
For further information about how to gain permission please contact the Research Department at email@example.com or Tel: 01772 773498
Research Passports, Honorary Research Contracts and Letters of Access
If your research team are not employed by Lancashire Care NHS Foundation Trust or another NHS Trust, they will need to complete the Research Passport Application Form and depending what research activities they are carrying out, upon validation of the passport, will either receive an Honorary Research Contract or non-NHS Letter of Access.
If a member of your research team is employed by an NHS Trust, they will need their NHS Human Resources Department to complete an NHS to NHS Confirmation of Pre-Engagement Checks Form and an NHS Letter of Access will be issued.
Please note that a researcher would not be given access to conduct the research project in the Trust until this was in place.
Please contact the Research Department at firstname.lastname@example.org or Tel: 01772 773498 to discuss these needs.
Good Clinical Practice - it is the Trusts local policy that any researchers working on an NIHR Portfolio or non-student Research project that involves service users and/or carers as participants, are to undertake GCP training, to be updated every two years. Please contact the R&D Department to discuss further or see here for GCP training dates available to you.
The Research Department, can, upon request provide you with study document templates to assist with your project submissions (i.e. information sheets, consent forms, protocol, CV).