What is a research passport and who needs one?
A research passport is the mechanism for non-NHS staff to obtain an Honorary Research Contract (HRC) or Letter of Access (LOA) when they propose to carry out research in the NHS.
The research passport system provides:
- one set of checks on a researcher conducting research in the NHS;
- one standard form completed by the researcher and his/her employer, and validated by an NHS organisation;
- a completed Research Passport which is presented to all the relevant NHS organisations; and faster study start-up.
You will not need a research passport if:
- you are employed by an NHS organisation*;
- you are an independent contractor (e.g. GP) or employed by an independent contractor;
- you have an honorary clinical contract with an NHS Trust e.g. clinical academics*; or
- you are a student on a healthcare placement.
*(Researchers employed by an NHS organisation or with an honorary clinical contract with an NHS Trust, who want to conduct research in another NHS organisation, should complete the NHS-to-NHS proforma and submit it to the relevant NHS R&D office(s)).
What is an HRC?
An HRC is a contract between an NHS organisation and a researcher. It allows the researcher access to the NHS organisation’s premises, patients, clinical samples and clinical personal information (with patient consent). Where a researcher is conducting activities that will have a direct bearing on quality of care, he/she will be accountable to the NHS organisation that gave permission for this activity and an HRC will be issued to clarify and confirm this accountability.
What is a LoA?
A LoA may be issued where an HRC is not appropriate. When researchers conduct activities with no direct bearing on quality of care, the liability for their actions rests with their substantive employer, and an HRC is not required. A LoA documents the responsibilities of researchers and may be used for a single project or a series of projects.
HRA Approval and the Research Passport System
Research in the NHS requires Health Research Authority (HRA) Approval. HRA approval is a single assessment of the governance and legal compliance aspects of research in the NHS (find out more about HRA Approval here). When a study is approved by the HRA, the researcher will receive an HRA Approval letter.
The HRA Approval letter (under the heading ‘HR Good Practice Resource Pack expectations’) will confirm, for each activity described in the HRA Schedule of Events, whether a LoA, HRC or neither are required (for researchers without a contractual relationship with the NHS organisation). HRA Approval will also specify the appropriate pre-engagement checks*, in accordance with the Research Passport System.
*(Criminal Records Bureau (Disclosure and Barring Service) checks will be accepted as a valid up to a maximum of three years. Occupational Health Screening will be accepted without the need to routinely repeat, unless required by the specific research project).
If an HRC or LoA is required, the researcher/s who will be conducting research in the NHS will need to complete the Research Passport form.
The Research Passport form
The Research Passport Form can be downloaded here. For University of Bath researcher, guidance on how to complete the form is here. Once completed, submit to the lead NHS Research and Development (R&D) Office.
The lead NHS R&D office
When the lead NHS R&D office receives the Research Passport form they will validate it by completing Section 8 and will process the HRC or LoA. They will then return the validated Research Passport form back to the researcher along with the HRC or LoA.
If the researcher requires a LoA for additional NHS organisations*, they must send the validated Research Passport form to the NHS R&D office for each NHS organisation. Contact details of NHS R&D offices can be found here.
As well as managing the research passport system on behalf of their NHS organisation, NHS R&D Offices also ensure all relevant approvals are in place before a research project can take place within their NHS organisation.
*(NOTE: Only one HRC is issued, if the researcher needs to access additional NHS organisations, a LoA will be issued by the relevant NHS R&D office for each additional NHS organisation).