Useful links and documents

Much of the health research at Bournemouth University involves collaborating with the NHS and therefore requires Trust approval.

The following documents have been compiled by Bournemouth University Clinical Research Unit (BUCRU) and Research Development & Support (RDS): 

• Research with NHS Trusts Guidance Sheet
• Collaborating with the NHS for Research

In contacting potential NHS sites, a full list of appropriate contacts can be found on the Research & Development Forum website.

Please ensure that you email Clinical Research as early as possible if you wish to conduct research within a healthcare setting. The NHS Trust’s research department should likewise be contacted at the earliest opportunity.

Remember - if BU is the Sponsor of your research then you should make contact with Clinical Research with any queries. If suitable they can then be re-directed to your research site(s).

A full list of the Clinical Governance SOPs and associated documents can be found in this table.

Clinical Governance workflows are also available via Sharepoint for the following procedures. Please get in touch if you have any queries surrounding these process or if you cannot access the documents:

• Amendments
• Archiving
• BU Ethics 
• BU Sponsorship
• Informed Consent
• IRAS Application (an overview)
• Monitoring
• NHS site C&C (Capacity & Capability) assessment (procedure following approvals received)
• Progress Reporting
• Reporting Deviations, Violations and Serious Breaches
• Safety Reporting
• Staffing and Delegation

The storage of human tissue or other relevant materials for research, may require a licence from the Human Tissue Authority, which BU does not currently hold.  If you obtain NHS REC approval, this will allow you to collect and store relevant materials for the duration of the project, and for up to one year after the declaration of the end of the research, for the purposes of analysis and verification of research data.

Please note – if you are collecting materials, rendering them acellular, and then extracting DNA, you will need NHS REC approval. This is referenced in the HTA Research Code of Practice, found here.
Email Clinical Research for further guidance.

The Human Tissue Act 2004 – Summary of Consent and Licensing Provisions for Research provided by the Medical Research Council.

National Institute for Health Research (NIHR) resources

• NIHR ENRICH – Enabling Research in Care Homes: the NIHR have released a support resource for researchers in care homes.  Follow this link to access the toolkit and other useful information such as advice, guidance and the latest news.
• The NIHR website hosts a number of pages and resources such as how the NIHR can help academic researchers to conduct and deliver research, and success stories from amongst the research community – access the following link to find out more.
• The NIHR offer guidance on how to disseminate your research once the results are available.

Health Research Authority (HRA) resources

‘How we’re supporting data-driven technology‘ which incorporates the pages:

• I’m developing medical software and
• I’d like to use patient data

Specific guidance/information on attending an NHS Research Ethics Committee (REC) meeting

• Attending a REC meeting – this page gives you information on areas such as what happens at a REC meeting and attending a REC meeting by telephone;
• Guidance for Study Representatives attending a Full REC meeting– this page gives you guidance and advice as to the process of attending a REC meeting and to help you familiarise yourself with the procedure of ethical review.

• Clinical researcher checklist – PDF and word format.
• There are plenty of template documents available to help you with study conduct, check with Research Ethics for BU templates.
• The Health Research Authority have provided templates and guidance for creating your PI Sheet and informed Consent Form. Similarly, they offer guidance and templates for writing your study protocol. In writing your PI Sheets, please ensure you follow HRA guidance with regard to GDPR transparency wording, found here.
• In addition to your study documents (protocol, PI Sheet, etc.) the Health Research Authority also require you to submit an Organisation Information Document and Schedule of Events/Schedule of Events Cost Attribution Tool. Further guidance can be found here and by emailing Clincial Research.
• Research Development & Support (RDS) suggested index for your study files (site-specific and Sponsor file). This document clearly sets out which documents a study monitor would expect to see in your files. You should provide your research site with an Investigator Site File, and in the format they require (i.e. paper or electronic).
• Version log for documents held in study files.
• Participant screening and enrolment logs.
• Case Report Form (CRF) guidance for design and completion.
• Template GP Letter.