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Much of the health research at ³ÉÈËÖ±²¥ involves collaborating with the NHS and therefore requires Trust approval.

The following documents have been compiled by ³ÉÈËÖ±²¥ Clinical Research Unit () and Research Development & Support (RDS):Ìý

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

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.

RememberÌý-Ìýif BU is the Sponsor of your research then you should make contact with ClinicalÌýResearch 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 thisÌý.

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

• (an overview)

The storage of human tissue or otherÌýÌýfor research, may require a licence from theÌý, which BU does not currently hold.ÌýÌýIf 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 noteÌý– 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, foundÌý.
Email ClinicalÌýResearchÌýfor further guidance.

The Human Tissue Act 2004 –ÌýÌýprovided by the Medical Research Council.

National Institute for Health Research (NIHR) resources

• NIHR ENRICH – Enabling Research in Care Homes: the NIHRÌýhave released a support resource for researchers in care homes.Ìý Follow thisÌýÌýto 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 followingÌýÌýto find out more.
• The NIHR offerÌýÌýon how to disseminate your research once the results are available.

Health Research Authority (HRA) resources

‘‘ which incorporates the pages:

• Ìýand

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

• Ìý– this page gives you information on areas such as what happens at a REC meeting and attending a REC meeting by telephone;
• – 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 –ÌýÌýandÌýÌýformat.
• There are plenty of template documents available to help you with study conduct, check withÌýResearch EthicsÌýfor BU templates.
• The Health Research Authority have provided templates and guidance for creating yourÌý. Similarly, they offerÌýÌýfor writing your study protocol. In writing your PI Sheets, please ensure you follow HRA guidance with regard to GDPR transparency wording, foundÌý.
• In addition to your study documents (protocol, PI Sheet, etc.) the Health Research Authority also require you to submit anÌýOrganisation Information DocumentÌýandÌýSchedule of Events/Schedule of Events Cost Attribution Tool. Further guidance can be foundÌýÌýand by emailing Clincial Research.
• Research Development & Support (RDS) suggestedÌýÌýfor 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).
• Ìýfor documents held in study files.
• ParticipantÌýÌýandÌý.
• Ìýfor design and completion.
• .