- The UK Policy Framework for Health and Social Care Research sets out principles of good practice in the management and conduct of health and social care research in the UK;
- Involving patients and the public in your study is important, especially at the research design stage. This is called ‘PPI’. See the National Institute for Health Research’s handbook for researchers and the Clinical Governance page;
- It’s important to register your study – the Research Ethics team have the appropriate access to provide user accounts to this system;
- When providing information to potential research participants, it is important that the information is written in a language that is understandable. The national reading age is 11 years old. The Health Research Authority help guide signposts readability scoring tools that you can make use of.
- Is my study research? Sometimes what is deemed research at BU, is not classed as such within the NHS. The tool can help decide for you, as well as the Defining Research table.
- Do I need NHS REC approval? – in the majority of cases, you will need to apply to the NHS Research Ethics Service for approval for your project. This tool helps you decide if this is a requirement. All health research taking place in the NHS/healthcare settings require Health Research Authority approval.
Email Research Ethics for further guidance.
- Do I need a clinical trial authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA)? Get in touch with Research Ethics as early as possible if you will be researching with medicinal products or devices.
Research using ‘relevant materials’
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 Research Ethics 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
- 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 Research Ethics.
- 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.
Workflows and Standard Operating Procedures
Clinical Governance workflows are now 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:
IRAS Application (an overview)
NHS site C&C (Capacity & Capability) assessment (procedure following approvals received)
Reporting Deviations, Violations and Serious Breaches
Staffing and Delegation
A full list of the Clinical Governance SOPs and associated documents can be found in this table.