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Useful Links and Documents


Useful links

  • 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;
  • It’s important to register your study – the Research Ethics team have the appropriate access to provide user accounts to this system.

Assessment tools


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.


NIHR resources

  • NIHR ENRICH – Enabling Research in Care Homes: the NIHR  have released a new 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.

HRA resources

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


Useful documents

  • There are plenty of template documents available to help you with study conduct, through the NIHR website (you will be aware of them through GCP training). Remember to check with your research site as well, as they may have handy templates to offer you.
  • 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 addition to your study documents (protocol, PI Sheet, etc.) the Health Research Authority also require you to submit a Statement of Activities and Schedule of Events. 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.
  • Version log for documents held in study files.
  • Participant screening and enrolment logs.

Workflows

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:

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