Research Governance Flashcards
What is research governance?
Broad range of regulations, principles and standards of good practice that ensures high quality research
What are the benefits of research governance?
Minimises risk to patients, makes sure research is robust and reliable, allows researchers to learn from where they went wrong, allows transparency
What areas does research governance cover?
Research proposal, expertise of researchers, consent process, funding, reporting results, information governance
What is the main institute that controls research governance?
Declaration of Helsinki
Why are women usually under-represented in research?
Due to concerns over pregnancy and risks to any future foetuses
What are some groups that are usually under-represented in research?
Ethnic minorities, disabled people, children, the elderly, women
What must be considered when doing any sort of research on human subjects?
That the importance of the objectives of the research outweighs the burdens to the research subjects
What are the principles of the GCP principles based on?
The Declaration of Helsinki
What does the GCP principles relate to?
Protocol development, sponsorship, indemnity, monitoring
What does the Data Protection Act relate to?
It outlines the rules for the collection, use and storage of personal data
What are the regulations surrounding data?
Data should be used fairly and only for intended purposes, should be appropriate and not excessive. must be accurate and up to date, must not be stored for longer than necessary and protected appropriately
What are some regulatory bodies for research governance?
Caldicott Guardian Approval = for data that isn’t for clinical use (e.g for quality improvement)
Research Ethics Committee = NHS when using patients
When would you need to apply to a higher regulatory body (e.g NHS instead of just the university)?
If you need more detailed information
