Healthcare Research Sponsorship Research Ethics and NHS Approval for Clinical Research Flashcards
Why is healthcare research done?
- Prevent illness
- Detect or diagnose illness
- Treat illness
- Improve quality of life
- Support patients/staff
- Improve clinical effectiveness
- Value for money
What is the primary aim of healthcare research?
Primary aim is to derive generalizable new knowledge
Why is a research governance framework used for research?
- Improves research quality and safeguards the public by:
- Enhancing ethical and scientific quality
- Promoting good practice
- Reducing adverse incidents and ensuring lessons are learned
- Forestalling poor performance and misconduct
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What does MHRA stand for?
Medicines and Healthcare Products Regulatory Agency
Who authorises all clinical trials in the UK?
Medicines and Healthcare Products Regulatory Agency (MHRA)
What is a research sponsor?
Is an institution or organisation responsible for initiation, management, financing (or arranging financing) for research
What are examples of potential research sponsors?
- Main funder of research
- Employer of chief investigator
- Educational institution
When must the prospective sponsor be named by?
Before submitting application through IRAS
What is a research sponsor’s role?
- Confirm that everything is ready for research to begin
- Puts in place and maintains everything to initiate, manage and fund study
- Research protocol, team and environment pass appropriate scientific quality assurance
- Study has ethical approval
- For clinical trials involving medicines, seeking authorisation (Medicines for Human Use (Clinical Trials) Regulations 2004 specifies responsibilities)
- Arrangements in place for good practice in conducting the study, monitoring and reporting
How is ethical approval achieved?
Ethical review achieved through review of research taking place within NHS by NRES Research Ethics Committees (NRES RECs):
- Gives opinion about proposed participant involvement and if research is ethical
- Most research conducted within NHS require this
What does NRES RECs stand for?
NRES Research Ethics Committees
Why are research ethics considered?
- Protect everyone from harm
- Preserves rights and dignities of participants
- Creates culture of respect and trust between researchers and participants
- Provides rearrange to participants, public and funders
- Maintains integrity and reputation of researchers and host institutions
What do ethical committees review?
- Relevance of trial
- Trial design
- Risks and benefits
- Protocol
- Suitability of the investigator and supporting staff
- Quality of the facilities
- Subject information
- Consent procedure
- Justification for including minors or adults unable to give informed consent
- Insurance/ indemnity
- Rewards or compensation for investigators and subjects
- Subject recruitment
- Registration on Public Database
Applications for ethical review through what?
Integrated Research Application System (IRAS)
What does IRAS stand for?
Integrated Research Application System