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
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
Projects that raise no ethical issues may apply for what instead of using IRAS for ethical approval?
- Projects that raise no ethical issues may apply for NRES REC approval using proportionate review service (PRS)
What does PPI stand for?
Patients and public involvement
Why do we need research and development approval when ethics are approved?
- Permissions
- Research Passports
- Training
- Support for researchers
- Quality Assurance: Monitoring and Audit
- Research Nurses
- Funding and contracts
- Reporting
What does a research and development division do?
- Ensures is high scientific and ethical standard
- Provides guidance
- Direct researcher to sources of information
What are functions of the research and development division?
- Processes research projections prior to issuing research and development permission
- Gathers required documentation for proposed research in NHS
What does the research and approval process ensure?
- An appropriate study sponsor is identified
- The scientific quality of the proposal (as required)
- That there is a favourable ethical opinion from an appropriate REC
- Appropriate regulatory authorisations are in place
- Appropriate risk/benefit analysis
- Provisions for appropriate insurance/indemnity
- The financial and resource implications of the study are assessed
- Appropriate trial registration
- All researchers have substantive or honorary NHS GG&C contracts
- All researchers are adequately qualified
- Support department approval
- Formal agreements or contracts with external bodies meet the requirements of the Board.
Why is a clinical audit done?
- Understand if clinical service is meeting standards of best practice
- Help to enforce good clinical practice
- Produce internal recommendations for improvements
What is the process of a clinical audit?
1) Identify problem or issue
2) Set criteria and standards
3) Observe practice/data collection
4) Compare performance with criteria and standards
5) Implementing change
Clinical audit is designed to answer what question?
“does this service reach the standard”
Why is a service evaluation done?
- Measures current practice within a service
- Results produce internal recommendations for improvements
Service evaluation is deigned to answer what question?
“what standard does this service achieve”
