Health care research Flashcards
Why might healthcare research be done?
Prevent illness
Detect or diagnose illness
Treat illness
Improve quality of life
Support patients/staff
Improve clinical effectiveness
Value for money
Who needs to go through the approvals process before undertaking research?
Anyone wanting to undertake research using NHS patients, staff, facilities or data
What is a clinical audit?
A quality improvement process
A way to understand whether a clinical service is meeting defined standards of best practice
A clinical audit is therefore designed to answer the question “does this service reach the standard?”.
5 steps to take when carrying out a clinical audit
- Identify a problem or issue
- Look at the set criteria & standards that already exist
- Observe practice / data collection
- Compare current performance with criteria and standards
- Implement change if required
What is a service evaluation?
A way to define or measure current practice within a service.
The results of the service evaluation help towards producing internal recommendations for improvements of that service alone
A service evaluation is designed to answer the question “what standard does this service achieve?”
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Results of research, or the theories gained from the research, should apply beyond the sample of the population upon which the research is based.
Aim of healthcare research
Generate new knowledge
Generalisable or transferable beyond the sample of population that the research is based on
Who regulates/sets guidelines for research in the UK?
Research governance framework
In what way does the governance of research improve the quality of research and safeguard the public?
It enhances the ethical and scientific quality - would be unethical to ask patients to take part in poorly run research
Promotes good practice
Reduces adverse incidents and ensuring lessons are learned
Forestalling poor performance and misconduct
What is a research sponsor?
Institution or organisation; ultimate responsibility for the initiation, management, financing (or arranging the financing) for that research. They arrange the contracts etc
Any research requiring the collaboration of the NHS must have an individual or organisation willing and able to take on the responsibilities of the research sponsor.
You must already have a prospective sponsor before applying for research
Who’s responsibility is it for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting?
The research sponsor
What happens if there is co-sponsorship?
Delegation of duties between the 2 sponsors in particular those relating to monitoring of the research and provision of insurance or indemnity (if something goes wrong) should also be provided.
Who’s responsibility is it to ensure that the sponsor(s) are aware of their proposal and accept their responsibilites?
Chief investigator
Where did the Northwick Park drug trial go wrong?
When one patient started to develop alarming side effects to the drug the researchers continued to administer the drug to other patients which is contrary to the clinical protocol
Although they didn’t die, some patients experienced multi-system failure and were left with long-lasting side effects from that drug
What went wrong with Dr Green’s research regarding women and carcinoma in situ of the cervix
The women themselves did not know they were taking part in a research study. They came into clinic for smears, treatment etc and didn’t know the treatment was experimental and that there were other treatment options.
They had not consented!
Who conducts an ethical review of a research proposal within the NHS?
NRES Research Ethics Committees
Role of NRES RECs?
They give their opinion about the proposed participant involvement and whether the research is ethical
They have had training on how to assess ethics applications.
Has medical and lay persons on the panel
What if a full NRES REC opinion is not required? Who might review your research instead?
internal ethics committee such as CERB (CLSM Ethics Review Board)
or by the Rowett Institute of Nutrition & Health or School of Psychology ethics committees.
Example of research not requiring a full NRES REC review?
Questionnaire survey on members of staff
Research ethics
Protect participants and researchers from harm
Preserve the rights and dignity of participants
Create a culture of mutual respect and trust between participants and researchers
Provide reassurance to the participants, wider public and funders regarding the ethical conduct of research
Maintain the integrity and reputation of the researchers and host institution(s)
What will a research committee review when coming to a decision on whether research is ethical?
Relevance of trial
Appropriateness of the trial design
Risks and benefits
Protocol
Suitability of the investigator and supporting staff
Quality of the facilities
Subject information - you’ve involved service users in this process
Consent procedure
Justification for including minors or adults unable to give informed consent - incapacity law different between England and Scotland
Insurance/ indemnity
Rewards or compensation for investigators and subjects - not undue influence to make someone take part in the research
Subject recruitment
Registration on Public Database - publish data
Applications for research must go through which system?
Integrated Research Application System
Why do you need a research and development approval from the NHS as well as an ethics approval?
They will check if you have permission to undertake the type of research you are doing
Research passport if you are not a member of NHS staff
You may need to undergo training in order to conduct research
Quality assurance - ensuring they are monitored and audited
help with your funding and contracts
What does research and development do?
Ensure research is conducted to high scientific, ethical and financial standards
Provide help/support/guidance to researchers undertaking non-commercial & commercial research involving NHS Grampian
Guide researchers through all the processes involved in research
Direct researchers to sources of further information
What does the R+D 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 (even if temporary)
All researchers are adequately qualified
Support department approval
Formal agreements or contracts with external bodies meet the requirements of the Board.
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So basically if you want to carry out research you must submit it to the NRES REC committee to review whether your research is ethical
After that, you must have approval by the NHS research and development team - they review everything
