14. Ethics of medical research

Question 1

Why do we complete research in healthcare?

Answer 1

To prevent illness
To detect or diagnose illness
To treat illness
To improve quality of life
To support patients/staff
To improve clinical effectiveness
For value for money

Question 2

What is a clinical audit?

Answer 2

Answers the question: Does this service reach a predetermined standard
A way to understand whether a service is meeting defined standards of best practice
Helps enforce good clinical practice
Produce recommendations for any necessary improvements

Question 3

What is a service evaluation

Answer 3

Answers the question: what standard does this service achieve?
A service evaluation is a way to define or measure current practice within a service
Results help produce recommendations for improvement

Question 4

What is the role of a sponsor in a trial design?

Answer 4

Responsible for the initiation, management and financing of that research
May be the employer of the investigator, a clinical institution or the care organisation where the research takes place

Question 5

What is meant be ethics approval on a study?

Answer 5

Ethical review is achieved by various committees who make sure the research was conducted properly. The most common group is the NRES (NHS research ethics committee

Question 6

What do ethics committees review?

Answer 6

Relevance of trial
Trial design
Risks and benefits
Protocol
Suitability of the investigator and supporting staff
Quality of the facilities
Subject info
Consent procedure
Insurance
Rewards or compensation for investigators and subjects

Question 7

What do the R&D do?

Answer 7

Identify an appropriate sponsor
Determine the scientific quality of the proposal
Appropriate risk/benefit analysis
Appropriate regulatory authorisations are in place
The financial and resource implications of the study are assessed
Appropriate trial registration
All researchers are qualified