Research Methodology 1

Question 1

Which studies require ethical approvals? [3]

Answer 1

• Studies involving human/animal participants
• Gathering novel data or information

• Creating knowledge that can be generalised beyond the participant
sample or setting

Question 2

Which projects do not require ethical

approvals? [2]

Answer 2

Service Evaluations (Service Improvement/ Quality Improvement):

Clinical Audit

Question 3

Describe the Declaration of Helsinki 1964

Answer 3

Ethics take precedence over law ​

Respect and welfare of subjects ​

Research requires independent ethical review

Question 4

What is service evaluation?

Answer 4

Finds out something about THAT service which can be used to
improve THAT service – knowledge created does not generalise
beyond the service to other settings/populations.

Question 5

What is a clinical audit?

Answer 5

As a service evaluation but evaluating service against a

benchmark.

Question 6

Who must clinical audits and service evaluations be reported to?

Answer 6

Registered with the trust in which they are being conducted

Question 7

What should be considered when applying for ethical approval?

Answer 7

Scientific rationale

Rigorous methodology

Informed consent

Group vulnerability

Data protection,

Safety

Question 8

Main principles of Nuremburg code

Answer 8

• Informed consent ​
• Risk and benefits in proportion ​
• Positive outcomes for wider society ​
• Participants can withdraw ​
• low risk of injury or psych impact ​
• Qualified staff