Ethics & Governance for Audit, Service Evaluation and Research

Question 1

Ethics vs governance?

Answer 1

• Ethics → what is morally correct
• Governance → what has received permission

Question 2

What is the aim of ethical research?

Answer 2

Ethical research aims to ensure that the potential benefits of any given study never take precedence over the wellbeing (most studies impose burdens and risks) and rights (most studies require informed consent) of study subjects/participants.

Question 3

You are designing a project comparing different techniques for measuring lactic acid levels in runners. Because your project will involve recruiting members of a local running club and subjecting project participants to invasive physiological tests, you apply for ethical approval from the local Ethics Committee.

Whilst you are waiting for this, new research comes to light that makes you reconsider your original hypothesis. In order to test your new theory, you will need to recruit more participants and let them know that a further invasive measurement will be required.

What can you change without seeking further approval (a so-called ‘amendment’) from the Research Ethics Committee?

1. Add an additional invasive measurement to the data you want to collect
2. Change the content of the participant information leaflet
3. Change your original hypothesis
4. Recruit additional participants

Answer 3

Change your original hypothesis

Question 4

What are the rights of study participants?

Answer 4

• Participation should be informed, voluntary and reversible e.g. written, informed consent wherever possible
• Special concerns apply to vulnerable individuals and groups who may be unable to give (or withhold) consent e.g. unconscious/unwell; colleagues/staff; observation

Question 5

What is the effect of incentives to participate (beyond remuneration for expenses) in studies?

Answer 5

Often undermine ‘voluntary’ participation

Question 6

What do audit-cum-service evaluations examine?

Answer 6

• Variation in practice may cause variation in compliance
• Variation in compliance may cause variation in benefit

Question 7

Give some situations where formal ethical approval and consent may NOT be needed

Answer 7

1. the changes in practice are routine and not part of the study’s design; and either
2. all of the data used have been collected during/as an established part of routine practice; or
3. the collection of any additional data used do not impose excessive burdens or risks on participants (though consent should then be obtained)