RESS2

Question 1

Ethics

Answer 1

What is morally correct

Question 2

Governance

Answer 2

What has received permission

Question 3

Aims of ethical research

Answer 3

To ensure that the potential benefits of any given study never take precedence over the wellbeing and rights of study subjects

Question 4

Wellbeing

Answer 4

Most studies impose burdens and risks

Question 5

Rights

Answer 5

Most studies require informed consent

Question 6

Different forms of burden and risks

Answer 6

• Administration of products that may harm the participant e.g. drugs
• The consideration of disturbing, unsettling or potentially upsetting issues e.g. health risks
• Inflicting physical or mental discomfort or pain e.g. prolonged testing
• Disclosure or loss of personal information e.g. breach of confidential info

Question 7

Rights of study participants

Answer 7

• Participation should be informed, voluntary and reversible e.g. written
• Special concerns apply to vulnerable individuals and groups who may be unable to give consent e.g. unconscious
• Incentives to participate (beyond renumeration for expenses) often undermine ‘voluntary’ participation e.g. access to care, co-authorship, financial

Question 8

Role of ethics and governance approval

Answer 8

Ethical review ensures that the burdens and risks have been assessed, and that the consent proposed is considered appropriate to protects the rights of participants

Question 9

Define Audits

Answer 9

Audits compare current practice against a target/standard

Question 10

Define Service Evaluations

Answer 10

Describes current practice

Question 11

What do Audit-cum-service Evaluations examine

Answer 11

• Variation in practice may cause variation in compliance

- Variation in compliance may cause variation in benefit

Question 12

What do Audits and Service Evaluations both do

Answer 12

• Evaluate changes in practice
• Use data from recrds that have already been collected
• Use additional data collected by the study

Question 13

When is ethical approval and consent not required

Answer 13

• the changes in practice are routine and not part of the study’s design; and either
• all of the data used have been collected during/ as an established part of routine practice; or
• the collection of nay additional data used do not impose excessive burdens or risks on participants

Question 14

Requirements of ALL studies

Answer 14

• Should be well-designed and with benefits that justify the risks
• Should seek to minimise the burden and risks to participants
• Ensure that participants provide consent
• Should be wary of expected and unanticipated burdens/ risks during study implementation