Ethics
What is morally correct
Governance
What has received permission
Aims of ethical research
To ensure that the potential benefits of any given study never take precedence over the wellbeing and rights of study subjects
Wellbeing
Most studies impose burdens and risks
Rights
Most studies require informed consent
Different forms of burden and risks
- 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
Rights of study participants
- 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
Role of ethics and governance approval
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
Define Audits
Audits compare current practice against a target/standard
Define Service Evaluations
Describes current practice
What do Audit-cum-service Evaluations examine
- Variation in practice may cause variation in compliance
- Variation in compliance may cause variation in benefit
What do Audits and Service Evaluations both do
- Evaluate changes in practice
- Use data from recrds that have already been collected
- Use additional data collected by the study
When is ethical approval and consent not required
- 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
Requirements of ALL studies
- 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
