SU7.1-2,SU8.1-3 | Ethics, Audit and Research — Glossary

The continuous loop of audit: set the standard, measure practice, compare, implement change, and re-audit to confirm improvement.

Respect for a patient's right to make their own informed decisions about their body, including the right to refuse treatment.

The ethical duty to act positively in the patient's best interests, to do good.

Standard-of-care test: a doctor is not negligent if acting in accordance with a practice accepted as proper by a responsible body of medical opinion.

The qualification of Bolam requiring that the body of medical opinion relied upon must itself withstand logical analysis.

The patient's ability to understand, retain, weigh and communicate a decision about their treatment.

An observational study comparing prior exposure in cases (with the outcome) and controls (without); yields an odds ratio and is efficient for rare outcomes.

A hypothesis-driven activity that generates new generalisable knowledge to determine what best practice should be.

An observational study following exposed and unexposed groups forward in time to incident outcomes; yields incidence and relative risk.

A range (conventionally 95%) within which the true effect is likely to lie; for a ratio measure, a CI that crosses 1 indicates a non-significant result.

The duty to protect information disclosed within the clinical relationship; strong but breachable for narrow, defensible exceptions.

Indian statute (replacing the 1986 Act) that brings medical services within consumer-court jurisdiction for deficiency-of-service claims.

A study measuring exposure and outcome at a single point in time; yields prevalence but cannot establish temporality.

The legal principle permitting life-saving treatment of an incapacitated or unconscious patient without formal consent, limited to what is immediately necessary.

The legal obligation, arising from the surgeon-patient relationship, to provide care of a reasonable standard.

The capacity to understand and respond to a patient's feelings and perspective, central to professional communication.

The systematic, reasoned study of right and wrong conduct — what we ought to do, as distinct from what the law minimally requires.

The ranking of study designs by their resistance to bias: systematic reviews/meta-analyses of RCTs > RCT > cohort > case-control > cross-sectional > case series > expert opinion.

A testable, falsifiable statement a research study is designed to support or refute; the null hypothesis states there is no real effect.

The process by which a competent, adequately informed patient voluntarily agrees to a specific procedure; the operational expression of autonomy.

A participant's voluntary agreement to take part in a study after understanding its purpose, procedures, risks and the right to withdraw.

The body that reviews and must approve research on human participants, weighing scientific merit and the risk-benefit balance to protect participants.

Fairness in the distribution of care and resources — treating like cases alike and not discriminating on irrelevant grounds.

A civil wrong proven only when all four elements are present: a duty of care, a breach of that duty, causation, and resulting damage.

The ethical duty to avoid causing harm (primum non nocere); in surgery, weighed as the risk-benefit balance of every operation.

The measure of association produced by a case-control study, comparing the odds of exposure in cases versus controls.

The probability of obtaining the observed result, or one more extreme, if the null hypothesis were true; conventionally <0.05 is called statistically significant.

The behaviours, attitudes and communication through which a clinician lives out their ethical obligations at the bedside.

An experimental study that allocates participants to intervention or comparator by randomisation, giving the strongest evidence of causation.

The step that closes the audit cycle by re-measuring practice after a change to confirm that improvement has occurred.

The ratio of the risk of an outcome in the exposed versus the unexposed group, typically derived from a cohort study or RCT.

An agreed benchmark of acceptable performance against which actual practice is measured.

A quality-improvement activity that compares actual practice against an agreed existing standard and acts to close any gap; it tests no hypothesis.

A structured synthesis (and statistical pooling) of all eligible studies on a question; at the apex of the evidence hierarchy when it pools RCTs.

The duty to be honest with patients, including the empathic breaking of bad news and the disclosure of complications.

The requirement that a consent decision be made freely, without coercion or undue pressure.