It is sometimes hard to find the dividing line between research and audit. The following is designed to make the distinction clearer.

Medical research

• May involve experiments on human subjects, whether patients, patients as volunteers, or healthy volunteers.

• Is a systematic investigation which aims to increase the sum of knowledge.

• May involve allocating patients randomly to different treatment groups.

• May involve a completely new treatment.

• May involve extra disturbance or work beyond that required for normal clinical management.

• Usually involves an attempt to test a hypothesis.

• May involve the application of strict selection criteria to patients with the same problem before they are entered into the research study.

Medical audit

• Never involves experiments, whether on healthy volunteers, or patients as volunteers.

• Is a systematic approach to the peer review of medical care in order to identify opportunities for improvement and to provide a mechanism for bringing them about.

• Never involves allocating patients randomly to different treatment groups.

• Never involves a completely new treatment.

• Never involves disturbance to the patients beyond that required for normal clinical management.

• May involve patients with the same problem being given different treatments, but only after full discussion of the known advantages and disadvantages of each treatment. The patients are allowed to choose freely which treatment they get.