Ethics of clinical trials

The primary aim of research is the generation of knowledge. The interests of the research subject, however, remain paramount. A research project should be approved by an ethics committee, thus ensuring high scientific and ethical standards. Particular attention must be paid to control groups, blinding, randomization, sample size and placebos. Risk must be minimized and subjects should know they may withdraw at any time. It may be appropriate for audit projects to be reviewed. Participants must be informed of, and must understand, the aims, methods, benefits, and potential risks of the study. This may present a problem in some areas of research, such as day surgery or when dealing with incapacitated patients. Researchers need to know the conditions stated in The Medicines for Human Use Act 2004 or the Adults with Incapacity (Scotland) Act 2000. In epidemiological research and disease registers, investigators are still bound by the principles of respect for the patient's autonomy. Records made for one purpose (e.g. anaesthetic charts) should not usually be disclosed for another purpose without the patient's consent. Each health authority, trust and primary care group require a ‘Caldicott Guardian’ to agree and review internal protocols for the protection and use of identifiable information obtained from patients. The Data Protection Act 1998 concerns the use of personal data in paper and electronic form. Systems of information collection should be constructed to balance public need and the rights of privacy of the individual. Consent should be obtained where practical, with anonymization of data whenever possible.