Medical research protocols should be completely overhauled

October 14, 2000

The case for a new system for oversight of research on human subjects (200;26:334-9)

The ethical criteria for medical research need to be completely overhauled. They are out of step with the shift towards evidence based medicine and new developments in technology and genetics, suggests an analysis in the Journal of Medical Ethics. Furthermore, the protocols rely too heavily on unchecked assumptions about the integrity and judgment of the individual investigators, says the author.

Patients taking part in research have the right to expect the same standards of safety, training, and regulation that passengers on public transport enjoy, contends Konrad Jamrosik, professor of public health at the University of Western Australia. Yet, he says, investigators may have no formal training in how to carry out research.

While ethics committees painstakingly pick through the design of a study, they do little to ensure that patients have been safely and ethically dealt with, once approval for the study has been granted, points out professor Jamrosik. Asking investigators to submit an annual report to show that no problems arose is equivalent to "regulating traffic by asking drivers to report retrospectively whether they obeyed every stop sign and speed limit, and never drove under the influence of alcohol."

Professor Jamrozik cites several anomalies and conflicts concerning the differences between experimental and observational studies, confidentiality, access to medical notes, and informed consent. And he notes that much of medical research conforms to the medical science needs of Western Europe, so excluding many other cultures and creeds.

He concludes that ethical issues need to be given far more prominence in medical training. And he suggests that researchers should be let loose on people only after they have obtained a formal licence, certifying their competence. Ethics committees, he says, should devote less time to scrutinising applications for research and more to policing infringements of good practice.

Professor Konrad Jamrozik, Department of Public Health, University of Western Australia.

BMJ Specialty Journals

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