A report in the British Medical Journal (BMJ) revealed that nearly half of all researchers published in five American medical journals failed to note whether or not they received approval from an ethics review board before beginning their study. "This raises concerns about the protection of human participants in clinical trials," the BMJ stated.

All research reports relating to child health published in 1999 in five American medical journals were reviewed for any statement about informed consent or ethics committee approval. All five journals require studies with human participants to report ethical approval. Of 561 studies, 40% did not report ethical approval.

Investigators may have failed to obtain and report ethical approval because of confusion about the requirements, suggest the authors. Alternatively, some researchers may have deliberately disregarded ethical approval standards and laws, they added.

Protecting participants in clinical research is, and must remain, one of the highest priorities of medicine, warned the authors.

They recommended that medical journals play a greater role in protecting human participants by ensuring that every research study includes a statement regarding human subjects and any reasons for exemption are provided.

SOURCE: British Medical Journal, Aug. 11, 2001, No 7308 Volume 323.