Study raises concerns over publication of unethical research

August 09, 2001

Forty per cent of research papers published in five American medical journals failed to report ethical approval or informed consent, despite the fact that all journals explicitly ask authors to document approval, finds a study in this week's BMJ. This raises concerns about the protection of human participants in clinical trials.

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. Such occurrences are likely to be rare, but they are not inconceivable, they add.

Protecting participants in clinical research is, and must remain, one of the highest priorities of medicine, say the authors. They recommend that medical journals can 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.
Failure to report ethical approval in child health research: review of published papers BMJ Volume 323, pp 318-319


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