While researchers running cancer trials in the UK often complain that the process of Research Ethics Committee (REC) review is too complex, onerous and bureaucratic, these committees perform an important function in making trial applications fit for purpose, a new study suggests.

In the study funded by the National Research Ethics Service, a team from the Department of Health Sciences at the University of Leicester and the Department of Cancer Studies and Molecular Medicine at Leicester Royal Infirmary looked at 80 anonymised decision letters on cancer trials, written by National Health Service RECs between March 2004 and December 2006.

The team led by Professor Mary Dixon-Woods found that informed consent was the issue RECs were most likely to raise when reviewing applications to run cancer trials. Often the committees were concerned that the information researchers wanted to give to enrolleees might not be easily understandable. They also discouraged researchers from presenting trials too enthusiastically and tried to stop them from providing misleading information, Dixon-Woods et al said.

On one patient information sheet, a REC pointed out, the side-effects of a cancer drug were described as mild, whereas the investigator’s brochure noted that several patients had experienced serious adverse events thought to be related to the therapy.

The RECs included in the study identified a high level of mistakes in applications for cancer trials, including missing information, ticking the wrong boxes, errors in the information provided and non-adherence to procedures.

The Leicester study, reported in The Lancet Oncology, was “the first time anyone has systematically analysed what RECs are saying about cancer trial proposals”, Dixon-Woods observed.

“RECs are looking for evidence that researchers are sensitive to ethical issues, in particular to participants’ interests, and that information given to potential participants explains the trial fully and truthfully,” she commented. “Researchers can improve their chances of success at ethical review by really good preparation.”

According to the University of Leicester, only 17% of research study applications in the UK are given an immediate favourable opinion by RECs.