such as "Introduction", "Conclusion"..etc
Researchers running cancer trials are often critical of the Research
Ethics Committee (REC) process they have to go through to get their
trials approved, complaining that it’s too complex, burdensome and
sometimes unreasonable. In the UK only 17% of research study
applications are given immediate favourable opinion by RECs.
But a new study from the University of Leicester, recently reported
in The Lancet Oncology, suggests that RECs may sometimes identify
important problems in applications to conduct cancer trials.
The Leicester study, funded by the National Research Ethics Service,
looked at 80 anonymised NHS REC decision letters concerning cancer
trials, written between March 2004 and December 2006.
When reviewing applications to conduct cancer trials, the issue RECs
are most likely to raise is that of informed consent. Committees are
often concerned that the information that researchers propose to give
patients may not be in language that can be easily understood. They
also discourage researchers from presenting trials too
enthusiastically, and seek to prevent researchers from providing
misleading information. One Committee pointed out that the cancer drug
side-effects were described as mild on the patient information sheet,
but in the investigator's brochure it was noted that several patients
had experienced serious adverse events thought to be related to the
The study found that RECs identify a high rate of mistakes in
applications, including missing information, ticking the wrong boxes,
errors in the information provided and not following correct procedures.
The findings support the conclusion that RECs, though by their
constitution somewhat bureaucratic, provide an important independent
check on clinical trials by ensuring that investigators do not omit
important information or underestimate risks in the information they
Professor Mary Dixon-Woods, of Medical Sociology in the Department
of Health Sciences at the University, commented: “There have been a lot
of complaints about REC procedures from researchers in recent years.
They often find the process onerous and bureaucratic. However, this
study is the first time anyone has systematically analysed what RECs
are saying about cancer trial proposals.
“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. Researchers can improve their chances of success at
ethical review by really good preparation.”
The study, led by Professor Dixon-Woods, was carried out with Emma
Angell, Carolyn Tarrant and Anne Thomas, in the Social Science Research
Group in the Department of Health Sciences at the University of
Leicester and the Department of Cancer Studies and Molecular Medicine
at the Leicester Royal Infirmary.
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