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 drug.
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 give patients.
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.
Ather Mirza | alfa
Team discovers how bacteria exploit a chink in the body's armor
20.01.2017 | University of Illinois at Urbana-Champaign
Rabies viruses reveal wiring in transparent brains
19.01.2017 | Rheinische Friedrich-Wilhelms-Universität Bonn
An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...
Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...
Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.
While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...
Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales
Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...
Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.
As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...
19.01.2017 | Event News
10.01.2017 | Event News
09.01.2017 | Event News
20.01.2017 | Awards Funding
20.01.2017 | Materials Sciences
20.01.2017 | Life Sciences