New guidance on placebo surgery published following Council recommendation

The Royal College of Surgeons (RCS) has published a Position Statement and article on placebo surgery, following a workshop organised by the Nuffield Council on Bioethics and co-hosted with the Health Research Authority (HRA), held originally to consider the Council’s recommendation for guidance on the use of placebo surgery in clinical trials of neural stem cell therapies.

The Council recommended in its 2013 report Novel neurotechnologies: intervening in the brain that guidance should be developed on the kinds of circumstances in which placebo neurosurgery may, or may not, be an appropriate part of clinical trials. The subsequent workshop, held in May 2015, brought together neurosurgeons and surgeons from other fields, for example, orthopaedic surgery, with patient representatives, regulators and research ethics committees to look at the issues surrounding the use of placebo surgery more widely.

Today’s RCS Position Statement advocates the increased use of placebo surgery in the design of trials, to help ensure that more effective surgical procedures are used. The statement includes guidelines on the ethical use of placebo surgery, including specific guidance on when it should, and when it should not, be considered.

The article is authored by attendees of the Council/HRA joint workshop and is published in the Bulletin of The Royal College of Surgeons of England. The article sets out different types of placebo surgical interventions that may be considered for use as a control in clinical trials. It then gives three illustrative scenarios and highlights issues for consideration in each – one example being the implantation of an electrode(s) for deep brain stimulation, an invasive procedure that intervenes in brain function and is currently used to treat Parkinson’s disease and other movement disorders.

Related links

Read more about the Council’s report Novel neurotechnologies: intervening in the brain

On our blog:

• With the brain in mind
• Registering the importance of sharing outcomes of brain stimulation
• Neurodevices that collect information: let’s not get distracted by mind-reading