Assessing the safety and quality of innovative procedures

• Research type

  Research Study

• Full title

  Assessing the safety, quality, and patient experience of technique-centred innovations in healthcare

• IRAS ID

  12868

• Contact name

  Jane Sandall

• Sponsor organisation

  King's College Hospital NHS Foundation Trust

• Eudract number

  N/A

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The advancement of medical care is, in large part, driven by innovative clinicians and courageous patients who, respectively, develop and submit to experimental treatments and technologies. As such technologies develop and are translated into mainstream clinical care they carry risks and uncertainties for patients, clinicians and healthcare organisations. This project aims to explore oversight processes, practices and rationales used by a large inner-city NHS Foundation Trust to address these issues. History has taught us of the risks associated with experimental/innovative treatments which are not rigorously tested prior to their diffusion into standard practice. However, while the development and regulation of pharmaceutical drugs is tightly regulated, more ??craft-based? developments, such as innovative surgical and clinical procedures, have remained largely under-regulated. This research is of significant importance to patients who may potentially be offered an innovative clinical procedure. By focussing on the development, supervision, and diffusion of these procedures, the research attempts to understand how innovation can occur as safely as possible. The research asks how the Trust, clinicians and patients manage the uncertainty and risk associated with the innovation of new clinical procedures, and how analysis of these groups might contribute to the development of appropriate governance and evaluation frameworks.This study includes ethnographic observation of the workings of an innovation review committee within the study Trust. In addition, the project conducts in-depth semi-structured interviews with committee members, clinical ??innovators??, patients who have been offered and/or undergoing innovative procedures, and a range of internal and external ??stakeholders??. The project will last until March 2012 and is being conducted by the King??s Patient Safety and Service Quality Research Centre which is funded by the NIHR.

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  09/H0808/2

• Date of REC Opinion

  30 Mar 2009

• REC opinion

  Further Information Favourable Opinion