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Updated: Aug 2, 2026

Working with Human Tissues for Translational Cancer Research
Published on: November 26, 2015
Improving risk disclosure during the consent process
T J Edwards1, I Finlay, D C Wilkins
1Department of Surgery, Derriford Hospital, Plymouth, UK.
Objectives:
To provide guidance about the risks which should be disclosed to patients and documented during the consent process.
Methods:
The Delphi Consensus Technique was used to decide what constitutes mandatory risk disclosure for three index procedures. Documentation of risk on consent forms was audited and compared to these locally agreed standards. A four stage strategy for change was undertaken following which practice was reviewed.
Results:
Mean mandatory risk documentation rose from 61.2% (95% CI: 58.1-64.4) pre-intervention, to 78.1% (95% CI: 72.6-83.6) post-intervention (ccc2; P < 0.001).
Conclusions:
Although we demonstrated some benefit from this simple approach, the need for pragmatic means of achieving and sustaining complete discussion and documentation of risks across all surgical interventions based on universally accepted standards remains.
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