Ethical issues of electronic patient data and informatics in clinical trial settings

Abstract

The field of cancer bio-informatics unites the disciplines of scientific and clinical research withclinical practice and the treatment of individual patients. There is a need to study patients andsometimes their families, over many decades, to follow disease progress and long-term outcomes.This may require research teams to access the routinely-collected health data from generalpractice and hospital health records, prior to and after the cancer diagnosis is made. This clinicalinformation will increasingly include data provided by patients or acquired from them throughwearable devices that can monitor or deliver treatment, and data acquired from genetic relativesof the patient.All of these data, whether explicitly collected for the purpose of a clinical study, or routinelycollected as part of a patient?s life-time healthcare journey, are personal health data. There areethical and legal requirements to manage these data with care. This chapter explores the ethicalrequirements for collecting, holding, analysing and sharing personal health data, and thelegislation covering such activities