Nizar, Nurul Ain
Farooki, Roopa
Mahapatra, Piyush
Halpern, Saul
Hoogenboom, Tim C. H.
Article History
Received: 3 June 2024
Accepted: 13 December 2024
First Online: 21 December 2024
Declarations
:
: This project utilised data collected as part of standard care and optional questionnaires. Data analysis was conducted using anonymised data, as the system allows for anonymous data extraction. The project was reviewed and approved by the East Kent Hospitals University NHS Foundation Trust Clinical Audit and Improvement Team, which deemed it a clinical audit improvement project that did not require further review by an ethics committee (Reference Number: RN903073). This determination was made in accordance with national regulations, including the Data Protection Act 2018, General Data Protection Regulation (GDPR) and applicable Health Research Authority (HRA) guidance.Ethical approval was not required for this study because the data used was fully anonymised and excluded from the definition of personal data under the Data Protection Act 2018. Similarly, Recital 26 of the General Data Protection Regulation (GDPR) states that "the principles of data protection do not apply to anonymous information." As such, anonymised data does not constitute personal data, and its use in this project complies with national regulations.Informed consent for data use was not required because the anonymised data was extracted from the hospital’s electronic database (Pathpoint eDerma) without patient interviews. However, questionnaire responses were provided voluntarily by patients who had given explicit consent.All methods in this project adhered to the ethical principles outlined in the Declaration of Helsinki. Furthermore, per Health Research Authority (HRA) guidelines, ethical approval is required only for research involving identifiable personal data. As the data in this project was anonymised and the study was classified as a clinical audit, ethical approval was not necessary.
: Not applicable.
: Authors NAN, TH and PM declare a competing interest in their employment by Open Medical Ltd.