What type of study is this?
The Articulate Pro study is classified as an "Evaluation of Clinical Care". For more information, see the table below:
Type of Study
This is Not a research study
The software is ready to use and no further developments to the software will be made as a result of the study.
The software is market authorised.
The Study Sponsor, The University of Oxford through its Clinical Trials and Research Governance Team
Has confirmed that this is not a research study
|NO Consent is required|
This is Not a clinical trial
|The project design does not fit the criteria for a clinical trial|
The Study Sponsor, The University of Oxford through its Clinical Trials and Research Governance TeamHas confirmed that this is not a clinical trial
NO Research Ethics Committee approval required
NO Consent is required
This is Evaluation of Clinical Care (Service Evaluation)
Under the control and responsibility of the clinicial team
Forms part of the usual patient care pathway
De-identified data used
Patient specific data behind secure NHS Firewall
The Study Sponsor, The University of Oxford Clinical Trials and Research Governance Study Classification Committee
Has reviewed the project and confirmed that this is Service Evaluation
NO Project Specific Consent is required
Opt out options available under existing OUHFT "Consent to Examination or Treatment Policy "
and via PALS (Patient Advisory and Liaison Service)
For further information please see:
Patient Advice and Liaison Service (PALS) - Oxford University Hospitals (ouh.nhs.uk)
OUHFT "Consent to Examination or Treatment Policy V 6 .2 January 2020
Other regulatory requirements for data either apply or not as below:
Set Aside 251 RE THE USE OF PATIENT DATA
Section 251 of the National Health Service Act 2006 and the Health Service (Control of Patient Information) Regulations 2002 allows the Secretary of State for Health to make regulations to set aside the common law duty of confidence for defined medical purposes. This would allow the use of patient data for medical purposes. BUT THIS DOES NOT APPLY TO THE STUDY AS WE ARE USING DE-IDENTIFIED PATIENT DATA.
National Data Opt Out (NHS)
DOES NOT APPLY to this project as the National Data Opt Out scheme only applies to data usage and processing in circumstances other than direct / individual care.
Data Protection Act 2018 / GDPR
In this project the LEGAL BASIS for processing data is:
Article 6 - 1e: Necessary for performance of a task carried out in public interest or in exercise of official authority
Article 9 (Special category data) - 2(h) Necessary for provision of health and/or social care, including preventative or occupational medicine.
Common Law Duty of Confidentiality
In this project scanned images are going to be added to the PathLAKE data lake. Patients whose data has been analysed using the Paige Prostate tool will need to have agreed to their data being used for research on the NHS "Consent to Procedure form" (Agreement to Investigation or Treatment form) that they signed before undergoing a biopsy. We will check each consent form.
The use of AI (computer assisted technology) and implied consent – guidance from the NHS Transformation Directorate
On 19th July 2022, The NHS Transformation Directorate published guidance about the use of AI and implied consent. They state:
“Artificial Intelligence (AI) is the use of digital technology to create systems capable of performing tasks commonly thought to require human intelligence”.
The guidance, available on their website here: Artificial Intelligence - NHS Transformation Directorate (england.nhs.uk) has been written to support the lawful and safe use of data for AI innovations.
The relevant part of the guidance, in relation to the Articulate Pro project, where we are using computer assisted technology in the form of the Paige Prostate software system, but where the final diagnosis is made by a pathologist, is the following:
“A health and care organisation may use your personal information in AI systems to provide you with individual care. AI can help a health and care professional reach a decision about your care, for example, diagnosing a condition you have or helping you choose a treatment option. In these cases, your consent to the use of your data is implied. Decisions will not be made by the AI system. Health and care professionals will always provide advice and allow you to make the final decision on the care and treatment you receive”.
For further information please go to the NHS Transformation Directorate website at the link above.