In 2008 we applied to the ethics committee to request the collection of survival data through the Office of National Statistics. We applied to request date and cause of death for all consented patients, in order that we can investigate cancer aggressiveness and survival in relationship to genotype as part of our research study. The amendment was approved by the MREC (Medical Research Ethics Committee) on 19/08/2008.
In 2011, we applied to The Medical Research Information Service (MRIS) part of the Information Centre for Health and Social Care to flag the cause of death of participants consented to the UKGPCS. We have previously been asking for consent to follow up patient health status with the Office of National Statistics. In order for our application to be successful, MRIS require specific wording to be used on our Patient Information Sheet and Consent Form.
The wording on the Patient Information Sheet was changed to “request to view your medical records and follow up your health status with the NHS Information Centre and NHS Central Register”.
The wording on the consent form was changed to “I understand that information held by the NHS and records maintained by The NHS Information Centre and the NHS Central Register may be used to help contact me and provide information about my health status”.
Participants were flagged by the cancer registry to confirm a date of death and cause of death. This was approved on 07th Jan 2011. We had a signed Data Sharing Agreement with MRIS on the 05th May 2011 and we received the first flagging data on 07th July 2011.
In 2021, NHS Digital (which comes under the Health and Social Care Information Centre) requested that participants in UKGPCS who consented prior to July 2008 would need to have data linkages held by NHS Digital covered by a separate approval as the study consent form was an older version that was applicable to 2008 but not to 2021. Hence, we have applied to the HRA CAG for support under section 251 of the NHS Act 2006 to process mortality data.
The decision on this application is awaited and mortality data will only be processed post 2008 until this is obtained.
Study data opt-out
If you are a study participant, and you joined the study before July 2008 then you can opt out of having your data from NHS Digital included in research, including for this study, and more information can be found at https://www.nhs.uk/your-nhs-data-matters/ or by clicking on ‘Your Health’ in the NHS app, and selecting ‘choose if data from your health records is shared for research and planning’.
If you are a study participant and you joined the study after July 2008 and would like to discuss or review your study consent then you are welcome to contact the study team (details below).
If you are uncertain whether this applies to you, or for any help or advice with regards to opt-out specifically from the UK Genetic Prostate Cancer Study, then please contact the study team by emailing [email protected] or [email protected].