Consent
Potential participants will be assessed by a member of the study team, eligibility will be confirmed and baseline assessments performed. Consent to enter the study will be sought from each participant only after a full explanation has been given and the PIS has been given. We have worked with our patient and public involvement (PPI) representatives to ensure that these materials are concise, clear and easy to understand.
The patient is free to refuse participation without giving reasons and without this affecting the care they receive. The participant is free to withdraw at any time from the study without giving reasons and without prejudicing their further treatment. Participants are provided with a contact point where they may obtain further information about the study in the PIS. Data and samples collected up to the point of withdrawal will be kept.
Consent to additional elements of the research will be driven by patients’ wishes giving them control over how their data is used. Patients will be offered the opportunity to consent to the following without affecting their inclusion within the core aspects of the study:
- Consent for future contact with information about studies that become available
- Consent for future contact for collection of additional information regarding this study
- Use of anonymised information collected from this study to be used in future studies which have received separate ethical approval
- All patients who are identified before their biopsy, have a cancer recurrence or who have a resection will be eligible for consent for storage of their tissue. This consent details that their tissue will be stored indefinitely and can be used for future, as yet undecided studies. Patients have the option to give consent for further biopsies (often in the case of recurrence) to be collected and transferred to a biobank for use in future research projects.
Patients may consent to as many or few additional elements as they wish.