SHORE-C Privacy Statement

Sussex Health Outcomes, Research & Education in Cancer (SHORE-C) conducts research into psychosocial oncology. Our work includes measuring aspects of health related Quality of Life (QoL) in patients undergoing treatment for cancer, their caregivers and health care professionals. These data are usually collected via questionnaires or interview. We also conduct oncology communications workshops for health care professionals in which data are collected using questionnaires and/or interviews.

Collection and use of personally identifiable and study data

  • If you consent to take part in one of our SHORE-C studies you will be asked to sign a consent form. If we are collecting quality of life data as part of a large clinical trial conducted elsewhere, the consent form will contain a section pertaining to quality of life. We may ask for your consent to hold your name and contact details and other study data classed as personal. Contact data (home address, email address, telephone number) will be used for the purposes of sending questionnaires, or other study related documents to you and to enable us to conduct telephone interviews or call you for any study related queries. Data collected are the responses to paper or online questionnaires, free text generated in the course of an interview, or audio recordings or transcripts.
  • When taking part in a study, you will be allocated a study number, which will be used as a code to identify you on all your study forms, questionnaires and interview data (study data). The reason for collecting your study data will depend upon the study design and will be explained in your patient information leaflet.
  • Your personal details will not be passed to anyone outside the study research team. The study research team may include persons working on the study at other locations, such as the hospital where you are being treated and the clinical trials unit conducting the study.
  • Your study data will be held electronically on a database using your study code only. We may periodically transfer these data to other members of the research team for the preparation of trial progress reports and analyses. It will not be possible to identify you on the data files sent from SHORE-C.
  • At the end of a study, your study data may be transferred to another research unit for statistical analysis and publication of the study results but it will not be possible to identify you in the data files transferred.
  • Authorised persons from the UK Regulatory Authority (the Medicines and Healthcare Products Regulatory Authority) or the study Sponsor (the organisation responsible for the overall conduct of the study) may require access to your study data as part of a clinical trials regulatory inspection. These inspections are conducted to ensure that studies are carried out to the highest possible scientific standards. All will have a duty of confidentiality to you as a research participant.

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Storage of your data

Any personally identifiable data obtained by SHORE-C while you are in a study will remain strictly confidential. The information will be held securely on paper and/or electronically at SHORE-C. Your study data will also be stored securely at SHORE-C on paper and/or electronically and will only be accessible by authorised personnel. Your personal and study data will be held in separate physical and electronic locations and access will be strictly controlled.

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Your right to withdraw from a study

Your participation in our studies is voluntary and at any time during a study, you have a right to withdraw consent. We will only use any study data collected up until the time you withdraw and will destroy any personal details that we hold (name and contact details).

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Study closure and archive

  • At the end of your participation in a study we will destroy any personal data (name and contact details) held at SHORE-C unless you have been offered the option to receive a copy of the published study results, in which case we will hold your details until we have sent them to you.
  • Any study data held at SHORE-C following study closure, will be archived for at least five years, according to applicable regulatory requirements (Good Clinical Practice, EU Clinical Trials Regulations). It will not be possible to identify you from the data held. At the end of the archiving period, arrangements for confidential destruction will be made.

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General Data Protection Regulation 2018

A ‘task in the public interest’ is relied on as a legal basis for processing data from participants of research. The legal bases for processing are regularly reviewed and balanced against individual rights and freedoms. In addition, consent from participants is obtained to avoid a breach of the common law duty of confidentiality.

Contact

  • If you have any questions about your data, please contact the SHORE-C researcher who interviews or sends questionnaires to you.
  • You can also contact the Sussex University data protection team at dpo@sussex.ac.uk.

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