Confidentiality and Ethics in Memo

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Chapter: Pharmacovigilance: MEMO in the United Kingdom

Studies in MEMO use highly confidential, although anonymised, medical data.


CONFIDENTIALITY AND ETHICS IN MEMO

Studies in MEMO use highly confidential, although anonymised, medical data. MEMO has an agreement with the Local Medical Committee of the British Medical Association never to divulge person-specific or GP-specific data, unless it is to a doctor requesting information on one of his or her own patients. All staff in MEMO sign confidentiality agreements and all databases are registered for research purposes with the Data Protection Officer. All studies in MEMO use de-identified data. The anonymisation process uses a randomly selected number mapped to the CHI number. The random number then becomes the link between databases. The Data Protection Officer is the only person that holds the mapping key. Ethics committees and Caldicott Guardians must approve study protocols before each study begins. Approved studies are logged in MEMO and may be audited by Caldicott Guardians at anytime. Any changes to a study protocol require resubmission to the ethics and Caldicott Guardians for approval of the change. As data protection and ethical issues continue to evolve, MEMO will ensure that it meets the standards in both these areas (Data Protection Act, 1998).

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