§ Mrs. Wise
To ask the Secretary of State for Health if he will make it his policy to require ethics committees to maintain long-term storage of the records of people involved in scientific clinical trials to enable long-term follow up to be carried out if it later emerges that this should be done to check for an unexpected long-term, or slow to develop, after-effect.
§ Mr. Dorrell
Research ethics committees have no powers to gain access to or require the long-term storage of the records of people involved in scientific clinical trials. Hospitals are currently required to keep the medical records of all patients, including those involved in trials, for a minimum of eight years after the end of treatment. In addition, a recent EC directive (91/507/EC, adopted on 19 July 1991 and shortly to be implemented in the UK) requires the person responsible for marketing a medicinal product to keep codes, identifying patients involved in the trial, for a minimum of 15 years. This additional requirement should further facilitate the identification of clinical trial subjects.