§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health (1) who requested 42 heart valves for use in clinical trials in the United Kingdom; and from whom;
308W(2) when the request was made to the United States of America for the use of heart valves in clinical trials.
§ Mr. SackvilleShiley requested permission from the United States Food and Drug Administration to export Björk-Shiley 70° C-C heart valves from the United States of America for use in clinical trials in the United Kingdom. The Medical Devices Agency has no record of the date of this request. In response to a request from Shiley, dated 25 February 1981, the Department of Health issued a letter on 27 March 1981, indicating no objection to importation of the valve for clinical trial purposes.
§ Mrs. Bridget PrenticeTo ask the Secretary of State for Health what information was given to patients implanted with heart valves in the course of the clinical trials.
§ Mr. SackvilleThe information given to patients before and during the course of a clinical trial is a matter for the professional judgment of the clinicians involved, taking into account the particular circumstances of each patient and the requirements of the clinical trial protocol.