Informed consent in trials for neurological emergencies: the example of XXXX .

@entity1 @entity510
BACKGROUND: In @entity1 with acute life threatening diseases, and in their relatives, the ability to make a balanced decision on participation in a clinical trial may be impaired. OBJECTIVES: To assess what relevant information could be recalled by @entity1 who were living independently after a @entity510 , and by their relatives; and to determine how these @entity1 and relatives had reacted to the informed consent encounter. METHODS: Twenty months (range 7 to 31) after treatment for @entity510 , 49 @entity1 and 47 relatives who had participated in one of two randomised trials on medical management were interviewed. The interview consisted of items on: spontaneous recall and knowledge of trial design; understanding of the trial design and the informed consent procedure; the amount and clarity of the information given; and reasons for participating. Finally @entity1 and relatives were asked whether they would participate again in similar circumstances. RESULTS: One third of the @entity1 recalled having participated in a clinical trial. Thirteen per cent of the @entity1 and 20% of the relatives felt that the information supplied had not been sufficient. Nine per cent of the @entity1 and half the relatives had read the written information. None of the @entity1 and one relative thought that participation had been obligatory. Twenty eight per cent of the @entity1 and 94% of the relatives felt in retrospect that they had been capable of making an adequate decision. Virtually all @entity1 and relatives would participate again in similar circumstances. CONCLUSIONS: Many @entity1 and their relatives have little recall of the informed consent procedure and the essentials of acute @entity510 trials. However, most were satisfied with the overall procedure and would participate again.
