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Elements of informed consent in clinical research with drugs: a survey of Spanish clinical investigators

Abstract. An anonymous survey was conducted on 302 Spanish clinical investigators in order to determine whether a patient't information sheet should be prepared for each clinical trial, and what items of information should be included. The survey, using close‐response type questions, included 23 proposed items of information. A total of 275 (91%) investigators considered it necessary that a patient't information sheet be prepared for each clinical trial. At least 83% of those investigators considered that seven items of information should always be included: an invitation to participate in a clinical trial, the aim of the study, a description of the predictable benefits and risks, a declaration that participation is voluntary, and a statement that refusal to participate does not imply loss of normal medical care and that the trial has been approved by a Clinical Trials Committee. Only 29% and 53% considered that the patient should always be informed about clinical trial design and data confidentiality, respectively. Overall, the responses obtained are in line with most of the elements of informed consent regarded as ‘basic’ in US regulations and included in the European Community and Nordic Good Clinical Practice guidelines.