Informed consent in clinical research with drugs in Spain: Perspective of clinical trials committee members

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Abstract
Summary A survey among members of 16 Clinical Trials Committees and the Clinical Trials Evaluation Team of the Spanish Ministry of Health was carried out to discover their opinions about the procedure used to obtain informed consent in clinical research with drugs. The responses of the 111 persons surveyed indicate that 97% consider that informed consent should be obtained before the patient is included in the trial, that it must “always” be in writing (68%), and that the consent form must previously have been approved by the Clinical Trials Committee (87%). The minimum information to be provided to the patient must be read by and later supplied to the subject (76%), and for at least 90% of the members surveyed it must “always” include: an invitation to participate in the clinical trial, information about the purpose, predictable benefits and risks of the trial, the statement that participation is voluntary and that refusal to participate would not imply loss of usual medical care, and that the trial was approved by the Clinical Trials Committee. Only 33% of those surveyed considered that the study design should “always” be described to the patient. In order to find out what the general outlook on this issue is in Spain, it is necessary to perform studies among medical investigators and patients.