[Good clinical practice in clinical trials: the responsibilities of the investigator. A survey of 827 hospital physicians (and II). Patient consent].

BACKGROUND

Among the responsibilities of the investigator, good clinical practice (GCP) includes that of obtaining informed consent (IC) from the patients prior to his/her inclusion into a clinical trial (CT). The attitude of the hospital physicians towards this question before the implementation of the GCP became mandatory in Spain was considered to be of interest.

METHODS

An anonymous survey with closed response questions was used. From December 1988 to February 1990 the survey was distributed among 1,706 hospital medical staff members of any specialty who had or had not participated in CT. The results of the questions regarding different aspects intimately linked to the obtaining of the IC from the patient are presented in this article.

RESULTS

A total of 827 hospital doctors responded to the survey. Most (96%) of those surveyed considered that the investigator must obtain the IC prior to inclusion in the CT with almost two thirds obtaining the same in writing in all CT. Nine out ten of those surveyed considered that the information provided to the patient to obtain the IC should be laid out in a document. At least 90% of the above consider that the document should always invite the patient to participate in a CT, declaring that participation is voluntary, that the patient may leave the study when he/she wishes and that refusing to participate does not imply loss of normal health care. To the contrary, at least 10% would not provide information as to who the promoter was, the design of the CT, specific experimental procedures of the CT as the number of patients to participate in the CT.

CONCLUSIONS

According to the good clinical practice guidelines, the responsibilities of the researcher with respect to informed consent of patients to participate in a clinical trial have, in general, been accepted by most of the hospital physicians surveyed in the present study. Theoretically, only the reduced acceptance of informing the patient as to the design of the clinical trial may cause some problems in the future.