Search

Objective: To determine whether a modified informed-consent procedure, in which permission is requested to send a questionnaire and to provide all the information about the study only after it is completed, would raise objections from patients who were asked to participate in a study on satisfaction with the follow-up care after a cerebrovascular accident., Design: Descriptive cohort study., Method: 123 patients were approached for the randomised study. The patients who were included were interviewed by telephone two weeks after they had been sent the postponed information., Results: During recruitment, 5 patients refused to participate but this was not because of the modified procedure. Of the 112 survivors, 102 (91%) could be interviewed and 79 had read the letter. Nobody (0%; 95% CI: 0-5) said that their trust in doctors had decreased; one patient (1%; 95% CI: 0-7) indicated decreased willingness to participate in future studies; two patients (3%; 95% CI: 0-9) were dissatisfied about the procedure followed., Conclusion: The participants in the trial had no major objections to the modified informed-consent procedure in which full information was given only after their participation had ended. Furthermore, patients did not refuse participation because of the modified procedure.

The article focuses on a framework and criteria developed to make obligatory the inclusion of a controversial risk in the model informed consent document while avoiding the need to list every possible harm that could inflict a person. It discusses research integrity that relies on government regulations and foundational documents, an overview of a study on the Action to Control Cardiovascular Risk in Diabetes (ACCORD) and a proposed example of the items to be included in a consent document.