THE ADEQUACY OF CONSENT FORMS FOR INFORMING PATIENTS ENTERING ONCOLOGICAL CLINICAL-TRIALS

The impact on 100 patients of information and consent forms signed pri or to medical oncology clinical trials was evaluated by a survey at a subsequent visit. Only 40 patients believed that the purpose of the fo rm was to explain the treatment, The form was listed as the major sour ce of information by 12 patients while 52 listed a doctor and 26 a nur se. Although 21 patients believed that the form made them less anxious , 19 patients believed that it made them more anxious. Despite 80 pati ents reading all of the form, 60 claiming to understand all of it and 68 claiming that it contained adequate information, in tests of recall only 52 patients could name all of their drugs and only 4 all of the side effects. The number of drugs named correlated with how much of th e consent form had been read (p = 0.003) and the highest education lev el achieved by the patient (p = 0.0003). Patients under 55 years had s ignificantly better recall. Patients with a better ECOG performance st atus were more likely to find the form very helpful. Such forms may no t ensure that the requirements for informed consent are satisfied.