Data on Informed Consent

Despite these limitations, three consistent results emerge from the published studies on informed consent. First, some problems exist with the informed consent process as it is currently practiced.23,34 In some cases, disclosure seems to be inadequate. Several studies have suggested that although regulations are being followed, informed consent documents have become increasingly unreadable, lengthy, and uninfor-mative.22,35,36 These studies have found the forms written at the level of scientific journals rather than at an acceptable 8th-grade reading level.35,36 Another study evaluating disclosure by asking European investigators their practice of obtaining consent found that 12% failed to inform their patients about the trial before randomization, 38% reported not always telling patients that they had been assigned their treatment randomly, and 5% never sought consent.37 However, in the Phase I setting the available data suggest disclosure may be better. The only study evaluating the substantive content of Phase I oncology consent forms found that 99% of 272 forms explicitly stated the study was research and that in 86% this statement was prominent.38 Furthermore, 92% indicated safety testing was the research goal. Overall, the mean length of the risks section was 35 lines in contrast with 4 lines as the average length of the benefit section; and 67% of the forms mentioned death as a potential consequence of participation in the study, whereas only 5% mentioned cure as a possible benefit. Only 1 consent form indicated that any benefits were expected. In a different study, evaluating disclosure during the physician-patient discussion in the Phase I setting, Tomamichel et al. reported that the lack of known treatments and the investigational nature of the Phase I

Satisfied Confidence in with

Awareness of benefit from informed Would

Satisfied Confidence in with

Awareness of benefit from informed Would



Sample size

Methods of evaluation

Reasons for participating

study purpose and design

enrolling in study

consent process

participate again

Rodenhuis et al.40

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Helping Your Child Learn To Read

Helping Your Child Learn To Read

When parents help their children learn to read, they help open the door to a new world. As a parent, you can begin an endless learning chain: You read to your children, they develop a love of stories and poems, they want to read on their own, they practice reading, and finally they read for their own information or pleasure. They become readers, and their world is forever expanded and enriched.

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