Next SectionObjectives To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. Methods The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, (...) interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. Results The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. Conclusions This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required. Clinical trial registration number ClinicalTrials.gov Identifier NCT00899392. (shrink)

Institutional review boards and researchers have struggled to ensure that subjects receive sufficient information to make knowledgeable decisions about study participation. But the quality of the consent forms that are a key component of this process has rarely been evaluated. We reviewed 215 consent forms approved by an IRB serving a major academic department from 1978–2002 and discovered two trends: greater consistency in the description of risks, and an increase in the length of consent forms. However, despite data indicating that (...) length and comprehension are inversely related, length of consent forms increased linearly. The findings demonstrate the dilemma in attempting to provide information on consent forms that is simultaneously accurate and concise. (shrink)

Although written consent forms are standard in clinical research, there is little regulatory or empirical guidance regarding how to most effectively review consent forms with potential participants. We developed an algorithm for embedding five questions with corrective feedback while reading consent forms with potential participants, and then applied it in the context of seven clinical research studies. A substantial proportion of participants within each protocol displayed initially inadequate responses to at least one question, but after the protocol elements were explained (...) again, most people demonstrated adequate understanding of them. These data illustrate the need for more attention not just to the content of consent forms, but also to the manner in which the forms are incorporated into the consent process. Embedding explicit inquiries about key protocol elements during consent form review and giving corrective feedback appears to be a simple yet effective way to foster better understanding of disclosed information. (shrink)