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)

Throughout the U.S., state laws require professionals who work with children to report cases of suspected child abuse to child protection services. Both practically and conceptually, however, significant problems arise from a lack of clarity regarding the threshold that has been set for reporting. Specifically, there is no consensus as to what constitutes reasonable suspicion, and little direction for how mandated reporters should gauge their legal and professional responsibilities when they harbor suspicion. In this paper we outline the context of (...) the problem, discuss the nature and scope of its conceptual underpinnings, and offer recommendations for moving towards a concrete, practical solution. (shrink)

What are the moral stakes involved when we will have the same power to engineer our bodies as we do our automobiles? Which specific bioethics problems will put the most pressure on our ethical traditions? What should we do now to prepare for this brave new world? With Greg Loeben, Ronald Munson, and Wade Robison.