The ethical treatment of cancer patientsparticipating in clinical trials requiresthat patients are well-informed about thepotential benefits and risks associated withparticipation. When patients enrolled in phaseI clinical trials report that their chance ofbenefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected (...) outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type can be confused with expressionsof uncertainty of the belief type. Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subservemultiple speech acts, some of which may beindirect. For example, a patient reporting ahigh expected benefit may be reporting a beliefabout the future, reassuring family members,and/or attempting to improve his or her outcome by apublic assertion of optimism. These sources oflinguistic confusion should be considered injudging whether the patient's reported expectation isgrounds for a bioethical concern that there hasbeen a failure in the informed consent process. (shrink)

When children are too young to make their ownautonomous decisions, decisions have to be madefor them. In certain contexts we allow parentsand others to make these decisions, and do notinterfere unless the decision clearly violatesthe best interest of the child. In othercontexts we put a priori limits on whatkind of decisions parents can make, and/or whatkinds of considerations they have to take intoaccount. Consent to medical research currentlyfalls into the second group mentioned here. Wewant to consider and ultimately reject one (...) ofthe arguments put forward for putting medicalresearch into the second category. We willargue that some objections to children'sparticipation in research are either based onan implausibly restrictive conception of whatis in fact in the child's best interests orthat there is an implicit and false premisehidden in this argument; i.e., the premise thatour children have so deeply fallen into moralturpitude that we must assume that they wouldnot want to fulfill their moral obligations,or, that they will grow up to be morallydeficient and will then wish not to have actedwell while a child. (shrink)

Special moral, regulatory, and scientific questions surround the inclusion of children in health-related research. These questions arise from a fundamental moral tension between the obligation to expose children to research participation to ensure that they share in the benefits that arise from it and the obligation to protect them from the harms associated with their inappropriate involvement in research. This tension is felt in the development of moral and regulatory frameworks for the protection of child research subjects and in the (...) implementation and interpretation of these frameworks by institutional review boards. (shrink)