In order to provide benefits to society, human medical trials must place subjects at risk of harm. This activity is thought to be justified in part by the consent of the subjects involved. But, studies have shown that most such consents are based on a therapeutic misconception (TM); the false belief of subjects that their researchers will act as their personal physicians (seeking their benefit and protecting them from harm), rather than placing them at risk of harm for the good of others. Toleration by researchers of the TM in their subjects is a form of "informational manipulation" that renders consent procedures disrespectful to subject autonomy. Consent obtained from subjects who labor under a TM is neither voluntary nor informed; as long as they have not been disabused of the TM, the action they take in enrolling in a trial is not the one they intend nor is it autonomously chosen. Changes in consent procedures should be adopted to ensure that all subjects are aware inter alia that (a) the health interests of future patients (as well as the researchers' and their sponsors' financial interests) may be more important to researchers than the interest of a subject in his or her health, and (b) normal subjects neither understand nor believe this when told. Close attention to the response of prospective subjects to this information should allow for the exclusion of all but the truly altruistic. However, the result of conscientious implementation of such policies would likely be that human medical research could no longer be conducted on more than a minimal level.
In this article, I examine a skeptical argument against the possibility of ethically justifying risky human subject research (rHSR). That argument asserts that such research is unethical because it holds the possibility of wronging subjects who are harmed and whose consent to participate was less than fully voluntary. I conclude that the skeptical argument is not in the end sufficient to undermine the ethical foundation of rHSR because it fails to take account of the special positive duty researchers owe their clients and future patients. Although the skeptical argument is defeated, it exacts certain novel concessions from the pro-research position. Of particular importance are the admissions (a) that researchers presumptively owe a fiduciary duty to research subjects, (b) that because the most important risks of rHSR are unknown and unquantifiable that duty must be explicitly waived by all subjects before they participate in any protocol, and (c) that such waivers must be made by individuals who satisfy objective criteria of competence for giving fully voluntary consent. The implementation of procedures responsive to these concerns might have a dampening effect on the conduct of research. However, the article concludes with a consideration of the likely benefits to researchers and society of a more cautious ethical regime.
Here, a central tenet of Mahāyāna Buddhism, the doctrine of expedient means, is defended in light of the Quinian doctrine of ontological commitment. The need for such a doctrine arises because of significant disparities between Mahāyāna Buddhist teachings and those of Theravāda Buddhism, which are historically prior. In particular, the Lotus Sūtra deploys the doctrine to explain why the Buddha had taught multiple vehicles (ways to enlightenment) when there is in fact only one, the Buddha’s own way. It is argued here (1) that at least some Buddhist apologetics have been directed toward defending the Buddha against an accusation that he lied; (2) that the Lotus Sūtra does not deny that the Buddha lied, but rather that he spoke a falsehood; and (3) that although it is unclear whether the Buddha can be defended against an accusation of lying, it is provable that he spoke no falsehood in preaching multiple vehicles. The proof depends on the logical regimentation of Mahāyāna and Theravāda views as formal languages with disparate discriminative resources. On this basis strict limits can be derived for the number of vehicles to which the users of each language are ontologically committed. The upshot is that the Mahāyāna Buddhist can claim that her theory supersedes the earlier teachings without having to deny the truth of those teachings; they were true because they were assertible in the theory of enlightenment in which they were originally presented.
Many bioethical arguments rely implicitly on the assumption that the concept of "human part" is one on which everyone must agree, because it is unambiguous. But various parties interpret this "unambiguous" term in incompatible ways, leading to contention. This article is an informal presentation of a topomereological system on whose preferred interpretation several distinct but related meanings of "human part" can be isolated: part of a human body, part of the completion of a human body, and part of a human being. A case is analyzed (the first total artificial heart (TAH) implantation), demonstrating in the process much of the apparatus of the system. By means of a casuistic methodology, the analysis is translated into recommendations for the ethical conduct of future TAH research. The more general conclusion, however, is that formal methods may provide useful tools for clarifying thought processes and organizing arguments in debates over bioethical issues.
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