Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out (...) direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

ABSTRACTA number of problems plague universal declarations. To the extent that those drafting and adopting the declaration represent a range of different views, consensus can only be obtained if the declaration makes minimalist claims that all can support, or makes claims that are vague enough that they can be interpreted to everybody's satisfaction. To the extent that a universal declaration avoids these problems, and takes an unequivocal and controversial stand, it does so by privileging the view that is hegemonic . (...) After discussing these problems I ask whether such declarations could nonetheless do any good. (shrink)

A dispute exists about whether bioethics should become a new discipline with its own methods, competency standards, duties, honored texts, and core curriculum. Unique expertise is a necessary condition for disciplines. Using the current literature, different views about the sort of expertise that might be unique to bioethicists are critically examined to determine if there is an expertise that might meet this requirement. Candidates include analyses of expertise based in "philosophical ethics," "casuistry," "atheoretical or situation ethics," "conventionalist relativism," "institutional guidance," (...) "regulatory guidance and compliance," "political advocacy," "functionalism," and "principlism." None succeed in identifying a unique area of expertise for successful bioethicists that could serve as a basis for making it a new discipline. Rather expertise in bioethics is rooted in many professions, disciplines and fields and best understood as a second-order discipline. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks (...) of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)

In his article 'Specifying, balancing and interpreting bioethical principles' (Richardson, 2000), Henry Richardson claims that the two dominant theories in bioethics - principlism, put forward by Beauchamp and Childress in Principles of Bioethics , and common morality, put forward by Gert, Culver and Clouser in Bioethics: A Return to Fundamentals - are deficient because they employ balancing rather than specification to resolve disputes between principles or rules. We show that, contrary to Richardson's claim, the major problem with principlism, either the (...) original version, or the specified principlism of Richardson, is that it conceives of morality as being composed of free-standing principles, rather than as common morality conceives it, as being a complete public system, composed of rules, ideals, morally relevant features, and a procedure for determining when a rule can be justifiably violated. (shrink)

ABSTRACT The Universal Draft Declaration on Bioethics and Human Rights seeks to provide moral direction to nations and their citizens on a series of bioethical concerns. In articulating principles, it ranks respect for human rights, human dignity and fundamental freedoms ahead of respect for cultural diversity and pluralism. This ranking is controversial because it entails the rejection of the popular theory, conventionalist ethical relativism. If consistently defended, this theory also undercuts other United Nations activities that assume member states and people (...) around the world can reach trans‐cultural judgments having moral authority about health, pollution, aggression, rights, slavery, and so on. To illustrate problems with conventionalist ethical relativism and the importance of rejecting it for reasons of health, human rights, human dignity and fundamental freedoms, the widespread practice of female genital circumcision or cutting is discussed. These surgeries are virtually a test case for conventionalist ethical relativism since they are widely supported within these cultures as religious and health practices and widely condemned outside them, including by the United Nations. (shrink)

In a recent issue of The Lancet, the historian Roger Cooter predicted that the field of bioethics will soon die of self-inflicted wounds. “Conspiring against it,” he wrote, “is exposure of the funding of some of its US centres by pharmaceutical companies; exclusion of alternative perspectives from the social sciences; retention of narrow analytical notions of ethics in the face of popular expression and academic respect for the place of emotions; divisions within the discipline ; and collusion with, and appropriation (...) by, clinical medicine.” Cooter's prognosis? “Hardly wet behind the ears, bioethics seems destined for a short lifespan.”. (shrink)

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science, and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions. Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks (...) of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved. (shrink)