Though the revised edition of A Theory of Justice, published in 1999, is the definitive statement of Rawls's view, so much of the extensive literature on Rawls's theory refers to the first edition.

The concept of minimal risk has been used to regulate and limit participation by adolescents in clinical trials. It can be understood as setting an absolute standard of what risks are considered minimal or it can be interpreted as relative to the actual risks faced by members of the host community for the trial. While commentators have almost universally opposed a relative interpretation of the environmental risks faced by potential adolescent trial participants, we argue that the ethical concerns against the (...) relative standard may not be as convincing as these commentators believe. Our aim is to present the case for a relative standard of environmental risk in order to open a debate on this subject. We conclude by discussing how a relative standard of environmental risk could be defended in the specific case of an HIV vaccine trial among adolescents in South Africa. (shrink)

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

: In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective (...) interpretation). The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well. (shrink)

What is the basis for arguing that a volunteer army exploits citizens who lack civilian career opportunities? How do we determine that a doctor who has sex with his patients is exploiting them? In this book, Alan Wertheimer seeks to identify when a transaction or relationship can be properly regarded as exploitative--and not oppressive, manipulative, or morally deficient in some other way--and explores the moral weight of taking unfair advantage. Among the first political philosophers to examine this important topic from (...) a non-Marxist perspective, Wertheimer writes about ordinary experience in an accessible yet philosophically penetrating way. He considers whether it is seriously wrong for a party to exploit another if the transaction is consensual and mutually advantageous, whether society can justifiably prohibit people from entering into such a transaction, and whether it is wrong to allow oneself to be exploited. Wertheimer first considers several contexts commonly characterized as exploitive, including surrogate motherhood, unconscionable contracts, the exploitation of student athletes, and sexual exploitation in psychotherapy. In a section outlining his theory of exploitation, he sets forth the criteria for a fair transaction and the point at which we can properly say that a party has consented. Whereas many discussions of exploitation have dealt primarily with cases in which one party harms or coerces another, Wertheimer's book focuses on what makes a mutually advantageous and consensual transaction exploitive and analyzes the moral and legal implications of such exploitation. (shrink)

Though the revised edition of A Theory of Justice, published in 1999, is the definitive statement of Rawls's view, so much of the extensive literature on Rawls's theory refers to the first edition. This reissue makes the first edition once again available for scholars and serious students of Rawls's work.

In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective interpretation). (...) The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well. (shrink)

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)

In this book, Alan Wertheimer seeks to identify when a transaction or relationship can be properly regarded as exploitative--and not oppressive, manipulative, or morally deficient in some other way--and explores the moral weight of taking ...

The U.S. Federal regulations allow institutional review boards (IRBs) to approve non-beneficial pediatric research when the risks are a minor increase over minimal, provided that the research is likely to develop generalizable knowledge about the subjects' disorder or condition. This “subjects' condition” requirement is quite controversial; commentators have argued for a variety of interpretations. Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should (...) be understood. (shrink)

Clinical research with children generates special ethical concern, raising the need for additional protections beyond those for research with competent adults. Most guidelines permit research with children when it offers a prospect of direct benefit, or poses minimal risk. Unlike many other guidelines, the U.S. federal regulations also allow institutional review boards to approve pediatric research that does not offer a prospect of direct benefit when the risks are no greater than a minor increase over minimal risk. To approve research (...) in this category, IRBs must find that two additional conditions obtain:1). The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; and 2). The intervention or procedure is likely to yield generalizable knowledge about the subjects disorder or condition which is of vital importance for the understanding or amelioration of the subjects disorder or condition. (shrink)

Despite its title, Alan Wertheimer’s new book is not another tiresome exploration of Marxist economic theories. Indeed, there is virtually no extended discussion of Marxism at all, since Wertheimer believes that what is unique to that perspective is highly problematic, given that when Marxists simply assert that capitalists do exploit wage laborers they are appealing to “the ordinary notion that one party exploits another when it gets unfair and undeserved benefits from its transactions or relationships with others”. His goal is (...) to analyze this ordinary sense of exploitation, to explore in detail some of the many forms it can take, and to begin some serious thinking about what he terms its moral weight and its moral force. This groundbreaking work, the first book-length treatment of its subject from a broadly analytic standpoint, should do much to disabuse non-Marxist philosophers of the notion that exploitation is largely peripheral to the central questions of moral and political philosophy. (shrink)