Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

DNA identification methods are such an established part of our law enforcement and criminal justice systems it is hard to believe that the technologies were developed as recently as the mid-1980s, and that the databases of law enforcement profiles were established in the 1990s. Although the first databases were limited to the DNA profiles of convicted rapists and murderers, the success of these databases in solving violent crimes provided the impetus for Congress and state legislatures to expand the scope of (...) the databases with little critical examination of each expansion's value to law enforcement or cost to privacy and civil liberties.We are now entering a new stage of DNA forensics, in which successive database expansions over the last decade have raised the possibility of creating a population-wide repository. In addition, new applications of DNA profiling, including familial and low stringency searches, have been added to DNA dragnets, the use of medical samples for forensic analysis, and other measures to create a series of crucial, yet largely unexplored, second-generation legal and policy issues. (shrink)

As forensic techniques continue to improve, reports on the success of the police in using DNA analysis for solving past and present criminal cases are becoming an everyday occurrence in the media. There are two avenues by which police can collect and obtain access to DNA samples. The first is on the basis of legislation that allows the police to forcibly collec t samples in some situations. The second is through an access order granted by the court, which allows access (...) to samples from existing collections held by other parties. The purpose of this paper is to compare these two legal mechanisms that allow the police to acquire and access DNA samples. My concern is the increase in collection of DNA samples for genetic research, the moves to standardise data collection and the computerisation of medical records, may make research collections more attractive to the police. Are we are prepared for research collections to become an extension of the National DNA Database used for crime detection? In the USA a decision has been made that the police should not be allowed access to samples and information derived from ‘sensitive’ research. This article considers ‘the certificates of confidentiality’ that have been instigated by the National Institute of Health in the USA in order to prohibit such uses of research collections by the police. In this article I consider whether certificates of confidentiality should be used in the UK, as a way of providing greater protection to researchers and participants in research. (shrink)

This is the third volume of Joel Feinberg's highly regarded The Moral Limits of the Criminal Law, a four-volume series in which Feinberg skillfully addresses a complex question: What kinds of conduct may the state make criminal without infringing on the moral autonomy of individual citizens? In Harm to Self, Feinberg offers insightful commentary into various notions attached to self-inflicted harm, covering such topics as legal paternalism, personal sovereignty and its boundaries, voluntariness and assumptions of risk, consent and its counterfeits, (...) coercive force, incapacity, and choice of death. (shrink)

Most regulations and guidelines require that potential research participants be told a great deal of information during the consent process. Many of these documents, and most of the scholars who consider the consent process, assume that all this information must be disclosed because it must all be understood. However, a wide range of studies surveying apparently competent participants in clinical trials around the world show that many do not understand key aspects of what they have been told. The standard view (...) of the conditions for valid consent therefore implies that these people have failed to give valid consent to research participation. In this paper we argue that the standard view is false. The primary function of the requirement that researchers disclose information about a study is the avoidance of illegitimate control over someone’s consent decision, which is a form of fraud.We derive the content and manner of appropriate disclosure by analysing the ways in which the manipulation of information can invalidate consent. Our analysis shows that the informational requirements for valid consent are conceptually distinct and thus unlikely to have identical contents. This implies that consent can be valid when not everything that ought to be disclosed by the person asking for consent is understood by the person who proffers it. (shrink)

New technology generates fantastic possibilities which challenge traditional distinctions between good and bad. Genetic analysis of DNA for forensic purposes is but one example of this. Here society’s need for convicting criminals can conflict with the same society’s need to assure the confidentiality of information about its members and their trust in its institutions. In order to illustrate the complexity of such challenges, a case report from Norway is presented. The point is to reflect on the way we handle trailblazing (...) health technologies in general and on cases where law and order is gained by means that can be conceived of as immoral in particular. The case calls for careful ethical reflection. (shrink)

The discovery of the molecular structure of deoxyribonucleic acid and the science of molecular biology have profoundly changed medicine’s diagnostic capability and promise to transform the therapeutic realm. When some genetic disorders are diagnosed, physicians can intervene for prevention or treatment. While the basic structure of DNA is the same for all human beings, no two individuals, other than identical twins, have the same DNA sequence. This discovery has had important repercussions in the criminal justice system, where DNA can serve (...) as an identification tool.At the crossroads of these different uses of DNA, there are great concerns about potential misuses of genetic information. Preventing disease, curing illness, and convicting criminals are all seen as worthwhile uses of the technology, but concerns of potential misuse in medicine or in the criminal justice system are not unfounded. A 1998 American Medical Association study showed that 68 percent of patients had fears that their genetic test results would be used against them by their employers or insurers. Others, pointing to racial profiling, have suggested that we may now face genetic profiling. (shrink)