: This paper examines informed consent in relation to research involving the newly dead. Reasons are presented for facilitating advance decision making in relation to postmortem research, and it is argued that the informed consent of family members should be sought when the deceased have not made a premortem decision. Regardless of whether the dead can be harmed, there are two important respects in which family consent can serve to protect the dead: (1) protecting the deceased's body from being used (...) for research that is incompatible with the person's premortem preferences and values and (2) protecting the deceased's body from being subject to disrespectful treatment. These claims are explained and justified, and several objections are critically examined. Additional reasons for securing family consent are presented including to protect them from additional emotional distress, to respect their wishes about wanting to have a say, and to maintain public trust in the medical profession and medical research. The paper also examines the scope of disclosure in relation to postmortem research. (shrink)

In a provocative 1974 article entitled “Harvesting the Dead,” Willard Gaylin explored potential uses of “neomorts,” or what are currently referred to as “heart-beating cadavers”—that is, humans determined to be dead by neurological criteria and whose cardiopulmonary function is medically maintained by ventilators, vasopressors, and so forth. Medical research was one of the potential uses Gaylin identified. He pointed out that tests of drugs and medical procedures that would have unacceptable health risks if performed on living human subjects could be (...) performed on neomorts without any health risks. According to Gaylin, the potential benefits of such research could be enormous, including not subjecting patients to ineffective or harmful medical procedures and eliminating delays in providing effective therapies to dying patients. (shrink)

Principlism has been advocated as an approach to resolving concrete cases and issues in bioethics, but critics have pointed out that a main problem for principlism is its lack of a method for assigning priorities to conflicting ethical principles. A version of principlism referred to as 'specified principlism' has been put forward in an attempt to overcome this problem. However, none of the advocates of specified principlism have attempted to demonstrate that the method actually works in resolving detailed clinical cases. (...) This paper shows that when one tries to use it, specified principlism fails to provide practical assistance in deciding how to resolve concrete cases. Proponents of specified principlism have attempted to defend it by arguing that it is superior to casuistry, but it can be shown that their arguments are faulty. Because of these reasons, specified principlism should not be considered a leading contender in the search for methods of making justifiable decisions in clinical cases. (shrink)

So-called ‘anonymous’ tissue samples are widely used in research. Because they lack externally identifying information, they are viewed as useful in reconciling conflicts between the control, privacy and confidentiality interests of those from whom the samples originated and the public (or commercial) interest in carrying out research, as reflected in ‘consent or anonymise’ policies. High level guidance documents suggest that withdrawal of consent and samples and the provision of feedback are impossible in the case of anonymous samples. In view of (...) recent developments in science and consumer-driven genomics the authors argue that such statements are misleading and only muddle complex ethical questions about possible entitlements to control over samples. The authors therefore propose that terms such as ‘anonymised’, ‘anonymous’ or ‘non-identifiable’ be removed entirely from documents describing research samples, especially from those aimed at the public. This is necessary as a matter of conceptual clarity and because failure to do so may jeopardise public trust in the governance of large scale databases. As there is wide variation in the taxonomy for tissue samples and no uniform national or international standards, the authors propose that a numeral-based universal coding system be implemented that focuses on specifying incremental levels of identifiability, rather than use terms that imply that the reidentification of research samples and associated actions are categorically impossible. (shrink)

Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important (...) by far is the power of information technology, which has transformed our lives in almost every domain. In the research setting, it is now easy to abstract information from electronic medical records. Computers make it possible to analyze enormous datasets and have contributed in essential ways to the dramatic increases in our understanding of genomics and other areas of biomedical science. (shrink)

Biomedical research has always relied on access to human biological materials and clinical information, resources that when combined form biobanks. In the past, it appears that investigators sometimes used these resources with relatively little oversight, and without the consent of the individuals from whom these materials and information were obtained. Several developments in the last ten to fifteen years have converged to place greater emphasis on the role of individual consent in the creation and use of biobanks. The most important (...) by far is the power of information technology, which has transformed our lives in almost every domain. In the research setting, it is now easy to abstract information from electronic medical records. Computers make it possible to analyze enormous datasets and have contributed in essential ways to the dramatic increases in our understanding of genomics and other areas of biomedical science. (shrink)