Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, (...) it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs. (shrink)

While the socio-ethical and legal issues surrounding clinical genetics have long been the subject of international interest, the thorny questions of genetic research and biobanking are more recent. Add to this the fact that national guidelines and laws usually precede international policymaking, and the delay in international approaches is understandable. In that regard, the United Nations Educational, Scientific and Cultural Organization’s 1997 Universal Declaration on the Human Genome and Human Rights is unique in its prospective guidance on genetic research. Also, (...) it is in the very nature of international normative instruments to be general, except on specific issues considered to be in the interest of humanity, such as research into human reproductive cloning or access to AIDS drugs. (shrink)

It is unclear whether the regulatory distinction between non-identifiable and identifiable information—information used to determine informed consent practices for the use of clinically derived samples for genetic research—is meaningful to patients. The objective of this study was to examine patients' attitudes and preferences regarding use of anonymous and identifiable clinical samples for genetic research. Telephone interviews were conducted with 1,193 patients recruited from general medicine, thoracic surgery, or medical oncology clinics at five United States academic medical centers. Wanting to know (...) about research being done was important to 72% of patients when samples would be anonymous and to 81% of patients when samples would be identifiable. Only 17% wanted to know about the identifiable scenario but not the anonymous scenario. Curiosity-based reasons were the most common among patients who wanted to know about anonymous samples. Of patients wanting to know about either scenario, approximately 57% would require researchers to seek permission, whereas 43% would be satisfied with notification only. Patients were more likely to support permission in the anonymous scenario if they had more education, were Black, less religious, in better health, more private, and less trusting of researchers. The sample, although not representative of the general population, does represent patients at academic medical centers whose clinical samples may be used for genetic research. Few patients expressed preferences consistent with the regulatory distinction between non-identifiable and identifiable information. Data from this study should cause policy-makers to question whether this distinction is useful in relation to research with previously collected clinically derived samples. (shrink)

: This essay distinguishes between two kinds of group harms: harms to individuals in virtue of their membership in groups and harms to "structured" groups that have a continuing existence, an organization, and interests of their own. Genetic research creates risks of causing both kinds of group harms, and engagement with the groups at risk can help to mitigate those harms. The two kinds of group harms call for different kinds of group engagement.

The demands of respect for persons when conducting clinical research are often reduced to respect for autonomy. In this paper, I re-examine the concept of respect for persons in light of important intuitions from our ordinary language usage of respect. I propose that there are many ways to respect persons as persons and that the core elements of respect for persons are: appreciating what is valuable or important about a person, recognizing the constraints or demands that such a valuation places (...) on one's own conduct, and acting in a way that expresses that recognition. On this account, in addition to autonomous agency, respect demands attention to important subjective experiences, persons' existence as part of communities, and considerations of comportment. This account has important implications for the conduct of clinical research with persons who are autonomous as well as with those who are not. Its implications, however, are different for these two populations, particularly with regard to concerns about well-being. (shrink)

We have a thriving biotechnology industry in the United States. There are over 1,450 biotechnology companies developing diagnostic and treatment technologies in medicine, creating more nutritional foods, and innovating new industrial processes. Yet this $28.5 billion sector of the economy is not without controversy. The “bio” in biotechnology comes from living, biological entities - people, plants, animals, and even bacteria. In the realm of biobanking, people are the source of the raw material for the discovery of genes for research, diagnosis, (...) and therapy, raising a host of issues about rights and responsibilities, fiduciary duties and societal obligations. (shrink)

We have a thriving biotechnology industry in the United States. There are over 1,450 biotechnology companies developing diagnostic and treatment technologies in medicine, creating more nutritional foods, and innovating new industrial processes. Yet this $28.5 billion sector of the economy is not without controversy. The “bio” in biotechnology comes from living, biological entities - people, plants, animals, and even bacteria. In the realm of biobanking, people are the source of the raw material for the discovery of genes for research, diagnosis, (...) and therapy, raising a host of issues about rights and responsibilities, fiduciary duties and societal obligations. (shrink)