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Bibliography (page 3 of 8)

Beskow, L. M., W. Burke, et al. (2001). "Informed Consent for Population-Based Research Involving Genetics." JAMA 286(18): 2315-2321.
      What follows is the abstract of a report by a group formed by the CDC to determine some rules for approaching population-based genetic research. Bridging the gap between gene discovery and our ability to use genetic information to benefit health requires population-based knowledge about the contribution of common gene variants and gene-environment interactions to the risk of disease. The risks and benefits associated with population-based research involving genetics, especially lower-penetrance gene variants, can differ in nature from those associated with family-based research. In response to the urgent need for appropriate guidelines, the Centers for Disease Control and Prevention formed a multidisciplinary group to develop an informed consent approach for integrating genetic variation into population-based research. The group used expert opinion and federal regulations, the National Bioethics Advisory Commission's report on research involving human biological materials, existing consent forms, and literature on informed consent to create suggested language for informed consent documents and a supplemental brochure. This language reflects the premise that the probability and magnitude of harm, as well as possible personal benefits, are directly related to the meaning of the results for the health of the participant and that appropriate disclosures and processes for obtaining consent should be based on an assessment at the outset of the likelihood that the results will generate information that could lead directly to an evidence-based intervention. This informed consent approach is proposed to promote discussion about how best to enable potential participants to make informed decisions about population-based research involving genetics and to suggest issues for consideration by research sponsors, institutional review boards, and investigators.

Clayton, E. W. (2003). "Ethical, Legal, and Social Implications of Genomic Medicine." N Engl J Med 349(6): 562-569.
      This excellent article describes a number of cases in which genetic information formed the basis of legal action. She described the public's worries about the availability of their genetic information to insurance companies and government agencies, its use in forensic investigations, and its use for discrimination in employment, even for medically sound reasons. She describes state regulations. She presents the dilemmas in the physician-patient relationship. Very worthwhile reading.

Clayton, E. W., K. K. Steinberg, et al. (1995). "Informed consent for genetic research on stored tissue samples." JAMA 274(22): 1786-1792.
      This somewhat dated report describes the results of a consensus development process arranged by the CDC. The diverse group involved concluded that consent was important unless samples were anonymized, that IRBs could usefully review proposals to use tissues, and that the matter was not settled.

Dickenson, D. (2004). "CONSENT, COMMODIFICATION AND BENEFIT-SHARING IN GENETIC RESEARCH." Developing World Bioethics 4(2): 109-124.
      This is a very thoughtful and interesting paper. It deals with the issues surrounding getting blood or tissue samples for genetic diagnostics and for the development of treatments for diseases. These include the lack of informedness in the consent, especially about the potential economic benefits, the commodofication of our bodies, which is somewhat distasteful and the nations of exploitation and bribery in getting samples from developing countries. There is also the question of the meaning of access to the results of the intervention.

Evers, K. (2002). "European perspectives on therapeutic cloning." N Engl J Med 346(20): 1579-82.
      The author, an ethicist, proposes extensive international regulations to protect individuals from potential abuse as a consequence of experiments in therapeutic cloning. Therapeutic cloning most likely will involvesomatic cell nuclear transfer and thus lots of donated ova. She worries about the commodification of human reproductive tissues, but does not come down for or against their use.

Fischbach, G. D. and R. L. Fischbach (2004). "Stem cells: science, policy, and ethics." J. Clin. Invest. 114(10): 1364-1370.
      Human embryonic stem cells offer the promise of a new regenerative medicine in which damaged adult cells can be replaced with new cells. Research is needed to determine the most viable stem cell lines and reliable ways to promote the differentiation of pluripotent stem cells into specific cell types (neurons, muscle cells, etc.). To create new cell lines, it is necessary to destroy preimplantation blastocysts. This has led to an intense debate that threatens to limit embryonic stem cell research. The profound ethical issues raised call for informed, dispassionate debate.
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