This Week in CGREAL

a newsletter of the Center for Genetic Research Ethics & Law in the Department of Bioethics, Case Western Reserve University

August 27 , 2007 

Home * Genetics in the News * Genetics in the Literature * Archive

Genetics in the News

Death Points to Risks in Research (Washington Post) "One Woman's Experience in Gene Therapy Trial Highlights Weaknesses in the Patient Safety Net ..." [Related: Gene Therapy Trial Death Caused by Massive Infection (Wired) "Until the therapies are better understood, even these few trials are too many. ..."]

Modern Medical Research Rests on a Bunch of Inbred Mice (Wired) "Beyond drugs, the greatest value of new, diverse mice may be in genetics. Scientists have tried to link mouse genes to disease or behavior and then translate those discoveries to people, with limited success. ..."

UF, French scientists seek test to detect gene doping in athletes (Univeristy of Florida News) "UF scientists are among several groups collaborating with national and global anti-doping organizations to develop a test that could detect evidence of doped DNA. .." [Related: Why not let doping close the gene gap? (The Japan Times Online) "The problem is not with the athletes, but with us. We cheer them on. We acclaim them when they win. ..."]

A guilty secret from a patient's past (Los Angeles Times) "Decades ago, he had conducted unethical experiments. Now, near his own death, he wanted to confess. ..."

Regulatory folly vs. judicial whimsy (The Washington Times) "The case of Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach pitted regulatory folly against judicial whimsy. ..."

U.S. military practices genetic discrimination in denying benefits (Los Angeles Times) "Those medically discharged with genetic diseases are left without disability or retirement benefits. Some are fighting back. ..."

American College of Medical Genetics responds to new FDA labeling decision for warfarin "ACMG releases comprehensive review of genetic testing and warfarin dosing ..."

The age of endarkenment (Guardian ) "Why is no one questioning the rise of new-age nonsense in the name of science ..."

Genome Boy " In 2007 I became the fourth subject in Harvard geneticist George Church's Personal Genome Project. As the PGP moves forward, I am chronicling the dawn of personal genomics, that is, people obtaining their genomic information for whatever reason(s) and figuring out what to do with it. ..."

Is death by old age a myth? (Dallas Morning News) "At the federal level, old age is not considered a cause of death. Organs wear down, diseases catch up; there's always a specific reason for a person's death. ..." [Related: Researchers use novel approach to uncover genetic components of aging "People who live to 100 or more have just as many and sometimes even more harmful gene variants compared with younger people. Now, scientists discovered the secret behind this paradox:. ..."Preventive treatments in elderly people needs rethinking "Rather than prolonging life, preventive treatments in elderly people may simply change the cause of death the manner of our dying. ..."]

Personalized Stem Cell Lines Available Through Leading Fertility Clinics"StemLifeLine will now offer individuals who have undergone in vitro fertilization (IVF) the opportunity to use s service to develop personal stem cell lines from their unused, stored embryos. ..."

Picky Eating May Be Genetic "If your kids fear unfamiliar foods, don't blame your parenting -- blame your genes. ..."

Spending On Direct-To-Consumer Advertising By Pharmaceutical Companies More Than Triples In Past Decade "Spending on direct-to-consumer advertising by the pharmaceutical industry has increased dramatically over the past decade despite a growing chorus of criticism and regulatory actions leveled against it. ..."

DOES THE ETHICS BUREAUCRACY POSE A THREAT TO CRITICAL RESEARCH? "The concerns I raise here are not with research ethics as such, but with bureaucracies that have gone awry in well-intentioned but misguided efforts to supervise research in politics and public policy. ..."

Personal-genetics startup Navigenics unstealths "Navigenics essentially intends to get people to have their genomes scanned in a rough-and-ready fashion in other words, they ll scan your genes with chips that look for single-letter variations in the genetic code, instead of laboriously reading it out letter by letter and then to match up what they find with the latest information on the diseases to which your genes might predispose you. ..." [Related: 23andMe and Illumina Forge Consumer Genomics Goliath"23andMe and Illumina have struck a bellwether deal in the fledgling field of consumer genotyping. ..."]

The a-China DNA Project "We are a collection of families just like you who have adopted our children from China and have a keen interest in their physical, emotional, social, and intellectual health and well being. We want to explore whether establishing an a-China DNA database will be beneficial to them in both the short and long terms. ..."

Antioxidant overload may underlie a heritable human disease "Despite the popular notion that antioxidants, such as vitamins C and E, offer health-promoting benefits by protecting against damaging free radicals, a new study reveals that, in fact, balance is the key.. ..." [Related: In limiting life span, study finds booming bacteria innocent]

deCODE discovers cause of major subtype of glaucoma "deCODE reports the discovery of two common single letter variations (SNPs) in the sequence of the human genome that appear to account for virtually all cases of a major subtype of glaucoma. ..."

Military to study better pain relief in battle zones "University of Michigan scientists win $1.3M grant to create and test nanoparticles that may deliver morphine to wounded soldiers faster and more safely ..."

New databases put wings on search for bipolar risk genes "A novel, free, public online database opening this week should greatly speed efforts to find genes linked to increase risk of bipolar disorder. ..."

 

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Genetics in the Literature

 

The AAAS Scientific Freedom Responsibility and Law Program, Human Enhancement and the Means of Achieving It "Human Enhancement can be used to augment any number of human functions and features. The means to HE are as diverse as the possible enhancements themselves. ..."

(2007). Symposium on Censorship and Institutional Review Boards. Northwestern University Law Review."On April 6 and 7, 2006, nearly two dozen scholars from around the country gathered at the Northwestern University School of Law to discuss “Censorship and Institutional Review Boards.” The views at the conference ranged from strong advocacy for the existing regulatory scheme to calls for its abolition, with most scholars falling somewhere in between. This special issue is an account of parts of this debate—as told by supporters and opponents alike—which, we hope, will inform theunderstanding of an institution that has rearranged traditional notions of academic freedom...."

(2007). "Autism Speaks: the United States pays up." Nature 448(7154): 628-629. "a US public-relations success that is driving research funds and expertise towards this childhood condition, and asks who is missing out ..."

(2007). "Clinical precision." Nature 448(7154): 623-624. "Disease advocates should influence, but not dictate, research priorities. ..."

(2007). "Innovation versus science?" Nature 448(7156): 839-839.

(2007). "The Metabolomics Standards Initiative." Nat Biotech 25(8): 846-848.

(2007). "Patenting the parts." Nat Biotech 25(8): 822-822. "Despite hand-wringing over the patenting of a minimized organism, both patents and open-source approaches will be needed to promote innovation and research progress in synthetic biology. ..."

Ainsworth, C. (2007). "Let down by the statistics." Nature 448(7156): 849-849.

Avent, N. D., A. Martinez, et al. (2007). "The BloodGen project: toward mass-scale comprehensive genotyping of blood donors in the European Union and beyond." Transfusion 47(1 Suppl): 40S-6S.

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Batt, S. (2007). "Limits on Autonomy: Political Meta-Narratives and Health Stories in the Media." The American Journal of Bioethics 7(8): 23 - 25.

Bledsoe, C. H., B. Sherin, et al. (2007). "Regulating Creativity: Research and Survival in the IRB Iron Cage." Northwestern University Law Review 101(2)"One could scarcely imagine a better example of a bureaucracy of the kind that so fascinated and infuriated Weber than the contemporary IRB system. ..."

Bolton, L. E., A. Reed, et al. (2007). "How Does Drug and Supplement Marketing Affect a Healthy Lifestyle?" Journal of Consumer Research 34. "A series of experiments provides evidence that drug marketing undermines intentions to engage in health-protective behaviors (i.e., a boomerang effect). ..."

Bortolotti, L. and B. Heinrichs (2007). "Delimiting the concept of research: an ethical perspective." Theoretical Medicine and Bioethics 28(3): 157-179. "We attempt to offer such an account, arguing that we need to consider both the procedural and functional dimensions of an activity before we can establish whether it is a genuine instance of scientific research. By placing research in a broader schema of activities, the similarities and differences between research activities and other activities become visible. We argue that, whether they be research or not, all the activities that are likely to affect the rights and interests of the individuals involved and impact on the rights and interests of other individuals raise ethical issues and might be in need of ethical regulation. ..."

Bradbury, A. R., J. J. Dignam, et al. (2007). "How Often Do BRCA Mutation Carriers Tell Their Young Children of the Family's Risk for Cancer? A Study of Parental Disclosure of BRCA Mutations to Minors and Young Adults." J Clin Oncol 25(24): 3705-3711. "This study describes the prevalence and experiences of parental communication of BRCA results to children under the age of 25 years old. Children of BRCA mutation carriers learn of their parents genetic test results many years before preventive interventions are indicated. Further research is needed to examine how young individuals understand this information and its psychosocial impact and influence on subsequent lifestyle and health behaviors. ..."

Burris, S. and J. Welsh (2007). "Regulatory Paradox: A Review of Enforcement Letters Issued by the Office for Human Research Protection." Northwestern University Law Review 101(2)."The heart of the problem is the paradoxical scheme of embedding virtue in federal regulations, and then constructing an enforcement system that purports to encourage reflection and deliberation but must in practice enforce procedural diligence and paperwork. ..."

Cambon-Thomsen, A., E. Rial-Sebbag, et al. (2007). "Trends in ethical and legal frameworks for the use of human biobanks." Eur Respir J 30(2): 373-382. "The use of biobanks is increasing and raises several ethical issues. What are the ethical trends and legal frameworks in the post-genomic era? Different levels and modalities of dealing with such issues are identified and vary from legally binding measures to "soft" regulations, such as ethical recommendations by various committees or professional organisations. A further level of complexity appears with the increasing international dimension of such activities in a context in which national positions vary on those topics. There is a tension between a necessary level of diversity in ethical positions and an indispensable common pedestal of principles and procedures to manage these issues in order to foster research. Current legal and ethical trends favour the facilitation of secondary use of samples, more biobank openness, balanced with a growing attention to dialogue and public/stakeholder consultation, an increased role for research ethics committees and more sophisticated data protection and governance structures. ..."

Cardona, B. (2007). "Anti-Aging Medicine and the Cultural Context of Aging in Australia." Ann NY Acad Sci: annals.1396.000. "This paper explores the management of the body in the anti-aging discourse and its implications on notions of "successful" and "healthy" aging policies. By looking at some of the preliminary findings of an ongoing study of anti-aging medicine in Australia, including interviews conducted with stakeholders in the anti-aging debate, this study explores some recurrent values and perceptions regarding anti-aging medicine, the renegotiation of boundaries between illness and health and the social, cultural and economic forces shaping understandings and practices around aging and the consumption of anti-aging technologies. ..."

Carlson, J. (2007). "Biobanking and biorepositories: looking to the future." Personalized Medicine 4(3): 369-371.

Chan, J., S. F. Knutsen, et al. (2007). "Feasibility of Running Clinics to Collect Biological Specimens in a Nationwide Cohort Study--Adventist Health Study-2." Annals of Epidemiology 17(6): 454-457. "Purpose Collecting biologic and questionnaire data allows analyses that can include both genetic/biomarker and behavioral factors. Therefore, the feasibility of collecting biological specimens from a nationally dispersed cohort (Adventist Health Study-2) was tested. We have demonstrated the feasibility of collecting biological specimens from black as well as nonblack subjects, with an efficient, cost-effective system, and limited personpower, overcoming many of the complexities imposed by scattered subjects, diversity of culture, as well as cumbersome and varied state legislation governing clinics and clinic personnel. ..."

Charrow, R. (2007). "Protection of Human Subjects: Is Expansive Regulation Counter-Productive?" Northwestern University Law Review 101(2)."The article questions whether a grantee’s voluntary commitment to apply federal rules to all of its research, irrespective of the funding source, is enforceable, both as a matter of simple contract law and under the Anti-Deficiency Act. Second, the article highlights some of the ambiguities of the current rules, such as what constitutes “research” and when “research” begins. These two sets of issues highlight the inherent tension between those who believe that regulation of science is appropriate and can only serve to enhance the scientific enterprise and those, such as myself, who believe that science can only thrive in an environment relatively free of regulatory hurdles and that prophylactic regulation is to be avoided unless one can empirically demonstrate that private remedies are inadequate. ..."

Chen, L.-S. P. C. and P. P. Goodson (2007). "Public Health Genomics knowledge and attitudes: A survey of public health educators in the United States." Genetics in Medicine 9(8): 496-503."This study assessed U.S. public health educators' attitudes toward genomic competencies, their awareness of efforts in the health promotion field to promote/incorporate genomics, and their basic & applied genomic knowledge.Although this sample of public health educators had unfavorable attitudes and limited genomic knowledge, training seems to affect these variables. . ..."

Coe, F. L. (2007). "The costs and benefits of a well-intended parasite: a witness and reporter on the IRB phenomenon." Northwestern University Law Review 101(2): 723-733.  "Time and work to save subjects from harm is, in fact, a simple equation: a balance of work and saving. Here is the center of the IRB controversy. How much work? How much saving? And, more importantly, saving from what? It must be evident already that I intend to offer a diatribe, unbridled animosity—that I intend an old-fashioned broadside such as has been thrown against—in ages past—a smug and oppressive ruling class that feeds off those it can control. ..."

Dash, L. (2007). "Journalism and Institutional Review Boards." Qualitative Inquiry 13(6): 871-874. "The author opposes any Institutional Review Boards (IRBs) overseeing the work of journalism professors and journalism students in any academic institution. He argues that the tendency for IRBs to require anonymity for persons interviewed immediately reduces the credibility of any journalistic story. The composition of an IRB is questioned on grounds that its faculty and public members may be uncomfortable with the thrust of a journalistic inquiry and, in reaction, thwart the intention of a journalist by refusing approval. The medical human subject IRB model of oversight is supported, but the author is perplexed how this medical model has awkwardly extended into such areas a social science. . ..."

Davis, D. S. (2007). "The Changing Face of "Misidentified Paternity"." Journal of Medicine and Philosophy 32(4): 359 - 373. "Advances in genetic research and technology can have a profound impact on identity and family dynamics when genetic findings disrupt deeply held assumptions about the nuclear family. Ancestry tracing and paternity testing present parallel risks and opportunities. As these latter uses are now available over the internet directly to the consumer, bypassing the genetic counselor, consumers need adequate warning when making use of these new modalities. ..."

De Grey, A. D. N. J. "The Case for Prioritizing Research on Late-Onset Life-Extension Interventions in Mammals." Rejuvenation Research 0(0): 1-3.

Dumas, L., Y. H. Kim, et al. (2007). "Gene copy number variation spanning 60 million years of human and primate evolution." Genome Res.: gr.6557307. "Given the evolutionary importance of gene duplication to the emergence of species-specific traits, we have extended the application of cDNA array-based comparative genomic hybridization (aCGH) to survey gene duplications and losses genome-wide across 10 primate species, including human. Many of the genes identified here are likely to be important to lineage-specific traits including, for example, human-specific duplications of the AQP7 gene, which represent intriguing candidates to underlie the key physiological adaptations in thermoregulation and energy utilization that permitted human endurance running. ..."

Erwin, P. B. (2007). "Foundations, promises and uncertainties of personalized medicine." Mount Sinai Journal of Medicine: A Journal of Translational and Personalized Medicine 74(1): 15-21. "This information underlies a new healthcare strategy focused on prevention and early intervention, rather than reaction to advanced stages of disease. Such a strategy can delay disease onset or minimize symptom severity. However, the uncertainties for personalized medicine are considerable, including economic, ethical, legal, and societal questions. Although much of its promise remains unproven to date, the foundations of personalized medicine appear solid and evidence is accumulating rapidly pointing to its growing importance in healthcare . ..."

Fisher, J. A. (2007). ""Ready-to-Recruit" or "Ready-to-Consent" Populations? Informed Consent and the Limits of Subject Autonomy." Qualitative Inquiry 13(6): 875-894. "This article queries the pharmaceutical industry's concept of "ready-torecruit" populations by examining its recruitment strategies for clinical trials and the types of human subjects who participate in these drug studies. The argument is that the pharmaceutical industry has profited from a system composed of what can more aptly be characterized as ready-to-consent populations, meaning populations who do not have better alternatives than participation in clinical trials. Furthermore, through qualitative research, this article aims to highlight some of the limitations of current U.S. federal regulation and to show how these limits signal problems that are not normally discussed in the medical ethics literature about research on human subjects. It does this by examining the impotence of informed consentboth as a concept and as a practicein light of recruitment strategies and the structural reasons motivating individuals to participate in clinical trials. ..."

Flicker, S., R. Travers, et al. (2007). "Ethical Dilemmas in Community-Based Participatory Research: Recommendations for Institutional Review Boards." Journal of Urban Health 84(4): 478-493. "We conducted a content analysis of forms and guidelines commonly used by institutional review boards (IRBs) in the USA and research ethics boards (REBs) in Canada. Our intent was to see if the forms used by boards reflected common CBPR experience. Results show that ethical review forms and guidelines overwhelmingly operate within a biomedical framework that rarely takes into account common CBPR experience. Consequently, IRBs and REBs may be unintentionally placing communities at risk by continuing to use procedures inappropriate or unsuitable for CBPR. . ..."

Hamburger, P. (2007). "Getting Permission." Northwestern University Law Review 101(2)."In sum, although the unconstitutionality of the IRB laws should be evident enough when one stands on the narrow constitutional point about licensing, it becomes all the more disturbingly clear when one extends one’s vision across the landscape of modern life out toward the wide horizons of scientific knowledge. ..."

Hansson, M. G., G. Helgesson, et al. (2007). "Commentary: Isolated Stem Cells--Patentable as Cultural Artifacts?" Stem Cells 25(6): 1507-1510. "This article argues that an isolated embryonic stem cell basically represents a cultural artifact that has no equivalent to cells of the embryo, and that it is likely that the isolation of adult stem cells has a similar consequence. An isolated stem cell could thus be distinguished as something other than the stem cell existing as part of a human body. Questions of morality, which may affect the patentability, should also be viewed in light of the distinction between isolated result and body part. At the same time, it is essential that patent authorities do not accept broad patent claims that will be detrimental to research. . ..."

Hashiloni-Dolev, Y. and S. Shkedi "On new reproductive technologies and family ethics: Pre-implantation genetic diagnosis for sibling donor in Israel and Germany." Social Science & Medicine In Press, Corrected Proof. "This paper discusses the policy debate and ethical discussion surrounding pre-implantation genetic diagnosis (PGD) for sibling donor (SD) in Germany and Israel. Based on an analysis of the regulations and ethical discourse concerning a unique form of new reproductive technology (NRT)--PGD for SD--we complement the scholarly discussion of NRTs in these countries, by pointing to an explanatory factor that has been so far neglected, namely the hegemonic notions regarding the ideal relationship between the generations, and the mutual obligations between different family members in Germany and Israel.. ..."

Hofmann, B. (2007). "That’s Not Science! The Role of Moral Philosophy in the Science/Non-science Divide." Theoretical Medicine and Bioethics 28(3): 243-256 "The science/non-science distinction has become increasingly blurred. This paper investigates whether recent cases of fraud in science can shed light on the distinction. Although this does not mean that ethics can save the life of science, it can play a significant role in its resuscitation. ..."

Holland, K. (2007). "The Epistemological Bias of Ethics Review: Constraining Mental Health Research." Qualitative Inquiry 13(6): 895-913. "This article investigates the concerns of a university research ethics committee in rejecting an application to interview people diagnosed with a mental illness. The paternalistic and medically derived concerns reflect assumptions about mental illness that are challenged by first-person perspectives, social movements in mental health, and newly emerging work within postpsychiatry. . ..."

Holm, S. (2007). "A rose by any other name... Is the research / non-research distinction still important and relevant?" Theoretical Medicine and Bioethics 28(3): 153-155...."

Holm, S. and L. Bortolotti (2007). "Large Scale Surveys for Policy Formation and Research–a Study in Inconsistency." Theoretical Medicine and Bioethics 28(3): 205-220. "In this paper we analyse the degree to which a distinction between social science and public health research and other non-research activities can account for differences between a number of large scale social surveys performed at the national and European level. The differences we will focus on are differences in how participation is elicited and how data are used for government, research and other purposes. . ..."

Hunter, D. (2007). "Proportional ethical review and the identification of ethical issues." J Med Ethics 33(4): 241-245. "Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted. ..."

Iredale, R., G. Elwyn, et al. (2007). "Attitudes of genetic clinicians in Wales to the future development of cancer genetics services." Journal of Evaluation in Clinical Practice 13(1): 86-89 " As demand for cancer genetics services continues to increase, some consensus about the future delivery of such services is necessary. Consultation with other stakeholder groups, especially primary care practitioners and patients, should also contribute to service planning. ..."

Kaiser, J. (2007). "ALAN KRENSKY INTERVIEW: Drawing a Map for the Twenty-Seven Divisions in NIH's Army." Science 317(5840): 887-.

Katzman, S., A. D. Kern, et al. (2007). "Human Genome Ultraconserved Elements Are Ultraselected." Science 317(5840): 915-. "The reason for this extreme conservation remains a mystery. It has been speculated that they are mutational cold spots or regions where every site is under weak but still detectable negative selection. However, analysis of the derived allele frequency spectrum shows that these regions are in fact under negative selection that is much stronger than that in protein coding genes. ..."

Kaye, C. I. M. D. P., J. M. Livingston, et al. (2007). "Assuring clinical genetic services for newborns identified through U.S. newborn screening programs." Genetics in Medicine 9(8): 518-527."The study purpose was to determine whether U.S. newborn screening and/or genetics programs systematically document whether newborns and their families, identified with genetic disorders through newborn dried blood spot screening, receive clinical genetic services. Systematic tracking of clinical genetic services for newborns identified by newborn screening programs is desirable and manageable. Recent national guidelines recommend tracking genetic counseling in newborn screening follow-up. ..."

Keymolen, K., V. Goossens, et al. (2007). "Clinical outcome of preimplantation genetic diagnosis for cystic fibrosis: the Brussels' experience." Eur J Hum Genet 15(7): 752-758...."

Klein, R. D. (2007). "Gene patents and personalized medicine." Personalized Medicine 4(3): 237-241.

Kopelman, L. M. (2007). "Using the Best Interests Standard to Decide Whether to Test Children for Untreatable, Late-Onset Genetic Diseases." Journal of Medicine and Philosophy 32(4): 375 - 394. "A new analysis of the Best Interests Standard is given and applied to the controversy about testing children for untreatable, severe late-onset genetic diseases, such as Huntington's disease or Alzheimer's disease. Using this standard, support is given for the professional consensus based on concerns about discrimination, analogies to adult choices, consistency with clinical judgments for adults, and desires to preserve of an open future for children. Support is also given for parents' legal authority to decide what genetic tests to do. ..."

Liu, H., M. M. Fergusson, et al. (2007). "Augmented Wnt Signaling in a Mammalian Model of Accelerated Aging." Science 317(5839): 803-806."The contribution of stem and progenitor cell dysfunction and depletion in normal aging remains incompletely understood. We explored this concept in the Klotho mouse model of accelerated aging. . ..."

Lott, J. P. and J. Savulescu (2007). "Towards a Global Human Embryonic Stem Cell Bank." The American Journal of Bioethics 7(8): 37 - 44. "Human embryonic stem cell technology could solve the organ shortage problem by restoring diseased or damaged tissue across a range of common conditions. However, such technology faces several largely ignored immunological challenges in delivering cell lines to large populations. We address some of these challenges and argue in favor of encouraging contribution or intentional creation of embryos from which widely immunocompatible stem cell lines could be derived. . ..."

Malek, J. and L. M. Kopelman (2007). "The Well-Being of Subjects and Other Parties in Genetic Research and Testing." Journal of Medicine and Philosophy 32(4): 311 - 319.

Mameli, M. (2007). "Reproductive cloning, genetic engineering and the autonomy of the child: the moral agent and the open future." J Med Ethics 33(2): 87-93. "Some authors have argued that the human use of reproductive cloning and genetic engineering should be prohibited because these biotechnologies would undermine the autonomy of the resulting child. In this paper, two versions of this view are discussed. According to the first version, the autonomy of cloned and genetically engineered people would be undermined because knowledge of the method by which these people have been conceived would make them unable to assume full responsibility for their actions. According to the second version, these biotechnologies would undermine autonomy by violating these people's right to an open future. ..."

Martin, G. M., A. Bergman, et al. (2007). "Genetic Determinants of Human Health Span and Life Span: Progress and New Opportunities." PLoS Genetics 3(7): e125. "We review three approaches to the genetic analysis of the biology and pathobiology of human aging. The first and so far the best-developed is the search for the biochemical genetic basis of varying susceptibilities to major geriatric disorders. . ..."

Master, Z. and B. Williams-Jones (2007). "The Global HLA Banking of Embryonic Stem Cells Requires Further Scientific Justification." The American Journal of Bioethics 7(8): 45 - 46...."

MATCHAR, D. B. (2007). "Is Genetic Testing for Cytochrome P450 Polymorphisms Ready for Implementation? ." American Family Physician 76(3). "The availability of an FDA-approved test for identifying CYP450 polymorphisms has brought the field of pharmacogenomics to the threshold of influencing clinical practice, which brings urgency to questions about the usefulness of such testing. ..."

Mervis, J. (2007). "GRANTS MANAGEMENT: NSF Survey of Applicants Finds a System Teetering on the Brink." Science 317(5840): 880-881.

Mills, A. E. and P. M. Tereskerz (2007). "Changing patent strategies: what will they mean for the industry?" Nat Biotech 25(8): 867-868. ..."

Mondadori, C. R. A., D. J. F. de Quervain, et al. (2007). "Better Memory and Neural Efficiency in Young Apolipoprotein E {varepsilon}4 Carriers." Cereb. Cortex 17(8): 1934-1947. "The apolipoprotein E (APOE){varepsilon} 4 allele is the major genetic risk factor for Alzheimer's disease, but an APOE effect on memory performance and memory-related neurophysiology in young, healthy subjects is unknown. We found an association of APOE {varepsilon}4 with better episodic memory compared with APOE {varepsilon}2 and{varepsilon} 3 in 340 young, healthy persons. We suggest that APOE {varepsilon}4 is associated with good episodic memory and an economic use of memory-related neural resources in young, healthy humans. ..."

Morse, J. M. (2007). "Does Health Research Warrant the Modification of Qualitative Methods?" Qualitative Health Research 17(7): 863-865."Are qualitative health research methods a subspecialty of qualitative inquiry? ..."

Mueller, J. H. (2007). "Ignorance Is Neither Bliss Nor Ethical." Northwestern University Law Review 101(2)."My intent here is to (1) describe how various distortions are used to defend and justify the ethics reviews, and (2) highlight some costs of the ethics enterprise that are routinely ignored. I will focus on social science and humanities research, in part because of my interests, but also because these disciplines seem most vulnerable to unwarranted censorship. When all of the results, intended and otherwise, are considered, it is clear that the constraints imposed on academic inquiry have not been accompanied by an increase in public benefits. ..."

Nannya, Y., K. Taura, et al. (2007). "Evaluation of genome-wide power of genetic association studies based on empirical data from the HapMap Project." Hum. Mol. Genet.: ddm205 " We investigated the extent to which this trade-off limits the genome-wide power with this approach by simulating a large number of case-control panels based on the empirical data from the HapMap Project.. ..."

 

O'Donnell, A. B., K. E. Lutfey, et al. (2007). "Using Focus Groups to Improve the Validity of Cross-National Survey Research: A Study of Physician Decision Making." Qualitative Health Research 17(7): 971-981."The authors demonstrate how qualitative methods can form a foundation for quantitative research by improving instrument validity, informing the data collection process, and improving cost-effectiveness in a study of physician decision making. ..."

Øhrstrøm, P. and J. Dyhrberg (2007). "Ethical Problems Inherent in Psychological Research based on Internet Communication as Stored Information." Theoretical Medicine and Bioethics 28(3): 221-241. "This paper deals with certain ethical problems inherent in psychological research based on internet communication as stored information. . ..."

Pielke, R. A. J. (2007). The Honest Broker: Making Sense of Science in Policy and Politics. Cambridge Cambridge University Press."Pielke examines the choices and consequences facing scientists who wish to contribute their research findings to policy-making. ..."

Price, C. C. (2007). "Cinematic Thinking: Narratives and Bioethics Unbound." The American Journal of Bioethics 7(8): 21 - 23.

Riccaboni, A., F. Lalatta, et al. (2007). "Genetic screening in 2,710 infertile candidate couples for assisted reproductive techniques: results of application of Italian guidelines for the appropriate use of genetic tests." Fertil Steril."OBJECTIVE: To report the results of the routine application of Italian guidelines that apply to infertile patient candidates for any assisted reproduction technique (ART). ..."

Ropers, H.-H. (2007). "New Perspectives for the Elucidation of Genetic Disorders." Am J Hum Genet 81(2): 199-207. "There is reason to believe that the complexity of many "multifactorial" disorders is primarily due to genetic heterogeneity, with defects of different genes causing the same disease. Because of the introduction of novel high-throughput, low-cost sequencing methods, sequencing and genotyping will soon converge, with far-reaching implications for the elucidation of genetic disease and health care. ..."

Rosenberg, A. A. (2007). "Four ways to take the policy plunge." Nature 448(7156): 867-867.h ..."

Roth, M. (2007). "Personalized medicine: using effective partnering for managing the risk of legal liability." Personalized Medicine 4(3): 329-339...."

Salmon, A. (2007). "Walking the Talk: How Participatory Interview Methods Can Democratize Research." Qual Health Res 17(7): 982-993 "In this article, the author explores the importance of participatory, respectful, and community-specific approaches to research relationships across differences in social location and experience. Group interviews can benefit both the participants and the research, support womens' agency, and democratize the research process while mitigating the potential for the misrepresentation and appropriation of women's experiences. ..."

Sanderson, S. C. and S. Michie (2007). "Genetic testing for heart disease susceptibility: potential impact on motivation to quit smoking." Clinical Genetics 71(6): 501-510."Our aim was to examine the potential impact of genetic testing for heart disease susceptibility on psychological predictors of smoking cessation. The results suggest that genetic testing for heart disease risk may enhance interventions designed to improve health via increasing smoking cessation rates. . ..."

Sharp, R. R. and M. W. Foster (2007). "Grappling with Groups: Protecting Collective Interests in Biomedical Research." Journal of Medicine and Philosophy 32(4): 321 - 337. "We analyze research practices developed in response to concerns about the involvement of indigenous communities in studies of genetic variation and consider their potential application in other contexts. We highlight several conceptual ambiguities and practical challenges associated with the protection of group interests and argue that protectionist strategies developed in the context of genetic research will not be easily adapted to other types of research in which social groups are placed at risk. We suggest that it is this set of conceptual and practical issues that philosophers, ethicists, and others should focus on in their efforts to protect identifiable social groups from harm resulting from biomedical research. ..."

Simmerling, M., B. Schwegler, et al. (2007). "Introducing a New Paradigm for Ethical Research in the Social, Behavioral, and Biomedical Sciences: Part I." Northwestern University Law Review 101(2)."In what follows, we argue that the principled model for ethical decision-making specified and implied in Belmont distorts the philosophical requirements of the ethical principles of beneficence, respect for persons, and justice in both their conceptual specification and practical application. In particular, we argue that Belmont’s model relies on a simplistic accounting of the concepts of beneficence, respect for persons, and justice. Furthermore, Belmont conflates the requirements of these principles. ..."

Sjoqvist, F. and E. Eliasson (2007). "The Convergence of Conventional Therapeutic Drug Monitoring and Pharmacogenetic Testing in Personalized Medicine: Focus on Antidepressants." Clin Pharmacol Ther 81(6): 899-902.

Slamet-Loedin, I. H. and I. A. Jenie (2007). "Nutrition: ethics and social implications." Forum Nutr 60: 66-79.

"In October 2003, the general conference of UNESCO adopted the International Declaration on Human Genetic Data, followed by the adoption of the Universal Declaration on Bioethics and Human Rights in October 2005 to ensure the respect of human dignity and the protection of human rights and fundamental freedoms in the collection, processing, use and storage of human genetic data with the requirement of equality, justice and solidarity. As in another branch of posthuman genome science, it is a global concern that the collected data should not be misused or create inequity. The ethical issues in nutrigenomics need clear and concise guidelines developed in accordance with the universally adopted declarations and ethical concern needs to be integrated in the scientific design. ..."

Subbiah, M. T. R. (2007). "Personalizing our diet to improve our health: the potential impact of nutrigenomics." Personalized Medicine 4(3): 233-236. ..."

Swen, J. J., T. W. Huizinga, et al. (2007). "Translating Pharmacogenomics: Challenges on the Road to the Clinic." PLoS Medicine 4(8): e2099 "More generally, the implementation of pharmacogenomics in routine clinical practice presents significant challenges. This article presents specific clinical examples of such challenges and discusses how obstacles to implementation of pharmacogenomic testing can be addressed. ..."

Thapar, A., G. Harold, et al. (2007). "Do intrauterine or genetic influences explain the foetal origins of chronic disease? A novel experimental method for disentangling effects." BMC Medical Research Methodology 7(1): 25. "We present a novel research strategy aimed at disentangling maternally provided pre-natal environmental and inherited genetic effects. A study based on children born by IVF treatment and who differ in genetic relatedness to the woman undergoing the pregnancy is feasible. The present report outlines a novel experimental method that permits disaggregation of maternally provided inherited genetic and post-implantation prenatal effects. ..."

Treadwell, M. C. (2006). "The role of informed consent in aneuploidy screening." Ultrasound in Obstetrics and Gynecology 28(3): 241.

Van Bebber, S. L., S.-Y. Liang, et al. (2007). "Valuing personalized medicine: willingness to pay for genetic testing for colorectal cancer risk." Personalized Medicine 4(3): 341-350.

van den Anker, J. N. (2007). "Do We Need to Incorporate Pharmacogenetics in Randomized, Controlled Trials of Frequently Used Medicines?" Pediatrics 120(1): 237-.

Wadman, M. (2007). "US genetics bill blocked again." Nature 448(7154): 631-631.a "One-man lobby halts antidiscrimination law. ..."

Werner, E. (2007). "SYSTEMS BIOLOGY: How Central Is the Genome?" Science 317(5839): 753-754.hg

Wickins, J. (2007). "The ethics of biometrics: the risk of social exclusion from the widespread use of electronic identification." Sci Eng Ethics 13(1): 45-54."The possibility of social exclusion resulting from the use of biometrics data for such uses as identity cards has not yet been fully explored. Social exclusion is unethical, as it unfairly discriminates against individuals or classes of people. Social exclusion is unethical, as it unfairly discriminates against individuals or classes of people. This article looks at some of the ways in which social exclusion might arise from the use of biometric data, and introduces a model of balancing individual interests with which to analyse whether it is justified to run the risk of excluding some members of society for the benefit of others. ..."

Williams, E. A. (2006). Good, Better, Best: The Human Quest for Enhancement. Invitational Workshop Convened by the Scientific Freedom, Responsibility and Law Program."Although convergence, economic competition, and consumer demand push in the direction of rapid HE development, ethical, legal and policy concerns pull in the direction of a more cautious approach. Advances in HE should be weighed against the effort needed to develop mechanisms for assessing the quality and safety of HE products, to consider the ethical and social impacts, and to define public policy objectives and design appropriate regulatorystructures. ..."

Zilberstein, M. (2004). "Mining the human genome for new health therapies." Fertility and Sterility 81(Supplement 2): 4-8 "The completion of the Human Genome Project heralds advances in determining the foundations of disease and in developing new therapeutic treatments. Tests already exist for the detection of some genetic abnormalities that can cause disease, and more are being developed. In the future, pharmacogenetics will be used to tailor treatment to specific patients. ..."

Zywicki, T. J. (2007). "Institutional Review Boards as Academic Bureaucracies: An Economic and Experiential Analysis." Northwestern University Law Review 101(2)."It is the thesis of this Article that the frequent suboptimal decision-making outcomes of IRBs results from the institutions and incentives that have been created within universities and IRBs. Understanding the problems that hamper IRB effectiveness and how to reform them requires an understanding of their underlying bureaucratic structure. Borrowing from the literature on the operation of governmental bureaucracy, this Article will take a first step toward modeling academic bureaucracies with an eye toward improving IRB operation. ..."

 

 

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