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Full-Text Articles in Health Law and Policy
Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch
Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch
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Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’s response to drugs, holds enormous promise for increasing the safety and efficiency of drug development while decreasing adverse reactions and the trial-and-error nature of drug prescription. However, pharmacogenomics may not be the panacea for all development and prescription problems. This article explores some of the obstacles to pharmacogenomic advancement including industry reluctance to pursue research because of potentially prohibitive costs associated with developing products and legal liability concerns. The implications pharmacogenomics has for drug research and development as well as various areas of law …
Pgtandme: Social Networking-Based Genetic Testing And The Evolving Research Model, Valerie Gutmann Koch
Pgtandme: Social Networking-Based Genetic Testing And The Evolving Research Model, Valerie Gutmann Koch
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The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling its direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and – highlighting the challenges associated with a new paradigm of “patient-driven” genomic research – focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article …
Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch
Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch
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This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.
Tales From The Crypt: Scientific, Ethical, And Legal Considerations For Biohistorical Analysis Of Deceased Historical Figures, Lori B. Andrews, Jordan K. Paradise
Tales From The Crypt: Scientific, Ethical, And Legal Considerations For Biohistorical Analysis Of Deceased Historical Figures, Lori B. Andrews, Jordan K. Paradise
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Biohistorical analysis involves using historic specimens of human remains or human material extracted or derived from historical artifacts to gather evidence about specimens that are identifiable or at least attributed to a historic figure at the time of the research. Biohistorical studies are being undertaken for myriad reasons, such as identification and authentication of remains, investigation into alleged criminal behavior, investigation into medical or psychological conditions, and even for purposes of commercialization. This article analyzes federal statutes, case law, and codes and guidelines from twenty-six professional organizations and societies informative to the field of biohistory. We surveyed the field, identified …
Nord Issues Gene Patenting Statement, Valerie Gutmann Koch
Nord Issues Gene Patenting Statement, Valerie Gutmann Koch
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No abstract provided.