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Full-Text Articles in Law
A Private Right Of Action For Informed Consent In Research, Valerie Gutmann Koch
A Private Right Of Action For Informed Consent In Research, Valerie Gutmann Koch
Valerie Gutmann Koch
No abstract provided.
A Policy In Flux: New York State’S Evolving Approach To Human Subjects Research Involving Individuals Who Lack Consent Capacity (Forthcoming), Valerie Gutmann Koch
A Policy In Flux: New York State’S Evolving Approach To Human Subjects Research Involving Individuals Who Lack Consent Capacity (Forthcoming), Valerie Gutmann Koch
Valerie Gutmann Koch
No abstract provided.
“Of Vital Importance”: The New York State Task Force On Life And The Law’S Report And Recommendations For Research With Human Subjects Who Lack Consent Capacity (With Susie A. Han), Valerie Gutmann Koch
“Of Vital Importance”: The New York State Task Force On Life And The Law’S Report And Recommendations For Research With Human Subjects Who Lack Consent Capacity (With Susie A. Han), Valerie Gutmann Koch
Valerie Gutmann Koch
No abstract provided.
Unique Proposals For Limiting Legal Liability And Encouraging Adherence To Ventilator Allocation Guidelines In An Influenza Pandemic, Valerie Gutmann Koch
Unique Proposals For Limiting Legal Liability And Encouraging Adherence To Ventilator Allocation Guidelines In An Influenza Pandemic, Valerie Gutmann Koch
Valerie Gutmann Koch
No abstract provided.
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
Valerie Gutmann Koch
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 …
Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch
Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch
Valerie Gutmann Koch
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 …
Changing Expectations For Board Oversight Of Healthcare Quality: The Emerging Paradigm (With Tracy E. Miller), Valerie Gutmann Koch
Changing Expectations For Board Oversight Of Healthcare Quality: The Emerging Paradigm (With Tracy E. Miller), Valerie Gutmann Koch
Valerie Gutmann Koch
Within healthcare institutions, leadership is an essential driver of expectations, performance, and culture. Yet boards of directors traditionally played a limited role in overseeing healthcare quality, providing final approval of credentialing decisions but deferring to the medical staff to set standards for the institution. Case law and standards provide little guidance for board performance in verseeing quality of care. Recent developments — the availability of comparative quality data, public reporting, and financial incentives for higher quality — have transformed expectations for board oversight. Enforcement of fraud and abuse laws based on poor quality of care, as well as federal standards …
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
Valerie Gutmann Koch
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.
American Society For Reproductive Medicine Addresses Preconception Gender Selection, Valerie Gutmann Koch
American Society For Reproductive Medicine Addresses Preconception Gender Selection, Valerie Gutmann Koch
Valerie Gutmann Koch
No abstract provided.
Nord Issues Gene Patenting Statement, Valerie Gutmann Koch
Nord Issues Gene Patenting Statement, Valerie Gutmann Koch
Valerie Gutmann Koch
No abstract provided.