Analysis of state laws on informed consent for clinical genetic testing in the era of genomic sequencing

Abstract

This article assesses the adequacy of informed consent to clinical genetic testing laws based on an examination of 15 states with institutions that had been involved in a National Institutes of Health-supported Clinical Sequencing Exploratory Research Consortium project. We identified relevant statutory provisions through a legal search engine and included statutes that describe the informed consent requirements for clinical genetic testing and/or the protections for genetic material, information, or data. We found that statutory definitions were often limited in problematic ways, such as focusing only on variants known to be associated with disease or negative health effects or associated with asymptomatic disease. Some statutes required complex levels of detail if applied to genomic technologies and set confusing disclosure standards for current use and future access. Others had exceptions from informed consent requirements for future research use, limited requirements for the destruction of specimens as opposed to derived data, or linked key definitional components to the evolving concept of "identifiability." Further reform and research are needed to ensure that state law protections advance as rapidly as the science they aspire to enable.

Privacidad y confidencialidad de los datos genéticos y genómicos de uso diagnóstico en Colombia

“…Por otro lado, en Colombia la no maleficencia es parte inherente de cualquier acto médico y la autonomía es un derecho conferido en la Constitución Política al relacionarse con la libertad individual para tomar decisiones. El consentimiento informado de forma escrita es la herramienta garante de este derecho en el ámbito de la salud [28,[47][48][49]50]. Sin embargo, no existe una legislación colombiana que precise el consentimiento informado basado en la complejidad de riesgos y beneficios en el manejo de la información genética, sino que se rige bajo la Ley 23 de 1981 como un documento estándar para cualquier otro tipo de intervención.…”

Privacy in the age of medical big data

“…The major U.S. federal law governing health data privacy is the Privacy Rule created under the Health Insurance Portability and Accountability Act (HIPAA)—there are also state-specific privacy laws, and the federal Common Rule, which protects research subjects, but they are not our focus here. 28…”

Laboratory and Clinical Implications of Incidental and Secondary Germline Findings During Tumor Testing

“…[42][43][44][45] Furthermore, genetic testing, and the knowledge it produces, is constantly evolving, making it difficult for state legislation to adequately govern informed consent while being malleable for future needs. 46 It will be important for molecular pathologists and geneticists to educate their respective state legislators so that laws are not too restrictive of access to genetic testing and information but will also ensure patient privacy and autonomy. Currently, state legislators must comply with the Genetic Information Nondiscrimination Act of 2008, 47 which protects Americans from discrimination based on their genetic information in both health insurance and employment.…”