Health Law and Policy Commons^™

A Systematic Literature Review Of Individuals' Perspectives On Privacy And Genetic Information In The United States, Ellen W. Clayton, Colin M. Halverson, Nila A. Sathe, Bradley A. Malin

Vanderbilt Law School Faculty Publications

Concerns about genetic privacy affect individuals' willingness to accept genetic testing in clinical care and to participate in genomics research. To learn what is already known about these views, we conducted a systematic review, which ultimately analyzed 53 studies involving the perspectives of 47,974 participants on real or hypothetical privacy issues related to human genetic data. Bibliographic databases included MEDLINE, Web of Knowledge, and Sociological Abstracts. Three investigators independently screened studies against predetermined criteria and assessed risk of bias. The picture of genetic privacy that emerges from this systematic literature review is complex and riddled with gaps. When asked specifically …

The Pregnancy Penalty, Jennifer Bennett Shinall

Vanderbilt Law School Faculty Publications

Despite the renaissance of pregnancy-related scholarship over the past decade, 322 very little has been documented empirically regarding the status of pregnant women in the labor market. As such, scholars and advocates have been constrained in their ability to assess both the adequacy of current legislation and the relative urgency for new legislation. Furthermore, in the absence of labor market data, they have been limited in their ability to propose reform measures that can target the pregnant women most in need of assistance. This Article has taken an initial step towards filling these critical gaps in the literature, utilizing a …

Navigating The Research-Clinical Interface In Genomic Medicine: Analysis From The Cser Consortium, Ellen Wright Clayton, Susan M. Wolf, Laura M. Amendola, Et Al.

Vanderbilt Law School Faculty Publications

Purpose: The Clinical Sequencing Exploratory Research (CSER) Consortium encompasses nine National Institutes of Health– funded U-award projects investigating translation of genomic sequencing into clinical care. Previous literature has distinguished norms and rules governing research versus clinical care. This is the first study to explore how genomics investigators describe and navigate the research–clinical interface. Methods: A CSER working group developed a 22-item survey. All nine U-award projects participated. Descriptive data were tabulated and qualitative analysis of text responses identified themes and characterizations of the research–clinical interface. Results: Survey responses described how studies approached the research–clinical interface, including in consent practices, recording …

Approaches To Carrier Testing And Results Disclosure In Translational Genomics Research, Ellen Wright Clayton, Kathryn M. Porter, Et Al.

Vanderbilt Law School Faculty Publications

Background: Clinical genome and exome sequencing (CGES) is primarily used to address specific clinical concerns by detecting risk of future disease, clarifying diagnosis, or directing treatment. Additionally, CGES makes possible the disclosure of autosomal recessive and X-linked carrier results as additional secondary findings, and research about the impact of carrier results disclosure in this context is needed.

Methods: Representatives from 11 projects in the clinical sequencing exploratory research (CSER) consortium collected data from their projects using a structured survey. The survey focused on project characteristics, which variants were offered and/or disclosed to participants as carrier results, methods for carrier results …