Advocacy

In 2015, the U.S. Food and Drug Administration (FDA) invited comment on its draft guidance for the regulatory oversight of laboratory-developed tests (LDTs). With a focus on genetic and genomic testing, ASHG submitted comments on the proposed regulatory oversight of such tests. Related: Comments Submitted in Response to FDA’s Draft Guidance: Framework for Regulatory Oversight... Read More

ASHG supports the teaching of evolution in public schools, and is disappointed by Tennessee’s enactment of a bill that weakens K-12 science instruction. House Bill 38, which became law in April 2012, undermined the teaching of evolution and several other scientific topics that form the basis of public scientific literacy. Related: ASHG Statement on Tennessee... Read More

In response to a 2011 request for information, ASHG submitted comments on the Advanced Notice of Proposed Rule Making for “Human Subjects Research Protection: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” The Society proposed adjustments to the review, approval, and follow-up for studies that will facilitate research and improve... Read More

In 2010, ASHG issued a policy statement outlining guiding principles related to patenting and licensing in the genetic testing arena. These principles address protection of intellectual property, quality of testing, and access to testing. Related: Guiding Principles on Protection of Intellectual Property: Patenting and Licensing in the Genetic Testing Arena (April 2010) Read More

In a 2010 commentary in The American Journal of Human Genetics, an ASHG task force analyzed key scientific and non-scientific aspects of genetic ancestry inference in academia and industry, and provided recommendations to advance discussion and facilitate the development of guidelines concerning the use of these technologies. The commentary built upon a previous statement by... Read More