The application of medical technology in the pediatric setting must serve the best interest of the child. Genetic testing of children and infants presents unique challenges. In contrast to the testing of adult patients, most children cannot understand the risks and benefits or provide informed consent. The American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) recently issued recommendations regarding genetic testing or screening of infants and children. In Ethical and Policy Issues in Genetic Testing and Screening of Children (“Report”), the AAP and ACMG review the scenarios in which genetic testing or screening of minors may occur and recommend best practices for such testing.Continue reading this entry
Yesterday Myriad urged the Federal Circuit to dismiss the “gene patenting” case on the ground that subject matter jurisdiction no longer exists. Myriad argued that in the alternative, the case should be remanded to the district court to address whether declaratory-judgment jurisdiction exists under the current facts of the dispute.
On November 24, 2009, President Obama established the Presidential Commission for the Study of Bioethical Issues (Commission) to advise him on bioethical issues generated by novel and emerging research in biomedical and related areas of science and technology. As part of this initiative, the Commission issued a Notice on March 27, 2012 (Federal Register) seeking comments on the ethical issues raised by the ready availability of large-scale human genome sequencing data.
Privacy And Access
Tremendous technological advances have reduced the cost of sequencing to the point where relatively inexpensive, rapid sequencing of whole genomes is not only likely but imminent. The emergence of this new technology raises, for the Commission, issues how this information can and ought to be collected, used, and governed. Of particular initial interest are issues relating to the privacy of and access to this information by patients, researchers, and medical professionals.
The Commission is particularly interested in comments informing policies, practices, research, and perspective on issues of privacy and data access as they relate to the integration of large scale human genome sequencing into research and clinical care. Of additional interest are models and mechanisms for protecting privacy in both genetic/genomic databases of sensitive information and the sharing and management of information and access to large-scale human genomic data.
To Submit Comments
Individuals, groups, and organizations interested in commenting may submit comments by email to firstname.lastname@example.org or by mail to the following address:
Public Commentary, The Presidential Commission for the Study of Bioethical Issues, 1425 New York Ave. NW., Suite C-100, Washington, DC 20005.
To assure consideration, comments must be received by May 25, 2012.
For additional insight into the Commission’s thinking on the issues concerning genetic testing, see the Commission’s blog.
The California Institute for Regenerative Medicine (CIRM) announced on January 17, 2012 that its governing board approved a $40 million initiative to fund one or two Stem Cell Genomics Centers of Excellence in California. CIRM was created by California’s Proposition 71, which authorized the state to issue $3 billion in grants over ten years to support biomedical research in support of regenerative medicine. Since its inception, CIRM has funded basic and translational research on all aspect of regenerative medicine. This is CIRM’s first targeted expansion into the study of the genetics of stem cell biology.
I spoke to Natalie DeWitt, Ph.D., Special Programs Officer of CIRM regarding the initiative and, in particular how the use of genomics will advance the goals of California’s initiative. Stem cells, she noted, are a good system for genetic studies because of the unique biology of the cells. For instance, stem cells can be differentiated to form specialized cell types useful for cell therapies and patient-specific disease modeling, e.g., with a particular type of stem cell – the iPS cell. Genomics technologies are important for understanding the molecular drivers of differentiation, and how genes interact with environmental conditions to produce disease states in specialized cell types. Genome characterization of cell lines destined for cell therapeutics will provide assurance that the cells are safe and do not have activated oncogenic pathways, or carry gene variants associated with disease.