Policy, legal and ethical issues in genetic research
We Speak Your Name: Brooklyn community celebrates Henrietta Lacks
The world owes much to Henrietta Lacks, the African-American woman whose cells were removed during a biopsy in 1951 and used for research without her knowledge or approval. Mrs. Lacks died at the age of 31, a few months after her diagnosis of cervical cancer. She would never know that more than six decades later, her cells would continue to grow and provide a foundation for advancements in biomedical research. Read more
Gene Patents: Supreme Court rules against
Whether or not human genes should be patent-eligible
has been a topic for debate since the 1980s and of keen interest to NHGRI. On June 13th, 2013, a long-running legal case over a patent held by Myriad Genetics on a gene linked to breast cancer reached conclusion with a Supreme Court ruling that isolated but otherwise unmodified DNA can not be the subject of a patent. (more
NHGRI/ASHG Genetics and Public Policy Fellowship
FDA proposes oversight of laboratory-developed tests
The U.S. Food and Drug Administration (FDA)
today announced steps it will take to ensure that certain tests used by health care professionals to diagnose and treat patients provide accurate, consistent and reliable results to inform patient care. These steps come at a critical time for genomic, or precision, medicine. As more and more genetic tests are developed and marketed, the public must be able to rely on the accuracy and clinical validity of these tests.
Read the FDA Release
Read a statement from NIH Director Francis Collins
Meeting on the implications of the ACMG Recommendations
Read the full summary of the workshop to discuss the potential implications on research policies of recommendations and guidelines regarding the management of incidental findings when patients undergo clinical exome or genome sequencing.
Last Updated: July 31, 2014