15
Jun2013

by Maeve Luthin, JD, Project Coordinator

It’s your favorite time of the week again! Take a few minutes to catch up with the research ethics world by reading through this edition of our Research Ethics Roundup.

US  Regulator Plans to Declare Research Chimps Endangered: The US Fish and Wildlife Service announced a proposal to classify captive chimpanzees as endangered species. The Service will work closely with the National Institutes of Health and the biomedical research community to examine the implications of the proposed rule.

An Experimental Drug’s Bitter End: The New York Times profiles individuals affected by Seaside Therapeutics’ decision to stop production of arbaclofen, a drug that failed a phase II clinical trial for fragile X syndrome and autism. Families and advocates of former research subjects are petitioning the company, as well as the US government, to continue to make the drug available.

Hospitals Want to Test Drug with No Consent: A Boston-based research team is looking to join a multisite study that provides emergency treatment for brain trauma patients. If approved, it would be the first study at a Boston hospital to use the Food and Drug Administration’s exemption from the informed consent requirement for studies conducted in emergency settings.

Supreme Court Rules Human Genes May Not Be Patented: In a unanimous decision that will have a far reaching impact on scientific research, the Supreme Court ruled that isolated human genes are not patentable, thus invalidating patent claims by Myriad Genetics’ on DNA codes found in the BRCA1 and BRCA2 genes. The Court held, however, that composite, or synthetic, DNA is patentable, as it is not a product of nature.

Geneticists Push for Global Data-Sharing
: The Global Alliance, a consortium of 69 institutions in 13 countries, will convene to develop standards and policies regarding data-sharing of personal DNA sequences combined with clinical information. The group also plans to address privacy and informed consent issues that might inhibit the use of such data.

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