Robinson Bradshaw

Topic: human subjects research

Some Thoughts on the New Common Rule for Human Subjects Research

On January 18, 2017, in one of its last official acts, the outgoing Obama administration issued a final revised version of the Common Rule—the regulation that governs the treatment of human subjects in all federally funded research. This was the culmination of a process that began in 2011 when the Department of Health and Human […]

NIH Refuses to March In—Again—And National Academies Challenge Human Subjects Regulation

The last few days have seen two significant news items from Washington. First, the National Institutes of Health have refused—yet again—to exercise their “march-in” rights to grant third-party licenses to a patented drug developed with federal funding. The drug in question is enzalutamide, a prostate cancer treatment marketed under the brand name Xtandi by Japanese […]

How Privacy Law Affects Medical and Scientific Research

Over the last five or so years my law practice has focused increasingly on privacy law, both domestic and international. In hindsight, this was a predictable outcome: as an intellectual property lawyer, many of my clients do business on the Internet or are engaged in scientific research and development, with many of the latter in […]

The Havasupai Indians and the Challenge of Informed Consent for Genomic Research

Pulitzer Prize-winning journalist Amy Harmon, of The New York Times, reports that a long-running dispute between Arizona State University (ASU) and the Havasupai Indians over the allegedly improper research use of DNA from members of the tribe has been settled. The research began two decades ago, ostensibly to search for a genetic variant that might […]

Kaiser’s Massive Genetic Database Leverages Its Patient Population (But It’s A One Way Street)

This week MIT’s Technology Review featured a story about Kaiser Permanente and its plans to use its Northern California patients to construct an enormous genetic database. The acronym-unfriendly Research Program on Genes, Environment, & Health, or RPGEH is funded in large part by a $25 million NIH research grant courtesy of February’s stimulus bill. The […]

Informed Consent for Pediatric Biobanking

What rules should govern the participation of children in large-scale genomic biobanking research? That’s the question that David Gurwitz, Isabel Fortier, Jeantine E. Lunshof and Bartha Maria Knoppers tackle in a policy forum piece in the current issue of Science. The Importance of Open Consent In considering the use of DNA samples and phenotypic data […]