Health Law Professor Diane Hoffmann awarded $1.1 million NIH grant

Maryland Carey Law Professor Diane Hoffmann and colleagues from the UMB campus have been awarded a $1.1 million grant from the National Institutes of Health’s National Human Genome Research Institute. The grant funds Hoffmann’s initiative to develop policy recommendations on the regulation of microbiome-based diagnostic tests, which are now available over-the-counter and through commercial and “citizen science” projects.

Much like the genetic tests popularized by companies like Ancestry and 23andMe, says Hoffmann, microbiome-based diagnostics and how the results are used, “raise legal and ethical concerns, such as appropriate communication of test results, concerns about clinical validity and utility, informed consent, privacy, and the potential for discrimination and stigma.”

Hoffmann describes the tests as the “new wave” of direct-to-consumer diagnostic and information tests, which until relatively recently have had few regulations in place governing their use. Meanwhile the market is growing as people are drawn by claims that the results can diagnose or predict everything from propensity for obesity to mental health conditions.

As principal investigator, Hoffmann has assembled an interdisciplinary team of University of Maryland, Baltimore (UMB) co-investigators representing the schools of Medicine, Nursing, and Pharmacy to work on the research project. Having medical professionals contributing to the research greatly enhances the depth of the work, she explains. “Cooperation with experts from different disciplines leads to a deeper understanding of the issues, so our work can fully identify and address problems or gaps in the current regulatory and legal framework, and encourage innovation, while ensuring that new microbiome-based products are safe and effective.”

Hoffmann is the Jacob A. France Professor of Health Care Law and director of Maryland Carey Law’s top-ranked Law and Health Care program. She was a primary author of Maryland’s Health Care Decisions Act, and, in the 1990s, served as acting staff director of the Senate Subcommittee on Aging, responsible for all health care and aging legislation for U.S. Senator Barbara Mikulski.

As well as Hoffmann, the group of researchers includes Dr. Mary-Claire Roghmann, professor, Department of Epidemiology and Public Health and associate dean for transdisciplinary research at the School of Medicine; Dr. Erik von Rosenvinge, assistant professor, School of Medicine, and chief of gastroenterology, Veterans Affairs Maryland Health Care System; Dr. Jacques Ravel, professor and associate director for genomics, Institute for Genome Sciences at the School of Medicine; Frank Palumbo, professor and executive director, School of Pharmacy Center on Drugs and Public Policy; Dr. Ester Villalonga Olives, assistant professor, pharmaceutical health services research, School of Pharmacy; and Dr. Anita Tarzian, associate professor, School of Nursing.

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