Karen Maschke has expertise on the ethical, regulatory and policy issues involving the development, assessment, and use of new biomedical technologies. She is the editor-in-chief of The Hastings Center for Bioethics’s journal Ethics & Human Research and is a Hastings Center fellow.

Maschke is the lead co-principal investigator of a four-year project, Informing Ethical Translation of Xenotransplantation Clinical Trials, funded by the National Center for Advancing Translational Sciences of the National Institutes of Health. Through engagement with diverse stakeholders (kidney transplant candidates, kidney transplant surgeons, nephrologists, and IRB chairs) the project will develop guidance for the ethical conduct of xenotransplant clinical trials with pig kidneys, decision aids for patients and IRB members, and case studies for clinicians. She was the co-principal investigator of another NIH/NHGRI-funded project, Actionable Ethics Oversight for Human-Animal Chimera Research, and a co-investigator on Public Deliberation on Gene Editing in the Wild, which was funded by the National Science Foundation.

Maschke has also worked on several NIH-funded studies and expert advisory groups that addressed privacy, transparency, and government surveillance issues related to the collection, storage, and use of biometric data and research and health data, including identifiable and deidentified genomic data. She was a collaborator and Hastings Center for Bioethics project manager on a European Commission-funded project, HIDE: Homeland Security, Biometric Identification, and Personal Detection Ethics.

Maschke’s recent op-ed in the Washington Post (with Elisa Gordon and Michael Gusmano) discusses ethical and policy challenges for xenotransplantation. Her book, Debating Modern Medical Technologies: The Politics of Safety, Effectiveness, and Patient Access (co-authored with Michael K. Gusmano), explores disputes about what evidence should be used to evaluate the safety and effectiveness of several technologies, including stem cell interventions, amyloid PET scans for Alzheimer’s disease, and mammography.

She is interviewed frequently by the media, appearing in reports by the Associated Press, the New York Times, the Wall Street Journal, the Washington Post, National Public Radio, Kaiser Health News, STAT News, Bloomberg Law, Vice News, and Reuters.

Maschke has a PhD in political science from Johns Hopkins University and a master’s degree in bioethics from Case Western Reserve University. Prior to joining The Hastings Center for Bioethics in 2003, she was an assistant professor of political science at Oakland University in Michigan and at the University of Georgia, and a bioethics fellow at the Cleveland Clinic.

In the Media

Associated Press on the second pig heart xenotransplant https://apnews.com/article/pig-heart-transplant-d894f6ce27b7db71ecb0ec393cac3e86

New York Times on the first pig heart xenotransplant https://www.nytimes.com/2022/01/13/health/pig-heart-transplant-bennett.html#:~:text=An%20ailing%20Maryland%20man%20who,young%20man%2C%20leaving%20him%20paralyzed

Vice News Tonight on biohacking. https://www.youtube.com/watch?time_continue=227&v=5JiNedvN4U8

Washington Post on use of unproven platelet treatment for sports injuries

Medpage on use of big data in medical research

Reuters on Rebecca Skloot’s book, The Immortal Life of Henrietta Lacks

Reuters live discussion with Rebecca Skloot

National Public Radio’s “All Things Considered” on the first human face transplant

Books

Karen J. Maschke and Michael K. Gusmano, Debating Modern Medical Technologies: The Politics of Safety, Effectiveness, and Patient Access.. Praeger, 2018.

Thomas H. Murray, Karen J. Maschke, and Angela Wasunna, eds. Performance-Enhancing Technologies in Sports: Ethical, Conceptual, and Scientific Issues. Johns Hopkins University Press, 2009.

Selected Commentary

Karen J. Maschke, Elisa J. Gordon, and Michael K. Gusmano, “After the Pig-to-Human-Heart Transplant, the FDA, Clinicians and Insurers Have Some Catching Up to Do,” Washington Post, January 13, 2022

Selected Scholarly Publications

Neuhaus CP, Pacia, DM, Crane, JT, Maschke KJ, Berlinger N. “All of Us and the Promise of Precision Medicine: Achieving Equitable Access for Federally Qualified Health Center Patients,” Journal of Personalized Medicine 2023 Mar 31;13(4):615.

Johnston J, Hyun I, Neuhaus CP, Maschke KJ, Marshall P, Craig KP, Matthews MM, Drolet K, Greely HT, Hill LR, Hinterberger A. “Clarifying the Ethics and Oversight of Chimeric Research.” Hastings Center Report. November-December 2022;52:S2-3.

Maschke, Karen J., Gusmano, Michael K. “Regulating Gene Editing in the Wild: Building Regulatory Capacity to Incorporate Deliberative Democracy,” In, Gene Editing in the Wild: Shaping Decisions through Broad Public Deliberation. Hastings Center Report. Special Supplement. November-December 2021:S42-S47.

Maschke, Karen J., Gusmano, Michael K., and Solomon, Mildred Z. “Breakthrough Cancer Treatments Raise Difficult Questions,” Health Affairs 2017;Oct 1;36(10):1698-1700.

Maschke Karen J. and Gusmano, Michael K. “Medicare and Amyloid PET Imaging: The Battle Over Evidence,” Journal of Aging & Social Policy 2017:15;29(2):105-22.

Maschke, Karen J. and Gusmano, Michael K. “Evidence and Access to Biomedical Interventions: The Case of Stem Cell Treatments,” Journal of Health Politics, Policy and Law 2016;41(5):917-936.