Karen J. Maschke
Research Scholar; Editor, Ethics & Human Research
Karen Maschke has expertise on the ethical, regulatory and policy issues involving the development, assessment, and use of new biomedical technologies. She has 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 and epigenomic data. She was a collaborator and the Hastings Center Project Manager on the European Commission-funded project, “HIDE: Homeland Security, Biometric Identification, and Personal Detection Ethics.” She currently is a co-Principal Investigator on the NIH-funded project “Actionable Ethics Oversight for Human-Animal Chimera Research,” and a co-Investigator on the NSF-funded project “Public Deliberation on Gene Editing in the Wild.” Maschke is the editor of the Hastings Center’s journal, Ethics & Human Research.
Maschke has published her work in Health Affairs, Journal of Health Politics, Policy and Law, BMC Medical Ethics, and the American Journal of Medical Genetics. Her recent 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, and mammography.
She is interviewed frequently by the media, appearing in Kaiser Health News, STAT News, Bloomberg Law, Vice News, OneZero, Spectrum, NPR, Reuters, and the Washington Post.
Maschke has a Ph.D. 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 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
Medical Tribune about early testing for Alzheimer’s disease
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
Selected Scholarly Publications
Karen J. Maschke, Michael K. Gusmano, “Medicare and Amyloid PET Imaging: The Battle Over Evidence,” Journal of Aging & Social Policy, forthcoming.
Karen J. Maschke, Michael K. Gusmano, “Politics, Values, and Access to Untested Medical Interventions: The Case of Stem Cell Treatments,” Journal of Health Politics, Policy and Law September 2016; 40(6).
Mildred Z. Solomon, Michael K. Gusmano, and Karen J. Maschke, “The Ethical Imperative and Moral Challenges of Engaging Patients and the Public with Evidence,” Health Affairs 2016:35(4):583-589.
Aaron J. Goldenberg, et al. (Karen J. Maschke a co-author), “IRB Practices and Policies Regarding the Secondary Research Use of Biospecimens,” BMC Medical Ethics 2015;8;16(1):1.
Suzette J. Bielinski, et al. (Karen J. Maschke a co-author), “Preemptive Genotyping for Personalized Medicine: Design of the Right Drug, Right Dose, Right Time, Using Genomic Data to Individualize Treatment Protocol,” Mayo Clinic Proceedings 2014;89(1):25-33.
Jeffrey R. Botkin, et al. (Karen J. Maschke a co-author), “Proposed Regulations for Research with Biospecimens: Responses from Stakeholders at CTSA Consortium Institutions,” American Journal of Medical Genetics 2014;164A(4):892-897.
Karen J. Maschke, “Returning Genetic Research Results: Considerations for Existing No-return and Future Biobanks,” Minnesota Journal of Law, Science & Technology 2012;13:559-574.
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.
Eric Trump and Karen J. Maschke, “Do Allografts Equal Organs?” MedPage Today, July 10, 2014.
Karen J. Maschke, “When Evidence is Contested,” Hastings Center Report 2014;44(3).
Matts G. Hansson and Karen J. Maschke, “Biobanks: Questioning Distinctions,” Science,2009;326(5954):797.
Karen J. Maschke, “Human Research Protections: Time for Regulatory Reform?” Hastings Center Report 2008;38(2):19-22.
Eric Trump and Karen J. Maschke, “A Stranger in the Mirror: Should Doctors Transplant Faces?” New York Times, October 12, 2004.
Posts by Karen J. Maschke
- Bioethics Forum Essay
Ethics and Evidence in the Search for a Vaccine and Treatments for Covid-19Read the PostBioethics Forum EssayIn the rush to find a Covid-19 vaccine and one or more drugs to treat the deadly disease, concerns are being raised that ethical standards for conducting human clinical trials and the evidentiary standards for determining whether interventions are safe and effective, might be loosened.Read the Post
- Bioethics Forum Essay
The Need for Open and High Quality Preclinical ScienceRead the PostBioethics Forum EssayAn investigative report The BMJ published recently about a failed tuberculosis vaccine trial conducted with infants in South Africa underscores several issues in translational science that are gaining increased attention: low standards in the rigor, reporting, and transparency of preclinical research...Read the Post
- From Bioethics Briefings
Biobanks: DNA and ResearchRead the PostFrom Bioethics BriefingsFraming the Issue With recent advances in molecular biology, human biospecimens have become enormously valuable for medical researchers. Biospecimens such as blood, surgical tissue, saliva, and urine contain genetic material that researchers analyze to identify gene variations associated with human d...Read the Post
Democratic Deliberation and Gene EditingRead the Post
Ethics & Human Research 2Read the Post
All of Us Research Program: Barriers to Caring for Patients with Genetic Findings that Require Medical AttentionRead the Post
- Hastings Center News
In the Media: The Hastings Center Responds to Covid-19Read the Post
PRESS RELEASE: 10-11-2019 Hastings Center Report, September-October 2019Read the Post
- Hastings Center News
In Search of Authentic Public EngagementRead the PostHastings Center NewsHastings Center research scholar Karen Maschke questioned recent calls in the ethics world for public engagement, enhanced governance, and greater transparency regarding technological innovation. “Making the calls is easy,” Maschke said, but taking action means disrupting existing centers of power, and requires hearing a multitude of challenges to the underpinnings of innovation. She spoke at a panel entitled “50 Years of Bioethics – Reflections from The Hastings Center” at a conference in Boston.Read the Post
- Hastings Center News
In Search of Authentic Public EngagementRead the PostHastings Center NewsHastings Center research scholar Karen Maschke questioned recent calls in the ethics world for public engagement, enhanced governance, and greater transparency regarding technological innovation. “Making the calls is easy,” Maschke said, but taking action means disrupting existing centers of power, and requires hearing a multitude of challenges to the underpinnings of innovation. She spoke at a panel entitled “50 Years of Bioethics – Reflections from The Hastings Center” at the annual Prim*r conference in Boston this week. Primr is a professional organization focused on research ethics.Read the Post
- In the Media
Hastings Scholar in Bloomberg Law on Combatting Sham Stem Cell StudiesRead the Post