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
- Hastings Center News
Issue Brief: Equitable Access to Precision MedicineRead the PostHastings Center NewsA new issue brief from The Hastings Center, “Strategies to Support Equitable Access to Precision Medicine for All of Us Participants from Federally Qualified Health Centers,” presents policy recommendations to mitigate disparities in access to appropriate medical follow-up after the return of genetic findings.Read the Post
Delivering in Another Tumultuous YearRead the Post
2021 Center HighlightsRead the Post
- Hastings Center News
Ethical and Policy Guidance for Translational Xenotransplantation Clinical TrialsRead the PostHastings Center NewsXenotransplantation is a novel experimental treatment that involves transplanting organs from nonhuman animals into humans to reduce the organ shortage—a public health problem. A new four-year research study, supported by the National Center for Advancing Translational Sciences of the Nationa...Read the Post
Ethical and Policy Guidance for Translational Xenotransplantation Clinical TrialsRead the Post
Short Course on Public Deliberation and Gene Editing in the WildRead the Post
Ethics & Human Research 2Read the PostPageEthics & Human Research (formerly IRB: Ethics & Human Research) aims to foster critical analysis of issues in science and health care that have implications for human biomedical and behavioral research, including developments that bring new challenges to existing ethical, regulato...Read the Post
All of Us Research Program: Barriers to Caring for Patients with Genetic Findings that Require Medical AttentionRead the Post
Bioethics Case StudiesRead the PostPageSearch for Topics in BioethicsSearch Tarasoff v. Regents of the University of California In this case [17 Cal. 3d 425, 551 P.2d 334, 131 Cal. Rptr. 14 (Cal. 1976)] the Supreme Court of California held that mental health professionals have a duty to protect individuals who are being threatene...Read the Post