To what extent are precision approaches to health new and what are clinical and ethical implications of these approaches for distinguishing between care and research? This issue of the AMA Journal of Ethics considers consent, governance, and appropriate uses of data. We also consider ethical questions surrounding novel clinical applications, public policy questions about stewardship of huge numbers of patients’ information, and questions about how to justly distribute these efforts’ risks and benefits.
Precision medicine creates patient subgroups to develop targeted interventions. This raises ethical issues about privacy, informed consent, and social justice. It also raises questions about cost, what to do with faulty data, and the role of genetic stratification in treating and monitoring patients.
AMA J Ethics. 2018;20(9):E798-803. doi:
Nicole Martinez-Martin, JD, PhD, Laura B. Dunn, MD, and Laura Weiss Roberts, MD, MA
Calibrating a machine learning model with data from a local setting is key to predicting psychosis outcomes. Clinicians also need to understand an algorithm’s limitations and disclose clinically and ethically relevant information to patients.
AMA J Ethics. 2018;20(9):E804-811. doi:
Mandatory genetic testing of health care professionals could help structure health care organizations’ responses to a pandemic. Patients and more susceptible employees can benefit, and these benefits must be weighed against concerns about fairness, autonomy, genetic privacy, and potential loss of employment opportunities.
AMA J Ethics. 2018;20(9):E819-825. doi:
Clara C. Hildebrandt, MD and Jonathan M. Marron, MD, MPH
Gene editing with CRISPR/Cas9 raises concerns about equitable access to therapies that could limit research participation by minority group members. These concerns can be addressed through public education, transparency, and stakeholder partnerships.
AMA J Ethics. 2018;20(9):E826-833. doi:
Holly K. Tabor, PhD and Aaron Goldenberg, PhD, MPH
Rare genetic disease research has something to teach precision medicine about addressing some patients’ limited access to treatment. Health disparities exacerbated by high costs and limited availability of drugs can, perhaps, be mitigated when patient activism accelerates drug development.
AMA J Ethics. 2018;20(9):E834-840. doi:
Targeted dosing to treat pediatric inflammatory bowel disease is challenging because dosing guidelines are based on data gathered from adult subjects of clinical trials. Patients’ families and health care organizations also incur high costs and must try to balance potential benefits against risks of ongoing monitoring.
AMA J Ethics. 2018;20(9):E841-848. doi:
Rebekah Davis Reed, PhD, JD and Erik L. Antonsen, PhD, MD
Though the National Aeronautics and Space Administration’s collection of disaggregated genetic data for occupational surveillance and research raises numerous privacy concerns, the Genetic Information Nondiscrimination Act of 2008 allows genetic information to be used to develop personal pharmaceuticals.
AMA J Ethics. 2018;20(9):E849-856. doi:
Emily L. Evans, PhD, MPH and Danielle Whicher, PhD, MHS
Clinical decision support systems leverage data generated in the course of standard clinical care to improve clinical practice. They need to ensure privacy and quality of patients’ data, but must also allow queries of electronic health records.
AMA J Ethics. 2018;20(9):E857-863. doi:
Cynthia E. Schairer, PhD, Caryn Kseniya Rubanovich, MS, and Cinnamon S. Bloss, PhD
AMA J Ethics. 2018;20(9):E864-872. doi:
Transitions in relabeling personalized medicine as precision medicine, precision health, or wellness genomics reflect shifting the locus of responsibility for health from individuals to clinicians and in shifting focus from genetic risk to genetic enhancement.
AMA J Ethics. 2018;20(9):E881-890. doi:
This photograph of a kaleidoscope of potentially life-saving and potentially life-threatening pills suggests ethical conflict inherent in clinicians’ strivings to meet patients’ pain relief needs without contributing crises of drug diversion.
AMA J Ethics. 2018;20(9):E894-896. doi:
Large precision health initiatives like the National Institutes of Health’s All of Us campaign raise important ethical questions about consent, privacy, and inclusivity. This month on Ethics Talk, we explore with Dr Katie Johansen Taber and Ysabel Duron strategies for protecting participants and ensuring that diverse communities are represented.
If clinicians incorporate a predictive model into their practice to assist them with prognosis, should they disclose their use of the model to patients?
A patient schedules a visit with her family physician to discuss the results of a direct-to-consumer (DTC) genetic test. How should the physician respond to the patient’s questions, given that the report contains technical and specific genetic information that is outside of her expertise?