Navigating Ethical Considerations for Undocumented Immigrants in Genetics Research

Abstract: Increasing threats to patients and families without legal status in the United States are generating ethical challenges for clinicians and researchers. In this panel, we present a case of a 35-month-old boy diagnosed with Hunter syndrome, whose father and carrier mother traveled from a country in Latin America to the United States to pursue a clinical research trial proposed to prevent and/or treat manifestations of his condition. Disease-causing changes in the IDS gene are associated with Hunter syndrome, also known as mucopolysaccharidosis type II, an X-linked disorder with an incidence of 1:100,000. Those affected with Hunter syndrome have a deficiency of the enzyme iduronate-2-sulfatase, leading to a buildup of a complex sugar molecule known as glycosaminoglycans, resulting in the progressive deterioration of several body systems. Current standard-of-care treatment of the condition is an enzyme replacement therapy (ERT) that can treat/prevent deterioration of these body systems, although this does not treat neurological manifestations of the condition. However, there are currently a number of clinical trials for redeveloped ERTs that are suggested to also be able to treat/prevent neurological symptoms. These drugs are not available clinically and only available to pursue via clinical research trials at select research sites. In this case, given the patient’s complex medical and social history, we highlight several ethical considerations for undocumented immigrants who pursue clinical research trials for clinical care. Additionally, we reflect on our roles as researchers and clinicians who serve this patient population with limited access to care for rare conditions.

Keywords: genetics, undocumented immigrants, clinical research trials