Policy‐makers, bioethicists, and patient advocates have been engaged in a fierce battle about the merits and potential harms of a federal right‐to‐try law. This debate about access to investigational medical products has raised profound questions about the limits of patient autonomy, appropriate government regulation, medical paternalism, and political rhetoric. For example, do patients have a right to access investigational therapies, as the right‐to‐try movement asserts? What is government’s proper role in regulating and facilitating access to drugs that are still in (...) development? In this review, we analyze the history of the right‐to‐try movement, review the arguments put forth by supporters and opponents of the legislation, and consider the movement’s consequences. Two possible scenarios may emerge. One is that the right‐to‐try pathway may fail to meaningfully increase patient access to investigational products. Alternatively, certain companies may attempt to rely on the federal right‐to‐try legislation to sell investigational products, taking advantage of the provision that allows for direct costs, as there is currently no clear mechanism for enforcement or monitoring of cost calculations. (shrink)

In late 2021, tennis star Chris Evert learned new genetic information about her sister, who died from ovarian cancer in January 2020. As Evert has explained in posts published by ESPN, her sister had a variant in the BRCA1 gene that was reclassified—upgraded—from a variant of uncertain significance (VUS) to pathogenic. Hearing about the variant’s reclassification likely saved Evert’s life. After getting genetic testing that showed she also carried the variant, Evert underwent prophylactic surgery. Clinical testing associated with the procedure (...) revealed she already had stage 1c ovarian cancer. The Wall Street Journal reported on a different variant reclassification story in 2019. Seven female relatives had prophylactic surgeries after cascade genetic testing indicated they each carried the same pathogenic variant in BRCA2. However, there was significant distress and confusion when one of the women received notice that the variant had been downgraded from pathogenic to a VUS. As these cases illustrate, reclassification of the clinical significance of genetic variants—which ranges from pathogenic, likely pathogenic, uncertain, likely benign and benign—can have profound impacts on individuals and families. Although genetic testing often provides valuable information, many identified variants are of uncertain significance, even in genes associated with disease. Many of these VUS will be reclassified as genomic data …. (shrink)

In the U.S., there is no requirement for research sponsors to compensate human research subjects who experience injuries as a result of their participation. In this article, we review the moral justifications that compel the establishment of a better research-related injury compensation system. We explore how other countries and certain institutions within the U.S. have adopted various systems of compensation. The existence of these systems demonstrates both that the U.S. lags behind other nations in its protection of human research subjects (...) and that the establishment of a compensation system is both practical and feasible. We then examine factors which have prevented the U.S. from establishing its own compensation system. We consider possible alternatives for the U.S. by examining the advantages and disadvantages of both established and proposed systems. We offer a new proposal that addresses the justice concerns which compel the establishment of a national compensation system, distributes the burdens of such a system on multiple stakeholders that benefit from research, and has the additional advantage of minimizing the administrative and logistical challenges associated with initiating such a system. (shrink)

Harms and risks to groups and third-parties can be significant in the context of research, particularly in data-centric studies involving genomic, artificial intelligence, and/or machine learning technologies. This article explores whether and how United States federal regulations should be adapted to better align with current ethical thinking and protect group interests. Three aspects of the Common Rule deserve attention and reconsideration with respect to group interests: institutional review board (IRB) assessment of the risks/benefits of research; disclosure requirements in the informed (...) consent process; and criteria for waivers of informed consent. In accordance with respect for persons and communities, investigators and IRBs should systematically consider potential group harm when designing and reviewing protocols, respectively. Research participants should be informed about any potential group harm in the consent process. We call for additional public discussion, empirical research, and normative analysis on these issues to determine the right regulatory and policy path forward. (shrink)

Volume 19, Issue 6, June 2019, Page 22-25.

Back in 1978, Louise Brown made international headlines simply for being born, the first to do so after in vitro fertilization (IVF). One ethicist acknowledged fears that IVF “might move us toward...