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Indiana Law Journal

Document Type

Article

Publication Date

2024

Publication Citation

99 Indiana Law Journal 933 (2024)

Abstract

When patients seek medical care, they trust their physician to offer treatments that are in their best medical interests and to engage them in a shared decision-making process to determine the best way forward. But today, in hospitals and doctors’ offices around the country, physicians also place patients in research studies that randomly assign them to a standard of care treatment, sometimes without the patients’ knowledge or consent. In such studies, patients may receive a treatment that results in worse outcomes for them, some of which can be serious and permanent. What’s more, there are reasons to be concerned that the burdens of this practice may fall more heavily on people of color and those who have less financial means, are less educated, or experience language barriers. Their social disadvantage or vulnerability may be further deepened by their illness.

As these studies are taking place, physician-researchers and ethics scholars have been increasingly advancing arguments in the ethics literature for bypassing consent practices that have been in place for over half a century. Though these arguments are weak and some illogical, government agencies have been funding research without consent and government oversight bodies have stood by doing little.

Advocates for bypassing consent have met some opposition, but thus far debate on this issue has taken place almost exclusively within the research and research ethics community and has focused almost entirely on ethical and regulatory requirements. The common law has been forgotten.

Yet physicians and other clinicians violate patients’ legal rights to bodily integrity and autonomy—in addition to breaching fiduciary duties of loyalty, discretion, and care—when they place their patients in these types of studies without their knowledge or consent. This Article examines common law duties to inform patients and obtain their consent prior to placing them in research studies that randomize them to medical treatments, even ones that are accepted as standard of care. Courts have yet to specifically address the scope of duties owed, although lawsuits stemming from involvement in such studies have recently been initiated and more should be anticipated in the future. Past cases reveal that patients randomized to medical treatments without their knowledge or consent could successfully sue for battery, lack of informed consent, and breach of fiduciary duty, among other claims. Understanding the common law duties associated with such claims does more than illuminate potential legal exposure for physicians and others conducting such research. Appreciating the ethical grounding of those legal duties also points the ethical way forward—for researchers to design consent processes that respect patients’ rights to know when decisions about their care will be affected by their placement in a research study and for oversight bodies to interpret existing research regulations as they traditionally have done—to honor a patient’s right to consent and its corollary—the right to refuse.

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