Browsing by Subject "Informed consent"

Nearly 60% of the US population experiencing posttraumatic stress disorder have not received a meaningful clinical response from traditional interventions (Akiki & Abdallah, 2018). Early research using psychedelics in tandem with psychotherapy may offer a more effective option (Feduccia et al., 2019) and has been shown to provide or contribute to long-term relief or remission from PTSD symptoms (in small samples). Funding for psychedelic-assisted therapy (PAT) clinical-trials has increased to nearly billions (Phelps et al., 2022) and while the research is propitious, it is far from complete. Concerns about safety and generalizability have begun to surface (Love, 2022), including recent allegations of abuse. Though abuse is an issue within all clinical practice, risk is amplified by the non-ordinary state of consciousness experienced in high-dose PAT trials. In the US, treatment models using mind-altering substances are shaped by FDA-approved clinical research trials, which in turn define ethical practices and standards of care. By examining how existing regulations recommend governance for the informed consent process and reviewing publicly available documents from PAT trials, I aim to: 1) illuminate how risk and accountability are currently communicated to PAT participants; and 2) suggest how existing research policy might be updated to make working with trauma patients under non-ordinary states of consciousness safer and more ethically robust.

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What is consent? What does it mean, what is its use, and what good does it do? My dissertation turns these questions over and over, looking at the answers given by three different eras of western history: the Information Age up to the present, the Enlightenment up to the birth of the United States, and the Middle Ages up to the Reformation. The structure of my thought reverses the chronology of history, because I imagine my project as an excavation. Starting with a survey of the present landscape, I work downward to the depth of the past, recovering a form of consent buried in a language we have lost. Always conscious of our present context, my technique is what some call “metamodern,” meaning I freely adopt a posture that is, at turns, postmodern and premodern. After discussing the scope and method of my work in chapter one, I devote the second chapter to a study of our databased economy. Tech firms are extracting biometric and behavioral data, setting up asymmetrical power relations with a small but all-important choice architecture, the Agree button. I offer a survey of the logics behind its automation. The third chapter then picks up where the second leaves off. I draw from my own experience working in clinical research, where it was my job to “consent people.” The strange grammar of that phrase prompts a discussion about the history and practice of informed consent. This leads to the fourth chapter, where I turn to John Locke’s theory of the social contract. From Locke, we receive the basic principles regulating our use of consent today. But as I show in the next chapter, a very different paradigm lies beneath it, which is what I want to recover. Chapter five thus traces the evolutions of "consentire" from Aquinas to Luther, giving careful attention to language they received from Augustine. The sixth and final chapter then explores the Augustinian grammar in the visionary work of Dante and Catherine of Siena, whom I believe can teach us another way to be modern.