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Comment
. 2022 Sep;52(5):42-43.
doi: 10.1002/hast.1420.

Xenotransplantation Clinical Trials and the Need for Community Engagement

Michael K Gusmano
Comment

Xenotransplantation Clinical Trials and the Need for Community Engagement

Michael K Gusmano. Hastings Cent Rep. 2022 Sep.

Abstract

There are several ethical concerns facing first-in-human clinical trials involving xenotransplantation. Who should participate in these trials? If we limit trial participation to those who have exhausted other treatment options, how can we avoid therapeutic misconception? How should we balance the desire for long-term monitoring of trial participants against the well-established principle that research participants have the right to withdraw from research? Finally, how should we balance concerns about equitable access to these trials with deep mistrust of the scientific community? In particular, should xenotransplant clinical trials attempt to address well-known inequities in clinical trial participation by race and ethnicity? In this commentary, I argue that clinical investigators and regulators have an obligation to engage with underrepresented communities to develop answers to these questions.

Keywords: community engagement; equity; research ethics; trust in research; xenotransplantation, clinical trials.

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References

    1. H. Silverman and P. N. Odonkor, “Reevaluating Ethical Issues in Porcine-to-Human Heart Xenotransplantation,” Hastings Center Report 52, no. 5 (2022): 32-42.
    1. K. M. Maschke, E. J. Gordon, and M. K. Gusmano, “After the Pig-to-Human Heart Transplant, the FDA, Clinicians and Insurers Have Some Catching Up to Do,” Washington Post, January 13, 2022.
    1. P. S. Appelbaum, C. W. Lidz, and T. Grisso, “Therapeutic Misconception in Clinical Research: Frequency and Risk Factors,” IRB: Ethics & Human Research 26, no. 2 (2004): 1-8.
    1. Silverman and Odonkor, “Reevaluating Ethical Issues in Porcine-to-Human Heart Xenotransplantation,” 40.
    1. M. K. Gusmano, V. G. Rodwin, and D. Weisz, Health Care in World Cities: New York, Paris, and London (Baltimore, MD: Johns Hopkins University Press, 2010); M. K. Gusmano et al., “Inequalities in Access to Revascularization: Evidence from New York,” Health Equity 3, no. 1 (2019): 458-63.

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