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Ethics and Medical Toxicology Research

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Abstract

Optimizing care in medical toxicology necessitates designing and conducting ethical research. Nevertheless, the context of medical toxicology can make clinical research ethically challenging for a variety of reasons: medical toxicology is typified by relative rare conditions; making precise and rapid diagnoses is often fraught with uncertainty; emergent and urgent clinical exigencies make consent difficult or impossible; and some exposures are stigmatized or related to illegal activities that can compromise collecting accurate data from patients. In this paper, we examine some of the ethical issues in medical toxicology research that are especially salient in effort to promote optimal research in the field. The particular issues to be addressed are as follows: (1) rare conditions and orphan agents, (2) randomization and control arms, (3) inclusion and exclusion criteria, (4) outcome measures, (5) consent, (6) confidentiality, (7) registries, (8) oversight, and (9) transparency and reporting. Thinking about these ethical issues prospectively will help researchers and clinicians appropriately navigate them.

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Authors and Affiliations

  1. Berman Institute of Bioethics, Johns Hopkins University, 1809 Ashland Ave, Baltimore, MD, 21205, USA

    Jeremy Sugarman

  2. Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA

    Jeremy Sugarman

  3. Department of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA

    Jeremy Sugarman

  4. Department of Emergency Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA

    Andrew Stolbach

Authors
  1. Jeremy Sugarman
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  2. Andrew Stolbach
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Correspondence to Jeremy Sugarman.

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Conflict of Interest

Dr. Sugarman is a member of Merck KGaA’s Bioethics Advisory Committee and Stem Cell Oversight Committee; a member of Quintile’s Ethics Advisory Panel; and has been a consultant to Novartis on a bioethics issue. None of these activities are directly related to the material discussed in this paper. Dr. Stolbach declares that he has no conflicts of interest.

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Additional information

Dr. Sugarman presented a version of this paper as the invited Presidential Keynote, “Exploring Ethical Issues in Medical Toxicology Research,” at the American College of Medical Toxicology’s Annual Scientific Meeting in San Juan, Puerto Rico on April 1, 2017.

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Sugarman, J., Stolbach, A. Ethics and Medical Toxicology Research. J. Med. Toxicol. 13, 255–258 (2017). https://doi.org/10.1007/s13181-017-0618-4

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  • DOI: https://doi.org/10.1007/s13181-017-0618-4

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