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Consenting to uncertainty: challenges for informed consent to disease screening—a case study

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Abstract

This paper uses chronic beryllium disease as a case study to explore some of the challenges for decision-making and some of the problems for obtaining meaningful informed consent when the interpretation of screening results is complicated by their probabilistic nature and is clouded by empirical uncertainty. Although avoidance of further beryllium exposure might seem prudent for any individual whose test results suggest heightened disease risk, we will argue that such a clinical precautionary approach is likely to be a mistake. Instead, advice on the interpretation of screening results must focus not on risk per se, but on avoidable risk, and must be carefully tailored to the individual. These points are of importance for individual decision-making, for informed consent, and for occupational health.

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Notes

  1. We would like to thank the Center for Bioethics at the University of Pennsylvania for inviting Mark Greene to serve as a Visiting Scholar and for stimulating the work on this paper. Thanks also to John Philpott, David Philpott, and anonymous reviewers for very helpful comments. We especially wish to acknowledge the invaluable research contributions of Heidi Fisher and Nicholas Slack.

  2. The U.S. Department of Energy identified sample analysis costs in a range up to a few hundred dollars in its 1999 assessment of the economic impact of its CBD prevention rule [8].

  3. The BeLPT is performed on a simple venous blood draw. Alternatives such as bronchial lavage lymphocyte proliferation testing or lung biopsy and more invasive. Also, in contrast to beryllium skin testing, which raises concerns about inducing a sensitivity to beryllium that was not present prior to testing, BeLPT does not challenge the individual being tested with beryllium [1].

  4. Translation by Mark Greene.

  5. CBD is managed with corticosteroids, which carry significant side effects.

  6. Relevant assumptions are tabulated, with their empirical justifications, on p. 1213 with graphs of the curves on p. 1214, and further discussion of the limitations of the assumptions on pp. 1218–1219 [4].

  7. Notation altered.

  8. The whole population P max(CBD) is 0.04 which is 0.04/0.06 = 0.67 of the BeLPT+ sub population.

  9. See also [4].

  10. This accords with Judd and colleagues’ finding that BeLPT screening is most cost effective in the early years of beryllium employment [4].

  11. Related issues are discussed in greater detail in [4]. Even measures that technically reduce CBD prevalence in the population of beryllium workers and former workers might increase the number of cases by increasing the exposed population with higher worker turnover.

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Authors and Affiliations

  1. Department of Philosophy, University of Delaware, Newark, DE, 19716, USA

    Mark Greene

  2. CADDRE Education and Outreach Manager, University of Pennsylvania School of Nursing, Claire M Fagin Hall, 438L, 418 Curie Boulevard, Philadelphia, PA, 19104-6096, USA

    Suzanne M. Smith

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  1. Mark Greene
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Correspondence to Mark Greene.

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Greene, M., Smith, S.M. Consenting to uncertainty: challenges for informed consent to disease screening—a case study. Theor Med Bioeth 29, 371–386 (2008). https://doi.org/10.1007/s11017-008-9087-8

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