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Regulating “Higher Risk, No Direct Benefit” Studies with Children: Challenging the US Federal Regulations

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Human Medical Research

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Abstract

Review boards must assess whether the risks and burdens are acceptable in relation to the potential benefits to the study subjects and/or the future patients for each proposed medical research study. If the study involves children and cannot directly benefit those children, the risks and burdens involved cannot be more than “minimal”. The two relevant ethics documents recognized in Europe forbid review boards to make any exceptions to the requirement of minimal risk and burden. Review boards in Europe, therefore, occasionally have to reject studies that could significantly improve medical care for sick children in the future. The US Federal Regulations offer two possibilities for approving such “higher risk, no direct benefit” studies. This paper argues that rather than following the US Federal Regulations completely, Europe should adopt a modified policy.

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Notes

  1. 1.

    The results of this analysis have already been published in the American Journal of Bioethics (Westra et al. 2010b).

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Acknowledgments

The work was supported by The Netherlands Organization for Health Research and Development (Grant number 92003475).

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Authors and Affiliations

  1. Department of Paediatrics, Leiden University Medical Centre, Leiden, The Netherlands

    Anna E. Westra, Jan M. Wit & Rám N. Sukhai

  2. Department of Medical Ethics and Philosophy of Medicine, Erasmus Medical Centre Rotterdam, Rotterdam, The Netherlands

    Inez D. de Beaufort

Authors
  1. Anna E. Westra
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  2. Jan M. Wit
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  3. Rám N. Sukhai
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  4. Inez D. de Beaufort
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Corresponding author

Correspondence to Anna E. Westra .

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Editors and Affiliations

  1. Inst. Medizinische Ethik und, Geschichte der Medizin, Universität Bochum, Markstr. 258a, Bochum, 44799, Germany

    Jan Schildmann

  2. , Institute for Medical Ethics, Ruhr University Bochum, Markstr. 258a, Bochum, 44799, Germany

    Verena Sandow

  3. , Institute of Ethics, History and, Ludwig-Maximilians-University Munich, Lessingstr. 2, Munich, 80336, Nordrhein-Westfalen, Germany

    Oliver Rauprich

  4. Inst. Medizinische Ethik und, Geschichte der Medizin, Universität Bochum, Markstr. 258a, Bochum, 44799, Germany

    Jochen Vollmann

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Westra, A.E., Wit, J.M., Sukhai, R.N., de Beaufort, I.D. (2012). Regulating “Higher Risk, No Direct Benefit” Studies with Children: Challenging the US Federal Regulations. In: Schildmann, J., Sandow, V., Rauprich, O., Vollmann, J. (eds) Human Medical Research. Springer, Basel. https://doi.org/10.1007/978-3-0348-0390-8_12

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