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Ethics in Pharmacologic Research in the Child with a Disability

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Abstract

This article reviews the unique ethical concerns that face clinicians, researchers, and family members in the realm of research involving children and youth with childhood-onset disabilities. Presented are the contemporary legal and regulatory environments in which we work and a synopsis of relevant articles on bioethics in this sector of the scientific literature. The most important ethical themes that emerged for children with disabilities include justice in research, consent and assent, child-centered communication, child- and family-centered decision making, participation in multiple studies, and therapeutic misconception. Two publicly recorded clinical studies are profiled to illustrate common considerations and concerns that arise during our ethical review of drug studies involving children with disabilities. It is concluded that the balance of access to current research and treatments must be weighed against risk for all involved. Collaborative planning amongst those involved in the development, review, approval, conduct, and oversight of drug study protocols can lead to effective scientific inquiry within the context of core ethical principles and child- and family-centered care.

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Acknowledgments

P. Rumney, J.A. Anderson, and S.E. Ryan did not receive funding for the preparation of this article and declare no conflicts of interest.

Author information

Authors and Affiliations

  1. Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, ON, M4G 1R8, Canada

    Peter Rumney & Stephen E. Ryan

  2. Department of Paediatrics, University of Toronto, Toronto, ON, Canada

    Peter Rumney

  3. Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, ON, M4G 1R8, Canada

    James A. Anderson

  4. Joint Centre for Bioethics, University of Toronto, Toronto, ON, Canada

    James A. Anderson

  5. Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada

    James A. Anderson

  6. Department of Occupational Science and Occupational Therapy, University of Toronto, Toronto, ON, Canada

    Stephen E. Ryan

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  1. Peter Rumney
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Correspondence to Peter Rumney.

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This article is part of the topical collection on Ethics of Pediatric Drug Research.

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Rumney, P., Anderson, J.A. & Ryan, S.E. Ethics in Pharmacologic Research in the Child with a Disability. Pediatr Drugs 17, 61–68 (2015). https://doi.org/10.1007/s40272-014-0102-4

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