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Pediatric Drugs

, Volume 21, Issue 4, pp 205–214 | Cite as

Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials

  • Susan M. Abdel-RahmanEmail author
Leading Article
  • 80 Downloads
Part of the following topical collections:
  1. Ethics of Pediatric Drug Research

Abstract

Individuals approached to participate in human subjects research, irrespective of age, must be completely apprised of the study, and researchers must ensure that the information is understood to the fullest extent possible, prior to decision making. However, evolving regulatory and institutional requirements have led to permission/assent/consent (PAC) forms that are unnecessarily complex, serving only to exacerbate the challenges associated with communicating this important information to prospective participants. At greatest risk are children and other individuals with low literacy, limited English proficiency, and diminished mental capacity, populations all too often neglected in clinical research. This paper examines various strategies that have been evaluated to facilitate informed PAC, drawing on experiences across a broad array of populations whose needs overlap with those of children. These strategies range from simplifying PAC forms for readability and creating multimedia PAC delivery tools to actively engaging participants on their understanding of PAC elements by leveraging testing, rewards, and third-party communications. Notably, the findings from strategies that have been explored in more than one setting are uniformly mixed with respect to their ability to improve comprehension, underscoring the challenges that persist in designing, implementing, and objectively examining strategies intended to facilitate informed PAC. However, these studies do serve to highlight efforts that may reduce anxiety around, and increase the satisfaction of participants with, the PAC process. Ultimately, accommodating a diverse participant pool will require the consideration, and continual refinement, of various PAC strategies along with the engagement of team members who are intimately familiar with these populations.

Notes

Compliance with Ethical Standards

Conflict of interest

S M. Abdel-Rahman does not have any conflicts of interest to declare.

Funding

No funding was received to support the preparation of this article.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Division of Clinical Pharmacology, Toxicology, and Therapeutic InnovationChildren’s MercyKansas CityUSA
  2. 2.Department of Pediatrics, School of MedicineUniversity of Missouri-Kansas CityKansas CityUSA

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