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Most medications given to infants, children, and pregnant women have not been labeled by regulatory agencies for use in these vulnerable groups. This often means that appropriate studies examining efficacy and safety, at the level demanded by the regulators, have not been conducted. Yet, it is important to acknowledge that many such studies have been and are being performed even without industry’s interest, by academics in numerous pediatric departments. We applaud these individuals, as they have not just accepted the reality that children and pregnant women are orphaned from the benefits of new and existing therapies. We also applaud the American government for leading the world in demanding and enforcing the pharmaceutical industry to conduct such studies by extending patent protection, as well as initiating large-scale studies on older, ‘off patent’ drugs. Europe has followed the American leadership, and it is hoped that other jurisdictions will also find ways to value the child, before and after birth, as worthy of benefiting from appropriately investigated therapy. The challenges of conducting ethically sound research in children are numerous. Many of the issues arise from the fact that the research subject cannot decide for himself/ herself, and informed decisions need to be made by parents or other guardians. Challenges also stem from the differences in drug handling in young infants due to organ immaturity, the potential increased risk of toxicity in ill children and the possibility of long-term developmental effects that may not be detected until years later. This theme issue of Pediatric Drugs is dedicated to discussing ethical challenges encountered in conducting drug research in infants, children, and pregnant women, and to identifying solutions that may enable clinician scientists and other pediatric researchers to conduct such studies. Topics covered herein include defining and measuring risks and benefits inherent in pediatric clinical research [1], consent and assent [2], and equipoise [3]. The theme issue also addresses the specific ethical considerations encountered when conducting research in different pediatric subpopulations, from the fetus [4] and newborns [5] to the adolescent [6], the developmentally challenged child [7], and the child with cancer [8]. Certain clinical situations are particularly challenging from a research ethics perspective and are covered in detail in this issue, including intensive care [9], the emergency department [10], and low-income countries [11]. Moreover, although a common set of regulations seem to operate around the world, they have not been interpreted uniformly by different jurisdictions and, therefore, in an attempt to be generalizable, we have tried to address these sources of variability, when appropriate. The Research Ethics Committee plays a pivotal role. Countries who are members of the World Medical Association are in agreement that the conduct of ethical research should reside in the hands of committees, referred to in This article is part of the topical collection on Ethics of Pediatric Drug Research.

Creating a New Ethical Climate for Drug Research in Children and Pregnant Women