This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.
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References
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D.Hoonet al., “Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015,”Pediatrics144, no. 4 (2019): e20190896,.
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Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Best Pharmaceuticals for Children Act (BPCA) Priority List of Needs in Pediatric Therapeutics, available at <https://www.nichd.nih.gov/sites/default/files/inline-files/2018PriorityList-Feb19.pdf> (last visited February 12, 2020).
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M.S.Sinhaet al., “Labeling Changes and Costs for Clinical Trials Performed under the Us Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012,”JAMA Internal Medicine178, no. 11 (2018): 1458-1466. The FDA Modernization Act of 1997 and the subsequent Best Pharmaceuticals for Children Act (BPCA) in 2002 incentivize drug companies to conduct pediatric clinical trials by offering them an extension on the exclusivity period associated with their patents for medications that they also test in children.
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Nuremberg Code, Trials of War Criminals before the Nuremberg Miltary Tribunals under Control Council Law No. 10: Nuremberg, October 1946-April 1949 (1947).
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The normative claim that children cannot be included in research because they cannot make their own decisions can be traced, at least in part, to Kantian ethics. In this framework, the inclusion of children in research is to treat individual pediatric research participants as a means to a greater goal. Under Kant’s categorical imperative, of course, humans are only supposed to be treated as ends in themselves, and never as a means to some other end. For more on this, see R.B.Redmon, “How Children Can Be Respected as ‘Ends’ Yet Still Be Used as Subjects in Non-therapeutic Research,”Journal of Medical Ethics12, no. 2 (1986): 77-82.
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S.Mnookin, “One of a Kind: What Do You Do If Your Child Has a Condition That Is New to Science?”The New Yorker, July14, 2014. However, we do not know of pediatric “self-experimentation” that is organized by disease advocacy groups or other unregulated researchers.
This account of approaching parents in face-to-face pediatric research is derived from conversations with experienced clinical research staff at our institutions (in particular, at the Division of Pediatric Clinical and Translational Research at the University of Louisville). This is the type of thing that rarely gets written about, because it typically doesn’t need to be made explicit. However, the ethics of online research make it important to uncover these implicit nuances of in-person research.
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We do not believe such an affidavit would need to be notarized. This would further impede pediatric research without substantively improving protections for children.
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S.Findlay, “Virtual Doctor Visits Are Getting More Popular, but Questions Remain about Who Pays,”The Washington Post, May6, 2018.
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“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,”76Federal Register 44,512-44,531 (July26, 2011).
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I.M.Heinet al., “Accuracy of the Macarthur Competence Assessment Tool for Clinical Research (Maccat-Cr) for Measuring Children’s Competence to Consent to Clinical Research,”JAMA Pediatrics168, no. 12 (2014): 1147-1153.
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SeeJ.Wilbanks, “Electronic Informed Consent in Mobile Applications Research,”Journal of Law, Medicine & Ethics48, no. 1, Suppl. (2020): 147-153.
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K.B.Brotherset al., “When Participants in Genomic Research Grow Up: Contact and Consent at the Age of Majority,”The Journal of Pediatrics168 (2016): 226-231.
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