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Online Pediatric Research: Addressing Consent, Assent, and Parental Permission

Published online by Cambridge University Press:  01 January 2021

Abstract

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.

Type
Symposium Articles
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

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References

Hoon, D. et al., “Trends in Off-Label Drug Use in Ambulatory Settings: 2006-2015,” Pediatrics 144, no. 4 (2019): e20190896,.CrossRefGoogle Scholar
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).+(last+visited+February+12,+2020).>Google Scholar
Sinha, M.S. et al., “Labeling Changes and Costs for Clinical Trials Performed under the Us Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012,” JAMA Internal Medicine 178, 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.CrossRefGoogle Scholar
Nuremberg Code, Trials of War Criminals before the Nuremberg Miltary Tribunals under Control Council Law No. 10: Nuremberg, October 1946-April 1949 (1947).Google Scholar
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 Redmon, R.B., “How Children Can Be Respected as ‘Ends’ Yet Still Be Used as Subjects in Non-therapeutic Research,” Journal of Medical Ethics 12, no. 2 (1986): 77-82.CrossRefGoogle Scholar
Ross, L.F., Newburger, J.W., and Sanders, S.P., “Ethical Issues in Pediatric Trials,” American Heart Journal 142, no. 2 (2001): 233-236.CrossRefGoogle Scholar
Binik, A., “Does Benefit Justify Research with Children?” Bio-ethics 32, no. 1 (2018): 27-35.Google Scholar
Committee on Bioethics, American Academy of Pediatrics, “Informed Consent, Parental Permission, and Assent in Pediatric Practice,” Pediatrics 95, no. 2 (1995): 314-317.Google Scholar
There are examples in the literature of parents trying out treatments on their children, with significant variation in the safety of these “experiments.” Examples include: Hauser, C., “Whatever Ails You, F.D.A. Says, Drinking Bleach Isn’t the Answer,” New York Times, August 13, 2019; Mnookin, S., “One of a Kind: What Do You Do If Your Child Has a Condition That Is New to Science?” The New Yorker, July 14, 2014. However, we do not know of pediatric “self-experimentation” that is organized by disease advocacy groups or other unregulated researchers.Google Scholar
Federal Trade Commission, “Complying with COPPA: Frequently Asked Questions — General Questions,” available at <https://www.ftc.gov/tips-advice/business-center/guidance/complying-coppa-frequently-asked-questions#General%20Questions> (last visited February 12, 2020).+(last+visited+February+12,+2020).>Google Scholar
Federal Trade Commission, “Complying with COPPA: Frequently Asked Questions — COPPA Enforcement,” available at <https://www.ftc.gov/tips-advice/business-center/guidance/complying-coppa-frequently-asked-questions#COPPA%20Enforcement> (last visited February 12, 2020).+(last+visited+February+12,+2020).>Google Scholar
See Federal Trade Commission, supra note 10.Google Scholar
Federal Trade Commission, “Complying with COPPA: Frequently Asked Questions — Verifiable Parental Consent,” available at <https://www.ftc.gov/tips-advice/business-center/guidance/complying-coppa-frequently-asked-questions#Verifiable%20Parental> (last visited February 12, 2020).+(last+visited+February+12,+2020).>Google Scholar
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.Google Scholar
Aiken, M., “The Kids Who Lie about Their Age to Join Facebook,” The Atlantic, August 30, 2016.Google Scholar
We do not believe such an affidavit would need to be notarized. This would further impede pediatric research without substantively improving protections for children.Google Scholar
Findlay, S., “Virtual Doctor Visits Are Getting More Popular, but Questions Remain about Who Pays,” The Washington Post, May 6, 2018.Google Scholar
“Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators,” 76 Federal Register 44,512-44,531 (July 26, 2011).Google Scholar
Hein, I.M. et al., “Accuracy of the Macarthur Competence Assessment Tool for Clinical Research (Maccat-Cr) for Measuring Children’s Competence to Consent to Clinical Research,” JAMA Pediatrics 168, no. 12 (2014): 1147-1153.CrossRefGoogle Scholar
See Wilbanks, J., “Electronic Informed Consent in Mobile Applications Research,” Journal of Law, Medicine & Ethics 48, no. 1, Suppl. (2020): 147-153.CrossRefGoogle Scholar
Brothers, K.B. et al., “When Participants in Genomic Research Grow Up: Contact and Consent at the Age of Majority,” The Journal of Pediatrics 168 (2016): 226-231.CrossRefGoogle Scholar
NIH, “Genetic and Rare Diseases Information Center, FAQs about Rare Diseases,” available at <https://rarediseases.info.nih.gov/diseases/pages/31/faqs-about-rare-diseases> (last visited February 12, 2020).+(last+visited+February+12,+2020).>Google Scholar
Teare, H.J.A. et al., “The Rudy Study: Using Digital Technologies to Enable a Research Partnership,” European Journal of Human Genetics 25, no. 7 (2017): 816-822.CrossRefGoogle Scholar
WHO, Priority Medicines for Europe and the World (2013), available at <https://www.who.int/medicines/areas/priority_medicines/Ch6_19Rare.pdf> (last visited February 12, 2020).+(last+visited+February+12,+2020).>Google Scholar
Escalera, B.N. et al., “Rare Commons: An Innovative Social Media Platform 2.0 for Collaborative Clinical Research on Pediatric Rare Diseases,” abstract from presentation at Pediatrics for the 21st Century, printed in Pediatrics 141 (2018): 141 (1 MeetingAbstract) 235.Google Scholar
Griggs, R.C. et al., “Clinical Research for Rare Disease: Opportunities, Challenges, and Solutions,” Molecular Genetics and Metabolism 96, no. 1 (2009): 20-26.CrossRefGoogle Scholar
McCormack, P. et al., “‘You Should at Least Ask’. The Expectations, Hopes and Fears of Rare Disease Patients on Large-Scale Data and Biomaterial Sharing for Genomics Research,” European Journal of Human Genetics 24, no. 10 (2016): 1402-1408; Wicks, P. et al., “Sharing Health Data for Better Outcomes on PatientsLikeMe,” Journal of Medical Internet Research 12, no. 2 (2010): e19.CrossRefGoogle Scholar
See McCormack, supra note 26.Google Scholar
See id.; Wicks, supra note 26.Google Scholar