1. Ethical Conduct of Research in Children: Pediatricians and Their IRB (Part 2 of 2).
- Author
-
Rose CD
- Subjects
- Child, Humans, Pediatricians, Biomedical Research ethics, Ethics Committees, Research ethics, Ethics, Research, Informed Consent legislation & jurisprudence
- Abstract
In part 1 of this series, we discussed the historical, ethical, and legal background that provides justification for the current system of protection of subjects of human experimentation. We also discussed briefly the implementation of those principles in institutional review board (IRB) operations. In part 2, we focus on legislation dealing with pediatric research, the rules and ethics of assent, and then turn our attention to minimal-risk studies. To that end, we discuss the minimal-risk threshold and the process of balancing benefit and risk in IRB decisions for pediatric studies. We define the notion of consent waiver as well as the procedures for expedited review, management of adverse events, and amendments to approved protocol. Finally, we mention some miscellaneous issues, including central and commercial IRB, reliance agreements, biobanks, and sample shipping regulations., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The author has indicated he has no potential conflicts of interest to disclose., (Copyright © 2017 by the American Academy of Pediatrics.)
- Published
- 2017
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