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To the Editor.-- As a nurse whose background is in newborn intensive care, I deeply appreciate the guidelines (1-3) of the American Academy of Pediatrics (AAP) that address the issue [...]

ABBREVIATION. AAP, American Academy of Pediatrics. The current set of federal regulations about how to treat extremely ill, premature, or terminally ill infants Yet, 20 years later these Baby Doe [...]

The US Federal Code limits research with healthy children to no more than a minimal risk of harm; it restricts research with children who have some disorder or condition to no more than a minor increase over minimal risk, unless potential harms are offset by potential benefits to them, as in therapeutic studies. Higher risk studies require "407 approval," named after the relevant section of the code describing requirements. Rarely used until recently, 407 approval requirements include Institutional Review Board approval and authorization by the Secretary of the Department of Health and Human Services after consultation with a panel of experts; a period for public comment; and assurances that there are adequate permission, consent, and assent. This 407-approval mechanism contains both procedural and interpretative ambiguities, which raise ethical concerns about 1) the expertise represented on advisory panels, 2) the scope of the information offered to the public for comment and its potential conflicts with investigators' intellectual property or commercial interests, 3) whether any upper level of risk exists, and 4) how it conforms with other policies such as the best interest of the child standard in the law or in medical decision making. Pediatrics 2004;113:1783-1789; children, ethics, experimentation, health policy, human subjects, IRBs, law, pediatrics, research., ABBREVIATIONS. IRB, Institutional Review Board; DHHS, Department of Health and Human Services; CFR, Code of Federal Regulations; OHRP, Office for Human Research Protections; NIH, National Institutes of Health; HIV, human [...]

To the Editor.-- I disagree with Dr Kopelman's analysis of the 21-year-old "Baby Doe" rules and her call for the American Academy of Pediatrics (AAP) to withdraw what she characterized [...]

To the Editor.-- I write to correct 1 factual error in the excellent review by Kopelman and Murphy (1) regarding the 407 panels and use this case to highlight a [...]

A response by Loretta M. Kopelman to a letter to the editor about her article "Are the 21-Year-Old Baby Doe Rules Misunderstood or Mistaken (Commentary)?," in a 2005 issue is presented.

Presents a response by L. M. Kopelman to a letter to the editor in response to his article "Are the 21-Year-Old Baby Doe Rules Misunderstood or Mistaken?," in the 2005 issue.

Presents a response by Loretta M. Kopelman to a letter to the editor about her article "Are the 21-Year-Old Baby Doe Rules Misunderstood or Mistaken?," in a 2005 issue.

Despite apparent disagreement in the scholarly literature on standards of pediatric decision making, a recognition that similar norms underpin many of the dominant frameworks motivated a June 2022 symposium "Best Interests and Beyond: Standards of Decision Making in Pediatrics" in St Louis, MO. Over the course of this 3-day symposium, 17 expert scholars (see author list) deliberated on the question "In the context of US pediatric care, what moral precepts ought to guide parents and clinicians in medical decision making for children?" The symposium and subsequent discussion generated 6 consensus recommendations for pediatric decision making, constructed with the primary goals of accessibility, teachability, and feasibility for practicing clinicians, parents, and legal guardians. In this article, we summarize these recommendations, including their justification, limitations, and remaining concerns., (Copyright © 2023 by the American Academy of Pediatrics.)