David M. Smolin (Samford University – Cumberland School of Law) has posted Nontherapeutic Research with Children: The Virtues and Vices of Legal Uncertainty on SSRN. Here is the abstract:
This essay examines the legal framework governing nontherapeutic research involving children, arguing that the law deliberately embraces uncertainty rather than providing clear substantive rules. Federal regulations prioritize process—through Institutional Review Boards, parental permission, and child assent—over definitive standards, reflecting societal ambivalence about subjecting children to risk for societal benefit. While pressures for pediatric research persist due to medical and regulatory needs, ethical and legal norms resist authorizing significant risk without direct benefit. The Maryland case Grimes v. Kennedy Krieger Institute illustrates state courts’ potential to impose categorical bans, contrasting with federal flexibility. Ultimately, legal ambiguity functions as a strategy to balance competing values, ensuring scrutiny without foreclosing research.