Pediatric Research Regulations under Legal Scrutiny: Grimes Narrows Their Interpretation

Author:

Kopelman Loretta M.

Abstract

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals (Maryland’s highest court) considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute (KKI), an affiliate of Johns Hopkins University.After briefly discussing the case at the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference56 articles.

1. 11. See Brief of Amici Curiae Association of American Medical Colleges, Association of American Universities, Johns Hopkins University, and University of Maryland Medical System Corporation in Support of Appellee's Motion for Reconsideration, Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807 (Md. 2001) (No. 128), available at . This will also be shown below.

2. 22. See Grimes v. Kennedy Krieger Institute, Inc. 782 A.2d 807, 850 (Md. 2001).

3. 56. In proposing this reconciliation, I have assumed that the understandings of “minimal risk” in the Grimes holding and 45 C.F.R. § 46 are similar. But this is an assumption worth considering in its own right, as is the assumption that “benefit” and “therapy” can be used interchangeably in this context.

4. 32. See Brief of Amici Curiae, supra note 11, at 6.

5. 42. See Kennedy Krieger Institute, supra note 3.

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