Interpretation of the Subjects' Condition Requirement: A Legal Perspective

45 C.F.R. 46.406.

Kopelman L. M. , “When Can Children with Conditions Be in No-Benefit, Higher-Hazard Pediatric Studies?” American Journal of Bioethics 7, no. 7 (2007): 5–10; Ross L. F. , “The Participation of Children in Nontherapeutic Diabetes Research in the US,” Nature Clinical Practice Endocrinology & Metabolism 3, no. 3 (2007): 378–379; Glass K. C. Binik A. , “Rethinking Risk in Pediatric Research,” Journal of Law, Medicine & Ethics 36, no. 3 (2008): 567–576.

Id. (Glass and Binik).

National Human Research Protections Advisory Committee, Report Clarifying Specific Portion of 45 CFR 46 Subpart D that Governs Children's Research, 2002, at 3, available at <http://www.hhs.gov/ohrp/nhrpac/documents/nhrpac16.pdf> (last visited April 29, 2010) (hereinafter Advisory Committee). Note: This report expressly indicates that it does not represent the official views of the OHRP.

See Kopelman , supra note 2.

Institute of Medicine, Ethical Conduct of Clinical Research Involving Children (Washington, D.C.: National Academies Press, 2004).

Segall E. J. , “Justice Scalia, Critical Legal Studies, and the Rule of Law,” George Washington Law Review 62 (1994): 991–1042, at 998.

See, e.g., Arnold v. County of Nassau, 252 F.3d 599, 602 (2d Cir. 2001); Ayala-Chavez v. INS, 945 F.2d 288, 294 (9th Cir. 1991); Kyle v. Director, OWCP, 819 F.2d 139, 142 (6th Cir. 1987).

Cross F. B. , The Theory and Practice of Statutory Interpretation (Stanford: Stanford University Press, 2009).

Frickey P. P. , “From the Big Sleep to the Big Heat: The Revival of Theory in Statutory Interpretation,” Minnesota Law Review 77 (1992): 241–267, at 248.

Posner R. A. , Law, Pragmatism, and Democracy (Cambridge: Harvard University Press, 2003).

Microsoft Corp. v. Comm'r , 311 F.3d 1178, 1183 (9th Cir. 2002).

Oxford English Dictionary, 5th ed. (New York: Oxford University Press, 2002).

Id.

Williams D. R. Sternthal M. Wright R. J. , “Social Determinants: Taking the Social Context of Asthma Seriously,” Pediatrics 123, Supp. 3 (2009): S174–S184.

See Segall , supra note 7.

Hurst J. , Dealing with Statutes (New York: Columbia, 1982).

Baltimore & Ohio Railway Co. v. Jackson, 353 U.S. 325, 331 (1957).

See Segall , supra note 7.

See supra note 1.

Id.

Gardebring v. Jenkins , 485 U.S. 415, 430 (1988); Moore v. Han-non Food Serv., Inc., 317 F.3d 489, 494–96 (5th Cir. 2003).

Email from Kristina Borrar, Office for Human Research Protections, September 25, 2008.

See Advisory Committee, supra note 4.

Gonzales v. Oregon , 546 U.S. 243 (U.S. 2006).

National Research Act at § 202(a)(1)(A) (1974), available at <http://www.hhs.gov/ohrp/documents/19780721.pdf> (last visited April 30, 2010).

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations on Research Involving Children, September 6, 1977.

Id.

Id.

Id.

“Proposed Regulations on Research Involving Children, Part V,” Federal Register (July 21, 1978): 31786–31794, at 31788.

See supra note 27.

Id.

Id.

45 C.F.R. 46.405.

Curran v. Bosze , 141 Ill. 2d 473, 497 (Ill. 1990) (holding that “a parent or guardian may give consent on behalf of a minor daughter or son for the child to donate bone marrow to a sibling, only when to do so would be in the minor's best interest.”).

See supra note 35; Peerzada J. M. Wendler D. , “Hematopoietic Stem Cell Transplant Research with Pediatric Donors: When Can Institutional Review Boards Approve It?” Transplantation 81, no. 12 (2006): 1616–1620.

Gordon B. Prentice E. Reitemeier P. , “The Use of Normal Children as Participants in Research on Therapy,” IRB: A Review of Human Subjects Research 18, no. 3 (1996): 5–8.

Institute of Medicine, Ethical Conduct of Research Involving Children, March 24, 2004.

King N. M. P. , “Defining and Describing Benefit Appropriately in Clinical Trials,” Journal of Law, Medicine & Ethics 28, no. 4 (2000): 332–343.

45 C.F.R. 46.407.