Abstract
Federal regulations governing human subjects research do not address key questions raised by incidental neuroimaging findings, including the scope of a researcher's disclosure with respect to the possibility of incidental findings and the question whether a researcher has an affirmative legal cuty to seek, detect, and report incidental findings. The scope of researcher duties may, however, be mapped with reference to common law doctrine, including fiduciary, tort, contract, and bailment theories of liability.
Notes
45 C.F.R. 46.111 (2007a).
45 C.F.R. 46.116 (2007b).
45 C.F.R. 46.117 (2007c).
Greenberg v. Miami Children's Hosp. Research Institute, 264 F. Supp. 2d. 1064 (S.D. Fla. 2003).
Grimes v. Kennedy Krieger Institute, 782 A.2d 807 (Md. 2001).
Iacangelo v. Georgetown University, 2006 U.S. Dist. LEXIS 95848 (D.D.C. Oct. 11, 2006); 2007 U.S. Dist. LEXIS 21081 (D.D.C., Mar. 26, 2007).
Institute for Women's Health v. Imad, No. 04-05-00555-CV (Feb. 15, 2006).
Lo v. Burke, 249 Va. 311 (1995).
Moore v. Regents, 51 Cal.3d 120, 128 (1990), cert. denied, 499 U.S. 936 (1991).
Suthers v. Amgen, Inc., 372 F. Supp.2d 416 (S.D.N.Y. 2005).
Suthers v. Amgen, Inc., 441 F.Supp.2d 478 (S.D.N.Y. 2006).
Whitlock v. Duke University, 637 F. Supp. 1463 (1986).