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Grimes v. Kennedy Krieger Institute8/16/2001
e parents were, or were not, informed. If the research methods, the protocols, are inappropriate then, especially when the IRB is willing to help researchers avoid compliance with applicable safety requirements for using children in nontherapeutic research, the consent of the parents, or of any consent surrogates, in our view, cannot make the research appropriate or the actions of the researchers and the Institutional Review Board proper.
The research relationship proffered to the parents of the children the researchers wanted to use as measuring tools, should never have been presented in a nontherapeutic context in the first instance. Nothing about the research was designed for treatment of the subject children. They were presumed to be healthy at the commencement of the project. As to them, the research was clearly nontherapeutic in nature. The experiment was simply a "for the greater good" project. The specific children's health was put at risk, in order to develop low-cost abatement measures that would help all children, the landlords, and the general public as well.
It was noted in Richard W. Garnett, Why Informed Consent? Human Experimentation and the Ethics of Autonomy, 36 Catholic Lawyer 455, 490 (1996) that:
"Most research poses no problems and is easily legitimated and justified, but the subject's consent to those experiments is not by itself a reliable indicator that they are justified, nor is it itself what justifies them."
In Olmstead v. United States, 277 U.S. 438, 479, 48 S. Ct. 564, 572-73, 72 L. Ed. 944, 957 (1928), Justice Brandis, dissenting, noted:
"Experience should teach us to be most on our guard to protect liberty when the Government's purposes are beneficent. Men born to freedom are naturally alert to repel invasion of their liberty by evil-minded rulers. The greatest dangers to liberty lurk in insidious encroachment by men of zeal, well-meaning but without understanding."
The research project at issue here, and its apparent protocols, differs in large degree from, but presents similar problems as those in the Tuskegee Syphilis Study conducted from 1932 until 1972 (The Tuskegee Syphilis Study, 289 New England Journal of Medicine 730 (1973)), the intentional exposure of soldiers to radiation in the 1940s and 50s (Jaffee v. United States, 663 F.2d 1226 (3d Cir. 1981), cert. denied, 456 U.S. 972, 102 S. Ct. 2234, 72 L. Ed. 2d 845 (1982)), the tests involving the exposure of Navajo miners to radiation (Begay v. United States, 591 F. Supp. 991 (1984), aff'd, 768 F.2d 1059 (9th Cir. 1985)), and the secret administration of LSD to soldiers by the CIA and the Army in the 1950s and 60s (United States v. Stanley, 483 U.S. 669, 107 S. Ct. 3054, 97 L. Ed. 2d 550 (1987); Central Intelligence Agency v. Sims, 471 U.S. 159, 105 S. Ct. 1881, 85 L. Ed. 2d 173 (1985)). The research experiments that follow were also prior instances of research subjects being intentionally exposed to infectious or poisonous substances in the name of scientific research. They include the Tuskegee Syphilis Study, aforesaid, where patients infected with syphilis were not subsequently informed of the availability of penicillin for treatment of the illness, in order for the scientists and researchers to be able to continue research on the effects of the illness, the Jewish Hospital study, and several other post-war research projects. Then there are the notorious use of "plague bombs" by the Japanese military in World War II where entire villages were infected in order for the results to be "studied"; and perhaps most notorious, the deliberate use of infection in a nontherapeutic project in order to study the degree of infection and the rapidity of the cour
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