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Grimes v. Kennedy Krieger Institute8/16/2001
ng blood from the control population, namely children growing up in modern urban housing. Federal guidelines are really quite specific regarding using children as controls in projects in which there is no potential benefit [to the particular children]. To call a subject a normal control is to indicate that there is no real benefit to be received [by the particular children]. . . . So, we think it would be much more acceptable to indicate that the `control group' is being studied to determine what exposure outside the home may play in a total lead exposure; thereby, indicating that these control individuals are gaining some benefit, namely learning whether safe housing alone is sufficient to keep the blood-lead levels in acceptable bounds. We suggest that you modify . . . consent form . . . accordingly." [Emphasis added.]
While the suggestion of the IRB would not make this experiment any less nontherapeutic or, thus, less regulated, this statement shows two things: (1) that the IRB had a partial misperception of the difference between therapeutic and nontherapeutic research and the IRB's role in the process and (2) that the IRB was willing to aid researchers in getting around federal regulations designed to protect children used as subjects in nontherapeutic research. An IRB's primary role is to assure the safety of human research subjects - not help researchers avoid safety or health-related requirements. The IRB, in this case, misconceived, at least partially, its own role.
The provisions or conditions imposed by the federal funding entities, pursuant to federal regulations, are conditions attached to funding. As far as we are aware, or have been informed, there are no federal or state (Maryland) statutes that mandate that all research be subject to certain conditions. Certain international "codes" or "declarations" exist (one of which is supposedly binding but has never been so held) that, at least in theory, establish standards. We shall describe them, infra. Accordingly, we write on a clean slate in this case. We are guided, as we determine what is appropriate, by those international "codes" or "declarations," as well as by studies conducted by various governmental entities, by the treatises and other writings on the ethics of using children as research subjects, and by the duties, if any, arising out of the use of children as subjects of research.
Otherwise healthy children, in our view, should not be enticed into living in, or remaining in, potentially lead-tainted housing and intentionally subjected to a research program, which contemplates the probability, or even the possibility, of lead poisoning or even the accumulation of lower levels of lead in blood, in order for the extent of the contamination of the children's blood to be used by scientific researchers to assess the success of lead paint or lead dust abatement measures. Moreover, in our view, parents, whether improperly enticed by trinkets, food stamps, money or other items, have no more right to intentionally and unnecessarily place children in potentially hazardous nontherapeutic research surroundings, than do researchers. In such cases, parental consent, no matter how informed, is insufficient.
While the validity of the consent agreement and its nature as a contract, the existence or nonexistence of a special relationship, and whether the researchers performed their functions under that agreement pursuant to any special relationships are important issues in these cases that we will address, the very inappropriateness of the research itself cannot be overlooked. It is apparent that the protocols of research are even more important than the method of obtaining parental consent and the extent to which th
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