In Grimes v. Kennedy Krieger Institute Inc, 366 Md. 29, 782 A.2d 807 (2001), the Court addressed the potential existence of a special relationship in the limited context of a nontherapeutic research study "that promises no medical benefit to the child whatsoever." Grimes, 366 Md. at 120. The particular situation addressed by Grimes involved "researchers recruiting people, especially children whose consent is furnished indirectly, to participate in nontherapeutic procedures that are potentially hazardous, dangerous, or deleterious to their health." Grimes 366 Md. at 93. Further, "the creation of study conditions or protocols or participation in the recruitment of otherwise healthy subjects to interact with already existing, or potentially existing, hazardous conditions, or both, for the purpose of creating statistics from which scientific hypotheses can be supported" was found by the Court to normally create a special relationship as a matter of law. Id. at 93. To the extent that Grimes set forth the law, it set forth law in the factual context of nontherapeutic research. It does not apply except indirectly in the context of therapeutic research9 The Court of Appeals held that the relationship between researcher and research subject can give rise to a duty whose breach constitutes negligence. Id. at 93-94. In reaching this holding, the Court recited the standard--albeit nebulous--definition of "duty" in negligence as "'an obligation, to which the law will give recognition and effect, to conform to a particular standard of conduct toward another.'" Id. at 86. Importantly, the Grimes Court explained that there is "no set formula" for inventing a duty, which, as Dean Prosser famously noted, is "not sacrosanct in itself, but is only an expression of the sum total of those considerations of policy which lead the law to say that the particular plaintiff is entitled to protection." The Grimes Court then recited several factors for consideration when determining whether a defendant owed a--previously unarticulated--duty to the plaintiff: In broad terms, these policies include: "convenience of administration, capacity of the parties to bear the loss, a policy of preventing future injuries, and the moral blame attached to the wrongdoer...." Prosser 53. As one court suggested, there are a number of variables to be considered in determining if a duty exists to another, such as: the foreseeability of harm to the plaintiff, the degree of certainty that the plaintiff suffered the injury, the closeness of the connection between the defendant's conduct and the injury suffered, the moral blame attached to the defendant's conduct, the policy of preventing future harm, the extent of the burden to the defendant and consequences to the community of imposing a duty to exercise care with resulting liability for breach, and the availability, cost and prevalence of insurance for the risk involved. (Grimes, 366 Md. at 86.) The Court of Appeals was particularly outraged by what it understood to be KKI's (Kennedy Krieger Institute) failure to warn parents of the risks of participating in the R&M Study both at the informed consent stage, and as risks became known or foreseeable during the study. Id. at 99. The consent forms signed by the parents did not explain that the success of the various levels of abatement was to be measured, in part, by the extent to which their children's blood was contaminated with lead. Id. at 38. Additionally, KKI failed to warn parents during the study that their children's blood lead levels were increasing. In the case of Ericka Grimes, appellant and one of the child subjects, KKI tested her home for the presence of lead after performing a partial abatement. Id. at 58. However, KKI did not reveal the results of the test that identified several lead "hot spots" until nine months later, after Ericka Grimes had already been lead poisoned. Id. at 59. The central legal question addressed by the Court of Appeals was what duty of care a researcher owes to the study participants. The Court specifically limited its holding to a nontherapeutic research study, which it defined as one that "generally utilizes subjects who are not known to have the condition the objectives of the research are designed to address . . . and is not designed to directly benefit the subjects utilized in the research, but, rather. . . the public at large." Id. at 36 n.2. In addressing the scope of the researcher's duty to research subjects in such a nontherapeutic study, the Court of Appeals in Grimes reached several conclusions: We hold that in Maryland a parent, appropriate relative, or other applicable surrogate, cannot consent to the participation of a child or other person under legal disability in nontherapeutic research or studies in which there is any risk of injury or damage to the health of the subject. We hold that informed consent agreements in nontherapeutic research projects . . . can, as a matter of law, constitute "special relationships" giving rise to duties, out of the breach of which negligence actions may arise. We also hold that, normally, such special relationships are created between researchers and the human subjects used by the researchers. Additionally, we hold that governmental regulations can create duties on the part of researchers towards human subjects out of which "special relationships" can arise. . . . The determination as to whether a "special relationship" actually exists is to be done on a case by case basis. The determination as to whether a special relationship exists, if properly pled, lies with the trier of fact. Id. at 113-14. The Court of Appeals reversed the trial court's grant of summary judgment and remanded based on the grounds that there were material facts in dispute as to whether a special relationship existed which would have imposed certain duties on KKI. Id. at 48.