782 A.2d 807 (2001) 366 Md. 29

Ericka GRIMES
v.
KENNEDY KRIEGER INSTITUTE, INC.
Myron Higgins, a minor, etc., et al.,
v.
Kennedy Krieger Institute, Inc.

Nos. 128, 129, Sept. Term, 2000.

Court of Appeals of Maryland.

August 16, 2001. Reconsideration Denied October 11, 2001.

*810 Kenneth W. Strong, Baltimore, for appellant, in No. 128, Sept. Term, 2000.

Suzanne C. Shapiro (Saul E. Kerpelman & Associates, P.A., on brief), Baltimore, for appellants, in No. 129, Sept. Term, 2000.

Michael I. Joseph (S. Allen Adelman and Susan B. Boyce of Godard, West, Adelman, *811 Sheff & Smith, LLC, on brief), Rockville, for appellees.

Deborah Thompson Eisenberg, Marc E. Steinberg, Tara Andrews, Baltimore, brief of the Public Justice Center, the National Health Law Program, and the East Harbor Village Center for appellants, amici curiae.

Angus R. Everton, Morgan Shelsby Carlo Downs & Everton, P.A., Hunt Valley, brief of the National Center for Lead-Safe Housing for appellees, amicus curiae.

Shale D. Stiller, George A. Nilson, William L. Reynolds and Evelyn W. Pasquier of Piper, Marbury, Rudnick & Wolfe, LLP, Baltimore; S. Allan Adelman and Michael I. Joseph of Godard, West, Adelman, Sheff and Smith, LLC, Rockville, for appellee, on reconsideration.

C. Christopher Brown of Brown, Goldstein and Levy, LLP, Baltimore, for National Center for Lead-Safe Housing, on reconsideration.

J. Joseph Curran, Jr., Attorney General of Maryland and Jack Schwartz, Assistant Attorney General of Maryland for University of Maryland Baltimore, on reconsideration.

Deborah Thompson Eisenberg and Marc Steinberg, Baltimore, for Public Justice Center, on reconsideration.

Ralph S. Tyler and Joseph H. Young of Hogan & Hartson, LLP, Baltimore, for American Medical Colleges, Association of American Universities, Johns Hopkins University and University of Maryland Medical System Corp., on reconsideration.

Vera Hassner Sharav of New York, NY, and Howard Fishman, Philadelphia, PA, for Alliance for Human Research Protection, on reconsideration.

Argued before ELDRIDGE, RAKER, WILNER, CATHELL, HARRELL, BATTAGLIA and ROBERT L. KARWACKI (retired, specially assigned), JJ. *808

*809 CATHELL, Judge.

Prologue

We initially note that these are cases of first impression for this Court. For that matter, precious few courts in the United States have addressed the issues presented in the cases at bar.^[1] In respect to nontherapeutic research using minors, it has been noted that "consent to research has been virtually unanalyzed by courts and legislatures." Robert J. Katerberg, Institutional Review Boards, Research on Children, and Informed Consent of Parents: Walking the Tightrope Between Encouraging Vital Experimentation and Protecting Subjects' Rights, 24 J.C. & U.L. 545, 562, quoting National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations [National Commission]: Research Involving Children 79-80 (1977). Our research reveals this statement remains as accurate now as it was in 1977.

In these present cases, a prestigious research institute, associated with Johns Hopkins University, based on this record, created a nontherapeutic research program^[2] whereby it required certain classes *812 of homes to have only partial lead paint abatement modifications performed, and in at least some instances, including at least one of the cases at bar, arranged for the landlords to receive public funding by way of grants or loans to aid in the modifications. The research institute then encouraged, and in at least one of the cases at bar, required, the landlords to rent the premises to families with young children. In the event young children already resided in one of the study houses, it was contemplated that a child would remain in the premises, and the child was encouraged to remain, in order for his or her blood to be periodically analyzed. In other words, the continuing presence of the children that were the subjects of the study was required in order for the study to be complete. Apparently, the children and their parents involved in the cases sub judice were from a lower economic strata and were, at least in one case, minorities.

The purpose of the research was to determine how effective varying degrees of lead paint abatement procedures were. Success was to be determined by periodically, over a two-year period of time, measuring the extent to which lead dust remained in, or returned to, the premises after the varying levels of abatement modifications, and, as most important to our decision, by measuring the extent to which the theretofore healthy children's blood became contaminated with lead, and comparing that contamination with levels of lead dust in the houses over the same periods of time. In respect to one of the protocols presented to the Environmental Protection Agency and/or the Johns Hopkins Joint Committee on Clinical Investigation, the Johns Hopkins Institutional Review Board (IRB), the researchers stated: "To help insure that study dwellings are occupied by families with young children, City Homes^[3] will give priority to families with young children when renting the vacant units following R & M [Repair and Maintenance] interventions."

The same researchers had completed a prior study on abatement and partial abatement methods that indicated that lead dust remained and/or returned to abated houses over a period of time. In an article reporting on that study, the very same researchers said: "Exposure to lead-bearing dust is particularly hazardous for children because hand-to-mouth activity is recognized as a major route of entry of lead into the body and because absorption of lead is inversely related to particule size." Mark R. Farfel & J. Julian Chisolm, Health and Environmental Outcomes of Traditional and Modified Practices for Abatement of Residential Lead-Based Paint,—80 American Journal of Public Health—1240, 1243 (1990). After publishing this report, the researchers began the present research project in which children were encouraged to reside in households where the possibility of lead dust was known to the researcher to be likely, so that the lead dust content of their blood could be compared with the level of lead dust in the houses at periodic intervals over a two-year period.

Apparently, it was anticipated that the children, who were the human subjects in the program, would, or at least might, accumulate lead in their blood from the *813 dust, thus helping the researchers to determine the extent to which the various partial abatement methods worked. There was no complete and clear explanation in the consent agreements signed by the parents of the children that the research to be conducted was designed, at least in significant part, to measure the success of the abatement procedures by measuring the extent to which the children's blood was being contaminated. It can be argued that the researchers intended that the children be the canaries in the mines but never clearly told the parents. (It was a practice in earlier years, and perhaps even now, for subsurface miners to rely on canaries to determine whether dangerous levels of toxic gasses were accumulating in the mines. Canaries were particularly susceptible to such gasses. When the canaries began to die, the miners knew that dangerous levels of gasses were accumulating.)

The researchers and their Institutional Review Board apparently saw nothing wrong with the search protocols that anticipated the possible accumulation of lead in the blood of otherwise healthy children as a result of the experiment, or they believed that the consents of the parents of the children made the research appropriate. Institutional Review Boards (IRB) are oversight entities within the institutional family to which an entity conducting research belongs. In research experiments, an IRB can be required in some instances by either federal or state regulation, or sometimes by the conditions attached to governmental grants that are used to fund research projects.^[4] Generally, their primary functions are to assess the protocols of the project to determine whether the project itself is appropriate, whether the consent procedures are adequate, whether the methods to be employed meet proper standards, whether reporting requirements are sufficient, and the assessment of various other aspects of a research project. One of the most important objectives of such review is the review of the potential safety and the health hazard impact of a research project on the human subjects of the experiment, especially on vulnerable subjects such as children. Their function is not to help researchers seek funding for research projects.

In the instant case, as is suggested by some commentators as being endemic to the research community as a whole, infra, the IRB involved here, the Johns Hopkins University Joint Committee on Clinical Investigation, in part, abdicated that responsibility, instead suggesting to the researchers a way to miscast the characteristics of the study in order to avoid the responsibility inherent in nontherapeutic research involving children. In a letter dated May 11, 1992, the Johns Hopkins University Joint Committee on Clinical Investigation (the IRB for the University), charged with insuring the safety of the subjects and compliance with federal regulations, wrote to Dr. Farfel, the person in charge of the research:

*814 "A number of questions came up.... Please respond to the following points[:]

...

2. The next issue has to do with drawing 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[s] ... 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,^[5] 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.

*815 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 the 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.^[6] The specific *816 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),^[7] 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,^[8] 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";^[9] and perhaps most notorious, the deliberate use of infection in a nontherapeutic project in *817 order to study the degree of infection and the rapidity of the course of the disease in the Rose and Mrugowsky typhus experiments at Buchenwald concentration camp during World War II. These programs were somewhat alike in the vulnerability of the subjects; uneducated African-American men, debilitated patients in a charity hospital, prisoners of war, inmates of concentration camps and others falling within the custody and control of the agencies conducting or approving the experiments. In the present case, children, especially young children, living in lower economic circumstances, albeit not as vulnerable as the other examples, are nonetheless, vulnerable as well.

It is clear to this Court that the scientific and medical communities cannot be permitted to assume sole authority to determine ultimately what is right and appropriate in respect to research projects involving young children free of the limitations and consequences of the application of Maryland law. The Institutional Review Boards, IRBs, are, primarily, in-house organs. In our view, they are not designed, generally, to be sufficiently objective in the sense that they are as sufficiently concerned with the ethicality of the experiments they review as they are with the success of the experiments. This has been the subject of comment in a constitutional context, in dissent, in a case involving the use of psychiatric medication on mental patients without their consent. In Washington v. Harper, 494 U.S. 210, 237, 110 S.Ct. 1028, 1045, 108 L.Ed.2d 178, 208 (1990), Justice Stevens said:

"The Court has undervalued respondent's liberty interest; has misread the Washington involuntary medication Policy..., and has concluded that a mock trial before an institutionally biased tribunal constitutes `due process of law.'" [Citation omitted.]

In footnote two of his dissent, Justice Stevens noted:

"([T]he Constitution's promise of due process of law guarantees at least compensation for violations of the principle stated by the Nuremberg Military Tribunals `that the "voluntary consent of the human subject is absolutely essential... to satisfy moral, ethical and legal concepts[.']"'); ([T]he Fourteenth Amendment protects the `freedom to care for one's health and person[.]')"

494 U.S. at 238, 110 S.Ct. at 1045, 108 L.Ed.2d at 208.

As can be seen from the letter from the Johns Hopkins University Joint Committee on Clinical Investigation, supra, to the researchers in this case, Justice Steven's doubts as to the effectiveness of such in-house review to assess the ethics of research were warranted. Here, the IRB, whose primary function was to insure safety and compliance with applicable regulations, encouraged the researchers to misrepresent the purpose of the research in order to bring the study under the label of "therapeutic" and thus under a lower safety standard of regulation. The IRB's purpose was ethically wrong, and its understanding of the experiment's benefit incorrect.

The conflicts are inherent. This would be especially so when science and private industry collaborate in search of material gains. Moreover, the special relationship between research entities and human subjects used in the research will almost always impose duties.

In respect to examining that special relationship, we are obliged to further examine its nature and its ethical constraints. In that regard, when contested cases arise, the assessment of the legal effect of research on human subjects must always be subject to judicial evaluation. One method of making such evaluations is the initiation *818 of appropriate actions bringing such matters to the attention of the courts, as has been done in the cases at bar. It may well be that in the end, the trial courts will determine that no damages have been incurred in the instant cases and thus the actions will fail for that reason. In that regard, we note that there are substantial factual differences in the Higgins and in the Grimes cases. But the actions, themselves, are not defective on the ground that no legal duty can, according to the trial courts, possibly exist. For the reasons discussed at length in the main body of the opinion, a legal duty normally exists between researcher and subject and in all probability exists in the cases at bar. Moreover, as we shall discuss, the consents of the parents in these cases under Maryland law constituted contracts creating duties. Additionally, under Maryland law, to the extent parental consent can ever be effective in research projects of this nature, the parents may not have been sufficiently informed and, therefore, the consents ineffective and, based on the information contained in the sparse records before this court, the research project, may have invaded the legal rights of the children subjected to it.

I. The Cases

We now discuss more specifically the two cases before us, and the relevant law.

Two separate negligence actions involving children who allegedly developed elevated levels of lead dust in their blood while participating in a research study with respondent, Kennedy Krieger Institute, Inc., (KKI) are before this Court. Both cases allege that the children were poisoned, or at least exposed to the risk of being poisoned, by lead dust due to negligence on the part of KKI. Specifically, they allege that KKI discovered lead hazards in their respective homes and, having a duty to notify them, failed to warn in a timely manner or otherwise act to prevent the children's exposure to the known presence of lead. Additionally, plaintiffs alleged that they were not fully informed of the risks of the research.

In the first case, Number 128, appellant, Ericka Grimes, by her mother Viola Hughes, appeals from a ruling of the Circuit Court for Baltimore City granting KKI's motion for summary judgment based on the sole ground that as a matter of law there was no legal duty, under the circumstances here present, on the part of KKI, owed to the appellants. In the second case, Number 129, appellant, Myron Higgins, by his mother Catina Higgins, and Catina Higgins, individually, appeal from a ruling of the Circuit Court for Baltimore City granting KKI's motion for summary judgment based on the ground that KKI had no legal duty to warn them of the presence of lead dust. The parties, in their respective appeals, presented almost identical issues to the Court of Special Appeals. Prior to consideration by that court, we granted certiorari to address these similar issues. We rephrase the issues in both cases in the language presented by appellants in Case Number 129:

"Was the trial court incorrect in ruling on a motion for summary judgment that as a matter of law a research entity conducting an ongoing non-therapeutic scientific study does not have a duty to warn a minor volunteer participant and/or his legal guardian regarding dangers present when the researcher has knowledge of the potential for harm to the subject and the subject is unaware of the danger?"^[10]

*819 We answer in the affirmative. The trial court was incorrect. Such research programs normally create special relationships and/or can be of a contractual nature, that create duties. The breaches of such duties may ultimately result in viable negligence actions. Because, at the very least, there are viable and genuine disputes of material fact concerning whether a special relationship, or other relationships arising out of agreements, giving rise to duties existed between KKI and both sets of appellants, we hold that the Circuit Court erred in granting KKI's motions for summary judgment in both cases before this Court. Accordingly, we vacate the rulings of the Circuit Court for Baltimore City and remand these cases to that court for further proceedings consistent with this opinion.

II. Facts & Procedural Background

A. The Research Study

In 1993, The Environmental Protection Agency (EPA) awarded Contract 68-D4-0001, entitled "Evaluation of Efficacy of Residential Lead Based Paint Repair and Maintenance Interventions" to KKI. KKI was to receive $200,000 for performing its responsibilities under the contract. It was thus a compensated researcher. The purpose of this research study was "to characterize and compare the short and long-term efficacy of comprehensive lead-paint abatement and less costly and potentially more cost-effective Repair and Maintenance interventions for reducing levels of lead in residential house dust which in turn should reduce lead in children's blood." As KKI acknowledged in its Clinical Investigation Consent Form, "[L]ead poisoning in children is a problem in Baltimore City and other communities across the country. Lead in paint, house dust and outside soil are major sources of lead exposure for children. Children can also be exposed to lead in drinking water and other sources." Lead poisoning poses a distinct danger to young children. It adversely effects cognitive development, growth, and behavior. Extremely high levels have been known to result in seizures, coma, and even death. See Centers for Disease Control and Prevention. Recommendations for Blood Lead Screening of Young Children Enrolled in Medicaid: Targeting a Group at High Risk, 49 Morbidity and Mortality Weekly Report 1 (Dec. 8, 2000).

Dr. Mark R. Farfel Sc.D., Director of KKI's Lead Abatement Department, testified in his deposition:

"The scientific goal of the study is to document the longevity of various lead base paint abatement strategies, factored in terms of reducing lead exposure in house dust and the children's blood lead levels.^[11]

...

*820 A. Our study design called for collection of blood lead, venous blood lead from participating children.

...

... [S]tudy protocol called for serial blood lead levels corresponding with the dust collection campaigns.... [T]he study goal was to get a baseline, two months, six months, twelve months, eighteen months evaluation.

...

... The study protocol, the data collection protocol was to get close in time the environmental measurements and the venous blood lead." [Emphasis added.]

The research study was sponsored jointly by the EPA and the Maryland Department of Housing and Community Development (DHCD). It was thus a joint federal and state project. The Baltimore City Health Department and Maryland Department of the Environment also collaborated in the study. It appears^[12] that, because the study was funded and sponsored in part by a federal entity, certain federal conditions were attached to the funding grants and approvals. There are certain uniform standards required in respect to federally funded or approved projects. We, however, are unaware of, and have not been directed to, any federal or state statute or regulation that imposes limits on this Court's powers to conduct its review of the issues presented. None of the parties have questioned this Court's jurisdiction in these cases. Moreover, 45 Code Federal Regulations (C.F.R.) 46.116(e) specifically provides: "The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective." Those various federal or state conditions, recommendations, etc., may well be relevant at a trial on the merits as to whether any breach of a contractual or other duty occurred, or whether negligence did, in fact, occur; but have no limiting effect on the issue of whether, at law, legal duties, via contract or "special relationships" are created in Maryland in experimental nontherapeutic research involving Maryland children.

The research study included five test groups, each consisting of twenty-five houses The first three groups consisted of houses with a considerable amount of lead dust present therein^[13] and each group received assigned amounts of maintenance and repair. The fourth group consisted of houses, which at one time had lead present in the form of lead based paint but had since received a supposedly complete abatement of lead dust. The fifth group consisted of modern houses, which had never had a presence of lead dust. The aim of the research study was to analyze the effectiveness of different degrees of *821 partial lead paint abatement in reducing levels of lead dust present in these houses. The ultimate aim of the research was to find a less than complete level of abatement that would be relatively safe, but economical, so that Baltimore landlords with lower socio-economical rental units would not abandon the units. The research study was specifically designed, in part, to do less than comprehensive lead paint abatement in order to study the potential effectiveness, if any, over a period of time, of lesser levels of repair and maintenance on the presence of lead dust by measuring the presence of lead in the blood of theretofore (as far as the record of the cases reveals) healthy children. In essence, the study at its inception was designed not only to test current levels of lead in the blood of the children, but the increase or decrease in future lead levels in the blood that would be affected by the various abatement programs. It appears that this study was also partially motivated, as we have indicated, supra, by the reaction of property owners in Baltimore City to the cost of lead dust abatement. The cost of full abatement of such housing at times far exceeded the monetary worth of the property—in other words, the cost of full abatement was simply too high for certain landlords to be able to afford to pay or be willing to pay. As a result, some lower level rental properties containing lead based paint in Baltimore had been simply abandoned and left vacant. The study was attempting to determine whether a less expensive means of rehabilitation could be available to the owners of such properties.

One way the study was designed to measure the effectiveness of such abatement measures was to measure the lead dust levels in the houses at intervals and to compare them with the levels of lead found, at roughly the same intervals, in the blood of the children living in the respective houses. The project required that small children be present in the houses. To facilitate that purpose, the landlords agreeing to permit their properties to be included in the studies were encouraged, if not required, to rent the properties to tenants who had young children.

In return for permitting the properties to be used and in return for limiting their tenants to families with young children, KKI assisted the landlords in applying for and receiving grants or loans of money to be used to perform the levels of abatement required by KKI for each class of home.

The research study was to be composed of two main components and a total of five groups of study houses.^[14] The first component of the study concerned the first three groups of houses. Houses in each group received different amounts of repair and maintenance.^[15] The following three groups of houses within the first component of the research study were:

Group 1—Repair & Maintenance Level I—Properties receiving a minimal level of repair and maintenance ($1,650.00).

*822 Group 2—Repair & Maintenance Level II—Properties receiving a greater level of repair and maintenance ($3,500.00).

Group 3—Repair & Maintenance Level III—Properties receiving an even greater level of repair and maintenance ($6,000.00-$7,000.00).

Repair & Maintenance Level I interventions were capped by DHCD at $1,650 and included wet-scraping of peeling and flaking lead-based paint and paint of unknown composition on all interior surfaces, including walls, trim, and doors; repainting of treated surfaces; installation of window well caps; repainting of all exterior window trim, repainting of all interior window sills; vacuuming of all horizontal surfaces and window components with a high efficiency particulate (HEPA) vacuum; and wet cleaning all horizontal surfaces. Level II interventions were capped by DHCD at $3,500 and included all the elements of Level I intervention plus two key additional elements: use of sealants and paints to make floors smoother and more easily cleanable, and in-place window and door treatments to reduce abrasion of lead-painted surfaces. Level III interventions were capped by DHCD at $6,000-$7000 and added window replacement and encapsulation of exterior door trim with aluminum, and the use of coverings on some floors and stairs to make them smooth and more easily climbable.^[16]

Measurements of lead in the blood of the children and vacuum dust samples from the houses were to be obtained at the following times: pre-intervention, immediately post intervention, and one, three, six, twelve, eighteen, and twenty-four months post intervention. Measurements of lead in the exterior soil were to be obtained at pre-intervention, immediately post intervention, and twelve and twenty-four months post intervention. Measurements of lead in drinking water were to be obtained at pre-intervention, and twelve and twenty-four months post intervention. Additionally, the parents of the child subjects of the study were to fill out a questionnaire at enrollment and at six-month intervals.

The second component of the research study was composed of two control groups:

Group 4—Properties identified as having previously been completely abated of lead paint which were to receive no additional repair and maintenance.

Group 5—Modern Urban Dwellings— Properties constructed after 1980 and presumed not to have lead-based paint which were to receive no repair and maintenance.

The study called for similar collection and evaluation of blood, dust samples, soil, and drinking water for lead content at similar time intervals as the first component. Measurements of lead in blood of the children and in vacuum dust samples in these houses were to be obtained at enrollment and six, twelve, eighteen, and twenty-four months post enrollment. Measurements of lead in the exterior soil and drinking water were to be obtained at enrollment, and at twelve and twenty-four months post enrollment. The participants in the fourth and fifth groups were instructed to fill out a questionnaire at enrollment and at six-month intervals.

The research study was to collect data from all five groups over a period of two years. There were two sets of criteria for enrollment in the research study—one for the properties and one for the residents. With respect to the properties involved in the first three test groups, the researchers were looking for structurally sound properties *823 that had been built prior to 1941^[17] or had documented lead-based paint in the unit based upon XRF testing.^[18] As Dr. Farfel testified in his deposition, "We were basically looking for the two-story, six-room rowhouse in Baltimore City with 8 to 10 windows in a structurally sound condition." Once a property was selected for use in the study, it was randomly assigned a repair and maintenance intervention level of I, II, or III.^[19]

With respect to the occupants, the researchers recruited families that had at least one small child. Dr. Farfel testified:

"For the family participant side, we were looking for families that obviously were willing to cooperate with the study by signing informed consent statements. We were looking for families that had at least one child under the age of 48 months and older than five months at the start of the study. These children were not to be mentally retarded or severely handicapped in any way that would limit their physical movement.

We were also excluding children that had sickle cell anemia, to the best of our knowledge, had sickle cell anemia.

We asked the families if they had any immediate plans to move. If they did, then they weren't eligible because we were interested in following the family over a period of years."

In summary, KKI conducted a study of five test groups of twenty-five houses each.^[20] The first three groups consisted of houses known to have lead present. The amount of repair and maintenance conducted increased from Group 1 to Group 2 to Group 3. The fourth group consisted of houses, which had at one time lead present but had since allegedly received a complete abatement of lead dust. The fifth group consisted of modern houses, which had never had the presence of lead dust. The twenty-five homes in each of the first three testing levels were then to be compared to the two control groups: the twenty-five homes in Group 4 that had previously been abated and the 25 modern homes in Group 5. The research study was specifically designed to do less than full lead dust abatement in some of the categories of houses in order to study the potential effectiveness, if any, of lesser levels of repair and maintenance.

If the children were to leave the houses upon the first manifestation of lead dust, it would be difficult, if not impossible, to test, over time, the rate of the level of lead accumulation in the blood of the children attributable to the manifestation. In other words, if the children were removed from the houses before the lead dust levels in their blood became elevated, the tests would probably fail, or at least the data that would establish the success of the test—or of the abatement results, would be of questionable use. Thus, it would benefit the accuracy of the test, and thus *824 KKI, the compensated researcher, if children remained in the houses over the period of the study even after the presence of lead dust in the houses became evident.

B. Case No. 128

Appellant, Ericka Grimes, resided at 1713 N. Monroe Street in Baltimore, Maryland (the Monroe Street property) with members of her family from the time of her birth on May 30, 1992, up until the summer of 1994. Her mother, Viola Hughes, had lived in the property since the Summer of 1990. In March 1993, representatives of KKI came to Ms. Hughes's home and successfully recruited her to participate in the research study. After a discussion regarding the nature, purpose, scope, and benefits of the study, Ms. Hughes agreed to participate and signed a Consent Form dated March 10, 1993.

Nowhere in the consent form was it clearly disclosed to the mother that the researchers contemplated that, as a result of the experiment, the child might accumulate lead in her blood, and that in order for the experiment to succeed it was necessary that the child remain in the house as the lead in the child's blood increased or decreased, so that it could be measured. The Consent Form states in relevant part:

"PURPOSE OF STUDY:

As you may know, lead poisoning in children is a problem in Baltimore City and other communities across the country. Lead in paint, house dust and outside soil are major sources of lead exposure for children. Children can also be exposed to lead in drinking water and other sources. We understand that your house is going to have special repairs^[21] done in order to reduce exposure to lead in paint and dust. On a random basis, homes will receive one of two levels of repair. We are interested in finding out how well the two levels of repair work. The repairs are not intended, or expected, to completely remove exposure to lead.

We are now doing a study to learn about how well different practices work for reducing exposure to lead in paint and dust. We are asking you and over one hundred other families to allow us to test for lead in and around your homes up to 8 to 9 times over the next two years provided that your house qualifies for the full two years of study. Final eligibility will be determined after the initial testing of your home. We are also doing free blood lead testing of children aged 6 months to 7 years, up to 8 to 9 times over the next two years. We would also like you to respond to a short questionnaire every 6 months. This study is intended to monitor the effects of the repairs and is not intended to replace the regular medical care your family obtains.

...

BENEFITS

To compensate you for your time answering questions and allowing us to *825 sketch your home we will mail you a check in the amount of $5.00. In the future we would mail you a check in the amount of $15 each time the full questionnaire is completed. The dust, soil, water, and blood samples would be tested for lead at the Kennedy Krieger Institute at no charge to you. We would provide you with specific blood-lead results. We would contact you to discuss a summary of house test results and steps that you could take to reduce any risks of exposure." [Emphasis added.]

Pursuant to the plans of the research study, KKI collected dust samples in the Monroe Street property on March 9, 1993, August 23, 1993, March 9, 1994, September 19, 1994, April 18, 1995, and November 13, 1995.^[22] The March 9, 1993 dust testing revealed what the researchers referred to as "hot spots" where the level of lead was "higher than might be found in a completely renovated [abated] house." This information about the "hot spots" was not furnished to Ms. Hughes until December 16, 1993, more than nine months after the samples had been collected and, as we discuss, infra, not until after Ericka Grimes's blood was found to contain elevated levels of lead.

KKI drew blood from Ericka Grimes for lead content analysis on April, 9, 1993, September 15, 1993, and March 25, 1994. Unlike the lead concentration analysis in dust testing, the results of the blood testing were typically available to KKI in a matter of days. KKI notified Ms. Hughes of the results of the blood tests by letters dated April 9, 1993, September 29, 1993, and March 28, 1994, respectively. The results of the April 9, 1993 test found Ericka Grimes blood to be less than 9 Sg/dL, which placed her results in the "normal" range according to classifications established by the Centers for Disease Control (CDC).^[23] However, on two subsequent retests, long after KKI had identified "hot spots," but before KKI informed Ms. Hughes of the "hot spots," Ericka Grimes's blood lead level registered Class III—32 μg/dL on September 15, 1993 and 22 μg/dL on March 25, 1994. Ms. Hughes and her daughter vacated the Monroe Street property in the Summer of 1994, and, therefore, no further blood samples were obtained by KKI after March 25, 1994.

In her Complaint filed in the Circuit Court for Baltimore City, Ms. Hughes sought to hold KKI liable for negligence for failing to warn of, or abate, lead-paint *826 hazards that KKI allegedly discovered in the Monroe Street property during the research study. Specifically, she alleged:

"3. As part of the [Research] Study, [appellant's] mother agreed to allow [KKI] to periodically inspect the Monroe Street property for the presence of lead-paint hazards. Upon inspection, [KKI] discovered the existence of lead-paint hazards within [appellant's] home, but failed to inform and/or warn [appellant