Opinion ID: 2386331
Heading Depth: 2
Heading Rank: 1

Heading: The Research Study

Text: 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] ... 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 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). 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 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 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.