Brief - Important information on this case.
| [1] | IN THE COURT OF APPEALS OF MARYLAND |
| [2] | No. 128 September Term, 2000,, No. 129 |
| [3] | 2001.MD.0000210 <http://www.versuslaw.com> |
| [4] | August 16, 2001 |
| [5] | ERICKA GRIMES v. KENNEDY KRIEGER INSTITUTE, INC. MYRON HIGGINS, A MINOR, ETC., ET AL. v. KENNEDY KRIEGER INSTITUTE, INC. |
| [6] | Circuit Court for Baltimore City Case numbers: 24-C-99-000925 and 24-C-95066067/CL
193461 |
| [7] | Eldridge Raker Wilner Cathell Harrell Battaglia, Karwacki, Robert L. (retired,
specially assigned), JJ. |
| [8] | The opinion of the court was delivered by: Cathell, J. |
| [9] | Raker, J. concurs in result only |
| [10] | Prologue |
| [11] | 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. *fn1
In respect to nontherapeutic research using minors, it has been noted that
"consent to research has been virtually unanalyzed by courts and legislatures."
R. Katerberg, Review Boards, Research on Children, and Informed Consent
of Parents: Walking the Tightrope Between Encouraging Vital Experimentation
and Protecting Subjects Rights, citing 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. |
| [12] | In these present cases, a prestigious research institute, associated with
Johns Hopkins University, based on this record, created a nontherapeutic
research program *fn2 whereby it required
certain classes 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. |
| [13] | 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 *fn3
will give priority to families with young children when renting the vacant
units following R & M [Repair and Maintenance] interventions." |
| [14] | 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 source of entry of lead dust into the body and because
absorption of lead dust is inversely related to particulate size."
R. Farfel & J. Chisolm, Health and Environmental Outcomes of Traditional
and Modified Practices for Abatement of Residential Lead-Based Paint, -
American Journal of Public Health -(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. |
| [15] | 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 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.) |
| [16] | 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. *fn4
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. |
| [17] | 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: "A number of questions come up. . . . Please
respond to the following points: |
| [18] | 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 property in
which there are no potential benefits [to the particular children]. To call
a control a normal control is to indicate that there is no 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 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
levels in acceptable bounds. We suggest you modify . . . consent forms .
. . accordingly." [Emphasis added.] |
| [19] | 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 nonthereapeutic 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. |
| [20] | 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. |
| [21] | Otherwise healthy children, *fn5 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. |
| [22] | 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. |
| [23] | 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 *fn6 .
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. |
| [24] | It was noted in Garnett, Why Informed Consent? Human Experimentation and
the Ethics of Autonomy, 36 Catholic Lawyer 455, 490 (1996) that: |
| [25] | "Most research poses no problems and is easily legitimated and justified,
but the subject's consent to these experiments is not, by itself, a reliable
indicator that they are justified, nor is it itself what justifies them." |
| [26] | In Olmstead v. United States, 277 U.S. 438, 479 (1928), Justice Brandis,
dissenting, noted: |
| [27] | "Experience should teach us to be most on 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." |
| [28] | 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 Tuskagee 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), *fn7 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, *fn8 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"; *fn9
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
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. |
| [29] | 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, 238, 110 S. Ct. 1028, 1045, 108 L. Ed. 2d (1990), Justice Stevens said: |
| [30] | "The Court has undervalued respondents' 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.'" |
| [31] | In footnote two of his dissent, Justice Stevens noted: |
| [32] | "(The 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.') (The Fourteenth
Amendment protects the `freedom to care for one's health and person.') .
. . ." 494 U.S. at 238, 110 S. Ct. at ___, 108 L. Ed. 2d at ___. |
| [33] | 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. |
| [34] | 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
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. |
| [35] | I. The Cases |
| [36] | We now discuss more specifically the two cases before us, and the relevant
law. |
| [37] | 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: |
| [38] | "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?"*fn10 |
| [39] | 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. |
| [40] | II. Facts & Procedural Background |
| [41] | A. The Research Study |
| [42] | 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). |
| [43] | Dr. Mark R. Farfel Sc.D., Director of KKI's Lead Abatement Department,
testified in his deposition: |
| [44] | "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.*fn11 |
| [45] | A. Our study design called for collection of blood lead, venous blood
lead from participating children. |
| [46] | . . . Study protocol called for serial blood lead tests corresponding
with the dust collection campaigns. . . . The study goal was to get a baseline,
two months, six months, twelve months, eighteen months evaluation. |
| [47] | . . . The study protocol, the data collection protocol was to get close
in time the environmental measurements and the venous blood lead. . . ."
[Emphasis added.] |
| [48] | 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 *fn12
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 (CFR) 46.117(e) specifically provides: "The
informed consent requirements of the 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. |
| [49] | 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 *fn13 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. |
| [50] | 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. |
| [51] | 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. |
| [52] | The research study was to be composed of two main components and a total
of five groups of study houses. *fn14
The first component of the study concerned the first three groups of houses.
Houses in each group received different amounts of repair and maintenance.
*fn15 The following three groups of
houses within the first component of the research study were: |
| [53] | Group 1 - Repair & Maintenance Level I - Properties receiving a minimal
level of repair and maintenance ($1,650.00). |
| [54] | Group 2 - Repair & Maintenance Level II - Properties receiving a greater
level of repair and maintenance ($3,500.00). |
| [55] | Group 3 - Repair & Maintenance Level III - Properties receiving an
even greater level of repair and maintenance ($6,000.00 - $7,000.00). |
| [56] | 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. *fn16 |
| [57] | 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. |
| [58] | The second component of the research study was composed of two control
groups: |
| [59] | Group 4 - Properties identified as having previously been completely abated
of lead paint which were to receive no additional repair and maintenance. |
| [60] | 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. |
| [61] | 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. |
| [62] | 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 *fn17 or had documented lead-based
paint in the unit based upon XRF testing. *fn18
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. *fn19 |
| [63] | With respect to the occupants, the researchers recruited families that
had at least one small child. Dr. Farfel testified: |
| [64] | "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. |
| [65] | We were also excluding children that had sickle cell anemia, to the best
of our knowledge, had sickle cell anemia. |
| [66] | 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." |
| [67] | In summary, KKI conducted a study of five test groups of twenty-five houses
each. *fn20 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. |
| [68] | 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. |
| [69] | B. Case No. 128 |
| [70] | 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. |
| [71] | 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: |
| [72] | "PURPOSE OF STUDY: |
| [73] | 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*fn21
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. |
| [74] | 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. |
| [75] | BENEFITS |
| [76] | To compensate you for your time answering questions and allowing us to
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.] |
| [77] | 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. *fn22
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. |
| [78] | 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 ęg/dL, which placed her results in
the "normal" range according to classifications established by
the Centers for Disease Control (CDC). *fn23
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 ęg/dL on September
15, 1993 and 22 ęg/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. |
| [79] | 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 hazards that KKI allegedly discovered in the Monroe Street property
during the research study. Specifically, she alleged: |
| [80] | "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] and her mother of such hazards and failed to take any action
to abate said hazards. As a consequence, [appellant] and her mother continued
to reside in the home unaware of the hazards and unaware of the dangers
to which [appellant] was being exposed." |
| [81] | KKI filed a Third Party Complaint against JJB, Inc., (JJB) the owners
of the Monroe Street property. Appellant filed an Amended Complaint to add
JJB as an additional defendant alleging negligence and violations of the
Maryland Consumer Protection Act. KKI filed a Motion for Summary Judgment
on the grounds that it did not owe any duty to appellant that it had breached.
On July 26, 2000, the Circuit Court for Baltimore City granted KKI's motion
and entered judgment in favor of KKI. Appellant dismissed her claims against
JJB and filed a Notice of Appeal on September 12, 2000. On February 8, 2001,
prior to consideration by the Court of Special Appeals, we issued a Writ
of Certiorari. |
| [82] | On appeal, appellant seeks review of the Circuit Court's decision granting
KKI summary judgment. She contends that KKI owed a duty of care to appellant
based on the nature of its relationship with appellant and her mother arising
out of: (1) a contract between the parties; (2) a voluntary assumption by
KKI; (3) a "special relationship" between the parties; and (4)
a Federal regulation. She argues that KKI's failure to notify her of the
lead dust hazards in the Monroe Street property until after more than nine
months had passed since the samples had been collected, and until after
Ericka Grimes's blood was found to be lead poisoned, constituted negligence
on the part of KKI in the performance of its duties to Ericka arising out
of the nature of the relationship between the parties. |
| [83] | C. Case No. 129 |
| [84] | In 1993, Mr. Polakoff, a professional owner and operator of rental properties,
had been recruited as a landlord by KKI through the Property Owners Association,
to volunteer the Federal Street property to the research study. His property
met the researchers' criteria, which we discussed, supra - that it was a
structurally sound property, built prior to 1941, that had documented levels
of lead-based paint in the unit. In December of 1993, KKI had Mr. Polakoff's
property tested by an outside contractor and it tested positive for lead
paint and dust throughout the house. Once accepted into the program, Mr.
Polakoff's property was randomly assigned a Repair & Maintenance Level
II intervention and subsequently underwent the repairs associated with Level
II intervention, discussed, supra, by Environmental Restoration, Inc. (Environmental).
Mr. Polakoff applied for a $3,500 loan from the Maryland Department of the
Environment to pay for the repairs, which was granted. The repairs were
completed in approximately April 1994. *fn24 |
| [85] | Appellant, Myron Higgins, was born on December 23, 1989. According to
Ms. Catina Higgins's deposition testimony, during the Spring of 1994 she
was looking for a home in which to reside with her several small children.
She located the property known as 1906 East Federal Street (the Federal
Street property) in an advertisement in the local newspaper listing the
property as a rental for $315 per month. She rented the property from CFOD-2
Limited Partnership. *fn25 She signed
a lease for the property on May 13, 1994 and moved in shortly thereafter. |
| [86] | On May 17, 1994, KKI collected and analyzed immediate post intervention
samples of dust using an experimental Cyclone dust collector. *fn26
A composite sample of dust from the first floor was 533 ęg/ft2, *fn27
a composite sample of the first floor windowsill was 2274 ęg/ft2, and a
composite sample of the interior entrance was 1530 ęg/ft2. On July 25, 1994,
pursuant to the protocols of the research study, a second series of dust
samples were obtained from the Federal Street property. While several of
the first floor lead dust levels dropped in value, this second sample found
that lead dust in the second floor area, which had registered figures under
the clearance level in the first sampling, were markedly increased. |
| [87] | After the Higgins family moved into the partially abated, vacant Federal
Street property, KKI approached Ms. Higgins and requested that she and her
son participate in the research study. Her participation and consent, in
addition to the landlord's previous consent for abatement of the property,
was necessary to permit KKI to enter the property to collect future dust
samples from the Federal Street property and to obtain blood samples from
her son. On May 24, 1994, Ms. Higgins agreed to participate and signed a
Consent Form regarding her and her child's participation in the study. As
in Case No. 128 the consent form did not contain a clear disclosure that
the researchers contemplated that, as a result of the experiment, the child
subjects might, and perhaps were anticipated to, accumulate some level of
lead contamination of their blood, and that the lead content of the children's
blood would be one of the methods by which the study would determine the
effectiveness of the various abatement procedures. |
| [88] | Pursuant to the protocols of the research study, KKI collected dust samples
in the Federal Street property on May 17, 1994, July 25, 1994, and November
3, 1994. KKI informed Ms. Higgins of the dust sample results by letters
dated June 24, 1994, September 14, 1994, and February 7, 1995, respectively.
Although KKI had recorded high levels of lead concentration in the dust
samples collected by the Cyclone vacuum during the May 17, 1994 visit, KKI
failed to disclose this information to Ms. Higgins in the letter dated June
24, 1994. *fn28 Instead, KKI relied
on the results obtained from the dust wipe samples collected and informed
her that there was no area in her house where the lead level was higher
than what might have been found in a completely renovated house. The dust
samples collected by dust wipe methodology in July and November showed areas
above the clearance levels and KKI did inform Ms. Higgins of these elevated
levels in the subsequent letters. Ms. Higgins contends that KKI knew of
the presence of high levels of lead-based paint and dust in the Federal
Street property as early as December of 1993, that even after Level II intervention
it still had high levels as of June 24, 1994, and that it was not until
she received a letter dated September 14, 1994 that KKI specifically informed
Ms. Higgins of the fact that her house had elevated lead levels. |
| [89] | KKI drew blood from Myron Higgins for lead content analysis on June 8,
1994, July 29, 1994, and November 9, 1994. KKI notified Ms. Higgins of the
results of the blood tests by letters dated July 18, 1994, August 2, 1994,
and December 6, 1994, respectively. The results of the tests were 17.5 ęg/dL,
21 ęg/dL, and 11 ęg/dL, respectively. The first and third tests placed him
in the CDC Class IIA while the second test placed him in CDC Class III.
KKI told Ms. Higgins that it had informed the BCHD of the second result
and that she "should provide the test result to [her] child's primary
health care provider right away." |
| [90] | Ms. Higgins contends that KKI was negligent in its failure to inform her
of its knowledge of the high levels of lead dust recorded by both XRF testing
in December 1993, prior to her moving into the unit and prior to the abatement
modification, and from the samples collected via the Cyclone vacuum in May
1994. Ms. Higgins asserts that this withholding of information combined
with KKI's letter dated June 24, 1994 informing her solely of the lower
results of the samples collected by dust wipe methodology was misleading
to her as a participant in the study. She implies that it gave her a false
sense of security that there were no potential lead-based paint or dust
hazards in her house. |
| [91] | Appellants, Myron Higgins, by his mother Catina Higgins, and Catina Higgins,
individually, filed suit in the Circuit Court for Baltimore City on February
26, 1995 against Mr. Polakoff. Appellants amended their Complaint to add
Chase Management, Inc., and CFOD-2 Limited Partnership as defendants to
this lawsuit. *fn29 On April 29, 1999,
Appellants further amended their Complaint to add KKI and Environmental
as additional defendants. In her Complaint filed in the Circuit Court for
Baltimore City, Ms. Higgins sought to hold KKI liable for negligence on
several different grounds. Specifically, she alleged: |
| [92] | "8. Both [KKI] and Environmental were negligent in undertaking to
abate, paint and repair the premises prior to and/or during the children's
occupancy and doing so in an unreasonable, incomplete, unworkmanlike and/or
illegal manner. |
| [93] | 9. Both [KKI] and Environmental were negligent in performing the lead
abatement in such a fashion as to increase, rather than decrease, the children's
exposure to lead, including, but not limited to, performing the abatement
using methods, which foreseeably increased the lead dust in the premises,
performing improper or inadequate cleanup, leaving lead debris on the premises
or in the vicinity of the premises accessible to the child. |
| [94] | 10. Both [KKI] and Environmental failed to warn [appellants] or the adult
caretaker of the lead hazard, which [KKI] and Environmental or their agents
knew or should have known or had reason to know existed in the premises. |
| [95] | 11. And [KKI and Environmental] were otherwise negligent." |
| [96] | KKI filed a Motion for Summary Judgment on the grounds that it did not
owe any duty to appellants. *fn30 On
April 5, 2000, the Circuit Court granted KKI's motion and entered judgment
in favor of KKI. On May 4, 2000, appellants filed a Motion to Reconsider,
which the Circuit Court denied on May 25, 2000. Appellants dismissed their
claims against Polakoff, Chase Management and CFOD-2 Limited Partnership
and filed a Notice of Appeal on July 20, 2000. On February 8, 2001, prior
to consideration by the Court of Special Appeals, we issued a Writ of Certiorari. |
| [97] | D. The Trial Courts' Findings |
| [98] | In Case No.128 (Grimes), the trial court, in granting KKI's motion for
summary judgment, stated: |
| [99] | "Whether or not there is a duty, the Court has to look at several
factors. . . . [1] . . . The Court does not find that there is a contract
as a matter of law . . . . The Court does not find the necessary elements
of a contract, that is mutual assent, offer, acceptance, and consideration,
so as to find a binding legal agreement by and between the parties. |
| [100] | [2] . . . The Court does not so find a special relationship to exist in
connection with the relationship between Kennedy Krieger Institute and the
plaintiff and minor plaintiff . . . . I do not find that there is a special
relationship as at least expressed by our courts of appeal so as to justify
a duty owed by Defendant Kennedy Krieger to the plaintiff. |
| [101] | . . . The Court does not so find that a duty was created as a matter of
law by the statute." |
| [102] | In case No.129 (Higgins), KKI argued "plaintiff cannot prove that
Kennedy Krieger owed any duty to the plaintiff in this case that would arise
to civil liability." In granting KKI's motion for summary judgment,
the trial court stated: |
| [103] | "On the first instance, I see no duty at all on the part of KKI to
inspect or test this premises or to test the individual. |
| [104] | KKI was sort of an institutional volunteer in the community. Coming in
to collect dust and blood samples, the next thing you know they get sued
and I think that there is absolutely no duty on the part of KKI simply because
it came in to then assume a higher standard of . . . [responsibility] in
respect to these facts. |
| [105] | KKI was not the owner of the property, not an agent for the owner, it
didn't [accept] other properties from the landlord. It did not prefer the
properties to the landlord. |
| [106] | There is no basis to suggest that KKI was anything more than an institutional
volunteer in that community. . . . It certainly cannot be raised by virtue
of a consent form to take a blood test. It cannot be raised to the level
of a standard of duty under the law." [Emphasis added.] |
| [107] | On appeal, appellants seek review of the circuit courts' decisions granting
KKI's respective summary judgment motions. They contend, contrary to the
trial courts' findings, that KKI owed a duty to warn appellants of the presence
of lead-based paint and dust because: (1) a "special relationship"
existed between the parties; (2) of the contractual duty created by the
consent agreement; (3) the danger was foreseeable; and (4) a Federal regulation
exists, which created such a duty. Specifically, they contend that KKI had
an affirmative duty to give appellants complete and accurate information
concerning the risks and hazards of participating in the study - to include
the XRF results and the Cyclone vacuum results. |
| [108] | III. Discussion |
| [109] | A. Standard of Review |
| [110] | We resolve these disputes in the context of the trial court's granting
of the appellee's motions for summary judgment in the two distinct cases.
The threshold issues before this Court are whether, in the two cases presented,
appellee, KKI, was entitled to summary judgment as a matter of law on the
basis that no contract existed and that there is inherently no duty owed
to a research subject by a researcher. Perhaps even more important is the
ancillary issue of whether a parent in Maryland, under the law of this State,
can legally consent to placing a child in a nontherapeutic research study
that carries with it any risk of harm to the health of the child. We shall
resolve all of these primary issues. |
| [111] | "In reviewing a grant of a summary judgment, we are first concerned
with whether a genuine dispute of material fact exists" and then whether
the movant is entitled to summary judgment as a matter of law. Williams
v. Mayor & City Council of Baltimore, 359 Md. 101, 113, 753 A.2d 41,
47 (2000); Hartford Ins. Co. v. Manor Inn of Bethesda, Inc., 335 Md. 135,
144, 642 A.2d 219, 224 (1994); Gross v. Sussex, Inc., 332 Md. 247, 255,
630 A.2d 1156, 1160 (1993); Beatty v. Trailmaster Prods., Inc., 330 Md.
726, 737, 625 A.2d 1005, 1011 (1993); Arnold Developer, Inc. v. Collins,
318 Md. 259, 262, 567 A.2d 949, 951 (1990); Bachmann v. Glazer & Glazer,
Inc., 316 Md. 405, 408, 559 A.2d 365, 366 (1989); King v. Bankerd, 303 Md.
98, 110-11, 492 A.2d 608, 614 (1985). "A material fact is a fact the
resolution of which will somehow affect the outcome of the case." King,
303 Md. at 111, 492 A.2d at 614 (citing Lynx, Inc. v. Ordinance Prods.,
Inc., 273 Md. 1, 327 A.2d 502, 509 (1974)). "[A] dispute as to facts
relating to grounds upon which the decision is not rested is not a dispute
with respect to a material fact and such dispute does not prevent the entry
of summary judgment." Salisbury Beauty Schs. v. State Bd. of Cosmetologists,
268 Md. 32, 40, 300 A.2d 367, 374 (1973). |
| [112] | This Court also has stated that "[t]he standard of review for a grant
of summary judgment is whether the trial court was legally correct."
Goodwich v. Sinai Hosp. of Baltimore, Inc., 343 Md. 185, 204, 680 A.2d 1067,
1076 (1996); see also Murphy v. Merzbacher, 346 Md. 525, 530-31, 697 A.2d
861, 864 (1997); Manor Inn, 335 Md. at 144, 642 A.2d at 224; Gross, 332
Md. at 255, 630 A.2d at 1160; Heat & Power Corp. v. Air Prods. &
Chems., Inc., 320 Md. 584, 592, 578 A.2d 1202, 1206 (1990). As we have said: |
| [113] | "Concerning summary judgment, Maryland Rule 2-501(e) provides: `The
court shall enter judgment in favor of or against the moving party if the
motion and response show that there is no genuine dispute as to any material
fact and that the party in whose favor judgment is entered is entitled to
judgment as a matter of law.' In determining whether a party is entitled
to judgment under this rule, the court must view the facts, including all
inferences, in the light most favorable to the opposing party. Beard v.
American Agency, 314 Md. 235, 246, 550 A.2d 677 (1988); Kramer v. Bally's
Park Place, 311 Md. 387, 389, 535 A.2d 466 (1988); Liscombe v. Potomac Edison
Co., 303 Md. 619, 621-22, 495 A.2d 838 (1985). The trial court will not
determine any disputed facts, but rather makes a ruling as a matter of law.
Scroggins v. Dahne, 335 Md. 688, 691, 645 A.2d 1160 (1994); Southland Corp.
v. Griffith, 332 Md. 704, 712, 633 A.2d 84 (1993); Beatty v. Trailmaster,
330 Md. 726, 737, 625 A.2d 1005 (1993). The standard of appellate review,
therefore, is whether the trial court was legally correct. See, e.g., Southland,
supra, 332 Md. at 712, 633 A.2d 84." Baltimore Gas & Electric Co.
v. Lane, 338 Md. 34, 42-43, 656 A.2d 307, 311 (1995), overruled on other
grounds by Baltimore Gas & Electric Co. v. Flippo, 348 Md. 680, 705
A.2d 1144 (1998); see also Dobbins v. Washington Suburban Sanitary Comm'n,
338 Md. 341, 344, 658 A.2d 675, 676-77 (1995). |
| [114] | As we said in Ashton v. Brown, 339 Md. 70, 660 A.2d 447 (1995): |
| [115] | "In reviewing the grant of summary judgment, this Court must consider
the facts reflected in the pleadings, depositions, answers to interrogatories
and affidavits in the light most favorable to the non-moving parties, the
plaintiffs. Even if it appears that the relevant facts are undisputed, `if
those facts are susceptible to inferences supporting the position of the
party opposing summary judgment, then a grant of summary judgment is improper.'"
Id. at 79, 660 A.2d at 452 (quoting Clea v. Mayor & City Council of
Baltimore, 312 Md. 662, 677, 541 A.2d 1303, 1310 (1988). |
| [116] | The purpose of the summary judgment procedure is not to try the case or
to decide the factual disputes, but to decide whether there is an issue
of fact, which is sufficiently material to be tried. See Goodwich, 343 Md.
at 205-06, 680 A.2d at 1077; Coffey v. Derby Steel Co., 291 Md. 241, 247,
434 A.2d 564, 567-68 (1981); Berkey v. Delia, 287 Md. 302, 304, 413 A.2d
170, 171 (1980). Thus, once the moving party has provided the court with
sufficient grounds for summary judgment, the nonmoving party must produce
sufficient evidence to the trial court that a genuine dispute to a material
fact exists. See, e.g., Hoffman Chevrolet, Inc. v. Washington County Nat'l
Sav. Bank, 297 Md. 691, 712, 467 A.2d 758, 769 (1983). With these considerations
in mind, we turn to the instant cases. |
| [117] | B. General Discussion |
| [118] | Initially, we note that we know of no law, nor have we been directed to
any applicable in Maryland courts, that provides that the parties to a scientific
study, because it is a scientific, health-related study, cannot be held
to have entered into special relationships with the subjects of the study
that can create duties, including duties, the breach of which may give rise
to negligence claims. We also are not aware of any general legal precept
that immunizes non-governmental "institutional volunteers" or
scientific researchers from the responsibility for the breaches of duties
arising in "special relationships." Moreover, we, at the very
least, hold that, under the particular circumstances testified to by the
parties, there are genuine disputes of material fact concerning whether
a special relationship existed between KKI and Ericka Grimes, as well as
between KKI and Ms. Higgins and Myron Higgins. Concerning this issue, the
granting of the summary judgment motions was clearly inappropriate. When
a "special relationship" can exist as a matter of law, the issue
of whether, given certain facts, a special relationship does exist, when
there is a dispute of material fact in that respect, is a decision for the
finder of fact, not the trial judge. We shall hold initially that the very
nature of nontherapeutic scientific research on human subjects can, and
normally will, create special relationships out of which duties arise. Since
World War II the specialness or nature of such relationships has been frequently
of concern in and outside of the research community. |
| [119] | As a result of the atrocities performed in the name of science during
the Holocaust, and other happenings in the World War II era, what is now
known as The Nuremberg Code evolved. Of special interest to this Court,
the Nuremberg Code, at least in significant part, was the result of legal
thought and legal principles, as opposed to medical or scientific principles,
and thus should be the preferred standard for assessing the legality of
scientific research on human subjects. Under it, duties to research subjects
arise. |
| [120] | "Following the Doctors' Trial (the `Medical Case'), which included
charges of conducting lethal studies of the effects of high altitude and
extreme cold, the action of poisons, and the response to various inducted
infections, the court issued `The Nuremberg Code' as a summary of the legal
requirements for experimentation on humans. The Code requires that the informed,
voluntary, competent, and understanding consent of the research subjects
be obtained. Although this principle is placed first in the Code's ten points,
the other nine points must be satisfied before it is even appropriate to
ask the subject to consent. |
| [121] | The Nuremberg Code is the `most complete and authoritative statement of
the law of informed consent to human experimentation.' It is also `part
of international common law and may be applied, in both civil and criminal
cases, by state, federal and municipal courts in the United States.' However,
even though the courts in the United States may use the Nuremberg Code to
set criminal and civil standards of conduct, none have used it in a criminal
case and only a handful have even cited it in the civil context. Even where
the Nuremberg Code has been cited as authoritative, it has usually been
in dissent, and no United States court has ever awarded damages to an injured
experimental subject, or punished an experimenter, on the basis of a violation
of the Nuremberg Code. There have, however, been very few court decisions
involving human experimentation. It is therefore very difficult for a `common
law' human experimentation to develop. This absence of judicial precedent
makes codes, especially judicially-crafted codes like the Nuremberg Code,
all the more important." [Emphasis added.] Annas, Mengele's Birthmark:
the Nuremberg Code in United States Courts, 7 Journal of Contemporary Health
Law and Policy 17, at 22-23 (Spring, 1991), citing in part to J. Applleman,
Military Tribunals and International Crimes 141; 1 Trials of War Criminals
Before Nuremberg Military Tribunals under Control Council Law No. 10, 11-14
(1946-1949); 2 Trials of War Criminals Before Nuremberg Military Tribunals
under Control Council Law No. 10, 181-82. *fn31 |
| [122] | ". . . .Why wasn't the Nuremberg Code immediately adopted by United
States courts as setting the minimum standard of care for human experimentation?
One reason, perhaps, is that there was little opportunity. As remains true
today, almost no experiments resulted in lawsuits in the 1940's, 50's, and
60's. A second reason may be that the Nazi experiments were considered so
extreme as to be seen as irrelevant to the United States. This may explain
why our own use of prisoners, the institutionalized retarded, and the mentally
ill to test malaria treatments during World War II was generally hailed
as positive, making the war `everyone's war.' Likewise, in the late 1940's
and early 1950's, the testing of new polio vaccines on institutionalized
mentally retarded children was considered appropriate. Utilitarianism was
the ethic of the day. . . . Noting that the code applied primarily to the
type of outrageous nontherapeutic experiments conducted during the war,
physician groups tended to find the Code too `legalistic' and irrelevant
to their therapeutic experiments,' and set about to develop an alternative
code to guide medical researchers. The most successful and influential has
been the World Medical Association's (WMA) Declaration of Helsinki, . .
. [see infra]" Mengele's Birthmark, supra at 24-25. |
| [123] | In his conclusions the author noted: |
| [124] | "However, since American judges promulgated the [Nuremberg] Code
under both natural and international law standards, it is disturbing that
we have not taken it more seriously in areas where there is no question
that it has direct application. . . . We have yet to succeed in eradicating
our birthmark that impels us to trample human rights and welfare when either
society's welfare seems in jeopardy, or the promise of `progress' is dangled
before us. . . . Neither Alymer nor Mengele will be called to account in
a world that puts expediency over ethics, and exalts progress over human
rights. " Mengele's Birthmark, supra at 43. |
| [125] | Karin Morin in her article, The Standard of Disclosure in Human Subject
Experimentation,19 Journal of Legal Medicine 157, 158 (June 1998), after
discussing the history of informed consent as it developed in medical practice,
describes nontherapeutic experimental research, differentiating it from
therapeutic medical treatment. She stated that "any manipulation, observation,
or other study of a human being - or of anything related to that human being
that might subsequently result in manipulation of that human being - done
with the intent of developing new knowledge and which differs in any form
from customary medical (or other professional) practice." Id. at 166,
quoting from a paper by Robert Levine to the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research. She
then states further: "Research is usually described in a formal protocol
that sets forth an objective and a set of procedures designed to reach that
objective." Id. at ___. |
| [126] | In respect to the difference between research involving treatment and
nontherapeutic research, she further notes that: ". . . practice represents
the utilization of knowledge, while research amounts to its creation. Because
experimentation takes place in the realm of the unknown, or at least the
`scientifically unproven,' several aspects distinguish it from treatment:
risks may be unforeseeable; assumptions are not supported by scientific
evidence and expertise is therefore more vulnerable than it is in clinical
practice; a subject's consent cannot be based on anticipated benefits; and
researchers and subjects may have conflicting interests." Id. at 213,
referring to an article by Delgado & Leskovac, Informed Consent in Human
Experimentation: Bridging the Gap Between Ethical Thought and Current Practice,
34 UCLA L. Review 67, 69 (1986). |
| [127] | Morin, in respect to nontherapeutic research, also postulates that: |
| [128] | "It is essential to recognize that society's interest in knowledge
may not coincide with an individual subject's interest; the individual subject
stands to gain nothing and lose everything, including his or her right of
self determination. . . . |
| [129] | . . . Some analysts contend that IRB review tends to focus exclusively
on consent requirements, rather than fully evaluating the merits of the
research. Yet, it is important to recognize that, even before consent becomes
an issue, the scientific merits and the acceptability of risks need to be
appraised. As at least one author has argued, this aspect of the review
may be jeopardized if members who have institutional allegiances are caught
between the desire to promote the interests of the institution and the need
to protect the subject. |
| [130] | C. Investigator-Subject Relationship |
| [131] | Another notable difference between treatment and experimentation lies
in the relationship between physician-patient and investigator-subject.
. . . |
| [132] | . . . Indeed, as discussed in relation to the notion of uncertainty, the
nature of the information held by the investigator can be very different
from that of the information held by a treating physician. . . . |
| [133] | Other than through the difference that relates to the disclosure of information,
the relationship between investigator and subject is unique in terms of
the purpose for which information is gathered. . . . Data are collected
to confirm or revoke a hypothesis, independently of the subject. Finally,
investigator's motivations differ from that of treating physicians. The
experiment is driven by the investigator's dedication to the advancement
of knowledge, and often by a commitment to those who have funded the research;
it is also driven by society's interest in future benefits that will flow
from medical discoveries. As one author remarks `the price of a bad outcome
is exacted from the individual who suffers the untoward reaction, whereas
the benefit of the breakthrough is available to society as a whole.'"
[Emphasis added.] Id. at ___. |
| [134] | In arguing that a fuller disclosure should be made when consent is sought
for nontherapeutic research, as opposed to therapeutic research, Morin notes: |
| [135] | "Furthermore, as long as courts continue to interpret the doctrine
of informed consent in experimentation as it applies in the context of treatment,
the uniqueness of the protection needed for human research subjects will
be overlooked. Failing to recognize that subjects who volunteer for the
sake of the advancement of science are differently situated from the patients
who stand to benefit from treatment results in an analysis that misconceives
the purpose of disclosure. Beyond informing the patient as to means available
to treat him or her, a subject must become a voluntary and willing participant
in an endeavor that may yield no direct benefit to him or her, or worse,
that may cause harm." Id. at 216-21 (citing numerous sources). |
| [136] | Just recently the research community has been subjected to question as
a result of genetic experimentation on a Pennsylvania citizen. Jesse Gelsinger
consented to participate in a research project at the University of Pennsylvania's
Institute of Human Gene Therapy. After Gelsinger's death, the U.S. Food
and Drug Administration ordered a halt to eight human gene therapy experiments
at the Institute. Additionally, other similar projects were halted elsewhere.
The FDA took the action after a "discovery of serious problems in the
Institute's informed consent procedures and, more generally, a lapse in
the researcher's ethical responsibilities to experimental subjects."
J. Barker, Human Experimentation and the Double Facelessness of a Merciless
Epoch, 25 New York University Review of Law and Social Change 603, 615 (1999). |
| [137] | Gelsinger had a different type of ornithine transcarbamylase deficiency
(OTC) disease, than that addressed by the research. His particular brand
of the disease was under control. There was no possibility that the research
being conducted would directly benefit him. It was thus, as to him, as it
was to the children in the case at bar, nontherapeutic; a way to study the
affects on the subjects (in the present case, the children) in order to
measure the success of the experiment. In Gelsinger's case, the research
was to test the efficiency of disease vectors. In other words, weakened
adenovirus (common-cold viruses) were used to deliver trillions of particles
of a particular OTC gene into his artery and thus to his liver. Gelsinger
experienced a massive and fatal immune system reaction to the introduction
of the common-cold virus. |
| [138] | There were problems with the extent of the informed consent there obtained.
Barker noted that: |
| [139] | "Is this a case of rogue experimenters giving a bad name to all genetic
research? Not at all. The program in Philadelphia is (or at least was) one
of the most prestigious in the world and the researchers there were first
rate. Rather, the problems with that program are indicative of systemic
problems with genetic research and informed consent as a protection of the
autonomy of research subjects. . . . |
| [140] | Why are there such serious problems with informed consent in some of these
trials, and why is there almost total noncompliance with regulations concerning
serious side effects? The answers to these questions are related. Informed
consent has suffered from pressure to get results-as quickly as possible.
. . . Informed consent procedures, properly followed, are troublesome, time-consuming,
costly, and may even threaten proprietary information valuable to the biotech
companies. The ethical face of the research subject may be obscured by such
factors. |
| [141] | . . . Researchers, under competitive pressure and also financial pressure
from corporate backers, operate under a paternalistic approach to research
subjects, asserting professional expertise and arguing experimental necessity
while minimizing the right to self-determination - a key aspect of the exercise
of autonomy - of their subjects. The result is a greater or lesser degree
of ethical effacement." Id. at __. *fn32 |
| [142] | Because of the way the cases sub judice have arrived, as appeals from
the granting of summary judgments, there is no complete record of the specific
compensation of the researchers involved. Although the project was funded
by the EPA, at the request of KKI the EPA has declined to furnish such information
to the attorney for one of the parties, who requested it under the federal
Freedom of Information Act. Whether the research's character as a co-sponsored
state project opens the records under the Maryland Public Information Act
has apparently not been considered. Neither is there in the record any development
of what pressures, if any, were exerted in respect to the researchers obtaining
the consents of the parents and conducting the experiment. Nor, for the
same reason, is there a sufficient indication as to the extent to which
the Institute has joined with commercial interests, if it has, for the purposes
of profit, that might potentially impact upon the researcher's motivations
and potential conflicts of interest - motivations that generally are assumed,
in the cases of prestigious entities such as John Hopkins University, to
be for the public good rather then a search for profit. |
| [143] | We do note that the institution involved, the respondent here, like the
Wendell Johnson Speech and Hearing Center, is a highly respected entity,
considered to be a leader in the development of treatments, and treatment
itself, for children infected with lead poisoning. With reasonable assurance,
we can note that its reputation alone might normally suggest that there
was no realization or understanding on the Institute's part that the protocols
of the experiment were questionable, except for the letter from the IRB
requesting that the researchers mischaracterize the study. |
| [144] | We shall further address both the factual and legal bases for the findings
of the trial courts, holding, ultimately, that the respective courts erred
in both respects. |
| [145] | C. Negligence |
| [146] | It is important for us to remember that appellants allege that KKI was
negligent. Specifically, they allege that KKI, as a medical researcher,
owed a duty of care to them, as subjects in the research study, based on
the nature of the agreements between them and also based on the nature of
the relationship between the parties. They contend specifically that KKI
was negligent because KKI breached its duty to: (1) design a study that
did not involve placing children at unnecessary risk; (2) inform participants
in the study of results in a timely manner; and (3) to completely and accurately
inform participants in the research study of all the hazards and risks involved
in the study. |
| [147] | In order to establish a claim for negligence under Maryland law, a party
must prove four elements: "(1) that the defendant was under a duty
to protect the plaintiff from injury, (2) that the defendant breached that
duty, (3) that the plaintiff suffered actual injury or loss[ *fn33
] and (4) that the loss or injury proximately resulted from the defendant's
breach of the duty." (Emphasis added.) Rosenblatt v. Exxon, 335 Md.
58, 76, 642 A.2d 180, 188 (1994) (citing Faya v. Almaraz, 329 Md. 435, 448,
620 A.2d 327, 333 (1993) and Lamb v. Hopkins, 303 Md. 236, 241, 492 A.2d
1297, 1300 (1985)); see Brown v. Dermer, 357 Md. 344, 356, 744 A.2d 47,
54 (2000); Richwind Joint Venture 4 v. Brunson, 335 Md. 661, 670, 645 A.2d
1147, 1151 (1994); Manor Inn, 335 Md. at 147- 48, 642 A.2d at 225; Southland
Corp., 332 Md. 704, 712, 633 A.2d 84, 88 (1993). Because this is a review
of the granting of the two summary judgments based solely on the grounds
that there was no legal duty to protect the children, we are primarily concerned
with the first prong -whether KKI was under a duty to protect appellants
from injury. |
| [148] | We noted in West Virginia Central Railroad Co. v. Fuller, 96 Md. 652,
666, 54 A. 669, 671 (1903): |
| [149] | "[T]here can be no negligence where there is no duty that is due;
for negligence is the breach of some duty that one person owes to another.
It is consequently relative and can have no existence apart from some duty
expressly or impliedly imposed. In every instance before negligence can
be predicated of a given act, back of the act must be sought and found a
duty to the individual complaining, the observance of which duty would have
averted or avoided the injury. . . . As the duty owed varies with circumstances
and with the relation to each other of the individuals concerned, so the
alleged negligence varies, and the act complained of never amounts to negligence
in law or in fact; if there has been no breach of duty." See Dermer,
357 Md. at 357, 744 A.2d at 54. |
| [150] | In Ashburn v. Anne Arundel County, 306 Md. 617, 627-28, 510 A.2d 1078,
1083 (1986), we also analyzed this first element of whether a duty existed: |
| [151] | "`Duty' in negligence has been defined as `an obligation, to which
the law will give recognition and effect, to conform to a particular standard
of conduct toward another.' Prosser and Keeton [on Torts] § 53 [(W. Keeton
5th ed. 1984)]. There is no set formula for this determination. As Dean
Prosser noted, `duty 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.' Id. 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. . . .' Id. As one court
suggested, there are a number of variables to be considered in determining
if a duty exists to another, such as: |
| [152] | 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. Tarasoff v. Regents
of University of California, 17 Cal. 3d 425, 434, 131 Cal. Rptr. 14, 22,
551 P.2d 334, 342 (1976). |
| [153] | `Perhaps among these the factor deemed most important is foreseeability.
See id. However, `foreseeability' must not be confused with `duty.' The
fact that a result may be foreseeable does not itself impose a duty in negligence
terms.'" [Some alterations in original.] See also Dermer, 357 Md. at
357, 744 A.2d at 54; Rosenblatt, 335 Md. at 76-77, 642 A.2d at 189. |
| [154] | With regard to the connection between the harm and the relationship between
the parties, we recently stated in Walpert, Smullian & Blumenthal, P.A.
v. Katz, 361 Md. 645, 658, 762 A.2d 582, 589 (2000) (quoting Jacques v.
First Nat'l Bank, 307 Md. 527, 534-35, 515 A.2d 756, 759-60 (1986)): |
| [155] | "Where the failure to exercise due care creates a risk of economic
loss only, courts have generally required an intimate nexus between the
parties as a condition to the imposition of tort liability. This intimate
nexus is satisfied by contractual privity or its equivalent. By contrast,
where the risk created is one of personal injury, no such direct relationship
need be shown, and the principal determinant of duty becomes foreseeability." |
| [156] | Furthermore, as we stated in Almaraz, 329 Md. at 449, 620 A.2d at 333,
"legal scholars have long agreed that the seriousness of potential
harm, as well as its probability, contributes to a duty to prevent it."
As we emphasized in Bobo v. State, 346 Md. 706, 714-15, 697 A.2d 1371, 1375-76
(1997): |
| [157] | "Two of the relevant factors to consider in determining whether such
a duty should be recognized are `the nature of the harm likely to result
from a failure to exercise due care, and the relationship that exists between
the parties.' Jacques v. First Nat'l Bank, 307 Md. 527, 534, 515 A.2d 756,
759 (1986) . . . . Such a relationship may be established in a number of
ways: (1) by statute or rule; (2) by contractual or other private relationship;
or (3) indirectly or impliedly by virtue of the relationship between the
tortfeasor and a third party." [Some citations omitted.] |
| [158] | The relationship that existed between KKI and both sets of appellants
in the case at bar was that of medical researcher and research study subject.
Though not expressly recognized in the Maryland Code or in our prior cases
as a type of relationship which creates a duty of care, evidence in the
record suggests that such a relationship involving a duty or duties would
ordinarily exist, and certainly could exist, based on the facts and circumstances
of each of these individual cases. Once we have determined that the facts
and circumstances of the present cases, considered in a light most favorable
to the nonmoving parties, are susceptible to inferences supporting the position
of the party opposing summary judgment, we are mandated to hold that the
granting of summary judgment in the lower court was improper. In addition
to the trial courts' erroneous conclusions on the law, the facts and circumstances
of both of these cases are susceptible to inferences that a special relationship
imposing a duty or duties was created in the arrangements in the cases sub
judice, and, ordinarily, could be created in similar research programs involving
human subjects. |
| [159] | IV. The Special Relationships |
| [160] | A. The Consent Agreement Contract |
| [161] | Both sets of appellants signed a similar Consent Form prepared by KKI
in which KKI expressly promised to: (1) financially compensate (however
minimally) appellants for their participation in the study; *fn34
(2) collect lead dust samples from appellants' homes, analyze the samples,
discuss the results with appellants, and discuss steps that could be taken,
which could reduce exposure to lead; and (3) collect blood samples from
children in the household and provide appellants with the results of the
blood tests. In return, appellants agreed to participate in the study, by:
(1) allowing KKI into appellants' homes to collect dust samples; (2) periodically
filling out questionnaires; and (3) allowing the children's blood to be
drawn, tested, and utilized in the study. If consent agreements contain
such provisions, and the trial court did not find otherwise, and we hold
from our own examination of the record that such provisions were so contained,
mutual assent, offer, acceptance , and consideration existed, all of which
created contractual relationships imposing duties by reason of the consent
agreement themselves (as well, as we discuss elsewhere, by the very nature
of such relationships). |
| [162] | By having appellants sign this Consent Form, both KKI and appellants expressly
made representations, which, in our view, created a bilateral contract between
the parties. At the very least, it suggests that appellants were agreeing
with KKI to participate in the research study with the expectation that
they would be compensated, albeit, more or less, minimally, be informed
of all the information necessary for the subject to freely choose whether
to participate, and continue to participate, and receive promptly any information
that might bear on their willingness to continue to participate in the study.
This includes full, detailed, prompt, and continuing warnings as to all
the potential risks and hazards inherent in the research or that arise during
the research. KKI, in return, was getting the children to move into the
houses and/or to remain there over time, and was given the right to test
the children's blood for lead. As consideration to KKI, it got access to
the houses and to the blood of children that had been encouraged to live
in a "risk" environment. In other words, KKI received a measuring
tool - the children's blood. Considerations existed, mainly money, food
coupons, trinkets, bilateral promises, blood to be tested in order to measure
success. "Informed consent" of the type used here, which imposes
obligation and confers consideration on both researcher and subject (in
these cases, the parents of the subjects) may differ from the more one-sided
"informed consent" normally used in actual medical practice. Researcher/subject
consent in nontherapeutic research can, and in this case did, create a contract.
*fn35 |
| [163] | B. The Sufficiency of the Consent Form |
| [164] | The consent form did not directly inform the parents of the fact that
it was contemplated that some of the children might ingest lead dust particles,
and that one of the reasons the blood of the children was to be tested was
to evaluate how effective the various abatement measures were. |
| [165] | A reasonable parent would expect to be clearly informed that it was at
least contemplated that her child would ingest lead dust particles, and
that the degree to which lead dust contaminated the child's blood would
be used as one of the ways in which the success of the experiment would
be measured. The fact that if such information was furnished, it might be
difficult to obtain human subjects for the research, does not affect the
need to supply the information, or alter the ethics of failing to provide
such information. A human subject is entitled to all material information.
The respective parent should also have been clearly informed that in order
for the measurements to be most helpful, the child needed to stay in the
house until the conclusion of the study. Whether assessed by a subjective
or an objective standard, the children, or their surrogates, should have
been additionally informed that the researchers anticipated that, as a result
of the experiment, it was possible that there might be some accumulation
of lead in the blood of the children. The "informed" consent was
not valid because full material information was not furnished to the subjects
or their parents. |
| [166] | C. Special Relationship |
| [167] | In Case Number 128, Ms. Hughes signed a Consent Form in which KKI agreed
to provide her with "specific blood-lead results" and discuss
with her "a summary of house test results and steps that [she] could
take to reduce any risks of exposure." She contends that this agreement
between the parties gave rise to a duty owed by KKI to provide her with
that information in a timely manner. She signed the Consent Form on March
10, 1993. The project began almost simultaneously. 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. 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 house." As we indicated, supra, this information
was not furnished to Ms. Hughes until December 16, 1993, more than nine
months after the samples had been collected and not until after Ericka Grimes's
blood was found to contain elevated levels of lead. She contends that not
only did KKI have a duty to report such information in a timely manner but
that it breached this duty by delaying to such a time that her daughter
was allowed to contract lead poisoning. Looking at the relevant facts of
Case Number 128, they are susceptible to inferences supporting the position
of appellant, Ericka Grimes, and, moreover, that, if true, would create
a "special relationship" out of which duties would be created.
Therefore, for this reason alone, the grant of summary judgment was improper. |
| [168] | In Case Number 129, Ms. Higgins also signed a Consent Form in which KKI
agreed to provide her with "specific blood-lead results" in respect
to her child and to discuss with her "a summary of house test results
and steps that [she] could take to reduce any risks of exposure." She
contends that this agreement between the parties gave rise to a duty owed
by KKI to provide her with complete and accurate information. Pursuant to
the plans of the research study, KKI collected dust samples in the Federal
Street property on May 17, 1994, July 25, 1994, and November 3, 1994. KKI
informed Ms. Higgins of the dust sample results by letters dated June 24,
1994, September 14, 1994, and February 7, 1995, respectively. Although KKI
had recorded high levels of lead concentration in the dust samples collected
by the Cyclone vacuum during the May 17, 1994 visit, KKI failed to disclose
this information to Ms. Higgins in the letter dated June 24, 1994. Instead,
KKI relied on the results obtained from the dust wipe samples collected
and informed her that there was no area in her house where the lead level
was higher than what might have been found in a completely renovated house. |
| [169] | Ms. Higgins contends that KKI knew of the presence of high levels of lead-based
paint and dust in the Federal Street property as early as December of 1993,
that even after Level II intervention such high levels still existed as
of June of 1994, and that it was not until she received a letter dated September
14, 1994 that KKI specifically informed Ms. Higgins of the fact that her
house had elevated lead levels. This was after her child, Myron, was diagnosed
with elevated levels of lead in his blood. |
| [170] | Specifically, Ms. Higgins contends that KKI was negligent in its failure
to inform her of its knowledge of the high levels of lead dust recorded
by both XRF testing in December 1993 and from the samples collected via
the Cyclone vacuum in May 1994 and that this withholding of information
combined with KKI's letter dated June 24, 1993, informing her solely of
the lower results of the samples collected by dust wipe methodology, was
misleading to her as a participant in the study. KKI does not argue the
facts as appellant presents them. Instead, it argues that no duty to inform
existed because although the Cyclone readings were high, they were not an
indication of a potential hazard because the clearance levels were based
on dust wipe methodology and the dust wipe results were not above the clearance
levels. Looking at the relevant facts of Case Number 129, they are susceptible
to inferences supporting the position of appellant, Ms. Higgins. Accordingly,
for this reason alone, the grant of summary judgment was improper. |
| [171] | As we indicated earlier, the trial courts appear to have held that special
relationships out of which duties arise cannot be created by the relationship
between researchers and the subjects of the research. While in some rare
cases that may be correct, it is not correct when researchers recruit people,
especially children whose consent is furnished indirectly, to participate
in nontherapeutic procedures that are potentially hazardous, dangerous,
or deleterious to their health. As opposed to compilation of already extant
statistics for purposes of studying human health matters, 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, would normally warrant or
create such special relationships as a matter of law. |
| [172] | It is of little moment that an entity is an institutional volunteer in
a community. If otherwise, the legitimacy of the claim to noble purpose
would always depend upon the particular institution and the particular community
it is serving in a given case. As we have indicated, history is replete
with claims of noble purpose for institutions and institutional volunteers
in a wide variety of communities. |
| [173] | Institutional volunteers may intend to do good or, as history has proven,
even to do evil and may do evil or good depending on the institution and
the community they serve. Whether an institutional volunteer *fn36
in a particular community should be granted exceptions from the application
of law is a matter that should be scrutinized closely by an appropriate
public policy maker. Generally, but not always, the legislative branch is
appropriately the best first forum to consider exceptions to the tort laws
of this State - even then it should consider all ramifications of the policy
- especially considering the general vulnerability of subjects of such studies
- in this case, small children. In the absence of the exercise of legislative
policymaking, we hold that special relationships, out of which duties arise,
the breach of which can constitute negligence, can result from the relationships
between researcher and research subjects. |
| [174] | D. The Federal Regulations |
| [175] | A duty may be prescribed by a statute, or a special relationship creating
duties may arise from the requirement for compliance with statutory provisions.
Although there is no duty of which we are aware prescribed by the Maryland
Code in respect to scientific research of the nature here present, federal
regulations have been enacted that impose standards of care that attach
to federally funded or sponsored research projects that use human subjects.
See 45 C.F.R. pt 46 (2000). 45 C.F.R. Article 46, Subpart A, is entitled
"Basic HHS[ *fn37 ] Policy for
Protection of Human Research Subjects" and Subpart D of the regulation
is entitled "Additional Protections for Children Involved as Subjects
in Research." 45 C.F.R. § 46.101(a) (2000) provides: |
| [176] | "Sec. 46.101 |
| [177] | (a) Except as provided in paragraph (b) of this section, this policy applies
to all research involving human subjects conducted, supported or otherwise
subject to regulation by any federal department or agency which takes appropriate
administrative action to make the policy applicable to such research. This
includes research conducted by federal civilian employees or military personnel,
except that each department or agency head may adopt such procedural modifications
as may be appropriate from an administrative standpoint. It also includes
research conducted, supported, or otherwise subject to regulation by the
federal government outside the United States." [Emphasis added.] |
| [178] | As we discussed, supra, this study was funded, and co-sponsored, by the
EPA and presumably was therefore subject to these federal conditions. These
conditions, if appropriate administrative action has been taken, require
fully informed consent in any research using human subjects conducted, supported,
or otherwise subject to any level of control or funding by any federal department
or agency. 45 C.F.R. 46.116 provides in relevant part: |
| [179] | "Sec. 46.116 General requirements for informed consent. |
| [180] | Except as pro |