*1 while also providing cognizable consumers with a forum for common law claims for which they could not otherwise obtain adequate relief. THE
JUDGMENT OF COURT OF SPECIAL APPEALS AFFIRMED WITH COSTS TO BE PAID BY THE PETI- TIONER.
782A.2d 807 Ericka GRIMES v. INSTITUTE,
KENNEDY KRIEGER INC. Myron Higgins, minor, etc., al., et
v.
Kennedy Krieger Institute, Inc. 128, 129, Sept. Term,
Nos. 2000. Appeals
Court Maryland. 16,
Aug. 2001.
Reconsideration Denied Oct. 2001. *5 Baltimore, 128, for Strong, appellant, W. No. Kenneth Term, 2000. Sept. (Saul Associates, P.A., Kerpelman C. E. & Shapiro
Suzanne Term, brief), Baltimore, appellants, Sept. on for No. 2000. (S. Boyce B. Joseph Allen Adelman and Susan
Michael I. Smith, Godard, West, Adelman, LLC, brief), & Sheff Rockville, appellees. *6 Thompson Eisenberg, Steinberg, Marc E. Tara
Deborah Andrews, Baltimore, Center, brief of the Public Justice and Program, Village National Health Law the East Harbor Center for amici curiae. appellants, Everton, Shelsby &
Angus Morgan R. Carlo Downs Ever- ton, P.A., Hunt brief of the National for Valley, Center Lead- for Housing appellees, Safe amicus curiae. Stiller, Nilson,
Shale George D. A. William L. Reynolds and Wolfe, of Evelyn Pasquier Piper, Marbury, W. & Rudnick LLP, Baltimore; S. Allan and Joseph Adelman Michael I. West, Godard, Adelman, Smith, LLC, Rockville, Sheff and for appellee, on reconsideration. Brown, LLP,
C. Brown of Christopher Levy, Goldstein and Baltimore, National for Housing, for Center Lead-Safe on reconsideration. Curran, Jr.,
J. Joseph Attorney Maryland General of and Schwartz, Attorney Jack Assistant Maryland General of for Baltimore, University Maryland on reconsideration.
Deborah Thompson Steinberg, and Marc Eisenberg Balti- more, Center, for Public Justice on reconsideration.
Ralph Tyler Hartson, and Joseph Young S. H. of Hogan & Baltimore, LLP, for Medical Colleges, American Association Universities, Hopkins American Johns and Uni- University versity Maryland Medical System Corp., reconsideration. York, NY,
Vera Hassner Sharav of New and Howard Fish- man, PA, Philadelphia, for Alliance for Human Research Protection, on reconsideration. ELDRIDGE, RAKER,
Argued WILNER, before CATHELL, HARRELL, BATTAGLIA and ROBERT L. (retired, assigned), KARWACKI specially JJ.
CATHELL, Judge.
Prologue these cases of first initially impression note that are We matter, in the few courts precious this Court. For presented have addressed the issues United States using nontherapeutic respect at bar.1 In research cases minors, has been it noted that “consent has been J. legislatures.” Robert virtually unanalyzed by courts Boards, on Chil- Katerberg, Review Research Institutional dren, Tight- Walking Parents: Consent of Informed Pro- Experimentation and Between Vital rope Encouraging 545, 562, quoting U.L. Subjects’ Rights, J.C. & tecting Subjects for the Protection Human National Commission Research, Recommen- Report Behavioral Biomedical and Involving Children Research [National Commission]: dations ' (1977). as this statement remains 79-80 Our research reveals *7 now was in 1977. accurate as it institute, cases,
In a present prestigious these research University, this rec- Hopkins based on associated with Johns it ord, whereby nontherapeutic program2 research created lead only partial of homes to have required certain classes and in at least some performed, modifications paint abatement instances, bar, arranged cases including at least one of the at or public funding way grants of for the landlords to receive then modifications. The research institute loans to aid in the bar, required, cases encouraged, in at least one of the at fairly point we only case on one 1. We note that we have found one close later; being we in the main a New York case that discuss address body opinion. of our implicat- profit are not 2. At least to the extent that commercial motives ed, directly therapeutic purpose help patient is to or aid research’s objectives suffering the of the research who is from health condition alleviation, designed hopefully by potential are the to address — alleviation, of the health condition. subjects Nontherapeutic generally are not utilizes who objectives designed to of the research are known have the condition address, designed directly subjects benefit utilized to is nоt to and/or but, rather, research, designed achieve results for to beneficial circumstances, (or, public large profit). under some premises the landlords to rent young families with In young children. the event already children resided one houses, of study it was contemplated that a child would remain in premises, and the child was encouraged remain, in order for his or her blood to periodically words, In analyzed. other continuing presence of the children that subjects were the study required order for to be complete. Apparently, the children parents and their judice involved the cases sub from a were were, case, lower economic strata at least one minori- ties. purpose research was to determine how effective
varying degrees paint lead abatement procedures were. Success was to be by periodically, determined a two-year over period time, measuring the extent to which lead dust in, to, remained or returned the premises varying after the modifications, and, levels of abatement as most important decision, by our measuring the extent to which the theretofore healthy lead, children’s blood became contaminated with comparing that contamination with levels lead dust in the houses periods over the same In time. respect one protocols presented to the Environmental Agency Protection Hopkins the Johns Joint Committee on and/or Clinical Investi- gation, the Hopkins (IRB), Johns Institutional Review Board the researchers stated: “To help insure that study dwellings are occupied by children, young families with City Homes3 give will priority to families young renting children when the vacant units following R & M [Repair and Maintenance] interventions.”
The same researchers completed had a prior study on abatement and partial abatement methods that indicated that lead dust remained returned to abated houses over a and/or period of time. In an article reporting on that study, very the same researchers said: “Exposure to lead-bearing dust is City apparently 3. Homes nonprofit entity was a affiliated the with Foundation, Enterprise managed that owned low income hous- and/or ing City. in Baltimore for because hand-to-mouth hazardous children
particularly entry of into the major as a route of lead activity recognized related to absorption inversely of lead is body and because Chisolm, Health R. & J. Julian size.” Mark Farfel particule Traditional Outcomes and Environmental Modified of Paint,— Leadr-Based Practices Abatement Residential for of (1990). Journal Public 80 American Health — the report, began pres- this the researchers publishing After encouraged were to which children project ent research was of lead dust possibility households where the reside that dust likely, so the lead known the researcher be of lead compared could the level content their blood period. over periodic two-year the houses at intervals dust children, the were anticipated it was that who Apparently, would, or might, in the at least subjects program, the human dust, the helping in their blood from thus accumulate lead extent to which the various researchers to determine the complete There no abatement methods worked. was partial agreements in the signed and clear consent explanation that to be was of the children the research conducted parents to measure success significant part, designed, least to which by measuring extent procedures the abatement ar- contaminated. It can be being blood was children’s be the that children gued the researchers intended (It clearly told parents. canaries the mines but never now, years, practice perhaps earlier even to determine whether rely subsurface miners to canaries gasses accumulating toxic dangerous were levels gasses. particularly susceptible mines. Canaries were to such die, began danger- the miners knew that When canaries accumulating.) ous levels of were gasses ap- Board and their Institutional Review researchers search nothing wrong protocols with the parently saw of lead in the blood anticipated accumulation possible experiment, otherwise children as a result healthy children parents that the consents of the they believed Institutional Boards appropriate. made the Review (IRB) family the institutional oversight are entities within *9 which an In entity conducting belongs. research research an IRB experiments, required can be some instances by regulation, either federal or state or sometimes the condi- governmental grants tions attached to are used fund research projects.4 Generally, primary their functions are to protocols assess the of the project determine whether the project itself is appropriate, procedures whether the consent adequate, are whether the methods to be employed meet standards, proper whether reporting requirements are suffi- cient, and the assessment of aspects various other of a re- search project. One of the most important objectives of such review is the review of the potential safety and the health hazard of a impact research human project subjects experiment, especially subjects on vulnerable such as children. function Their is not to help researchers seek funding for projects. research case,
In the instant as is suggested by some commentators as being endemic to whole, the research community as a infra, here, the IRB involved Hopkins Johns University Joint Committee on Investigation, Clinical in part, abdicated that responsibility, instead suggesting to the researchers a way to miscast the characteristics of order to avoid the responsibility inherent in nontherapeutic research involving 11, children. In a letter dated May the Johns Hopkins University (the Joint Committee on Investigation Clinical IRB for the University), charged insuring with safety subjects compliance regulations, federal wrote to Dr. Farfel, person in charge of the research: respect 4. In supported to research by any conducted or agency, federal Boards, Institutional Review among requirements, other must furnish (1) members, agency with: degrees, list of IRB representa- their capacity, experience, tive employment relationships between the entity. member and the required Each IRB is to have at least racial, five varying backgrounds; members of gender, there must be diversity. and cultural Each IRB has to contain at least one scientific member and one non-nonscientific member and one member who is not any way. affiliated with the institution in No member of an IRB A, conflicting can have a interest. 45 C.F.R. Subtitle sections 46.103 and 46.107. up.... respond
“A number of came Please questions the following points[:] *10 the drawing
2. has to with blood from The next issue do namely growing up children modern population, control guidelines really specific Federal are housing. quite urban in which projects children controls regarding using as. To particular is the potential children]. there no [to benefit no is to indicate there is subject call a a normal control that [by particular received children].... real benefit to be acceptable we think it be much more to indicate So would to studied determine what group’ bеing ‘control .that in a may play expo- the home total lead exposure outside sure; are indicating that these control individuals thereby, benefit, housing whether gaining namely learning safe some levels in keep acceptable alone is to the blood-lead sufficient ... modify form[s] that consent suggest you bounds. We [Emphasis ... accordingly.” added.] IRB make this would not suggestion While the or, thus, regulated, less less experiment any nontherapeutic (1) two the IRB had things: this statement shows of the between therapeutic difference partial misperception role in process research and the IRB’s nontherapeutic and (2) willing getting that the IRB was to aid researchers protect children used regulations designed around federal An subjects nontherapeutic primary as research. IRB’s safety subjects is to of human research role assure —not safety health-related help requirements. researchers avoid or IRB, misconceived, case, at least its own partially, The in this role. funding imposed by or conditions federal provisions
entities, are at- pursuant regulations, to federal conditions aware, As far we are or have been funding. tached as informed, (Maryland) no or state statutes there are federal subject that all research be certain conditions. mandate (one of “codes” “declarations” exist Certain international or held) that, binding has never been which is but so supposedly We theory, at least in establish standards. shall describe them, Accordingly, we on a clean slate this write infra. guided, case. We are as we determine what is appropriate, by “declarations,” those international “codes” or by as well as entities, studies by governmental by conducted various treatises other writings using on the ethics of children as duties, subjects, if out any, arising subjects use of as children of research. children,5 view, healthy
Otherwise in our not should in, in, living enticed into or remaining potentially lead-tainted housing subjected and intentionally program, to a research contemplates which probability, possibility, even the poisoning lead or even the accumulation of lower levels of lead blood, in order for the extent the contamination of the children’s blood to be used scientific researchers assess paint success lead or lead dust abatement measures. *11 Moreover, view, parents, our whether improperly by enticed trinkets, stamps, money items, food or other have no more right to intentionally unnecessarily place po- children tentially hazardous nontherapeutic research surroundings, cases, than consent, do researchers. In such parental no informed, matter how is insufficient.
While the of validity agreement the consent and its nature contract, as a the or existence nonexistence of a special relationship, and whether performed researchers their functions agreement under that pursuant to any special rela- tionships important are issues these cases that we will address, very inappropriateness of the research itself cannot be overlooked. It is apparent that the protocols of research are even more than important the method of obtain- ing parental consent were, and the extent to which parents not, or were If methods, informed. the research the protocols, then, are inappropriate especially when the IRB is to willing help researchers avoid compliance applicable with safety re- quirements research, using children nontherapeutic record, 5. As far as is known from the the children involved at the inception heаlthy, although appellee of the were unwilling was to argument. so concede at oral any surrogates, or of our parents, consent of the consent actions view, appropriate make research or the cannot proper. Institutional Board researchers Review parents to the relationship proffered The research tools, measuring the researchers wanted use as children in a nontherapeutic have context presented never been should was Nothing about the research de- in the first instance. They subject of the children. were for treatment signed project. healthy to be at commencement presumed them, clearly nontherapeutic was nature. As to research greater good” project.6 a “for the experiment simply The was risk, in order put specific children’s health goal the cost of the level of effective The ultimate was to find minimal 6. assess, help paint lead costs so as to landlords lead dust abatement attempting positively, feasibility to abate hopefully the commercial housing, in order marginally profitable, lower rent-urban lead dust in housing housing One help preserve such in the Baltimore market. methods abatement so that some the aims was to evaluate low-cost landlords, rental those would not their units. For landlords abandon economically pro- complete deemed feasible. The abatement was not partial particular a ject be able whether level would to assess beyond lead elevated abatement caused child’s blood content to be the health of children. level deemed hazardous to involved, presumably, would be from a lower rent-urban The tenants consenting parents these cases was At least one of the in one of class. assistance, being public was described her counsel as apparently minority. parents class or were The children of middle rich involved. not "Indeed, experimen- law and of human the literature on the ethics subjects, warnings especially replete that all but vulner- tation is subjects]. subjects, are abuse [as able at risk of inclusion subject prisoners, are subjects vulnerable included who Those *12 Martin, coercion, Clay 509 F.2d The Prisoner’s Cases: v. 109 [see (1975); Bailey, Munney Lally, F.Supp. Dingee, & 481 203 Neuser v. 956, (1977)]; Prudden, (1979); 181 Valenti v. 58 A.D.2d 397 N.Y.S.2d minorities, minorities, elderly racial ethnic and the ... and children injections/informed case consent [see and women the silicone 164, Orentreich, (1992)], 710 Retkwa v. 154 Misc.2d 584 N.Y.S.2d frequent history of abuses to be the most victims whom shows experimentation.” human Charo, Women, Protecting Pregnancy and Clinical Alta us to Death: R. Trials, 135, (Fall, 1993); also In 38 Louis U.LJ. 135 see re Research St. ("The 796, (1995) F.Supp. Litigation, 874 800 Cincinnati Radiation alleges patients____The complaint experiments utilized cancer terminal and, patients were in the most of the selected African-American
43 help abatement that would all develop low-cost measures landlords, children, and the as well. general public Garnett, Why Con- It was noted Richard W. Informed Hum,an Autonomy, and the Ethics Experimentation sent? (1996) 455, Lawyer 36 Catholic 490 that: poses problems easily legitimat- “Most research no and is justified, subject’s experi- ed and but the consent to those not, itself, they are ments is reliable indicator it justified, justifies nor is itself what them.” States, 479, 438, In Olmstead v. United 277 U.S. 48 S.Ct. 564, 572-73, 944, (1928), Brandis, 72 L.Ed. Justice dissent- ing, noted:
“Experience
guard
should teach us to be most on our
liberty when the
are
protect
purposes
Government’s
benefi-
naturally
cent. Men born to
alert to repel
freedom are
invasion of their liberty by
greatest
evil-minded rulers. The
dangers
liberty
lurk in
insidious encroachment men of
zeal, well-meaning
understanding.”
but without
here,
project
The resеarch
at issue
and its apparent proto
cols,
from,
differs in large degree
but
similar
presents
prob
lems as
Tuskegee Syphilis Study
those
from
conducted
(The
1932 until 1972
Tuskegee Syphilis Study, 289 New Eng
(1973)),
land Journal of Medicine 730
the intentional exposure
of soldiers to radiation in
(Jaffee
the 1940s and 50s
v. United
(3d
States,
Cir.1981),
denied,
972,
exposure
(9th
States,
aff'd, 768 F.2d
(1984),
1059
991
F.Supp.
591
7
of
to soldiers
Cir.1985,)
administration
LSD
and the secret
(United
States
1950s and 60s
Army
the
the
by the CIA and
3054,
550
669, 107
97 L.Ed.2d
Stanley,
v.
483
S.Ct.
U.S.
Sims,
159,
(Central
v.
Intelligence Agency
471 U.S.
(1987));
(1985)).
1881,
experi
research
173
The
85 L.Ed.2d
105 S.Ct.
of research sub
also
instances
prior
that follow were
ments
poisonous
to infectious or
intentionally exposed
jects being
They include
of scientific research.
the name
substances
aforesaid, where
infect
Study,
patients
Tuskegee Syphilis
the
of the avail
informed
subsequently
were not
syphilis
ed with
illness, in
for the
of the
order
for treatment
ability
penicillin
research on
to be able to continue
and researchers
scientists
illness,
study,8
Hospital
the Jewish
effects
the
Then there are the
projects.
post-war
other
several
military
Japanese
use of
bombs”
“plague
notorious
villages were infected
order
II where entire
World War
notorious,
“studied”;9
most
perhaps
results to be
in order
nontherapeutic project
in a
use of infection
deliberate
course
rapidity
and the
of the
of infection
study
degree
Mrugowsky typhus experiments
Rose and
disease
II.
during World War
camp
concentration
at Buchenwald
vulnerability
alike in the
were somewhat
programs
These
men,
African-American
debilitated
subjects; uneducated
already working
uranium mines
Navajo
been
in' the
7.
miners had
case,
Navajos were
present
Unlike the
when the
commenced.
being
placed
environment
to be
recruited
the researchers
not
unhealthy substances.
tested for
Hospital study where
Generally
as the Jewish Chronic Disease
8.
known
injected
cells
patients were
with cancer
chronically ill and debilitated
Hosp., 47
v. Jewish Chronic Disease
their consent. See
without
Zeleznik
199,
(1975).
Application
Hyman,
And see
It is clear to this Court medical scientific and communities cannot be to permitted authority assume sole determine what is ultimately right aрpropriate respect and projects involving to research of young children free limitations and consequences application Maryland Boards, IRBs, are, law. The Institutional primarily, Review view, organs. they in-house In our are not designed, general ly, sufficiently objective to be that they sense are as sufficiently ethicality concerned with the of the experiments review as they they experiments. are with the success of the subject This has been the of comment in a constitutional context, dissent, in a case involving psychiatric the use of medication on In patients mental without their consent. 210, 237, 110 Washington 1028, 1045, v. 494 Harper, U.S. S.Ct. 178, (1990), 108 L.Ed.2d Justice Stevens said: interest; “The Court respondent’s liberty has undervalued Washington has misread the involuntary Policy medication ..., and has concluded that a mock an trial before institu- tionally biased tribunal constitutes process ‘due law.’” [Citation omitted.] dissent,
In footnote two of his Justice Stevens noted: “([T]he promise Constitution’s of due process guaran- law compensation tees least principle violations of the Nuremberg stated Military Tribunals ‘that the “vol- untary consent of subject the human is absolutely essential moral, ([T]he satisfy ’); ... legal ethical and concepts[.’]” protects Fourteenth Amendment ‘freedom care for health person[.]’)” one’s 1045, 108
to the researchers to assess the ethics of such in-house review the effectiveness Here, IRB, primary whose of research were warranted. safety compliance applicable function was to insure misrepresent the researchers regulations, encouraged under the bring in order to purpose of the research standard safety and thus under a lower “therapeutic” label of its ethically wrong, purpose The IRB’s regulation. benefit incorrect. understanding experiment’s so especially inherent. This would be The conflicts are industry collaborate search private science and when Moreover, relationship between special gains. material will subjects human used the research research entities and always impose almost duties. are relationship, we examining special
In to respect its ethical con- further examine its nature and obliged to arise, the In that when contested cases regard, straints. subjects on human legal of the effect of research assessment judicial evaluation. One method always subject must appropriate initiation of actions such evaluations is the making courts, attention of the as has such matters to the bringing end, that in the may in at bar. It well be been done the cases damages that no have been trial courts will determine fail for in cases and thus the actions will incurred the instant substan- In we note that there are regard, that reason. that and in the Grimes cases. Higgins tial factual differences themselves, actions, ground are not defective on But the courts, can, possibly to the trial duty according that no legal body in main length reasons discussed exist. For the researcher duty normally a exists between opinion, legal exists in the cases at bar. subject probability and in all discuss, Moreover, parents the consents of the as we shall creating contracts Maryland law constituted these cases under law, Maryland pa- to the extent Additionally, duties. under projects in research of this consent can ever be effective rental nature, sufficiently informed may not have been parents and, and, therefore, based on the the consents ineffective court, this sparse reсords before information contained legal rights may have invaded project, the research subjected to it. children
I. The Cases us, the two cases before specifically We now discuss more and the relevant law. who involving actions children separate negligence
Two levels of lead dust their blood allegedly developed elevated Ken- respondent, while a research participating (KKI) Institute, Inc., are before this Court. nedy Krieger at least poisoned, that the children were allege Both cases dust due to being poisoned, to the risk of lead exposed they allege of KKI. negligence part Specifically, on the and, homes respective KKI discovered lead hazards their them, duty notify timely failed to warn having prevent exposure manner or otherwise act to the children’s Additionally, plaintiffs alleged of lead. presence known fully were not informed of the risks of the research. they case, Grimes, by In Ericka appellant, the first Number ruling her from a of the Circuit Hughes, appeals mother Viola City granting summary Court for Baltimore KKI’s motion for judgment ground based on the sole that as a matter of law legal duty, pres- there was no under the circumstances here ent, KKI, In the part appellants. owed second case, 129, appellant, Myron Higgins, by Number his mother Higgins, individually, Catina from Higgins, appeal Catina ruling City granting of the Circuit Court for Baltimore summary judgment ground KKI’s motion for based on the *16 KKI legal duty presence had no to warn them of the in parties, respective appeals, presented lead dust. The their almost to the Prior Special Appeals. identical issues Court court, granted to consideration we certiorari to ad- in rephrase dress these similar issues. We the issues both language presented by appellants cases Case Num- ber 129: for ruling
“Was the trial court incorrect a motion that as a of law a summary judgment entity matter research an conducting ongoing non-therapeutic study scientific does participant to warn a minor volunteer duty not have a when guardian regarding dangers present his legal and/or for harm to knowledge potential has the researcher subject danger?”[10] is unaware of the subject and the court incor- in the affirmative. The trial was We answer normally rela- special create programs rect. Such research nature, a contractual that create can be of tionships and/or result in may ultimately of such duties duties. The breaches least, Because, very there actions. negligence viable concerning of material fact genuine disputes are viable and relationships arising or other special relationship, whether a KKI between rise to duties existed agreements, giving out of Court we hold that the Circuit appellants, and both sets of summary judgment for KKI’s motions granting erred Accordingly, we vacate the cases before this Court. both City for Baltimore and remand rulings of the Circuit Court proceedings for further consistent these cases to that court opinion. with this Background
II. Facts & Procedural Study A. Research (EPA) Agency Protection In The Environmental 68-D4-0001, of Effica- entitled “Evaluation awarded Contract Based Paint and Maintenance cy Repair of Residential Lead $200,000 KKI for to KKI. receive Interventions” under the contract. It was thus performing responsibilities its purpose researcher. The this compensated long- short and study compare was “to characterize and less lead-paint abatement and efficacy comprehensive term and Mainte- costly potentially Repair more cost-effective reducing levels of lead residential nance interventions No.128, language: phrased question in Appellant, 10. in Case similar ruling entity conducting a that a research "Did the Circuit Court err in subject study duty participating in the does not owe a to a human knowledge potential for harm to the when the researcher obtains danger?” participant unaware of the who is granting of We resolve these issues in the context of the trial court’s summary judgment. appellee's motions for
49 in children’s lead in turn should reduce house dust which Investigation in its Clinical acknowledged KKI blood.” As in problem in is a Form, children poisoning “[L]ead Consent country. communities across City and other Baltimore major sources outside soil are house dust and paint, Lead exposed can also be for children. Children lead exposure poisoning and other sources.” Lead drinking lead in water adversely effects young children. It danger a distinct poses Extremely high and behavior. cognitive development, growth, coma, seizures, even have known result levels been Prevention. for Disease Control and See Centers death. Young Lead Chil- Screening Blood Recommendations for Risk, High Targeting Group dren Enrolled Medicaid: 2000). (Dec. 8, 1 Weekly Morbidity Mortality Report Sc.D., Abate- R. Farfel Director of KKI’s Lead Dr. Mark in his Department, deposition: ment testified goal study “The scientific of the is to document paint strategies, of various lead base abatement longevity in house reducing exposure factored terms lead dust levels.[11] and the children’s blood lead lead, for study design A. Our called collection blood from participating venous blood lead children.
... levels [Sjtudy protocol called serial blood lead corresponding campaigns.... with the dust collection [T]he months, baseline, months, study goal get was to two six months, eighteen twelve months evaluation. context, referring general
11. From Dr. Farfel was to children in making purpose manifestly when this remark. The of the was not in the blood of the that were to reduce the level lead children subjects study, but to create a controlled research environment focusing of lead dust. The success of the abate- on abatement various measured, procedures significant part, ment would be not reduc- blood, ing by periodic the levels of lead in the children’s but measure- Thus, reasonably ments of the level of lead in their blood. it can be argued in KKI’s interest for the children to leave the it not experiment prior to its conclusion. ... collection was to study protocol, protocol data the environmental measurements and the get close time *18 blood [Emphasis added.] venous lead.” jointly by was the EPA and study sponsored The research Maryland Department Housing Community of and Devel- (DHCD). joint It state opment was thus federal and project. City Department Mary- The Baltimore Health and also land of the Environment collaborated Department that, study. appears12 study It because the was funded and in sponsored part by entity, a federal certain federal condi- funding grants approvals. tions were attached to the and in required respect There are certain uniform standards however, We, funded or are federally approved projects. of, to, any have not been directed federal or state unaware regulation imposes pow- statute or limits on this Court’s presented. ers to conduct its review of the issues None jurisdiction this in these cases. parties questioned have Court’s 46.116(e) (C.F.R.) Moreover, Regulations 45 Code Federal in requirements “The informed consent specifically provides: federal, policy preempt any applicable this are not intended to state, information to be require or local laws which additional in effective.” legally disclosed order for informed consent be conditions, recommendations, or state Those various federal etc., at a trial on the merits as to may well be relevant occurred, any duty whether breach of a contractual or other or did, fact, occur; in no negligence limiting whether but have law, duties, whether, at via contract legal effect on the issue of in “special relationships” Maryland experi- are created children. nontherapeutic involving Maryland mental research included five test each consist- study groups, The research ing twenty-five groups houses. The first three consisted present houses with a considerable amount of lead dust there- assigned in13 each received amounts of mainte- group by pre-trial summary 12. These cases were decided below motions judgment. The record is therefore not extensive. purposes study, 13. For of this the researchers considered lead in dust micrograms square equal per elevated if it was more than or to 200 foot houses, group The fourth consisted repair. nance and form of lead based present at one time had lead which complete abatement supposedly but had since received paint houses, consisted of modern group of lead dust. The fifth aim of the of lead dust. The presence which had never had a of different analyze was to the effectiveness study research levels of reducing abatement degrees partial paint lead ultimate aim of the present lead dust these houses. The of abatement complete was to find a less than level safe, economical, that Balti- but so relatively that would units would more landlords with lower socio-economical rental study specifically not abandon the units. The research comprehensive paint to do less than lead designed, part, effectiveness, any, if potential abatement order to time, mainte- period repair over a of lesser levels *19 by measuring presence nance on the of lead dust the presence (as in of the of lead the blood of theretofore far as the record reveals) essence, In healthy study cases children. the at its only was not to test current levels of lead inception designed children, in of in the blood but the increase decrease in future lead levels the blood that would be affected was appears study various abatement It that this programs. motivated, indicated, supra,, by also as we have partially in of property City reaction of owners Baltimore to the cost of such lead dust abatement. The cost of full abatement housing monetary at times far exceeded the worth of the words, cost of was property other full abatement —in simply high too for certain landlords to be able to afford to floors, equal micrograms per square more than or to 500 foot for sills, equal micrograms per square window and more than or to 800 for window levels or foot wells. These were maximum allowable Maryland Department "clearance standards” that the of the Environ- (MDE) following had abatements. ment said must be met full lead dust only § COMAR 26.02.07.12. We note that these "clearance standards” fully apply to abated wherein all the lead been re- houses dust has moved, houses, to not lead not which have been abated and still have 1, 2, discussed, present, Groups dust as is the case in and 3 infra. discuss,
Additionally, parties disagree as we 26 and *20 liberty referring groups Groups 14. We have taken the to the test as 2, 3, 4, clarify attempt verbiage opinion and 5 in an of this due to provide did not names for fact the research abbreviated Groups 4 and 5. Although co-sponsored the EPA funded and the cost of the actual 15. research, provided repair and of the houses funds maintenance by by through provided were loans made DHCD the Lead Paint Abate- Assembly. Maryland Program Code ment established the General (1957, §§ Repl.VoL, Cum.Supp.), through 2- 1988 1990 Art. 83B 2-301 1, 1995, July through On these loans were made the Lead Hazard 313. Laws, Maryland Program Chapter Reduction Loan as enacted 1995 re- Properties Level & Maintenance Group Repair I— 1— maintenance repair and a minimal level ceiving ($1,650.00). re- Properties Level & Maintenance
Group Repair II— 2— and maintenance repair level of ceiving greater ($3,500.00). Properties re- & Maintenance Level
Group Repair III— 3— maintenance repair level of and ceiving greater an even ($6,000.00-$7,000.00). capped I were Level interventions
Repair & Maintenance and $1,650 wet-scraping peeling included by DHCD at and composition and of unknown flaking paint paint lead-based doors; walls, trim, surfaces, repaint- and including all interior surfaces; caps; of window well ing of treated installation trim, of all interi- repainting of all exterior window repainting sills; vacuuming of all horizontal surfaces and or window (HEPA) high efficiency particulate window with a components vacuum; II all horizontal surfaces. Level cleaning and wet $3,500 and capped by interventions were DHCD included I additional plus key all the elements of Level intervention two of sealants and to make floors smoother paints elements: use cleanable, easily in-place and more and window and door lead-painted treatments to reduce abrasion of surfaces. Level $6,000-$7,000 capped by III were DHCD at and interventions of exterior door replacement encapsulation added window aluminum, trim with on some floors coverings and the use climbable.16 easily and stairs to make them smooth and more Measurements of lead in the blood of the children and samples vacuum dust from the houses were to be obtained at following pre-intervention, immediately post times: inter- vention, one, three, six, twelve, twenty-four eighteen, months intervention. Measurements of lead the exte- post (1957, Maryland Repl.VoL), §§ 335. See Code Art. 83B 2-1401 through 2-1411. descriptions repairs were conducted of what and maintenance 16. provided by at the different levels of intervention were KKI’s brief to this Court in Case Number 129. *21 54 immediately pre-intervention, to be obtained at
rior soil were intervention, months twenty-four post twelve and post and drinking of lead water were intervention. Measurements twenty-four and pre-intervention, obtained at and twelve be of the Additionally, parents months intervention. post fill out a at subjects study questionnaire of the were to child at six-month intervals. enrollment and study composed of the research was component The second control groups: two having previously identified as been Group Properties 4— to receive no paint abated of lead which were completely maintenance. repair additional and Dwellings Properties construct- Group 5—Modern Urban — presumed paint after 1980 and not to have lead-based ed no and maintenance. repair which were to receive blood, called for similar collection and evaluation study The soil, water for lead content at samples, drinking dust and Measurements component. similar time intervals as the first samples of the children and vacuum dust of lead blood six, at enrollment and these houses were be obtained twelve, twenty-four post and months enrollment. eighteen, water drinking of lead in the exterior soil and Measurements enrollment, twenty- at twelve were to be obtained at in the fourth post participants four months enrollment. questionnaire instructed to fill out a groups and fifth were enrollment and at six-month intervals. from study groups
The research was to collect data all five two There were two sets of criteria for period years. over a for properties enrollment in the research —one respect properties to the involved one for residents. With were groups, looking the first three test the researchers structurally properties prior sound that had been built paint 194117or lead-based in the unit based had documented purposes study, presumed present lead 17. For dust buildings prior requirements same controlled selec- built to 1941. The fully Group except properties allegedly had been tion of that those abated. in his deposition, As Dr. Farfel testified upon testing.18 XRF six-room row- looking two-story, for the *22 basically “We were in structurally 8 to 10 windows a City house in Baltimore for was selected use property sound condition.” Once maintenance randomly assigned repair it study, was I, II, III.19 intervention level of or the researchers recruited respect occupants, to the With Dr. Farfel that had at least one small child. testified: families side, looking were family participant “For the we with the obviously willing cooperate families that were to We were study by signing informed consent statements. looking age for families that had at least one child under the of 48 months than five months at the start of the and older study. mentally These children were not to be retarded severely limit their handicapped any way would physical movement. excluding
We were also sickle children had cell anemia, knowledge, to the best of our had sickle cell anemia. they
We asked the families if had any plans, immediate did, If they they eligible move. then weren’t because we in following family period were interested over a of years.” summary,
In KKI study groups conducted five test twenty-five houses each.20 groups The first three consisted of houses present. repair known to have lead The amount of maintenance 1 to 2 Group Group conducted increased from Group houses, 3. The fourth group consisted which had at x-ray analyzer 18. XRF refers to "an fluorescence which measures the 26.16.01.02(27). § paint lead content in materials.” other COMAR Actually, assignment slightly the random was more involved. As- 19. signment property currently being was based on whether the was used Occupied dwellings assigned as a residence. were either Level I or dwellings II assigned Level intervention at a ratio of 2:1. Vacant were equal either Level III or Level II at a ratio of 2:1. The result was an groups. distribution of houses into each of the three only actually participated 20. The record indicates that houses study opposed as to 125. received a allegedly but had since present one time lead group The fifth consisted abatement of lead dust. complete houses, presence of lead which had never had modern testing first three homes each of the twenty-five dust. The groups: two control compared to be to the levels were then previously 4 that had been Group homes twenty-five in Group homes 5. The research and the 25 modern abated to do less than full lead dust designed study specifically of houses order categories in some of the abatement effectiveness, any, if of lesser levels potential maintenance. repair and the first upon to leave the houses
If the children were difficult, dust, if not impossi- it would be manifestation of lead test, time, accumula- ble, the rate of the level lead over *23 to the manifesta- the children attributable tion in the blood of words, from the if the children were removed tion. In other in their blood became the lead dust levels houses before fail, elevated, or at least the data probably the tests would abatement success of the test —or would establish the Thus, benefit results, use. it would questionable would be of test, KKI, compensated and thus accuracy of the researcher, period in the houses over the if children remained of lead dust in the houses presence even after the of the became evident.
B. No. Case Grimes, at 1713 N. Monroe Street Ericka resided Appellant, (the Baltimore, property) Monroe Street Maryland in 30, May of her birth on family of her from the time members mother, Viola 1992, until the summer of 1994. Her up in since the Summer of 1990. property had lived Hughes, 1993, Hughes’s of KKI came to Ms. representatives In March participate her to successfully home and recruited nature, regarding a discussion study. After study, Hughes agreed Ms. scope, and benefits purpose, Form March signed a Consent dated participate 1993. in clearly
Nowhere the consent form was it to the disclosed that, contemplated mother that the researchers as a result of blood, experiment, the child accumulate in her might lead in experiment and that order for the it was succeed in necessary that the child remain the house as the lead in the decreased, child’s blood increased or so that it could be in part: measured. The Consent Form states relevant “PURPOSE OF STUDY: know, you may poisoning
As lead children is a problem City country. Baltimore and other communities across the in paint, major Lead house dust and outside soil are sources exposure exposed lead children. Children can also be drinking lead water and other sources. We under- your stand that house is to have going special repairs21 exposure paint done order to reduce to lead and dust. basis, On a random homes will one of receive two levels of repair. We are interested in out how finding well the two intended, levels of work. repair repairs are not expected, to completely exposure remove lead. are doing study
We now to learn about how well different practices reducing exposure work for to lead in paint and dust. asking you We are and over one other hundred families to allow us to test for your lead and around homes up to 8 to 9 times over the next two years provided your qualifies years house for the full two of study. eligibility Final will be testing determined after the initial *24 repairs 21. This Consent Form refers to that were to be made to the property. Monroe Street KK1 contends in its briefs to this Court that appellant’s already completely residence had been abated as of October 1990, 15, subjected repairs and was not to be to and maintenance groups, Group because it was a member of one of the control 4. The suggests parties appeared agree during argu- evidence and the oral ment property before this Court that the Monroe Street was a member Group Regardless, reviewing 4. because we are this matter in the granting summary judgment context of the upon based a trial court and, remand, duty determination that no existed as a matter of law will, addressed, necessity, the facts of each case need to be we do not was, group need to resolve to which it was a member or whether there fact, case, duty as a damages matter of a breach of even for that matter. testing of free blood lead doing are also your home. We times over up to 7 to 8 to 9 years, 6 months aged children to a you respond also like would years. the next two We This is intended every 6 months. questionnaire short and is not intended repairs to monitor the effects your family care obtains. regular medical replace the BENEFITS answering and your questions time you сompensate
To you mail a check home we will your us to sketch allowing you would mail In the future we amount of $5.00. full questionnaire each time the in the amount of check $15 dust, soil, water, samples blood completed. Institute at Kennedy Krieger at the for lead would be tested you specific would you. provide charge no We you contact to discuss would blood-lead results. We could take you steps house test results summary of [Emphasis added.] exposure.” risks any to reduce study, KKI collected of the research plans to the Pursuant 9,1993, on March property Street the Monroe samples dust 19, 1994, 18, 1994, 23, 1993, 9, April September March August 9, 13, March 1993 dust 1995, 1995.22 The and November to as “hot the researchers referred revealed what testing “higher might than of lead was where level spots” This infor- house.” renovated completely [abated] found Hughes not furnished to Ms. spots” the “hot mation about 1993, months after the 16, more than nine until December discuss, not until and, infra, we collected as had been samples to contain elevated blood was found after Ericka Grimes’s levels of lead. reason, samples typically unexplained processing the dust
22. some For Hughes sample Ms. of the dust KKI notified took several months. 1993, 16, 1993, 17, May December dated December results via letters 18, 1996, 28, 1994, 19, 1995, 19, 1994, January July October discussed, supra, appellant moved out of the respectively. weAs first property Summer of after the three Street Monroe collected, presented, and the results to Ms. samples were both dust Hughes.
59 KKI drew blood from Ericka Grimes for lead content 9, analysis 1993, 15, 1993, on April, 25, September and March 1994. Unlike the lead analysis concentration testing, dust the results of the blood were testing typically available to KKI in a matter of days. KKI Hughes notified Ms. of the results 9,1993, of the blood tests by 29, letters dated April September 1993, 28, 1994, and March respectively. The results of the 9, April 1993 test found Ericka Grimes blood be less than 9 Pg/dL, which placed her results in the “normal” range accord- ing classifications established the Centers for Disease (CDC).23 However, Control subsequent retests, two long KKI after had identified “hot but spots,” before KKI informed Ms. Hughes of the “hot spots,” Ericka Grimes’s blood lead registered level Class III—32 ¡xg/dL 15, on September 22 |xg/dL 25, on March 1994. Ms. Hughes and her daughter vacated the Monroe Street property the Summer 1994, and, therefore, no further blood samples were ob- KKI 25,1994. tained after March In Complaint her filed in the Circuit Court for Baltimore City, Ms. Hughes sought to KKI hold for negligence liable of, failing abate, to warn lead-paint hazards that KKI allegedly discovered the Monroe Street property during the research study. Specifically, she alleged:
“3. As part Study, [appellant’s] [Research] mother agreed to allow to periodically inspect [KKI] the Monroe Street property for presence of lead-paint hazards. gg/dL is an micrograms per abbreviation for reading deciliter. A 23. of 9 Pg/dL means that the micrograms child had 9 every of lead for deciliter generally Co., 661, blood. See Jones v. Funding Mid-Atlantic 362 Md. 12, (2001). 668-69 n. 766 A.2d 621 n. 12 At the time Ericka Grimes was tested for poisoning, lead the CDC used following classify nomenclature to blood lead concentrations in children: (Normal) Class I equal gg/dL than or to 9 —less elevated) (Moderately Class IIA gg/dL —10-14 elevated) (Moderately Class IIB gg/dL —15-19 elevated) (Highly Class III gg/dL —20-44 elevated) (Urgently Class IV gg/dL —45-69 (Critically Class V elevated) greater equal than or gg/dL to 70 — Children, Preventing See Poisoning Lead Young Centers for Disease (October 1, 1991). Control of lead- discovered the existence Upon inspection, [KKI] home, to inform within but failed paint [appellant’s] hazards *26 and and her mother of such hazards [appellant] warn and/or a to As any failed take action abate said hazards. to to reside сonsequence, [appellant] and her mother continued the the the and unaware of home unaware of hazards exposed.” was dangers [appellant] being to which (JJB) JJB, Inc., Complaint Party against KKI a Third filed filed an property. Appellant the Monroe Street the owners of to JJB as an additional defendant Complaint Amended add Maryland Consumer and violations the alleging negligence Summary on Judgment Act. KKI a Motion for Protection filed it any to that grounds duty appellant that it did not owe 2000, 26, Court for Balti- July had On the Circuit breached. judgment KKI’s motion entered City granted more and against her and of KKI. claims JJB Appellant favor dismissed 12, February 2000. On Appeal September filed a Notice of on 2001, 8, prior by Special Appeals, consideration Court we issued a of Certiorari. Writ Circuit appeal, seeks review of the Court’s appellant
On that summary judgment. KKI She contends granting decision nature of duty appellant KKI of care to based owed a of: arising and mother out relationship appellant its her (2) (1) voluntary assumption a a parties; contract between the KKI; (3) parties; relationship” a between by “special (4) KKI’s failure to regulation. argues She Federal notify her of the lead dust hazards Monroe Street passed after than nine months had since property until more collected, until Ericka had been after samples poisoned, was found to be lead constituted Grimes’s blood KKI in the of its duties negligence part performance on the Ericka out of nature of the between arising relationship parties. No. C. Case 1993, Polakoff, operator In Mr. owner professional KKI had been recruited as landlord properties, rental Association, to volunteer through Property Owners Federal Street property study. the research property His criteria, discussed, met the researchers’ which we supra —that it awas structurally property, 1941, sound built prior to had documented levels of paint lead-based the unit. In December of KKI had Mr. Polakoff s property tested an outside contractor and it positive tested for lead paint and dust throughout the house. Once into accepted the program, Mr. Polakoff s property was randomly assigned a Repair & Maintenance II Level intervention and subsequently under- went repairs intervention, associated with II Level dis- cussed, supra, by Restoration, (Environ- Environmental Inc. mental). $3,500 Mr. Polakoff applied for a loan from the Maryland Department of the pay Environment for the repairs, which granted. repairs were completed in *27 approximately April 1994.24
Appellant, Myron Higgins, was born 23, on December 1989. According to Ms. Higgins’s Catina deposition testimony, dur- ing Spring of 1994 she was for a looking home in which to reside with her several small children. She located the prop- erty known as (the 1906 East Federal Street Federal Street property) in an advertisement in the local newspaper listing the property as a rental for per month. She $315 rented the Polakol’f, landlord, 24. Mr. a or a representative, landlord’s testified in deposition properties about the that KKI recruited into program: "Q. my understanding It’s that subject this house study was to a out Kennedy of Institute— A. That is correct. A. I voluntarily put property this study____After into ... [the] that abatement], [partial a tenant with ... at least one age child under the three would have to move property. into the The child and the property periodically would be tested—the through children blood tests.... Well, they A. actually they [KKI] solicited me and were looking for properties.... vacant Q.... you you What said is were aware program only that this was partial be a abatement? A. Yes.” affidavit, In an Mr. Polokoff stated that KKI parents “wоuld refer young Property.” children to the Partnership.25 signed a from Limited She property CFOD-2 13, May shortly on 1994 and moved property lease for thereafter. 1994, analyzed immediate May KKI collected and
On an samples using experimental Cy of dust post intervention from the composite sample A dust clone dust collector.26 of the first (jog/ft2,27 composite sample floor first was composite sample pg/ft2, was 2274 floor windowsill 25, 1994, On p-g/ft2. July was 1530 the interior entrance study, a second pursuant protocols to the research Partnership, property from CFOD-2 Limited 25. She rented the Inc., general partner. Management, was a Mr. Lawrence which Chase Management, property The was President of Chase Inc. Polakoff already level of lead dust abatement was vacant and had received the Higgens by protocols. words specified In other Ms. was, being moving her into a site recruited into child intentionally, completely abated. not figures presented by disagree validity as parties to the 26. The collecting samples. Apparently, KKI used two different dust these methods, drastically resulted varied results. results which samples from collected an were obtained dust discussed above samples gave all Cyclone dust collector. These experimental vacuum results, present lead therein was far above the which indicated that the See, However, supra, 13. accepted Maryland clearance levels. note KKI, wipe according levels based dust the clearance are collec- Cyclone presented KKI evidence that additional tion not collection. technique wipe samples were the dust these collected Maryland samples presence of lead clearance indicated below Thus, argues a lead that there was no indication of hazard levels. KKI duty appellant property and thus in the Federal Street no inform *28 Cyclone samples. the document, 1992, 18, But, request prior May a for in a related renewal study, following justification: to "Prior the KKI included the renewal study, study side-by-side we conducted a of dust the start of the main by Kennedy wipe samples traditional method collected Institute’s the study. by cyclone use in We the HVS3 device selected for the main and samples higher loadings wipes the that had lead than found the HVS3 possibly being ... to its more efficient types, all surface attributable for collecting rough cracks surfaces.” dust in by suggested argument representative, posi- KKI’s at oral KKI’s As hazard, they even that levels of do not constitute if tion is lesser lead argument ignores possibility the accumulation risk. The of constitute from in the of the children various sources. of lead blood micrograms square per pg/ft2 27. refers to foot. dust samples
series of were obtained from the Federal Street property. While several the first floor lead dust levels value, in found that dust in dropped sample this second lead area, figures the second floor which had under the registered level the first sampling, markedly clearance were increased. abated, Higgins family After the the partially moved into Higgins vacant Federal Street KKI Ms. property, approached her son requested participate she and the research consent, Her study. participation and to addition the previous landlord’s consent the property, abatement necessary permit KKI to property enter the to collect samples future dust from the Federal property Street and to 24, 1994, obtain blood from samples her son. On May Ms. Higgins agreed to participate and Form signed Consent her regarding and her child’s participation study. As Case No. 128 the consent form contain did not a clear disclo- that, sure that the contemplated researchers as a result experiment, subjects might, child and perhaps were antici- to, pated accumulate some level of lead contamination of their blood, the lead content of the children’s blood would one of which by methods would determine the effectiveness of the various abatement procedures.
Pursuant protocols study, the research KKI col- lected dust samples 17, the Federal property May Street on 1994, 25, 1994, July 3, and November 1994. KKI informed Ms. Higgins sample the dust by results letters dated June 24, 1994, 1994, September 14, 7, 1995, and February respec- tively. Although KKI had recorded levels of high lead concen- tration in the dust samples Cyclone collected vacuum 17, visit, during May KKI failed to disclose this information Ms. Higgins the letter dated June 1994.28 duty 28. KKI contends no Higgins high that it had Ms. inform lead samples concentration results obtained from dust collected Cyclone argues Maryland vacuum dust KKI collector. that the clear- solely ance levels for lead concentration in dust based are dust wipe Thus, technique Cyclone collection and not the testing. vacuum Cyclone results, technique typically gives higher because the and be- levels, wipe registered dust samples cause the under the clearance KKI *29 64
Instead, wipe from KKI relied on the results obtained the dust her that there no area in collected and informed was samples higher might was than house where the lead level what her in completely renovated house. dust have been found methodology July in and samples by wipe collected dust and KKI areas above the clearance levels November showed of levels in the subse- inform Ms. these elevated Higgins did KKI of Ms. that knew the Higgins letters. contends quent paint of and dust the high of levels lead-based presence 1993, as as of that property early Street December Federal II as high after intervention it still had levels of even Level 24, 1994, it not until she received a letter and that was June 14, specifically KKI informed Ms. September 1994 that dated of fact her house had elevated lead levels. Higgins that Myron content Higgins KKI blood from lead drew 8, 9, 1994, 29,1994, 1994. July and November analysis June results tests Higgins by KKI Ms. blood notified 1994, 2, 1994, 6, 18, and July August December letters dated 1994, pg/dL, were 17.5 respectively. The results of tests 11 The first and third pg/dL, pg/dL, respectively. IIA him CDC while second test placed tests Class that Higgins him in CDC III. KKI told Ms. it placed Class result that she had informed the BCHD the second provide primary the test result to child’s health [her] “should provider right away.” care was in its negligent
Ms. KKI failure Higgins contends knowledge its levels lead high to inform her of dust to testing prior recorded both XRF December her modification, moving prior into the unit and abatement samples Cyclone May and from the collected via vacuum withholding this informa- Higgins 1994. Ms. asserts that 24,1994 KKI’s informing tion combined letter dated June solely the samples her of the lower results of collected dust duty argues potential hazard thus no that there was no inform argument, supra, appellants. We have addressed this in footnote 26. are, Moreover, process appropriate, whether is which both resolved, necessary, dispute. It is thus a if on remand. matter methodology wipe misleading her as a participant study. She it implies gave her a false sense of *30 security potential that there were no or paint lead-based dust in hazards house. her Myron
Appellants, Higgins, by his mother Higgins, Catina Higgins, and Catina filed suit in individually, the Circuit Court 26, for City on February against Baltimore Mr. Polakoff. Appellants amended their to Complaint Manage- add Chase ment, Inc., and CFOD-2 Partnership Limited as defendants to 1999, this lawsuit.29 On April Appellants further amended their to Complaint add KKI and Environmental as additional In defendants. her in Complaint filed the Circuit Court for City, Higgins sought Baltimore Ms. to hold KKI liable for negligence on several grounds. Specifically, different she alleged:
“8. Both and negligent [KKI] Environmental were in abate, undertaking to paint and repair premises prior the to during the occupancy doing children’s so in and an and/or unreasonable, incomplete, unworkmanlike illegal and/or manner.
9. Both and negligent [KKI] Environmental were performing the lead abatement such a fashion as to increase, decrease, rather than exposure the children’s lead, to, including, but not performing limited the abatement methods, using which foreseeably increased the lead dust premises, the performing or improper inadequate cleanup, leaving lead debris on the premises vicinity or premises accessible to the child.
10. Both [KKI] Environmental failed to warn [ap- pellants] hazard, or adult caretaker of the lead which and Environmental agents [KKI] or their knew should have known or had reason to know premises. existed
11. [KKI And were negli- Environmental] otherwise gent.” 1992, prior In Higgins beginning tenancy to Ms.
29. her Federal property, Street ownership property Polakoff transferred CFOD-2, a partnership partner. limited in which general Chase was a Summary grounds Judgment KKI filed a Motion 5, 2000, appellants.30 April On any duty it not owe did argument. position respect In this at oral continued to maintain 30. It cases, exchanges following occurred: two to the No. 128:] "[Case danger saying children from you’re is there’s no The Court: What dust? lead contained in been established this Court. Respondent: Not that has ever studies, that, they do what Court: know how about scientific I show? through ingest But lead dust. there’s Respondent: ... Children do dangerous. nothing in record about how much is recognized that dust is hazard? ... It is house The Court: agree, purpose this was to Respondent: I and that defining what that try that hazard. But in terms to eliminate is, regulation----So why State has done so statute hazard *31 duty Kennedy higher a the landlord? to have than then should have testing something you landlord was were for the The Court: Because abate, obliged namely dust. not to back the level where Respondent: But the results never came to The a hazard. it was defined as duty parent you find out this no to warn the when The Court: There's information? a Respondent: it's of a level that it’s hazard. Not unless such The Kennedy apparently form said that Court: ... The consent The lead, appellant’s the results with promised to test home for discuss mother, steps to risks.... So that could be taken reduce her discuss My they're going is keyed question ... If how is that to blood levels? agreement an to discuss the results test the for lead there’s to home obligation you isn't an and if find it in the dust there with mother any irrespective of whether there’s discuss mother to that elevated blood levels? plaintiff alleges that was a lead Respondent: in this case there The to there was no in the home that needed be discussed. And hazard say they Kennedy going to did that were inform hazard the home. when; to dust No indication as parents of the result of the tests. during study or afterwards. if that would be study, participant a when an Court: don’t think that The You says going you, to tell Krieger in and that I’m institute like comes right rely representation that and believe that have a doesn’t fashion, timely would they’re going told that in a which mean to be study when at the but it’s determined? not end they that Respondent: expectation would be would told I think any problems. ... And this case if there were problem? The Court: What's Respondent: problem is a lead The A hazard. Respondent: There was no standard at the time for what constitutes respect a hazard with to lead dust in homes. levels, Kennedy Krieger spot ... The Court: But considered the hot you occupants that and intended that of the house act on you gave you encouraged information because them kits and them to clean those areas better. Respondent: Sure. It's in the best interests of the children in the ... home have The Court: is it in their best then not to advise the How interest parent were the time [Past until 9 months after these tests taken? they something could do about it? when] Respondent: immediately.... These tests ... were not tun only parent The ... Court: So the benefit to the was the remunera- given entering tion that was into this informed consent allowing part study? their children to be a of this Respondent: looking The It sounds like Your Honor is at this in- getting something formed as a contract each side consent where is just out of this. And that’s not the case. The informed consent Kennedy informing participant that. It’s what it intends to do. Respondent: There was some remuneration involved as an get participants incentive to enroll continue to follow through. Kennedy parents The Court: had a reason not to tell these that their exposed kids were something dangerous, they because if did the parents might stay study leave the kids wouldn’t in the to be studied down the road. That's sort of what bothers me an awful lot. you arisen, participants If study danger inform ihe in the that a has participants they’re longer leave the house and no in the study gets very and the specifically says skewered. And it agreement they're going consent to test for lead dust ... seven or eight repairs very specifically says times after the are and it made testing that the results of parents. the house will be shared with the They you may very assert didn't do it. That well be factual matter, dispute you ... as to ... *32 facts went on a motion for facts, summary judgment. dispute If there’s a of material I don't you summary know how judgment. win on motion for Respondent: They The ... were all told within the time frame of the study Kennedy nothing itself.... keep did to hold back information people study. They clearly everybody in the told if there was some during study.... lead in their dust you during you’re The Court: study talking When talk about day, day study, about the last includes the last which is twenty-four months down the line. your theory, study The years, Court: Under if the went on for ten it day years.... would be O.K. to tell them on the last after the ten Respondent: only dealing The I’m with the case at hand. my question? ... you Could answer The Court: expect that the participant had no reason to Respondent: If the The forthcoming sooner. would be results duty unless the your would not arise position is the The Court: So by some the level established in the dust exceeded level of the lead here? that wasn’t reached other standard Respondent: Yes. The Why protect against a risk.... her Your contract was The Court: you saying warning? enough require a Are spots] [hot wasn’t that and risk? in the words hazard that there’s a difference complained of in not what she Respondent: There is. That was The complaint. her and the was a lead hazard that there Respondent: ... She claimed reported. wasn’t hazard if there was you’re saying wasn’t a hazard even there The Court: And a risk? every- everything we do. In Respondent: a risk with Yes. There’s life, thing with there’s risk. ground there get summaiy judgment on the didn’t The Court: You allegation a hazard. was insufficient granted the court---- Summary judgment was because Respondent: contract, privity, no granted there’s no because] [It The Court: whatsoever, just I can’t of a cause of action. duty ... no element no your argument here. square that with they’re inconsistent---- Respondent: I don’t see that all, no contract----He found that there was Court: First of he regulation, which set governmental statute or that there was no found ... He found no duly. also didn’t he? also up He found that this relationship. special study stay Kennedy participants to Respondent: needed the just weren’t valid---- full time or the results given being five dоllars Suppose instead of these folks The Court: event, dollars, suppose they offered a were ... for each fifteen event, you say this was a contract? each would dollars for thousand you argue wasn’t a contract? Would still this ... any without either side could withdraw Respondent: Yes. Because the other. claim for breach of contract from unilaterally. doesn't contract That You can terminate the The Court: point.... prior to that that there isn’t a contract mean 129:] No. [Case get any say appellant case did not Respondent: that the in this To appellant study pretty disingenuous. What the benefit from the being able to live in a home [was] of in this had the benefit repairs these done to it.... that had normal, into paint, that is moves The Court: A child that has no lead up with elevated lead partially has been abated ends a house that you say a benefit? paint levels and that’s *33 granted judgment KKI’s motion and entered the Circuit Court 4, 2000, in favor of KKI. filed a Motion to May appellants On Reconsider, 25, May which the Court on 2000. Circuit denied Polakoff, dismissed their claims Chase Appellants against Management Partnership and CFOD-2 Limited and filed a 8, 2001, Notice of Appeal July February prior 2000. On consideration the Court of we Special Appeals, issued Writ of Certiorari. Findings
D. The Trial Courts’ (Grimes), court, In Case No.128 the trial in granting KKFs motion summary judgment, stated: Respondent: We don’t know what this child’s lead levels were before home, moving into this nor do we know where this child was
poisoned. thought your study required healthy The Court: I children to be study? included in the Respondent: only way Because that was the to measure if the get poisoned children did as well as.... No, Respondent: why and this is it doesn’t bother me. Because these disrepair. Kennedy improved homes were in went in there and improved home and in this case the home so that it was below Kennedy clearance standard.... This home was made safe and landlord, instructed the ‘Put children in these homes that we’ve made safe.’ The we Court: 'So can test them how [the children] to see safe we’ve made [the houses]?' them Respondent: Yes. safe, they’re why The Court: If test the children's blood? see, Respondent: they they The testing Because had to were to see which levels worked the best. they trying they The Court: Weren’t to see how could do it most inexpensively? Respondent: problem City Sure. Because there's in Baltimore landlords.... The they Court: But that almost assumes that realize that some of the partial you deny abatements would not be successful. How can that? Respondent: they expected What repair was that different levels of would have different levels of effectiveness over time. And that’s they testing. what were they Court: To see which cheaply? abatement could use most To try properties and abate City. more in Baltimore Respondent: disagree Yeah. I don't with that. all of And that was for society large benefit of at these children.” the Court has to look duty, not there is a “Whether or several factors.... [1] ... The Court does *34 not find that of law.... The Court does as a matter there is a contract contract, that is mutual of a necessary not the elements find consideration, a so as to find assent, offer, acceptance, the by parties. and between binding legal agreement relationship so a special ... does not find The Court Kenne- relationship between in connection with the to exist plain- and minor plaintiff and the dy Krieger Institute as special relationship is a ... I not find that there tiff. do justify as to a appeal our courts of so expressed by at least Kennedy Krieger plaintiff. to the by Defendant duty owed as duty find that a was created ... Court does not so by matter of law the statute.” KKI cannot argued “plaintiff (Higgins), In case No.129 plaintiff to the any duty owed Kennedy Krieger that prove In KKI’s liability.” granting arise to civil this case would trial court stated: the summary judgment, motion for instance, part at all on the duty I see no “On the first or to test the individu- premises this inspect KKI to test al. of an institutional volunteer in the commu-
KKI was sort samples, the next in to collect dust and blood nity. Coming I think that there is sued and you they get know thing it simply of KKI because duty part no on the absolutely of ... [responsi- a higher in to then assume standard came facts. respect these bility] an agent not property, KKI was not the owner of owner, from the [accept] properties it other didn’t to the landlord. properties It not prefer landlord. did anything that KKI was more suggest basis to There is no volunteer community.... It than an institutional of a consent form to raised virtue certainly cannot be raised to the level of It cannot be take a blood test. [Emphasis added.] the law.” duty standard of under circuit courts’ review of the appellants seek appeal, On judgment mo- summary KKI’s granting respective decisions contend, findings, trial courts’ They contrary tions. to the duty appellants presence that KKI owed a to warn (1) relationship” because: paint “special lead-based and dust (2) duty of the contractual creat- parties; existed between the (3) foreseeable; danger consent agreement; ed (4) exists, such a regulation duty. a Federal which created that KKI an Specifically, they duty contend had affirmative give appellants complete concerning and accurate information the risks and hazards of include participating —to XRF vacuum results. Cyclone results and III. Discussion A. Standard of Review trial court’s disputes We resolve these the context *35 granting appellee’s summary judgment motions for the two distinct cases. The threshold issues before this Court whether, KKI, are in the two cases presented, appellee, summary judgment entitled to as a matter of law on the basis duty that no contract and that there is no inherently existed subject a aby Perhaps owed to research researcher. even important ancillary parent more is the issue of whether a State, of this Maryland, legally under the law can consent to a in a placing nontherapeutic child that carries any with it risk of harm to of the health the child. We shall all of primary resolve these issues.
“In reviewing grant summary judgment, of a we are first with a genuine dispute concerned whether of material fact exists” and then whether the movant is entitled sum mary judgment as matter of law. v. & Mayor Williams Baltimore, 101, 113, 41, City Council 359 753 47 Md. A.2d of (2000); Bethesda, Inc., Ins. Co. v. Manor Inn 335 Hanford 135, Inc., 144, 219, (1994); Sussex, 224 Md. 642 A.2d v. Gross 255, 247, 1156, (1993); 332 Md. 630 A.2d 1160 v. Beatty Prods., Inc., 726, 737, 1005, Trailmaster 330 Md. 625 A.2d (1993); Collins, 259, 1011 Developer, Arnold Inc. v. 318 Md. 262, 949, (1990); Glazer, 567 A.2d 951 Bachmann v. Glazer & Inc., 405, 408, 365, (1989); King 316 Md. 559 A.2d 366 v.
72 (1985). Bankerd, 608, “A 98, 110-11, 614 492 A.2d 303 Md. will somehow the resolution of which fact is a fact material 111, 492 King, 303 Md. at of the case.” affect the outcome Inc., Prods., Inc. v. Ordnance 273 (citing Lynx, 614 A.2d at (1974)). 502, as to facts 1, dispute 509 “[A] Md. 327 A.2d is not rested which the decision relating grounds upon to a material dispute fact and such dispute respect not a summary judgment.” Salisbury entry not prevent does 40, 32, Cosmetologists, Bd. 268 Md. Schs. v. State Beauty (1973). 367, 300 A.2d 374 has stated that standard “[t]he
This Court also
the trial
summary judgment
is whether
grant
for a
review
Balti
Hosp.
v. Sinai
correct.” Goodwich
legally
court was
Inc.,
(1996);
more,
see
185, 204,
1067,
680 A.2d
1076
343 Md.
Merzbacher,
530-31,
525,
A.2d
v.
346 Md.
697
Murphy
also
Inn,
144,
224;
Manor
861,
(1997);
73
See,
legally
e.g.,
trial court was
correct.
South
whether the
land,
712,
not to
the case
decide the factual
but
fact,
sufficiently
decide whether there is an issue of
which is
Goodwich,
205-06,
B. General Discussion law, know of no nor Initially, we note we have we been courts, any applicable Maryland provides directed to *37 scientific, because it is a study, to a scientific parties that the to have entered into study, cannot be held health-related that can subjects the relationships special duties, duties, may give the breach of including which create of any also are not aware claims. We negligence rise “insti- nongovernmental that immunizes legal precept general respon- from the or scientific researchers tutional volunteers” “special relation- arising for the breaches of duties sibility least, that, Moreover, we, hold under the very at the ships.” there are parties, circumstances testified to particular a concerning special of material fact whether disputes genuine Grimes, KKI Ericka as well between and relationship existed Higgins Myron Higgins. KKI Ms. and Con- as between and issue, granting summary judgment cerning this a relation- clearly inappropriate. “special motions was When law, whether, given as a matter of the issue ship” can exist facts, exist, a relationship does when there is special certain for respect, fact in that decision dispute of material fact, initially We shall hold judge. not the trial finder scientific research on hu- very nontherapeutic nature of can, will, normally special create relation- subjects man and II arise. Since World War out of which duties ships frequently has been relationships or nature of such specialness community. in and outside of the research of concern in the name of performed of the atrocities As result Holocaust, happenings and other during science era, Nuremberg as The II what is now known World War Court, to this the Nurem- special evolved. Of interest Code Code, part, legal was the result of berg significant at least as to medical or scienti- thought legal principles, opposed preferred and thus should be the standard principles, fic subjects. on human legality of scientific research assessing it, subjects arise. Under duties (the Case’), which the Doctors’ Trial ‘Medical “Following lethal studies of the effects charges conducting included cold, poisons, altitude extreme the action of high infections, the court issued to various induced response summary legal require- as a Nuremberg ‘The Code’ requires The Code on humans. experimentation ments for *38 informed, understanding voluntary, competent, and that the subject Although be obtained. this of the research consent ten the other placed points, is first the Code’s principle appropriate it is even nine must be satisfied before points consent. subject ask the is ‘most and authori- Nuremberg complete
The Code to human of the law of informed consent tative statement It is also of international common experimentation.’ ‘part cases, may applied, by law and both civil and criminal state, municipal federal and courts the United States.’ However, though may even the courts in the United States Nuremberg use the Code to set criminal and civil standards conduct, of it in a only none have used criminal case and handful have even cited it the civil context. Even where authoritative, Nuremberg Code has been cited as it has dissent, usually been and no United States court has ever injured awarded to an damages experimental subject, or punished experimenter, an on the basis of a violation of the have, however, Nuremberg There very Code. been few court involving experimentation. decisions human It is very therefore difficult for a ‘common law’ of human experi- to develop. judicial precedent mentation This absence of codes, especially judicially-crafted makes codes like the Code, Nuremberg important.” all the more omit- [Footnotes [Emphasis ted.] added.] Annas,
George Mengele’s J. Birthmark: The Nuremberg Code Courts, Contemporary in United States 7 Journal of Health 1991) 17, Policy (Spring, (citing part Law & 19-21 to J. 141; Appleman, Military Tribunals and International Crimes 1 Trials Nuremberg Military War Criminals Tribu- of Before 10,11-14 (1946-1949); nals Law Under Control Council No. Nuremberg Military Trials War Criminals Tribu- Before (1946-1949); nals Control Law Under Council No. 181-82 Annas, Katz, L. B. G. Glantz & Consent to Human Informed (1977)).31 Experimentation: Subject’s The Dilemma 21 complete Nuremberg 31. The text of the Code is as follows: subject absolutely voluntary of the human essen- "1. The consent tial. legal capacity to person that the involved should have This means consent; free give be so situated as to be able to exercise should force, choice, any power fraud, element of without the intervention deceit, duress, over-reaching, other ulterior form of con- or coercion; knowledge compre- straint or have and and should sufficient subject matter involved as to enable him hension the elements This latter ele- understanding enlightened malee an and decision. requires acceptance of an affirmative decision ment that before experimental subject there should be made known to him the the nature, duration, purpose experiment; the method and conducted; to be means which it is all inconveniences and hazards person upon his health or and the effects reasonably expected; to be participation experiment. may possibly come from his in the which duty responsibility ascertaining quality the consent initiates, directs, engages upon who rests each individual may duty responsibility not be personal It is a which experiment. impunity. delegated to another with *39 yield 2. The experiment be such as to results the should fruitful by study, good society, unprocurable other methods or means of of unnecessary in nature. not random and experiment designed so and based on the results of 3. The should be knowledge history experimentation and а of the natural of the animal problem anticipated that the results will disease or other under justify performance experiment. the of the experiment should be. so conducted as to avoid all unneces- 4. The injury. sary physical suffering and and mental prior 5. No experiment should be conducted where there is a reason to occur; disabling injury except, perhaps, that death or will believe experimental physicians experiments where the also serve as those subjects. degree of to be taken never exceed that deter- 6. The risk should by importance problem be the humanitarian of the to solved mined experiment. the adequate pro- Proper preparations should be made and facilities 7. subject protect experimental against possi- even remote vided to the disability, injury, of or death. bilities scientifically only by quali- experiment 8. The should be conducted required persons. highest degree of skill and care should be fied stages experiment engage through all of those who conduct or experiment. During experiment subject be 9. the course of the the human should liberty bring experiment an end if he has reached the at experiment physical or mental state where continuation of the impossible. seemed to him to be experiment charge must 10. During the course the scientist any stage, probable prepared experiment he has be to terminate if believe, good faith, superior in the exercise skill and cause required experi- judgement him that a continuation careful injury, disability, experimental likely or death to the ment is to result in subject.” [Emphasis added.] Nuremberg immediately adopted Code “Why wasn’t the minimum standard of setting United States courts as reason, perhaps, for human One experimentation? care today, As remains true opportunity. that there was little 1940’s, experiments almost no resulted lawsuits 50’s, may A second reason the Nazi and 60’s. as so extreme as to be seen experiments were considered our may explain why This irrelevant to the United States. retarded, and the prisoners, own use of the institutionalized II during ill to test malaria treatments World War mentally making ‘everyone’s as the war generally positive, hailed 1950’s, Likewise, early war.’ the late 1940’s and mentally testing polio of new vaccines institutionalized Utilitarian- appropriate. retarded children was considered Noting the Code day.... ism was the ethic type outrageous nontherapeutic to the applied primarily war, during physician groups conducted experiments ‘legalistic’ tended to find the Code too and irrelevant develop and set about to an therapeutic experiments, their guide alternative code to medical researchers. The most successful and influential has been the World Medical Asso- ” (WMA) ciation’s Declaration of Helsinki.... [see infra.] (footnotes omitted). Birthmark, at 24 In his Mengele’s supra, conclusions the author noted:
“However, judges promulgated since American the [Nurem- under both natural and international law stan- berg] Code dards, it is that we not taken it more disturbing have seriously in areas where there is no that it has question direct application....
... in yet eradicating We have to succeed our birthmark that us to human welfare when impels trample rights in society’s jeopardy, promise either welfare seems or the ‘progress’ dangled Alymer before us.... Neither nor Mengele puts will be called account a world that 78 ethics, exalts over human
expediency progress over rights.” omitted). (footnotes
Id. at 43-44 Disclosure in article, Standard of Karine Morin her Medi- Subject Experimentation, Human Legal 19 Journal (June 1998), of informed discussing history 157 after cine nonther- practice, it in medical describеs developed consent as research, differentiating it from thera- apeutic experimental “any manipulation, She stated that peutic medical treatment. observation, being anything or other of a human of—or might subsequently result being related to that human being that human with the intent of manipulation of —done form from knowledge any new and which differs developing Id. at (or customary professional) practice.” medical other National 166 from a Robert Levine (quoting paper Human of Biomedi- Subjects for the Protection of Commission Research). then states further: “Re- cal and Behavioral She in a formal that sets forth usually protocol search is described objective procedures designed an and a set of reach Id. objective.” at 167. involving
In to the difference between research respect research, further notes nontherapeutic treatment and she that:
“[Pjractice knowledge, the utilization of while represents experimentation research amounts to its creation. Because unknown, or at least the place takes the realm the it from ‘scientifically unproven,’ aspects distinguish several unforeseeable; are may assumptions treatment: risks is there- expertise not scientific evidence and supported practice; more vulnerable than it is clinical sub- fore benefits; ject’s anticipated consent cannot be based subjects may conflicting have interests.” researchers and (footnotes omitted) Leskovae, 213, Id. (citing Delgado & Experimentation: Bridging in Human Consent Informed Practice, Thought Ethical and Current Gap Between (1986)). L. UCLA Rev. *41 research, postulates also
Morin, nontherapeutie respect that: society’s interest to recognize essential
“It is subject’s coincide with an individual may not knowledge nothing and gain stands to interest; subject the individual right of self-determina- including his her everything, lose ... tion. tends to that IRB review . contend analysts
.. Some fully than rather requirements, on consent exclusively focus Yet, important it is of the research. evaluating the merits issue, the that, becomes an consent even recognize before risks need to be the acceptability merits and scientific aspect this argued, one author has As at least appraised. if members who have institu- jeopardized bemay the review promote the desire to caught are between allegiances tional protect the need to of the institution and the interests subject.... Investigator-Subject Relationship
C. experi- difference between treatment Another notable relationship physician-patient between mentation lies investigator-subject.... Indeed, to the notion of ... as discussed relation by the the nature of the information held uncertainty, informa- very can different from that investigator by treating physician.... tion held to the through than the difference that relates Other information, investi- relationship between disclosure subject unique purpose terms gator and are gathered.... information is Data collected which of the sub- hypothesis, independently or revoke a confirm motivations from those of ject. Finally, investigators’ differ by the inves- experiment is driven treating physicians. of knowledge, tigator’s dedication the advancement to those who have funded the often a commitment research; by society’s it is also driven interest future *42 benefits that will flow from medical discoveries. As one remarks; price author ‘the of a outcome is exacted from bad reaction, the who suffers the untoward whereas individual to a breakthrough society the benefit of the is available as ” whole.’ (footnotes omitted). added) argu- Id. at 215-18 In (emphasis ing that a fuller disclosure should be madе when consent is research, sought nontherapeutic opposed therapeutic as to research, Morin notes:
“Furthermore, to long interpret as as courts continue in experimentation applies doctrine of informed consent as it treatment, in the context of of the uniqueness protection subjects needed for human research will be overlooked. Failing recognize subjects to that who volunteer for the differently sake of the advancement of science are situated from the who stand to benefit from treatment patients analysis results an that misconceives the purpose Beyond informing patient disclosure. as to means her, him subject available to treat or must become a voluntary willing participant may an endeavor that her, worse, to him or yield may no direct benefit cause harm.”
Id. at 220. recently community subjected
Just the research has been question genetic experimentation as a result of on a Pennsyl- Gelsinger vania citizen. Jesse consented to in a participate project University Pennsylvania’s at the Institute death, Therapy. Gelsinger’s of Human After the U.S. Gene Drug eight Food and Administration ordered a halt to human gene therapy experiments Additionally, at the Institute. oth- er similar elsewhere. FDA took projects were halted “discovery action after a of a number of serious problems and, procedures gener- Institute’s informed consent more ally, lapse responsibilities the researchers’ ethical Barker, experimental subjects.” Jeffrey H. Human Experi- mentation Epoch, and the Double Facelessness a Merciless Change Law and University Review of Social York 25 New (1999). 603, 616 transcarbamy- ornithine type
Gelsinger had a different (OTC) disease, that addressed than deficiency lase was under brand of the disease particular His research. being the research possibility no control. There was thus, him, as to him. It was directly benefit would conducted bar, nontherapeutic; in the case at to the children as it was (in case, subjects present affects on the way children) experi- to measure the success order case, to test the research was Gelsinger’s In ment. words, ade- In other weakened vectors. efficiency disease viruses) (common-cold trillions of were used deliver novirus artery and thus to into his particular gene of a OTC particles *43 fatal immune a massive and experienced Gelsinger his liver. common-cold virus. the introduction of the system reaction to con- of the informed with the extent problems There were Barker noted that: sent there obtained. a giving bad just rogue experimenters this a case of
“Is program at all. The to all research? Not genetic name (or was) prestigious of the most is at least one Philadelphia were first-rate. the researchers there in the world and Rather, that are indicative program with problems con- and informed genetic with research systemic problems of research sub- autonomy protection sent as ... jects. with informed problems there such serious
Why are trials, almost total why is there consent in some of these and serious side ef- regulations concerning noncompliance In- related. questions to these are fects? The answers get to results— pressure consent has suffered from formed procedures, as Informed consent quickly possible.... as followed, troublesome, time-consuming, costly, are properly information valuable may proprietary and even threaten face of the research The ethical companies. the biotech factors. by can be obscured such subject Researchers, ... competitive pressure under and also backers, pressure financial from corporate operate under a paternalistic approach subjects, to research asserting pro- expertise arguing experimental fessional and necessity while minimizing right key aspect to self-determination —a subjects. of autonomy exercise their The result is a —of greater degree lesser ethical effacement.” Id, at 617-20.32 judice cases sub arrived, way
Because have as from appeals granting summary judgments, there is no months, past country 32. In the several has also learned of another by project approved "community” the scientific and conduct- volunteers,” by performed ed appropri- "institutional that was without subjects attempt ate concern for the children that were used as prove hypothesis. particular experiment a scientific was conduct- discontinued, scientists, by ed American and was and then concealed in post-World period War II because of concerns raised students would, discovered, experiment” that it was "monster if compared experiments to the World War II and would ruin the careers experi- of the scientists and researchers involved. The leader of the ment, Iowa, professor University prior experi- at the State to the uncovered, being prestigious ment even had a scientific institute named Speech Hearing after him—the Wendell Johnson Center. Wendell Johnson was a stutterer. As his education and career advanced, hypotheses stuttering emphasized he formulated by genetic conditioned in children environmental causes rather than others, by parents, or inherited traits. He believed that criticism during years, childhood caused children lose confidence in their cases, ability by speech, resulting, to communicate in the worst stuttering. *44 point, theory At a searching that Johnson was scientist with a for subjects prove Obviously, knowledgeable parents to it. educated and/or not, methods, permit attempt would if aware of his him to to turn their children into stutterers. Accordingly, university's blessing, approached nearby with the he orphanage state that had been utilized in other research the universi- and, ty, involved, guise improving speech orphans under the of the of the begin experiment. had a research assistant the time, orphans Over she conditioned several of the who had not stuttered, very theretofore to become stutterers. She was successful. Thereafter, only minimal and unsuccessful efforts were made to cure orphans stuttering the affected of the that the scientists had induced. thereafter, Shortly project compared when the to World War II experiments, it published, was terminated. No research was ever of the research- compensation specific the record of complete EPA, at by the was funded project Although ers involved. TCKT to furnish such EPA declined has of request re- who parties, one of the attorney for to the information Act. Information Freedom the federal it under quested state co-sponsored as a character the research’s Whether Informa- Public Maryland under the records project opens is there Neither considered. not been apparently Act has tion if were any, pressures, of what development any in the record the consents obtaining the researchers respect exerted community there was some pathology although speech scientific destroyed study were concealed knowledge The documents of it. survived. and have not been conditioned unstuttering orphans that had The theretofore lives, experiencing severe entire for thеir stutterers stutter remained not until a letter experiment. It was of the lifelong problems because aged assistant to have orphans caused the now from one of the sixty-year- press, that the and she contacted an attack of conscience Iowa, University the successor light. experiment came to The old Iowa, experiment in a recent University confirmed the Slate apology. articles experiment in a series of was informed nation (California) beginning June Mercury News on Dyer in the San Jose Jim 10, experiment "regretta- spokesman university termed 2001. A study ever be that should “This is not ble.” He stated further: suggested its any When it was era.” considered defensible renamed, university institute should research and clinical defending way I ever think of this spokesman stated:- "In no would Dyer, Jim A study. later, way. than unfortunate.” In no It’s more lifetime researcher, Mercury Jose News orphans haunts San experiment on (June 2001); long-ago experi- Dyer, Orphans retain scars Jim from 11, 2001); ment, (June Dyer, University Mercury Jim Jose News San stutter, orphans to San experiment induced apology issues Marshall, 14, 2001); (June Dyer Nancy J. Discusses Mercury News Jose Weekly Best of National Study Stuttering, Edition: The a 1930s 23, 2001). (June Public Radio News bar, the children in the at issue in the case at to the research Similar exper- study deliberately placed potentially in a harmful stuttering were theory to test a good of science in order environment for imental University that, many helped more children. The proven, might have if Iowa, acknowledged impropriety of that belatedly, however has KKI continues apologized for its involvement. experiment and inherently inappropriate less propriety that is assert the —no orphans in the Midwest stuttering research on vulnerable so than the ago. sixty years *45 Nor, the parents conducting experiment. and for the reason, same is there a sufficient indication as to the extent to joined interests, which has the Institute with commercial if it has, purposes profit, for the that might potentially impact upon the researcher’s motivations and potential conflicts of assumed, generally interest —motivations that are in the cases of prestigious, Hopkins University, entities such as John to be for public good rather then a search for profit. involved,
We do note that the institution respondent here, Center, like the Johnson Speech Hearing Wendell is a highly respected entity, considered to leader treatments, itself, development and treatment for children assurance, infected with lead poisoning. With reasonable we can note that its reputation might normally suggest alone that there no understanding realization or on the Institute’s part protocols experiment were questionable, except for the letter from the IRB requesting that the re- searchers mischaracterize the study.
We shall further address legal both the factual and bases courts, findings of the trial holding, ultimately, that the respective courts in both respects. erred Negligence
C. It important for us to remember that appellants allege KKI, that KKI was negligent. Specifically, they allege as researcher, them, a medical a duty subjects owed of care to as study, the research based on agreements the nature of the between them and also based the nature of the relationship parties. They between the contend specifically that KKI was (1) negligent because KKI duty design breached its to: study that not placing risk; did involve children at unnecessary (2) participants inform study of results a timely (3) manner; and completely inform accurately partici- pants the research all the hazards risks involved in the study. Inappropriate experimentation country involving in this children as
subjects is not new. under negligence claim for
In order to establish “(1) *46 that law, four elements: prove must party Maryland from plaintiff duty protect under a defendant (3) duty, that (2) that the defendant breached that injury, loss[33] (4) that the loss or injury actual plaintiff suffered breach from the defendant’s resulted injury proximately or Exxon, added.) v. 335 Md. Rosenblatt (Emphasis duty.” Almaraz, (1994) 329 180, v. (citing Faya 188 58, 76, 642 A.2d (1993) v. 448, 327, Hopkins, and Lamb 435, A.2d 333 620 Md. (1985)); Brown v. 1297, 1300 see 236, 241, 492 A.2d 303 Md. (2000); 47, Richwind 344, 356, 54 Dermer, 744 A.2d 357 Md. 1147, Brunson, 661, 670, Md. 645 A.2d 335 v. Joint Venture 4 225; Inn, 147-48, at 642 A.2d (1994); 335 Md. 1151 Manor (1993). 84, 704, 712, 88 633 A.2d 332 Md. Corp., Southland summary of the two granting a review of the Because this is legal that there was no grounds solely based judgments children, concerned primarily we are duty protect duty protect KKI was under prong-whether the first injury. from appellants Fuller, Railroad Co. v. Virginia Central
We noted West (1903): 669, 652, 666, 671 96 54 A. Md. is duty is no negligence can be no where there
“[T]here duty that one due; is breach of some negligence relative and can consequently owes to another. It is person impli- apart duty expressly no existence from some have can negligence In before every instance edly imposed. act, sought back of the act must be predicated given of a complaining, to the the observ- duty and found a individual would have averted or avoided duty ance of which with circumstances and duty As the owed varies injury.... concerned, other of the individuals with the relation to each varies, complained act negligence and the alleged so the permanent injury suggestion of actual 33. We note that there was little opinion Our is not with these two cases. to the children involved damages proven present can be directed to the matter of whether cases. 86 fact;
never amounts to if negligence law or there has no duty.” been breach of Dermer, 357,
See
certainty plaintiff injury, that the suffered the the close ness of the connection between the defendant’s conduct suffered, injury and the the moral blame attached to the conduct, harm, policy defendant’s of future preventing of extent the burden to the defendant and conse quences community imposing duty to the a to exercise breach, care with resulting liability for and the availabili cost ty, prevalence of insurance for the risk involved. Regents University California, 17 Cal.3d Tarasoff v. 425, 434, 14, 22, (1976). 334, 131 Cal.Rptr. 551 P.2d 342 Perhaps among these the factor important deemed most However, foreseeability. is id. See ‘foreseeability5 must ‘duty.’ not be confused with The fact that may a result foreseeable does not a impose duty negligence itself original.] terms.” alterations in [Some
87 Rosenblatt, Dermer, 357, 54; at 744 A.2d at also 357 Md. See 76-77, regard 189. to the 642 A.2d at With 335 Md. between the relationship and the connection between harm Blumen- Smullian & recently Walpert, we stated parties, (2000) Katz, 658, 582, thal, 645, 762 A.2d 589 P.A. v. 361 Md. Bank, 527, 534-35, 307 515 v. First Nat’l Md. (quoting Jacques 756, (1986)): A.2d 759-60
“
care creates a risk of
‘Where the failure
exercise due
an inti-
only,
generally required
economic loss
courts have
parties
mate nexus between the
as a condition
imposition
liability.
of tort
This intimate nexus is satisfied
contrast,
by
By
contractual
or its
where
privity
equivalent.
the risk
no such direct
personal injury,
created
one
shown,
relationship
principal
need be
and the
determinant
”
duty
foreseeability.’
becomes
Furthermore,
Almaraz,
449,
as we stated
“Two of the relevant factors to consider in determining duty whether such a recognized should be are ‘the nature care, harm likely to result from a failure to exercise due and the relationship parties.’ exists between the Bank, 527, 534, v. Nat’l Jacques First 307 Md. A.2d (1986).... relationship may Such be established (1) (2) rule; of ways: number statute or contractual *48 (3) private relationship; indirectly impliedly or other or or relationship virtue of the between the and a tortfeasor party.” third citations [Some omitted.] KKI relationship The that existed between both sets of and in appellants the case at bar was that of researcher medical study subject. Though recognized and research not expressly in Maryland prior type Code or in our cases as a care, relationship which creates a in duty evidence suggests relationship involving duty record such a a or exist, exist, ordinarily certainly duties would and could based on the facts and circumstances of each these individual that the facts circum- cases. Once we have determined and cases, present light stances of the considered most to infer- nonmoving .parties, susceptible favorable to the are summary of the supporting position party opposing ences we to hold that judgment, granting are mandated In summary judgment improper. the lower court was law, to the trial courts’ erroneous conclusions on the addition facts and circumstances of both of these cases are suscep- special relationship imposing duty tible to that a inferences in the arrangements duties was created cases sub and, judice, ordinarily, could be created similar research subjects. human programs involving Special Relationships IY.
A. The Agreement Consent
Contract Both Form appellants signed sets similar Consent (1) KKI in KKI to: prepared by expressly promised which (however minimally) for financially compensate appellants (2) participation study;34 samples their collect lead dust homes, appellants’ analyze samples, from discuss the taken, appellants, steps results with and discuss that could be (3) lead; exposure which could reduce collect blood $5.00 $15.00 34. The record reflects that in addition to the sums periodic payments participation mentioned in the consent form as for stages study, compensation flowing of the there was a stream of Gifts, trinkets, food, subjects parents. coupons the research and the for etc., given subjects parents periodically. would be to the or their Moreover, E.P.A., seeking funding the researchers informed the when approval, that: planned "A number of incentives are both in the clinic and in the recently type completed that were well received home (1) Maryland Project, coupons things ranging Lead in Soil i.e. (2) skating trips groceries; gifts from for the children as T- such summer, gloves during shirts in the and hats and winter clinic (3) ongoing appointments parents $10.00- incentives for such as coupons provided $20.00 food at each clinic visit for blood collection. Lastly, respondents they provide $15.00 will be reimbursed time each questionnaire information.” *49 provide аppellants from children in the household and samples return, In appellants of the blood tests. with the results (1) allowing in KKI into agreed participate study, by: to the (2) samples; periodically homes to collect dust appellants’ (3) the children’s filling questionnaires; allowing out and blood drawn, tested, in If study. to be and utilized the consent trial court not agreements provisions, contain such and the did otherwise, from our examination of the find and we hold own contained, assent, mutual provisions record that such were so offer, existed, all of which creat- acceptance, and consideration relationships imposing ed contractual duties reason (as well, as we discuss else- agreement consent themselves' where, very relationships). the nature of such Form,
By having appellants sign this Consent both which, KKI in expressly representations, made appellants view, contract At parties. our created bilateral between least, it very suggests appellants agreeing were KKI in participate expectation to the research with the albeit, less, minimal they compensated, would more subject of all information for the ly, necessary be informed to freely participate, partic choose whether to and continue ipate, promptly any might and receive information that bear willingness participate study. on their to continue to full, detailed, continuing warnings This prompt, includes as to all potential risks and hazards inherent KKI, return, during research or that arise the research. the children to move into the houses getting and/or time, remain there over given right and was test the KKI, children’s blood for lead. As consideration to it got access to the houses to the blood of children that had been words, In encouraged to live a “risk” environment. other KKI received a tool'—the blood. measuring children’s Consid existed, trinkets, mainly money, erations food coupons, bilater al promises, blood be tested order to measure success. here, “Informed consent” of which type imposes used obligation and confers consideration on both researcher and (in cases, subject subjects) parents may these differ normally from the more one-sided “informed consent” used in Researcher/subject consent nonth- practice. actual medical did, can, a con- and in this case create erapeutic research *50 tract.35 Form Sufficiency
B. The the Consent directly not inform the parents The consent form did that it was that some of the children contemplated of the fact dust and that one of the reasons might ingest particles, lead was to be tested was to evaluate how the blood the children measures were. effective the various abatement expect clearly A would to be informed parent reasonable ingest that her would contemplated that it was at least child degree and that the to which lead dust particles, lead dust as one of the the child’s blood would be used contaminated would mea- ways experiment in which the success of the furnished, if information it The fact that such was sured. research, subjects to obtain human for the might be difficult information, supply not the need to or alter the does affect subject information. A human failing provide ethics of such respective parent information. The is entitled to all material clearly have informed that order for the should also been stay helpful, measurements to be most the child needed study. until the conclusion of the Whether assessed the house standard, children, subjective objective or an or their additionally have been informed that the surrogates, should that, it experiment, as a result of the anticipated researchers be some accumulation of lead might that there possible The “informed” consent was not the blood of the children. full information was not furnished to valid because material subjects or their parents. Special Relationship
C. 128, In a Consent Form Hughes signed Case Number Ms. KKI -her with blood-lead agreed provide “specific which of house results summary results” and discuss with her “a test 35. We make no determination as to whether informed consent obligations. therapeutic generate can contractual medical context and steps that [she] could take to any reduce risks of expo- sure.” She contends that agreement this between the parties gave rise to a duty owed KKI to provide her with that information in a timely manner. signed She the Consent 10, Form on March 1993. The project began almost simulta- neously. KKI collected dust samples the Monroe Street 9, 1993, property 23, 1993, March August 9, 1994, March 19, 1994, 18, September 1995, April 13, and November 1995. The March 1993 dust testing revealed what the researchers spots,” referred as “hot where the level lead was “higher than might be found in a completely renovated house.” As we indicated, supra, this information was not furnished to Ms. Hughes 16, 1993, until December 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. *51 She contends only that not KKI did have a duty report such in information a timely manner but that it breached this duty by delaying to such a time that daughter her was allowed to contract lead poisoning. Looking at the relevant facts of Case 128, Number they susceptible are to inferences supporting the position of appellant, Grimes, and, Ericka moreover, that, if true, would create a “special relationship” out of which duties Therefore, would be created. alone, for this reason grant of summary judgment was improper.
In 129, Case Number Ms. Higgins also signed a Consent Form in which KKI agreed to provide her with “specific blood- lead in results” respect to her child and to discuss with her “a summary of house test results steps and that could [she] 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 complete with and accurate information. Pursuant to the plans of the research study, KKI collected dust samples in the Federal Street property 17, 1994, on May 25, 1994, July 3, and November 1994. KKI informed Ms. Higgins of the dust sample by 24, results letters dated June 1994, 14, September 1994, 7, 1995, February respectively. KKI Although had recorded high levels of lead concentration in samples dust collected by Cyclone vacuum during
92 visit, 17, this information May KKI failed disclose 24, Instead, 1994. in the dated June to Ms. letter Higgins wipe samples obtained from the dust KKI on the results relied house that there was no area her collected and informed her been might than what have higher where lead level was house. completely found renovated presence KKI of the Ms. contends that knew Higgins and dust the Federal Street high paint levels of lead-based 1993, even Level as that after property early as December 1994, high II such levels still existed as June intervention dated September that not until she received a letter it was 14,1994 fact specifically Higgins KKI Ms. of the informed This was after her that her house had elevated lead levels. child, levels of his Myron, diagnosed was with elevated lead blood. negligent contends that KKI was
Specifically, Higgins Ms. of the levels knowledge high to inform her of its its failure XRF testing lead recorded both December dust in May via vacuum samples Cyclone and from the collected withholding 1994 and that this information combined 1993, informing solely her KKI’s lettеr dated June wipe collected methodolo- samples lower results of the dust KKI study. gy, misleading participant her as Instead, them. argue appellant presents does not the facts as duty although no inform existed because argues it of a they were were not an indication Cyclone readings high, levels were hazard because the clearance based potential not methodology the dust results were wipe wipe dust *52 of Looking at the relevant facts above the clearance levels. 129, they susceptible support- are to inferences Case Number for Accordingly, Ms. appellant, Higgins. ing position alone, im- judgment grant summary this reason proper. earlier, appear trial courts have held
As we indicated arise be out of which duties cannot special relationships the sub- relationship created between researchers and may cases be jects of the research. some rare While correct, it is not correct when researchers recruit people, especially children whose consent is furnished indirectly, to participate nontherapeutic procedures that are potentially hazardous, dangerous, or deleterious to their health. As opposed to compilation of already extant statistics for pur- poses of studying matters, human health the creation conditions or protocols or participation in the recruitment of otherwise healthy subjects to interact already existing, or potentially existing, conditions, both, hazardous for the purpose of creating statistics from which scientific hypotheses can supported, normally would warrant or create such special relationships as matter of law.
It is of little moment that an entity is an institutional volunteer in a community. otherwise, If the legitimacy of the claim to noble purpose always would depend upon the particu- lar institution and the particular community it is serving given indicated, case. As we have history is replete with claims of noble for purpose institutions and institutional volun- teers a "widevariety of communities.
Institutional may or, volunteers good intend to do as history has proven, even to do evil may do or good evil depending on the institution and the community they serve. Whether an institutional volunteer36 in a particular community should be granted exceptions from 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 all consider ramifications of the policy especially considering general — vulnerability subjects of such case, studies—in this small children. In the absence of the exercise legislative policy- Moreover, 36. it is not clear that KKI was a any mere volunteer event. It received funding developing for conducting the research. recognized Whether it profit is unknown from the record. The "for profit” nature of may some research well increase the duties of re- searchers safety insure subjects, may research well increase researchers’ or an susceptibility institution’s damages respect any injuries subjects. incurred *53 94 out of which duties relationships, hold that
making, special we result arise, negligence, can constitute can of which the breach researcher and research sub- relationships between from the jects. Regulations
D. The Federal statute, or a by special duty may prescribed A be from the creating may requirement duties arise relationship there is statutory provisions. Although for cоmpliance prescribed by Maryland we aware duty no which are here to research of nature respect scientific Code impose have enacted that regulations been present, federal or to funded federally sponsored care that attach standards of See 45 C.F.R. subjects. that use human projects research A, (2000). entitled Subpart 45 Part Part C.F.R. HHS[37] of Human Research Policy “Basic for Protection regulation is “Addi Subpart D of the entitled Subjects” and Subjects in Re as Children Involved tional Protections 46.101(a) (2000) provides: 45 C.F.R. section search.” “Sec. 46.101 (b) section,
(a) provided paragraph as this Except involving subjects human this to all research policy applies by conducted, subject regulation otherwise supported or takes any department agency appropriate or which federal to such applicable make policy administrative action to civil- This research conducted federal research. includes except that each de- military personnel, ian or employees modi- may procedural such partment agency adopt or head an administrative may appropriate as from fications conducted, supported, also research standpoint. It includes subject regulation govern- the federal or otherwise [Emphasis ment added.] outside United States.” discussed, funded, and co- supra, we this As subject EPA was therefore sponsored, by presumably conditions, if appropriate these conditions. These federal taken, informed require fully administrative action has been Department of and Human Services. 37. HHS refers to the Health conducted, subjects human any using consent subject any or supported, otherwise level of control or by any department 45 C.F.R. funding agency. federal *54 46.116 provides part: section relevant requirements “Sec. 46.116 General for informed consent. Except provided policy, as elsewhere in this no investiga- may tor involve a human being subject as covered this unless policy investigator the has obtained legally the informed of or subject consent the the effective subject’s legally representative. authorized investigator An seek shall such consent only under circumstances provide the prospective subject representative or the suffi- cient opportunity to consider or whether not to participate and that minimize the possibility coercion or undue of The information that given subject is to or the influence. the representative shall be in language understandable subject representative. or consent, No informed written, whether oral or may any include lan- exculpatory guage through subject which the representative or the made to waive or appear to waive any subject’s legal rights, or appears releases or investigator, release the sponsor, the or agents institution its from liability negli- gence.
( n ) Basic elements consent. pro- informed as Except (c) (d) vided in paragraph section, or of this in seeking informed consent following information shall provid- be subject: ed to each
(2) A description any reasonably foreseeable risks or discomforts to subject;
(4) A disclosure of appropriate procedures alternative or treatment, courses of if any, that might be advantageous subject; ( n ) risk, For research involving more than minimal an explanation as to any whether compensation expía- and an if any treatments are available as to whether medical
nation so, of, and, if or where they what consist injury occurs obtained; bemay information further (b) ap- of informed consent. When Additional elements following or elements informa- propriate, one more subject: tion also to each provided shall (1) or proce- A that the treatment particular statement (or subject embryo to the involve risks may dure which are fetus, pregnant) is or become subject may if the unforeseeable; currently
(5) findings developed new significant A statement may which relate to the course the research during *55 pro- will be willingness participation to continue subject’s subject ...[Emphasis added.] to the vided as concerns involved Subpart regulation D of the children subjects in 45 C.F.R. section 46.407 therefore addi- research. tionally provides: not otherwise which approvable
“Sec. 46.407 Research understand, or alleviate presents opportunity prevent, an health or welfare of children. affecting a problem serious IRB not or fund research that the does will conduct HHS 46.404, 46.405, requirements meets of Sec. Sec. believe if: only or Sec. 46.406
(a) IRB a reason- presents The finds understanding, prevention, to further the opportunity able the health or problem affecting or of a serious alleviation children; welfare of
(b) awith Secretary,[38] panel The consultation after science, disciplines (for med- experts pertinent example: proto- the record that the research 38. We have found no indication in however, again approved by Secretary. emphasize, We cols were The summary judgment cases were determined on motions these is, Moreover, perhaps accordingly, incomplete. because record
97 icine, education, ethics, law) and following opportunity for comment, public review and has determined either: (1) That the research in fact satisfies the conditions of 46.404, 46.405, 46.406, Sec. or Sec. as or applicable, Sec. (2) following: The
(i) presents The research opportunity reasonable further the understanding, or of a prevention, alleviation children; problem affecting serious health or welfare of (ii) The research will be conducted in accordance with principles; sound ethical
(iii) Adequate are provisions soliciting made for as- sent of permission children and the of their or parents guardians, as set forth in [Emphasis Sec. 46.408.” added.] These federal regulations, especially requirement for adherence sound ethical principles, right strike at the heart of KKI’s defense of the granting Summary Motions Judgment. Fully lacking in consent is these cases. informed not comply research did the regulations. There clearly was more than minimal risk involved. Under the regulations, children should not have been used for the pur- pose measuring how much they lead would accumulate their blood living partially while abated houses to which they remain, were initially encouraged recruited because study.
In the case of
University,
Whitlock v. Duke
F.Supp.
(M.D.N.C.1986),
(4th
by,
which is in the federal at 45 C.F.R. section 46.407(b), requires nontherapeutic "national review” where research risk, involving children entails risks over a minimal which is defined as beyond risks every day that which a child confronts in life. a has a court held that researcher Id. at 1471. That 46.116. reasonably that are subject of all risks to inform the duty organic a who subject involved suffered Whitlock foreseeable. The District experiments. damage decompression brain from (and the Court by held was affirmed ultimately Court Circuit) heightened a although Fourth that Appeals an adult research a researcher duty existed between to disclose all foreseeable researcher participant requiring presented no that the risks, in there was evidence Whitlock damage foreseeable. organic risk of brain cases, from the clearly distinguishable present result That is children lead- exposing associated with where the risks foreseeable, by but were well known only were not paint based and, fact, reasonably foreseeable KKI, it to have been had by be might blood contaminated by KKI that the children’s blood of the contamination because the extent of lead used would, part, be to measure significant children Moreover, in abatement methods. of the various effectiveness cases, directly not inform the consent forms did present contemplated, that some possible, it was even parents that lead, accumula- depending upon a harmful substance level tion, blood of the children. contaminate the might institution, is KKI, required obtain
Clearly, as research consent, using sound fully informed participant’s human applica- from of the wording It is clear principles. ethical of informed requirement that this regulations federal ble of the the duration during consent continues case, In changing special risks. this applies to new arise be created relationship might might out of which duties question federally imposed regulations. of the reason this of informed consent created duty whether becomes law, into a as a matter of translates regulation, state federal relationship arising unique of care out duty We answer doctor-patient. as researcher-subject, opposed State, may, depend- In this it in the affirmative. question facts, duty. create such a on the ing Code, Nuremberg applied intended Additionally, this rejected country, internationally, expressly and never *57 inherently implicitly, speaks strongly and to the existence of special relationships imposing ethical duties on researchers subjects. who conduct on human nontherapeutic experiments Nuremberg specifically requires Code researches to make known to human subjects of research “all inconveniences and reasonably expected, upon hazards to be and the effects his or person may possibly health which come from his partic- added.) ipation experiment.” (Emphasis the The breach of Code, obligations imposed by on researchers the Nuremberg might well actions support sounding negligence cases that, such as those issue here. We reiterate as well given cases, were, the facts and of of circumstances both these there least, very at the genuine disputes of material facts concerning and relationship parties, compliance duties and regulations. Appropriateness V. The Ethical of the Research The World Medical Association in its Declaration of Helsin- 39ki included a code of investigative ethics for researchers and by was an attempt community medical to establish its own set of rules for conducting research on human subjects. The Declaration part: states relevant
“HI. Non-therapeutic biomedical research involving hu- subjects man
(Non-clinical research) biomedical 1. In purely application medical reseаrch scientific carried out on a being, human it is the duty by 39. The Declaration Helsinki was crafted the international medical profession, preferable Nuremberg as to the lawyers Code crafted judges Declaration, adopted right after the Second World War. The or, matter, Code, Nuremberg formally have never been entities, adopted by governmental the relevant although Nuremberg apply Code was universally. profession, intended to The medical ancillary its organs, Nuremberg felt that the Code was too origins restrictive because of its from Nazi horrors of that era. code, questions Serious arise in this case under either even under the general provisions more apparently Declaration of Helsinki favored doctors and scientists. and health protector to remain the physician life being biomedical research is carried person whom *58 out. healthy per- subjects The should be volunteers —either
2. is experimental design the not patients or for whom sons patient’s to the illness. related investigator investigating or the team should dis- 3. The it judgement the research or their continue his/her if continued, to the be individual. may, if harmful man, society the interest science and 4. In research on of related never take over considerations precedence should being subject.” [Emphasis well added.] of Helsinki, Assembly in Declaration of World Medical Adopted (WMA) (June 1964), 29th WMA by 18th amended Assembly (Octo- Venice, (October, 1975), Italy 35th WMA Tokyo, Japan 1989). 1983), Hong Kong (September and the 41st WMA ber duty of whether a exists under The determination policy law is the function of various consid Maryland ultimate or, if it Legislature, has not adopted by erations as either situation, by Maryland it to this respect as has not spoken, view, healthy In should not be courts. our otherwise children experimentation of or research subjects nontherapeutic is, It potential has the to be harmful the child. first foremost, and the researcher responsibility and such entity to to the harmlessness of nonthera research see relieve parents research. Consent of can never peutic not feel it duty. proper of this We do serves researcher placed permit concerns to children public policy harm, during proce potential nontherapeutic situations of dures, surrogates, if other consent. parents, even or Under circumstances, given, is even where consent types these that there inappropriately, suggest albeit considerations policy partic special relationship remains a between researchers duty study, imposes to the research which care. ipants found entirely principles This is consistent with Nuremberg Code. permitted completely
Researchers cannot ever be consents, immunize when especially themselves reliance subject, party the information furnished to the or the consent duty is in a material A ing, incomplete respect. researcher’s is not or of a by, extinguished by, created the consent research subject approval. duty IRB to a vulnerable re consent, subject search obtain independent although the of consent is must ing perform. one the duties researcher All especially subjects of this is so when the of research are duties, children. legal legal protections, might Such additionally be warranted conflict of likely because interest between the goal experimenter the health of subject, especially, the human but not exclusive ly, when such always research is commercialized. There is potential substantial conflict of interest on the part of re *59 searchers as subjects between them and the human in used If their research. participants study withdraw from the study research to its prior completion, then the results of the study could be rendered meaningless. There is thus an inherent reason for conveying not to subjects information as it arises, that might subjects cause the to leave the research project. That conflict stronger dictates a reason for full and continuous disclosure. research,
In the study participant’s “well-being is subordi- nated to the dictates a research protocol designed to advance knowledge Katz, for the sake of future patients.” Jay Human Experimentation and Rights, Human 38 St. Louis U. (1993). 7, L.J. In a recent report, the National Bioethics Advisory recognized Commission this conflict between pursuit of knowledge scientific well-being and the of research participants requires some oversight scientific investigators: intentions,
“However noble the investigator’s when research involves human participants, the uncertainties inherent any research study raise the prospect unanticipated In harm. designing research an investigator must finding focus on creating situations which one can test time, scientific hypotheses. At the same important no matter how important the research questions, it is not without participants appropriate
ethical to use human Thus, conflict the need there can between protections. to and hypotheses requirement respect and the test This con- who research. protect participate individuals resulting that can arise within flict and the tension over- guidance need and enterprise suggest sight.” Commission, Policy Advisory Bioethics Ethical and
National (Dec. 2-3 Involving Participants, Issues in Research Human 2000) added). subjects human (emphasis When are used research, are subjects the human rights in scientific subjects seek of the courts when such protection afforded the any committed. wrongs redress for duties, relationship A the breach of special giving rise because, might also arise might negligence, which constitute are a better to antici- generally, investigators position discover, health risks pate, potential and understand re- subjects. their Practical exist between inequalities searchers, knowledge, participants and superior who have risk.” poorly placed protect often themselves from “who are gap knowledge investigators Id. 3. between “[G]iven the inherent conflict of interest faced participants solely not be investigators, participants cannot and should Id. responsible for their own at 3-4. protection.” of the research duty requires protection This requires harm subjects from unreasonable researcher *60 of subjects potential inform the promptly completely the existing profound from to time because of hazards time institutions, in place investigators, trust that participants them harm. enterprise protect as a whole from knowledgeable and investi seemingly prestigious “Faced with simply gators engaged pursuit, participants may in a noble socially is or of benefit important assume that research they participation not be aware that individually; may them Id. could be harmful to their interests.” opinion, cases in this As evident from the discussed of regard protection subjects human abuses with experimental country. research still occur this This is also recognized by government’s attempts the federal to insure the Shalala, protections subjects. of human research See Donna Ph.D., Done, Protecting Research Be Subjects Must —What England 343 New Journal of Medicine 11 (September 2000). was,
The of purpose the case at bar Sc.D., words of Dr. Mark R. Farfel Director of KKI’s Lead Department Abatement “to document longevity of various lead base paint strategies, abatement factored in terms of reducing exposure lead house dust and the children’s blood words, lead levels.” In other purpose experiment was to determine whether expensive way there was less than full abatement that would in reducing be cost-effective lead poisoning children from a lower economic background. The study, by design, its placed retained children in areas and/or where they might come into contact with elevated levels of lead dust. KKI Clearly, contemplated that at least some of the children would develop elevated blood levels lead while participating study. At 45 C.F.R. section 46.111 Crite- research, ria IRB approval regulations require IRBs to encourage safety aspects research rather than “(b) encouraging noncompliance regulations: When some or all subjects ..., ... such as children economi- [are] cally or educationally disadvantaged persons additional safe- guards have been ... included to protect rights added.) subjects.” welfare these (Emphasis While we acknowledge that foreseeability does not necessar- ily create a duty, recognize we that potential harm to the children participants of this study was both foreseeable and potentially A “special extreme. relationship” also exists in circumstances experiments where such are conducted.
VI. Parental Consent Subjects for Children to Be
Potentially Nontherapeutic Hazardous Research issue whether a can parent consent to the partic- ipation of her his child in a nontherapeutic health-related study that is known to potentially hazardous to the health *61 with moral and questions profound raises
of the child serious to know- right parent does have implications. ethical What in to health risks or therapy a child not need of ingly expose in if it can knowingly danger, a child even place otherwise in good? specific it the The issue these greater is for argued authority of to the primarily contested cases does not relate to of KKI and similar entities parent, procedures the but the The may in such health-related studies. issue be involved consent on behalf of the children has parents’ right of the to cases, in of these but should be fully presented been either not moralists, but to only lawyers judges, not of concern ethicists, in consenting parents the contested and others. The of subjects experiment; the the the cases bar were not the Additionally, practice presents poten- this children were. in their initiating of actions own names problems tial children indeed, they damaged if have been as upon reaching majority, scienti- nontherapeutic as being guinea pigs a result used Children, noted, are in our it should be not fic research. hamsters, rats, monkeys, and the like. society equivalent of importance this matter and this overriding Because of the in the of children —we shall address Court’s interest welfare issue. ethics of relatively few cases area Most involving children have projects of various research protocols give can informed consent merely parent assumed that a nontherapeutic research. their children participation addressed, has single case which issue been resolved, fur- agree, will be discussed a case which we ther, infra. child, in of a specific
It is not the best interest to be a research nontherapeutic project, placed be, be, environment, proves or which might possibly which have long the health of the child. stressed hazardous to We concern overriding interests of child” “best Whatever relating this in matters childrеn. Court general the interests parent, interests of a and whatever a re- might, fostering according research that public
105 children, of all hypothesis, good searcher’s be for this the case, particular for the particular Court’s concern child is, simply, all other interests. It and we hope, over-arches in to succinctly put, any healthy not the best interest of child in nontherapeutic be a situation where his or intentionally put impaired, may her health in order to test methods that may ultimately all children. benefit otherwise, legal
To think to turn over human and ethical solely community, concerns to the scientific is to risk embark- in ing slippery slopes, past, that all to often the here and elsewhere, we, in or practices any community, have resulted unwilling accept. should be ever have of all con- general
We little doubt the motives were, for part, cerned these contested cases the most proper, thought protocols albeit our view not well out. The research, aware, those of which we have been made were, event, any unacceptable legal a context. One children, not simply expose healthy incapable does otherwise (consent), to a personal nontherapeutic assent research research, environment that is known at the inception the might ingest cause the children to especially lead dust. It is troublesome, when a measurement of the success of the is, experiment in significant respect, to be deter- mined the extent to which the blood of the children absorbs, by, and is contaminated substance that the re- can, amounts, searcher knows sufficient solely whether from sources, the research environment or from all cumulative long cause serious and term adverse health effects. Such a practice legally is not acceptable. Brown, (1972),
In v. Conn.Supp. Hart 289 386 A.2d faced, that court was prospectively, approve with whether to transplant of a from kidney seven-year-old one identical twin to the other presented twin. The medical information the court indicated that without the transplant recipient twin would have to an undergo period dialysis extensive treatment with expectation a 50% only chance she could survive that treatment than years; more five life productive to live normal and expected
donor twin was rejection problems with one There were severe kidney. from the that would have transplant kidney parents of a side effects of subjected recipient possible twin immuno-suppressive drugs. twin recipient an action behalf parents brought
The hospital per- that had refused against the doctor parents absent a court order that the operation form the right had to consent to the guardian operation. *63 action, therefore, declaratory judgement concerning a sought to parents right the or litem had the guardian whether a ad the the donor twin. transplant to on behalf of consent attorney ad an guardian court first as litems appointed The twin, person represent the donor and another represent unreported After cases from citing the twin. three recipient Strunk, case of Strunk v. Massachusetts, of and the the State the (Ky.1969), adopted 445 the Connecticut court S.W.2d 145 judgment.” upheld giving It the “doctrine substituted only noting the but after the extensive parents, consent that and the court had undertaken. process parties court noted: legal presents in this matter problems
“One balancing rights parents rights of the natural and directly, rights of minor donor children —more unusual circumstances of this case child. Because of the field, it would great progress the fact of medical this and parents that the natural would able substitute appear close, consent for that of their minor children after their objective their motivation independent investigation in this accomplished This has been matter reasoning. clergyman, physi- of a defendant participation donor, cians, guardian litem attorney ad and, donee, indeed, guardian for the this court ad litem itself. it
A further before this court is whether should question medically to a brief life and complicated abandon the donee parents the natural to take some permit eventual death
107 in order to probability on reason and medical action based alive.... keep both children jurisdiction authority
There is
our American
on a
legally permitted
can be
nontherapeutic operations
guardians
or other
consent
long
parents
minor as
as the
the procedure.”
375-76,
court
cited the
Hart Moran, Strunk, v. Bonner v. supra; cases of Strunk (1941) and the unreported 126 F.2d U.S.App.D.C. Massachusetts cases. the graft
Bonner was an unusual case that involved donee ing badly of skin from a minor donor cousin to a burned case, In cousin. the court did not answer whether guardian, give or other relative or could parent, appropriate (as cousin) nontherapeutic proce consent for a to the donor necessary The issue was whether their consent was dure. circumstances, in that cousin had appar under the the donor (and ently any express may donated the skin without consent an aunt as a already improperly have done so when consented The trial court found that the minor cousin was surrogate). sufficiently procedure, mature so as to be able to assent to the *64 avoiding thus a as to a or parent, determination whether relative, appropriate given surrogated could have consent. trial court a gave jury.40 “mature minor” instruction to the ultimately The trial court’s decision was overturned. The court, appellate reversing, stated: constrained, therefore,
“We are to feel that the court should, outlined, in below the circumstances we have have instructed that the parent necessary.... consent the was But by testimony, clearly appears his own it that he [the infant, to physician] explain, failed even to the the nature or extent of proposed operation.” the first Bonner, clear, at U.S.App.D.C. 126 F.2d 123. As is say that court not consent parental always did would be recognizes 40. The doctrine of "mature minor” that some minors are sufficiently mature to consent. itself, ingredient it a only necessary that was sufficient equation. case, a mentally
In the donor was proposed the Strunk of the parents sought permission Her incompetent adult. of the adult’s having incompetent to consent to one court brother. The transplanted twenty-six-year-old to her kidneys adopting to the “doc- permission parents, court the granted judgment.” trine of substituted in gleaned to be the Hart primary importance
What is of or cases that the consent- parents guardians is not Strunk they sought permission but that first procedures, ed to the courts, consenting to permission, and received before to of their minor respect some nontherapeutic procedure children, to other of their children. therapeutic but that was judice, impartial judicial
In the no review case sub parents. oversight sought by the researchers or to manu Additionally, improper attempt of the IRB’s spite value, no such value therapeutic absolutely there was facture respect subjects to the minor used the research study. In the absence of mеasure effectiveness circumstance, review, in requirement for such a judicial researchers, be, boards would and their scientific based review it judges appropriate if of whether is to use permitted, sole pres nature here nontherapeutic children research ent, measured, of an to be experiment where success part, degree to which the research environ substantial absorption of into the blood of poisons ments cause the be the sole permitted judge Science cannot children. of such research methods on human sub appropriateness jects, hold that in these especially respect children. We cases, study protocols, those which contested aware, appropriate. we were not are in nonthera
When it comes children involved *65 research, potential the risks to the peutic with health subject Maryland, will not to science to be children we defer ethicality or legality determinant of such sole reason, view, is from the experiments. apparent our
109 Moreover, in in the case at bar. at issue protocols research children, that we hold using nontherapeutic that which appropriate cannot make of a alone parent consent innately inappropriate. Health, 165 Mental In T.D. v. New York State Office of (1995), presented court was 62, 1015 Misc.2d 626 N.Y.S.2d agency had control over as which state dispute with a between incapable using persons generally experiments approval and included patients Most were mental consent. giving subjects. agreed The trial court adult and minor both sum- subjects, granting partial a representatives opinion, In its it stated: judgement to that effect. mary to the declaratory judgment a as plaintiffs “The seek November validity regulations promulgated of the OMH 527.10) (14 procedures which set forth the NYCRR nonconsensual mental participation be followed for the experiments. It is high-risk impor- patients potentially action is not a broad- tant to note at the outset this any and all research challenge plaintiffs based to those subjects. proce- on human It is limited performed stroke, attack, convulsions, which cause heart may dures hallucinations, including or other diseases and disabilities death, which, shedding light possible while on possibly others, therapeutic no direct future treatments offer subject. Plaintiffs contend that participating benefit which challenge only approximately their affects studies children, utilize or involve more than a incapable individuals minimal risk.... objected for substitut- provisions
What is most to are the cautiously ... makers. Courts when third ed decision tread for an parties incapable are relied to make decisions in- medical course does not patient. proposed When emergency purpose bettering volve an and is not for the condition, suffering, may it be doubt- patient’s ending committee, guardian, ful if a maker —a surrogate decision holder, relative, parent or even a proxy health-care consent to a ward to be used properly give permitting could *66 110 no experimental research with direct thera- prospect ‘Parents be free
peutic may benefit to himself. patient they it does not martyrs to become themselves. But follow free, circumstances, to make martyrs are in identical age have reached the of full and they their children before can for them- legal they discretion when make choice (Prince Massachusetts, 158, [170, v. 321 U.S. 64 selves.’ (1944)].)” 438, L.Ed. 645 S.Ct. (citations omitted) (some 65-71,
Id. at
The intermediate declaration, finding additional sec- modified the trial court’s In to the inappropriate. respect tiоns the statute issue for minors to parental consent accepting reasonableness harmful, research, nontherapeutic participate potentially that court stated: for
“We find that allow unacceptable provisions also of minors for participation consent to be obtained on behalf risk[41] in greater nontherapeutic than minimal research or, no parent legal guardian, from the minor’s or where available, from an mem parent family or adult guardian child.... making ber involved treatment decisions among not here with choice dealing parental We are alternatives, treatment but with a reasonable decision subject nontherapeutic proce- the child treatments and or side may permanent dures that cause harmful fatal ... parent guardian, effects. It follows therefore or may painful not consent have child submit and/or that hold no potentially life-threatening procedures research "meaning probability and 41. risk has been defined as ‘that the Minimal anticipated magnitude or are not of harm discomfort daily greater ordinarily in and of themselves than those encountered in during physical psychological or or or life the routine examinations ” Boards, Children, Katerberg, tests'.’ Institutional Review Research on Tightrope Walking En- Consent Parents: Between Informed couraging Experimentation Protecting Subject’s Rights, 24 Vital (Winter 1998), University part College and Law Journal of 46.102(i). quoting Regulations 45 Code Federal section from
Ill limit a .... not for the child We do of benefit prospect to a child’s right to consent legal guardian’s parent a valid represents research that therapeutic participation of treat- equivalent the functional may alternative *67 ment.” Health, 228 A.D.2d Mental
T.D. New York State v. Office of (1996). concur with 95, 123-24, 191-92 We 650 N.Y.S.2d that assessment. to nonth- conflicting respect there are views
Additionally, consent, research, person of a as to whether even erapeutic that is consenting, justify protocol can a research capable unjustifiable. otherwise timeless and of consent raises some ‘justifying’
“This side if to activities and people consent thorny questions. What John or even evil? Even repugnant, results which are slavery... Today, . we Mill worried about consensual Stuart appear graphic, consent to wonder whether a woman’s or immun- justifies demeaning, pornography or even violent to a If she to consent pornographer. appears izes the brutalized, does her relationship repeatedly which she or brutality punish stymie stop consent efforts our the brute? little, just they as did squirm make us problems
These first, ‘Yes, ways say, three out: We can Mill. We have consented, you is consented justifies consent whatever to— second, closed;’ consent is defi- particular so case ‘This so the result or action you really did not consent and cient— third, consented, your You but consent justified;’ is not or result.’... justify cannot this action three crucial difference between these yet Note the subtle first, option king, In the consent is while third options: extra- shaped governed by a moral universe assumes however, option, considerations. The second consensual might two. We block reflects the tension between the other action, service to consent’s pay lip the consented-to but we ourselves that had the consent justifying by assuring role untainted, ‘informed,’ it it would have had been had been fact, precisely moral In we service because pay lip, force. not silently, suspect we often that consent cannot and does always justify.... Rather than admit the consent does act, justify denigrate not and not we the consent could and, neсessarily, the consenter as well. our subterfuge designed
This is it is to hide cheating; profess allow us to simultaneous commitment unease conflict.” to values that often
Garnett, Why Human Experimentation Consent? Informed 455, 458-60 Autonomy, and the Ethics of Lawyer 36 Catholic omitted). (1996) (footnotes The article continues: worry experimenter, about the behavior “We should subject’s about culpability, about our own and not choosing capacities. consent, aim objective which be-
Such restrictions *68 subjective rather than at haviors and results decision-mak- are common in the criminal law. For exam- ing processes, a factual guilty usually supported by must be ple, pleas basis, knowing voluntary. recognize and and that be We rationally plead guilty to crimes might quite defendants willing did commit and that be they prosecutors might not However, because such embroil accept pleas. pleas to such falsehood, legal a monstrous we refuse system might accept admitting they them while indeed correctly perceived the defendant’s best interests. law,
Similarly, in contract and often balance consumer we respect for consensual general preference our unfettered other of arrangements against purpose concerns.... One better undeniably supposedly these rules is substitute judiciary what is judgment legislature of the and the about in a really person’s best interest.... recognized
... The the need Nuremberg explicitly Code place scope experiments. limits on of non-paternalistic researcher, or The Code more of an experiment, asks society than mere consent.” us, degree no on the record before Based
Id. at 494-97.42 information to furnished consent, degree no parental here, ethically at issue the experiment could make the parents in the first instance. wrong It was legally permissible. or Conclusion VII. rela Maryland parent, appropriate hold that
We consent to cannot tive, surrogate, applicable or other disability legal under person a child or other participation any risk in which there or studies research nontherapeutic subject. of the to the health damage injury agreements consent informed hold We circumstances under certain projects, nontherapeutic that, certain circum contracts; under can constitute law, can, as a matter stances, agreements such research duties, out of rise relationships” giving “special constitute also may arise. We negligence actions breach of which created relationships are that, special such normally, hold used subjects the human between researchers regula governmental we hold that Additionally, researchers. towards part on the researchers tions can create duties can arise. “special relationships” subjects out of which human with the Likewise, relationships are consistent such duties and Code. Nuremberg provisions “special rela as to whether The determination on a case basis. to be done case tionship” actually exists is *69 experimenta- "Categorical on human research and limitations 42. tion, Many might unavoidably die of slow us down.... [would] ... slight willing to take risks on the would otherwise be AIDS who really drug might But these work.... that the next miracle chance occasionally guilty going free—a might defendant be—like the losses question so much whether we can price paying. is not worth dignity, from subter- to human free afford to honor our commitment to, ..., ought we to. or whether fuges but whether we can afford not all-consuming pursuit of perfectionism and of the ... The lure of scientist, curiosity all and the knowledge, both the conceit dignity of our consрire tempt play fast and loose with the us to subjects and ourselves. Id. at 502. The determina- Williams, 753 A.2d 68. 359 Md. at See exists, properly if relationship special whether a tion as to ample that there was fact. We hold the trier of pled, lies with fact determi- support finder’s in the cases at bar evidence contract, or out arising out of of duties nation of the existence codes, out regulations out of relationship, or special of a them, in of the cases. all of each record, the Circuit Courts present that on the We hold pled the facts as of the law and of assessment erred their cases judgment both summary KKI’s motions for granting rulings of the we vacate the Accordingly, before this Court. these cases City and remand for Baltimore Circuit Court this opin- consistent with further proceedings that court for ion.43 THE CIRCUIT COURT OF 128: RULING
CASE NO. MO- APPELLEE’S CITY GRANTING BALTIMORE FOR AND IS VACATED JUDGMENT TION FOR SUMMARY THAT FOR PROCEED- COURT REMANDED TO CASE OPINION; TO COSTS WITH THIS CONSISTENT INGS BE PAID BY KKI. THE COURT OF CIRCUIT 129: RULING
CASE NO. APPELLEE’S MO- GRANTING BALTIMORE CITY FOR AND VACATED JUDGMENT IS FOR SUMMARY TION THAT COURT FOR PROCEED- REMANDED TO CASE OPINION; TO COSTS THIS CONSISTENT WITH INGS BE PAID BY KKI.
RAKER, only: concurring result Judge, of whether the question the narrow present appeals These appel- summary judgments in granting erred Circuit Courts Institute, on the entity, a research lee, Kennedy Krieger law, no to warn that, duty it owed as a matter ground al., human Myron Higgins, et Ericka Grimes and appellants, agreements required consent appellants also asserted that 43. The original appeared after the repair if lead dust again their homes KKI to agreements do not so taken. The consent measures were abatement further. opinion, we do not address this issue light of our provide. In
115 study. I concur research participating its subjects judgment in the Court’s only join Court of the judgment summary judgments in granting erred that the Circuit Courts further cases should be remanded These appellee. proceedings. appel I that because find judgment
I in the Court’s concur that there to establish sufficient facts alleged lants have in these parties relationship between special existed breached, that, gives if rise cases, of care duty which created a Arundel Ashburn v. Anne negligence. See to an action (1986). I 617, 630-31, 510 A.2d 306 Md. County, duty to a giving rise special relationship hold that a would for an action care, be the basis the breach of which would cases and would remand the existed these cases negligence, I agree proceedings. for further at bar to the Circuit Courts duty protection that includes the majority with the this requires from unreasonable harm and subjects subjects completely and to inform research researcher from resulting participation hazards promptly potential 93, 98-99, of the maj. 113. As a result study. op. See I to reach the duty, unnecessary of this tort find it existence by any parties, not even raised thorny question, in these cases agreements whether the informed consent (stat maj. at 46 legally binding op. constitute contracts. See parents that consents of the these cases under ing “the duties”); id. at 89 Maryland creating law constituted contracts our of the record (stating that “we hold from own examination contained, assent, offer, mutual provisions that such were so existed, all of which created acceptance, and consideration imposing contractual duties reason of the relationships ...”); agreements (stating themselves id. at 113 consent in nontherapeu consent agreements hold informed “[w]e circumstances can consti projects, tic research under certain .”). . . tute contracts
I
sent
message
have some concern with
mixed
majority
duty arising
as to whether the existence of a tort
of law for the
special relationship
question
from a
existed is a
*71
For
by
a
to be determined
the trier of fact.
question
court or
condi-
states that “the creation of
example,
majority
of other-
protocols
participation
tions or
or
recruitment
to
...
conditions
healthy subjects
wise
interact with
hazardous
special relationships
...
normally
... would
warrant
create
added).
at
The
Maj.
(emphasis
a matter
92-93
as
law.”
of
that
consent
majority
agreements
also concludes
“informed
...,
circum-
nontherapeutic
projects
under certain
law,
stances,
can,
...
rela-
‘special
as a matter
constitute
of
duties,
out of the breach of which
tionships’ giving rise
added).
arise.”
at 113
may
(emphasis
actions
Id.
negligence
Baltimore,
hand,
v.
359 Md.
citing
the other
On
Williams
101,
(2000),
that
ultimately
A.2d 41
concludes
majority
753
be
duty
the determination as to whether a
care existed
by
is a
to be determined
the trier
parties
question
tween
maj.
I
case-by-case
fact on a
basis. See
at 113.
op.
holding
conclusion. The
relied
disagree with that
Williams
Ashbum,
a
only
stated
that
order for such
upon
“[i]n
which
police
to be
[special] relationship
perpetra
found between
tor,
ongoing
it must
that
was some
alleged
type
be
there
actor.”
police
custodial
between the
officer and the
relationship
burn,
2,
n. 2.
Accordingly, granting summary judgments the Circuit Courts’ reverse appellees.
ON MOTION FOR RECONSIDERATION PER CURIAM.
The Court has considered the motion for reconsideration motion and the submissions the various amici curiae. The denied, explanation. with this case, in in Some of the issues raised this the briefs and at in this argument, important impression oral were ones first State, and the therefore to address those attempted Court in issues a full and exhaustive manner. The case reached us summary judgments the context of entered the Circuit Court, rulings presented by which entailed the evidence motions, plaintiffs, purposes even when taken them, a light most favorable to was insufficient as matter of prospect liability. disagreed law to establish the We that determination. we the various Although discussed issues detail, arguments only considerable conclusion that that, we as a matter of was on the reached law record us, currently summary judgment improperly before granted presented sufficient evidence was both cases —that which, if light plaintiffs taken most favorable to the by jury, justify believed would suffice verdicts favor Thus, plaintiffs. the cases were remanded for furthеr *74 in proceedings Every bearing the Circuit Court. issue or for factual liability damages open develop- remains further ment, any relevant evidence not otherwise precluded under our rules of evidence is admissible.
120 in to the argument support opposition
Much of in of and the what question for centered on the of motion reconsideration authority to in- govern parent’s provide limitations should her child for the of his or minor participation formed consent In at one that a study. Opinion, point in a the we said medical ... in consent the child participation “cannot to parent there risk nontherapeutic any research or studies which is subject.” think injury damage to the health the As we or risk,” Opinion, by “any of the we is clear from Section VI beyond minimal of risk meant articulable risk kind any any that is The context of the state- inherent endeavor. non-therapeutic study no medical promises ment was a whatever, risk any benefit the child so balance between indicated, negative. As we necessarily and benefit is study some question determination of whether offered benefit, as regarded therapeutic therefore could be nature, than that minimal risk open or involved more is development on further factual remand.
RAKER, Judge, dissenting. motions respectfully denying
I dissent from order previously I views ex- for reconsideration. adhere 16, herein on pressed my concurring opinion August filed 2001. ability of a or majority’s parent discussion in a of a minor child
guardian
participation
to consent
regarding
research
and the discussion
nontherapeutic
the research
in these cases involve
the ethics of
conducted
are a
public policy
serious
considerations. The statements
that,
case,
public policy
posture
of this
declaration
Harrant,
Gaver v.
See
Assembly.
best
to the
are
left
General
v.
28-29,
210,
(1989);
Harrison
17,
316 Md.
557 A.2d
217
Educ.,
442, 460,
Mont. Co. Bd
295 Md.
A.2d
(1983).
Inasmuch as these issues were never raised
below,
had
pleadings
parties
this Court
no basis
issues;
very
change
address
if a
to be made
complex
these
studies,
regulating
unless
policy
State’s
court,
it
clearly presented
legislative
to the
should be made
*75
App.,
Nat'l Bk. v. United Jewish
286 Md.
enactment. See Md.
(1979).
274,
merits the close
STATE of Term, 143, Sept. No. 2000. Appeals Maryland.
Court of
Oct. 2001. notes infra accurately appropriate obtaining analyzing to the as method for samples. such dust result, or be to As a some lower level rental pay willing pay. in Baltimore had been properties containing paint lead based study attempting left vacant. The was simply abandoned and means of rehabilitation expensive to determine whether a less to of such properties. could be available the owners to way study designed One was measure the effective- of such abatement measures to measure the lead ness them compare dust levels the houses at intervals and found, intervals, the same roughly with the levels of lead living houses. The respective the blood the children houses. project required present that small children be agreeing permit To facilitate that the landlords purpose, properties encouraged, their to be included the studies were if not to rent to tenants who had required, properties young children. permitting properties In return for be used and chil- limiting young return for their tenants to families with dren, in applying receiving KKI assisted the landlords for and used to the levels of grants money perform or loans KKI abatement for each class home. required study composed compo- The research was to be of two main groups study nents and a total of five houses.14 The first study groups concerned the first three component group houses. Houses each received different amounts of following maintenance.15 The three repair groups component houses within the first of the research were: