grimes v. kennedy krieger md. 807 - columbia university

807Md.GRIMES v. KENNEDY KRIEGERCite as 782 A.2d 807 (Md. 2001)

independent judicial action upon the re-quest of either party until after final reso-lution of the administrative proceeding.See Kim v. Comptroller of the Treasury,350 Md. 527, 537, 714 A.2d 176, 180(1998)(quoting Maryland–National Capi-tal Park & Planning Comm’n. v. Craw-ford, 307 Md. 1, 18, 511 A.2d 1079, 1087–88(1986)); Goicochea v. Langworthy, 345Md. 719, 729, 694 A.2d 474, 479, cert. de-nied, 522 U.S. 924, 118 S.Ct. 321, 139L.Ed.2d 249 (1997)(explaining that in themedical malpractice arbitration context,where a tort action is filed in a circuitcourt before the arbitration process hasconcluded, the trial court should ‘‘stay thecivil action pending the conclusion of arbi-tration proceedings’’ rather than to dismissthe case); McCullough, 314 Md. at 613,552 A.2d at 886 (explaining that where anindividual has both an administrative and ajudicial remedy and the agency has pri-mary jurisdiction over the matter, the trialcourt may retain jurisdiction during thependency of the administrative proceed-ings). Such a procedure will ensure thatthe desire of the Commission to ‘‘haveeveryone feel that his complaint whetherlarge or small, will have a patient andcourteous hearing and an honest decision’’will be achieved without leaving complain-ants who seek remedies beyond the scopeof the Commission without a forum forredress. See First Report of the PublicService Commission of Maryland, Decem-ber 31, 1910, at 33.

Based on our consideration of the statu-tory language and the legislative intentbehind its enactment, we hold that con-sumers, such as Intercom, do have theability to pursue an independent judicialaction in addition to the administrativeremedies provided by the PSC, providedthat they exhaust their administrativeremedies prior to adjudication of an inde-pendent judicial action. In so doing, weoverrule the holding of the Court of Spe-cial Appeals in Bits ‘‘N’’ Bytes, to the

extent that the court held that the statuto-ry remedies provided under the PublicUtility Companies Article were the exclu-sive remedies available to consumers whohave complaints against public servicecompanies.

Our holding that the Commission hasprimary jurisdiction over cases involvingentities regulated by the Public UtilityCompanies Article allows many caseswhich are exclusively regulatory in natureto be resolved within the Commission.For those cases where a party pleads acommon law cause of action, the Legisla-ture having vested the Commission withprimary jurisdiction will allow the agencyto imprint the matter with its expertise inthis area of law and public policy while alsoproviding consumers with a forum for cog-nizable common law claims for which theycould not otherwise obtain adequate relief.

JUDGMENT OF THE COURT OFSPECIAL APPEALS AFFIRMEDWITH COSTS TO BE PAID BY THEPETITIONER.

,

366 Md. 29

Ericka GRIMES

v.

KENNEDY KRIEGERINSTITUTE, INC.

Myron Higgins, a minor, etc., et al.,

v.

Kennedy Krieger Institute, Inc.

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

Court of Appeals of Maryland.

Aug. 16, 2001.Reconsideration Denied Oct. 11, 2001.

Minor participants in nontherapeuticresearch program studying effectiveness of

808 782 ATLANTIC REPORTER, 2d SERIESMd.

lead paint abatement procedures broughtnegligence actions against research insti-tute arising from participants’ alleged de-velopment of elevated levels of lead dust inblood while participating in study. The Cir-cuit Court, Baltimore City, Stuart R. Ber-ger, Allen L. Schwait, JJ., granted re-search institute’s motion for summaryjudgment. Participants appealed. Aftergrant of certiorari, the Court of Appeals,Cathell, J., held that: (1) parent or otherapplicable surrogate cannot consent to theparticipation of a child or other personunder legal disability in nontherapeutic re-search or studies in which there is any riskof injury or damage to health of the sub-ject;(2) informed consent agreements innontherapeutic research projects can con-stitute contracts as well as special relation-ships giving rise to duties, out of thebreach of which negligence action mayarise; (3) normally, such special relation-ships are created between researchers andhuman subjects used by researchers; (4)governmental regulations can create dutieson part of researchers toward human sub-jects out of which special relationships canarise; and (5) fact issues as to existence ofduty precluded summary judgment.

Vacated and remanded.

Raker, J., concurred and filed opinion.

1. Appeal and Error O863

In reviewing a grant of a summaryjudgment, Court of Appeals is first con-cerned with whether a genuine dispute ofmaterial fact exists and then whether themovant is entitled to summary judgmentas a matter of law. Md.Rule 2–501(e).

2. Judgment O181(2)

‘‘Material fact,’’ for summary judg-ment purposes, is a fact the resolution of

which will somehow affect outcome of case.Md.Rule 2–501(e).

See publication Words and Phrasesfor other judicial constructions anddefinitions.

3. Judgment O181(2)Dispute as to facts relating to grounds

upon which decision is not rested is not adispute with respect to a material fact, andsuch dispute does not prevent entry ofsummary judgment. Md.Rule 2–501(e).

4. Judgment O185(2)In determining whether party is enti-

tled to summary judgment, court mustview facts, including all inferences, in lightmost favorable to opposing party. Md.Rule 2–501(e).

5. Judgment O186In determining whether party is enti-

tled to summary judgment, trial court willnot determine any disputed facts, but rath-er makes a ruling as a matter of law.Md.Rule 2–501(e).

6. Appeal and Error O863Standard of appellate review on trial

court’s summary judgment ruling iswhether trial court was legally correct.Md.Rule 2–501(e).

7. Appeal and Error O934(2)In reviewing a grant of summary

judgment, Court of Appeals must considerfacts reflected in pleadings, depositions,answers to interrogatories and affidavits inlight most favorable to nonmoving parties,and, even if it appears that relevant factsare undisputed, if those facts are suscepti-ble to inferences supporting position ofparty opposing summary judgment, then agrant of summary judgment is improper.Md.Rule 2–501(e).

8. Judgment O178Purpose of summary judgment proce-

dure is not to try case or to decide factual


disputes, but to decide whether there is anissue of fact, which is sufficiently materialto be tried. Md.Rule 2–501(e).

9. Judgment O185(2)

Once moving party has provided trialcourt with sufficient grounds for summaryjudgment, nonmoving party must producesufficient evidence to court that a genuinedispute to a material fact exists. Md.Rule2–501(e).

10. Negligence O202

To establish claim for negligence,party must prove four elements: (1) thatdefendant was under a duty to protectplaintiff from injury, (2) that defendantbreached that duty, (3) that plaintiff suf-fered actual injury or loss, and (4) thatloss or injury proximately resulted fromdefendant’s breach of duty.

11. Physicians and Surgeons O7

By having children’s parents sign con-sent form for having children participate innontherapeutic research program studyingeffectiveness of lead paint abatement pro-cedures, both research institute and par-ents expressly made representations,which, in Court of Appeals’ view, created abilateral contract between parties.

12. Infants O13

‘‘Informed’’ consent for having chil-dren participate in nontherapeutic re-search program studying effectiveness oflead paint abatement procedures was in-valid, where full material information wasnot furnished to the subjects or their par-ents.

13. Negligence O214, 222

Duty may be prescribed by statute, ora special relationship creating duties mayarise from requirement for compliancewith statutory provisions.

14. Negligence O211

Determination of whether a duty ex-ists under state law is ultimate function ofvarious policy considerations as adopted bylegislature, or, if it has not spoken, bystate courts.


Physicians and Surgeons O7

Duty to a vulnerable subject of nonth-erapeutic research is independent of con-sent, although the obtaining of consent isone of duties a researcher must perform.



Duty to vulnerable subjects of nonth-erapeutic research requires the protectionof subjects from unreasonable harm andrequires researcher to completely andpromptly inform subjects of potential haz-ards existing from time to time.

17. Infants O13

It is not in the best interest of anyhealthy child, in a nontherapeutic researchproject, to be placed in a research environ-ment, which might possibly be, or whichproves to be, hazardous to health of child,to test methods that may ultimately bene-fit all children.

18. Infants O2

Doctrine of ‘‘mature minor’’ recog-nizes that some minors are sufficiently ma-ture to consent to treatment.

See publication Words and Phrasesfor other judicial constructions anddefinitions.

19. Infants O13

Research study protocols were not ap-propriate for nontherapeutic research pro-gram involving use of children to studyeffectiveness of lead paint abatement pro-cedures, where no impartial judicial reviewor oversight was sought by researchers or


by children’s parents who signed informedconsent forms.

20. Infants O13

When it comes to children involved innontherapeutic research, with the potentialfor health risks to the subject children instate, Court of Appeals will not defer toscience to be sole determinant of ethicalityor legality of such experiments.

21. Infants O13

In nontherapeutic research using chil-dren, the consent of a parent alone cannotmake appropriate that which is innatelyinappropriate.

22. Infants O13

A parent, appropriate relative, or oth-er applicable surrogate cannot consent tothe participation of a child or other personunder legal disability in nontherapeutic re-search or studies in which there is any riskof injury or damage to health of the sub-ject.

23. Negligence O321


Informed consent agreements innontherapeutic research projects, undercertain circumstances, can constitute con-tracts and can constitute special relation-ships giving rise to duties, out of thebreach of which negligence actions mayarise.

24. Negligence O321


Normally, special relationships givingrise to duties, out of the breach of whichnegligence actions may arise, are createdbetween researchers and human subjectsused by researchers in nontherapeutic re-search projects.

25. Negligence O321


Governmental regulations can createduties on part of researchers towards hu-man subjects of nontherapeutic researchproject, out of which special relationshipscan arise and form basis for negligenceclaims.

26. Negligence O214Determination as to existence of a

special relationship giving rise to duty, outof the breach of which a negligence actionmay arise, is to be done on a case by casebasis.

27. Negligence O1692Determination as to existence of a

special relationship giving rise to duty, outof the breach of which a negligence actionmay arise, lies with trier of fact, if proper-ly pled.

28. Judgment O181(33)Genuine issues of material fact existed

as to whether research institute owedduties to a parent and minor participantsin nontherapeutic research program study-ing effectiveness of lead paint abatementprocedures, precluding summary judgmentin negligence action against institute aris-ing from participants’ alleged developmentof elevated levels of lead dust in bloodwhile participating in study. Md.Rule 2–501(e).

Kenneth W. Strong, Baltimore, for ap-pellant, in No. 128, Sept. Term, 2000.

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

Michael I. Joseph (S. Allen Adelman andSusan B. Boyce of Godard, West, Adelman,


Sheff & Smith, LLC, on brief), Rockville,for appellees.

Deborah Thompson Eisenberg, Marc E.Steinberg, Tara Andrews, Baltimore, briefof the Public Justice Center, the NationalHealth Law Program, and the East Har-bor Village Center for appellants, amicicuriae.

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

Shale D. Stiller, George A. Nilson, Wil-liam L. Reynolds and Evelyn W. Pasquierof Piper, Marbury, Rudnick & Wolfe, LLP,Baltimore; S. Allan Adelman and MichaelI. Joseph of Godard, West, Adelman, Sheffand Smith, LLC, Rockville, for appellee,on reconsideration.

C. Christopher Brown of Brown, Gold-stein and Levy, LLP, Baltimore, for Na-tional Center for Lead-Safe Housing, onreconsideration.

J. Joseph Curran, Jr., Attorney Generalof Maryland and Jack Schwartz, AssistantAttorney General of Maryland for Univer-sity of Maryland Baltimore, on reconsider-ation.

Deborah Thompson Eisenberg and MarcSteinberg, Baltimore, for Public JusticeCenter, on reconsideration.

Ralph S. Tyler and Joseph H. Young ofHogan & Hartson, LLP, Baltimore, forAmerican Medical Colleges, Association ofAmerican Universities, Johns HopkinsUniversity and University of MarylandMedical System Corp., on reconsideration.

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

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

CATHELL, Judge.

Prologue

We initially note that these are cases offirst impression for this Court. For thatmatter, precious few courts in the UnitedStates have addressed the issues present-ed in the cases at bar.1 In respect tonontherapeutic research using minors, ithas been noted that ‘‘consent to researchhas been virtually unanalyzed by courtsand legislatures.’’ Robert J. Katerberg,Institutional Review Boards, Research onChildren, and Informed Consent of Par-ents: Walking the Tightrope Between En-couraging Vital Experimentation andProtecting Subjects’ Rights, 24 J.C. & U.L.545, 562, quoting National Commission forthe Protection of Human Subjects ofBiomedical and Behavioral Research, Re-port and Recommendations [NationalCommission]: Research Involving Chil-dren 79–80 (1977). Our research revealsthis statement remains as accurate now asit was in 1977.

In these present cases, a prestigiousresearch institute, associated with JohnsHopkins University, based on this record,created a nontherapeutic research pro-gram 2 whereby it required certain classes

1. We note that we have found only one casefairly close on one point we address later;that being a New York case that we discuss inthe main body of our opinion.

2. At least to the extent that commercial profitmotives are not implicated, therapeutic re-

search’s purpose is to directly help or aid apatient who is suffering from a health condi-tion the objectives of the research are de-signed to address—hopefully by the allevia-tion, or potential alleviation, of the healthcondition.


of homes to have only partial lead paintabatement modifications performed, and inat least some instances, including at leastone of the cases at bar, arranged for thelandlords to receive public funding by wayof grants or loans to aid in the modifica-tions. The research institute then encour-aged, and in at least one of the cases atbar, required, the landlords to rent thepremises to families with young children.In the event young children already resid-ed in one of the study houses, it wascontemplated that a child would remain inthe premises, and the child was encour-aged to remain, in order for his or herblood to be periodically analyzed. In otherwords, the continuing presence of the chil-dren that were the subjects of the studywas required in order for the study to becomplete. Apparently, the children andtheir parents involved in the cases subjudice were from a lower economic strataand were, at least in one case, minorities.

The purpose of the research was to de-termine how effective varying degrees oflead paint abatement procedures were.Success was to be determined by periodi-cally, over a two-year period of time, meas-uring the extent to which lead dust re-mained in, or returned to, the premisesafter the varying levels of abatement modi-fications, and, as most important to ourdecision, by measuring the extent to whichthe theretofore healthy children’s bloodbecame contaminated with lead, and com-paring that contamination with levels oflead dust in the houses over the sameperiods of time. In respect to one of theprotocols presented to the EnvironmentalProtection Agency and/or the Johns Hop-

kins Joint Committee on Clinical Investi-gation, the Johns Hopkins InstitutionalReview Board (IRB), the researchers stat-ed: ‘‘To help insure that study dwellingsare occupied by families with young chil-dren, City Homes 3 will give priority tofamilies with young children when rentingthe vacant units following R & M [Repairand Maintenance] interventions.’’

The same researchers had completed aprior study on abatement and partialabatement methods that indicated thatlead dust remained and/or returned toabated houses over a period of time. Inan article reporting on that study, the verysame researchers said: ‘‘Exposure to lead-bearing dust is particularly hazardous forchildren because hand–to–mouth activity isrecognized as a major route of entry oflead into the body and because absorptionof lead is inversely related to particulesize.’’ Mark R. Farfel & J. Julian Chi-solm, Health and Environmental Out-comes of Traditional and Modified Prac-tices for Abatement of Residential Lead–Based Paint,—80 American Journal ofPublic Health—1240, 1243 (1990). Afterpublishing this report, the researchers be-gan the present research project in whichchildren were encouraged to reside inhouseholds where the possibility of leaddust was known to the researcher to belikely, so that the lead dust content of theirblood could be compared with the level oflead dust in the houses at periodic inter-vals over a two-year period.

Apparently, it was anticipated that thechildren, who were the human subjects inthe program, would, or at least might,accumulate lead in their blood from the

Nontherapeutic research generally utilizessubjects who are not known to have the con-dition the objectives of the research are de-signed to address, and/or is not designed todirectly benefit the subjects utilized in theresearch, but, rather, is designed to achieve

beneficial results for the public at large (or,under some circumstances, for profit).

3. City Homes apparently was a nonprofit enti-ty affiliated with the Enterprise Foundation,that owned and/or managed low incomehousing in Baltimore City.


dust, thus helping the researchers to de-termine the extent to which the variouspartial abatement methods worked. Therewas no complete and clear explanation inthe consent agreements signed by the par-ents of the children that the research to beconducted was designed, at least in signifi-cant part, to measure the success of theabatement procedures by measuring theextent to which the children’s blood wasbeing contaminated. It can be argued thatthe researchers intended that the childrenbe the canaries in the mines but neverclearly told the parents. (It was a practicein earlier years, and perhaps even now, forsubsurface miners to rely on canaries todetermine whether dangerous levels oftoxic gasses were accumulating in themines. Canaries were particularly suscep-tible to such gasses. When the canariesbegan to die, the miners knew that dan-gerous levels of gasses were accumulat-ing.)

The researchers and their InstitutionalReview Board apparently saw nothingwrong with the search protocols that antic-ipated the possible accumulation of lead inthe blood of otherwise healthy children asa result of the experiment, or they be-lieved that the consents of the parents ofthe children made the research appropri-ate. Institutional Review Boards (IRB)are oversight entities within the institu-tional family to which an entity conductingresearch belongs. In research experi-ments, an IRB can be required in someinstances by either federal or state regula-tion, or sometimes by the conditions at-

tached to governmental grants that areused to fund research projects.4 General-ly, their primary functions are to assessthe protocols of the project to determinewhether the project itself is appropriate,whether the consent procedures are ade-quate, whether the methods to be em-ployed meet proper standards, whether re-porting requirements are sufficient, andthe assessment of various other aspects ofa research project. One of the most im-portant objectives of such review is thereview of the potential safety and thehealth hazard impact of a research projecton the human subjects of the experiment,especially on vulnerable subjects such aschildren. Their function is not to helpresearchers seek funding for research pro-jects.

In the instant case, as is suggested bysome commentators as being endemic tothe research community as a whole, infra,the IRB involved here, the Johns HopkinsUniversity Joint Committee on Clinical In-vestigation, in part, abdicated that respon-sibility, instead suggesting to the research-ers a way to miscast the characteristics ofthe study in order to avoid the responsibil-ity inherent in nontherapeutic research in-volving children. In a letter dated May11, 1992, the Johns Hopkins UniversityJoint Committee on Clinical Investigation(the IRB for the University), charged withinsuring the safety of the subjects andcompliance with federal regulations, wroteto Dr. Farfel, the person in charge of theresearch:

4. In respect to research conducted or sup-ported by any federal agency, InstitutionalReview Boards, among other requirements,must furnish the agency with: (1) a list ofIRB members, their degrees, representativecapacity, experience, and employment rela-tionships between the member and the re-search entity. Each IRB is required to haveat least five members of varying backgrounds;

there must be racial, gender, and culturaldiversity. Each IRB has to contain at leastone scientific member and one non-nonscien-tific member and one member who is notaffiliated with the institution in any way. Nomember of an IRB can have a conflictinginterest. 45 C.F.R. Subtitle A, sections46.103 and 46.107.


‘‘A number of questions came upTTTT

Please respond to the following points[:]

TTT

2. The next issue has to do withdrawing blood from the control popula-tion, namely children growing up inmodern urban housing. Federal guide-lines are really quite specific regardingusing children as controls in projects inwhich there is no potential benefit [tothe particular children]. To call a sub-ject a normal control is to indicate thatthere is no real benefit to be received[by the particular children]TTTT So wethink it would be much more acceptableto indicate that the ‘control group’ isbeing studied to determine what expo-sure outside the home may play in atotal lead exposure; thereby, indicatingthat these control individuals are gainingsome benefit, namely learning whethersafe housing alone is sufficient to keepthe blood–lead levels in acceptablebounds. We suggest that you modifyTTT consent form[s] TTT accordingly.’’[Emphasis added.]

While the suggestion of the IRB wouldnot make this experiment any less nonth-erapeutic or, thus, less regulated, thisstatement shows two things: (1) that theIRB had a partial misperception of thedifference between therapeutic and nonth-erapeutic research and the IRB’s role inthe process and (2) that the IRB waswilling to aid researchers in gettingaround federal regulations designed toprotect children used as subjects in nonth-erapeutic research. An IRB’s primaryrole is to assure the safety of human re-search subjects—not help researchersavoid safety or health-related require-ments. The IRB, in this case, miscon-ceived, at least partially, its own role.

The provisions or conditions imposed bythe federal funding entities, pursuant tofederal regulations, are conditions attachedto funding. As far as we are aware, orhave been informed, there are no federalor state (Maryland) statutes that mandatethat all research be subject to certain con-ditions. Certain international ‘‘codes’’ or‘‘declarations’’ exist (one of which is sup-posedly binding but has never been soheld) that, at least in theory, establishstandards. We shall describe them, infra.Accordingly, we write on a clean slate inthis case. We are guided, as we determinewhat is appropriate, by those international‘‘codes’’ or ‘‘declarations,’’ as well as bystudies conducted by various governmentalentities, by the treatises and other writ-ings on the ethics of using children asresearch subjects, and by the duties, ifany, arising out of the use of children assubjects of research.

Otherwise healthy children,5 in our view,should not be enticed into living in, orremaining in, potentially lead-tainted hous-ing and intentionally subjected to a re-search program, which contemplates theprobability, or even the possibility, of leadpoisoning or even the accumulation of low-er levels of lead in blood, in order for theextent of the contamination of the chil-dren’s blood to be used by scientific re-searchers to assess the success of leadpaint or lead dust abatement measures.Moreover, in our view, parents, whetherimproperly enticed by trinkets, foodstamps, money or other items, have nomore right to intentionally and unneces-sarily place children in potentially hazard-ous nontherapeutic research surroundings,than do researchers. In such cases, pa-rental consent, no matter how informed, isinsufficient.

5. As far as is known from the record, thechildren involved at the inception of the study

were healthy, although appellee was unwill-ing to so concede at oral argument.


While the validity of the consent agree-ment and its nature as a contract, theexistence or nonexistence of a special rela-tionship, and whether the researchers per-formed their functions under that agree-ment pursuant to any special relationshipsare important issues in these cases that wewill address, the very inappropriateness ofthe research itself cannot be overlooked.It is apparent that the protocols of re-search are even more important than themethod of obtaining parental consent andthe extent to which the parents were, orwere not, informed. If the research meth-ods, the protocols, are inappropriate then,especially when the IRB is willing to helpresearchers avoid compliance with applica-ble safety requirements for using children

in nontherapeutic research, the consent ofthe parents, or of any consent surrogates,in our view, cannot make the researchappropriate or the actions of the research-ers and the Institutional Review Boardproper.

The research relationship proffered tothe parents of the children the researcherswanted to use as measuring tools, shouldnever have been presented in a nonthera-peutic context in the first instance. Noth-ing about the research was designed fortreatment of the subject children. Theywere presumed to be healthy at the com-mencement of the project. As to them,the research was clearly nontherapeutic innature. The experiment was simply a ‘‘forthe greater good’’ project.6 The specific

6. The ultimate goal was to find the cost of theminimal level of effective lead paint or leaddust abatement costs so as to help landlordsassess, hopefully positively, the commercialfeasibility of attempting to abate lead dust inmarginally profitable, lower rent-urban hous-ing, in order to help preserve such housing inthe Baltimore housing market. One of theaims was to evaluate low-cost methods ofabatement so that some landlords would notabandon their rental units. For those land-lords, complete abatement was not deemedeconomically feasible. The project would beable to assess whether a particular level ofpartial abatement caused a child’s blood leadcontent to be elevated beyond a level deemedhazardous to the health of children.

The tenants involved, presumably, would befrom a lower rent-urban class. At least one ofthe consenting parents in one of these caseswas on public assistance, and was describedby her counsel as being a minority. Thechildren of middle class or rich parents ap-parently were not involved.

‘‘Indeed, the literature on the law andethics of human experimentation is repletewith warnings that all subjects, but espe-cially vulnerable subjects, are at risk ofabuse by inclusion [as research subjects].Those vulnerable subjects included prison-ers, who are subject to coercion, [see ThePrisoner’s Cases: Clay v. Martin, 509 F.2d109 (1975); Bailey, Dingee, Neuser & Mun-ney v. Lally, 481 F.Supp. 203 (1979); Valen-

ti v. Prudden, 58 A.D.2d 956, 397 N.Y.S.2d181 (1977) ]; children and the elderly TTT

and racial minorities, ethnic minorities, andwomen [see the silicone injections/informedconsent case of Retkwa v. Orentreich, 154Misc.2d 164, 584 N.Y.S.2d 710 (1992) ],whom history shows to be the most fre-quent victims of abuses in human experi-mentation.’’

R. Alta Charo, Protecting us to Death: Women,Pregnancy and Clinical Research Trials, 38 St.Louis U.L.J. 135, 135 (Fall, 1993); see also Inre Cincinnati Radiation Litigation, 874F.Supp. 796, 800 (1995) (‘‘The experimentsutilized terminal cancer patientsTTTT Thecomplaint alleges that most of the patientsselected were African–American and, in thevernacular of the time, charity patients.’’);Lainie Ross, Children as Research Subjects: AProposal to Revise the Current Federal Regula-tions Using a Moral Framework, 8 Stan. L. &Policy Rev. 159, 164 (Winter 1997)(‘‘The fail-ures in the informed consent process lead toserious inequities in research, specifically forthe poor and less educated who bear most ofthe research burden. Studies show that theprocess of informed consent serves as a socialfilter: Better educated and wealthier individ-uals are more likely to refuse to participateand are underrepresented in most research.The problem is perpetuated in pediatrics,where parents who volunteer their childrenwere found to be significantly less educatedand underrepresented in the professional and


children’s health was put at risk, in orderto develop low-cost abatement measuresthat would help all children, the landlords,and the general public as well.

It was noted in Richard W. Garnett,Why Informed Consent? Human Experi-mentation and the Ethics of Autonomy, 36Catholic Lawyer 455, 490 (1996) that:

‘‘Most research poses no problemsand is easily legitimated and justified,but the subject’s consent to those exper-iments is not, by itself, a reliable indica-tor that they are justified, nor is it itselfwhat justifies them.’’

In Olmstead v. United States, 277 U.S.438, 479, 48 S.Ct. 564, 572–73, 72 L.Ed.944, 957 (1928), Justice Brandis, dissent-ing, noted:

‘‘Experience should teach us to bemost on our guard to protect libertywhen the Government’s purposes are be-neficent. Men born to freedom are nat-urally alert to repel invasion of theirliberty by evil-minded rulers. Thegreatest dangers to liberty lurk in insidi-ous encroachment by men of zeal, well-meaning but without understanding.’’

The research project at issue here, andits apparent protocols, differs in large de-gree from, but presents similar problemsas those in the Tuskegee Syphilis Studyconducted from 1932 until 1972 (The Tusk-egee Syphilis Study, 289 New EnglandJournal of Medicine 730 (1973)), the inten-

tional exposure of soldiers to radiation inthe 1940s and 50s (Jaffee v. United States,663 F.2d 1226 (3d Cir.1981), cert. denied,456 U.S. 972, 102 S.Ct. 2234, 72 L.Ed.2d845 (1982)), the tests involving the expo-sure of Navajo miners to radiation (Begayv. United States, 591 F.Supp. 991 (1984),aff’d, 768 F.2d 1059 (9th Cir.1985),7 andthe secret administration of LSD to sol-diers by the CIA and the Army in the1950s and 60s (United States v. Stanley,483 U.S. 669, 107 S.Ct. 3054, 97 L.Ed.2d550 (1987)); Central Intelligence Agency v.Sims, 471 U.S. 159, 105 S.Ct. 1881, 85L.Ed.2d 173 (1985)). The research experi-ments that follow were also prior instancesof research subjects being intentionally ex-posed to infectious or poisonous sub-stances in the name of scientific research.They include the Tuskegee Syphilis Study,aforesaid, where patients infected with sy-philis were not subsequently informed ofthe availability of penicillin for treatmentof the illness, in order for the scientistsand researchers to be able to continueresearch on the effects of the illness, theJewish Hospital study,8 and several otherpost-war research projects. Then thereare the notorious use of ‘‘plague bombs’’by the Japanese military in World War IIwhere entire villages were infected in or-der for the results to be ‘‘studied’’; 9 andperhaps most notorious, the deliberate useof infection in a nontherapeutic project in

managerial occupations compared to theirnon-volunteering counterparts.’’ (footnoteomitted)).

7. The Navajo miners had been already work-ing in the uranium mines when the studycommenced. Unlike the present case, theNavajos were not recruited by the researchersto be placed in the environment being testedfor unhealthy substances.

8. Generally known as the Jewish Chronic Dis-ease Hospital study where chronically ill anddebilitated patients were injected with cancer

cells without their consent. See Zeleznik v.Jewish Chronic Disease Hosp., 47 A.D.2d 199,366 N.Y.S.2d 163 (1975). And see Applica-tion of Hyman, 42 Misc.2d 427, 248 N.Y.S.2d245, rev’d Hyman v. Jewish Chronic DiseaseHospital, 21 A.D.2d 495, 251 N.Y.S.2d 818(1964), rev’d 15 N.Y.2d 317, 206 N.E.2d 338,258 N.Y.S.2d 397 (1965).

9. See generally A. Brockman, The Other Nu-remberg: The Untold Story of the Tokyo WarCrime Trials (1987); P. Williams & D. Wal-lace, Unit 731: Japan’s Secret Biological War-fare in World War II (1989).


order to study the degree of infection andthe rapidity of the course of the disease inthe Rose and Mrugowsky typhus experi-ments at Buchenwald concentration campduring World War II. These programswere somewhat alike in the vulnerability ofthe subjects; uneducated African–Ameri-can men, debilitated patients in a charityhospital, prisoners of war, inmates of con-centration camps and others falling withinthe custody and control of the agenciesconducting or approving the experiments.In the present case, children, especiallyyoung children, living in lower economiccircumstances, albeit not as vulnerable asthe other examples, are nonetheless, vul-nerable as well.

It is clear to this Court that the scienti-fic and medical communities cannot bepermitted to assume sole authority to de-termine ultimately what is right and ap-propriate in respect to research projectsinvolving young children free of the limita-tions and consequences of the applicationof Maryland law. The Institutional Re-view Boards, IRBs, are, primarily, in-house organs. In our view, they are notdesigned, generally, to be sufficiently ob-jective in the sense that they are as suffi-ciently concerned with the ethicality of theexperiments they review as they are withthe success of the experiments. This hasbeen the subject of comment in a constitu-tional context, in dissent, in a case involv-ing the use of psychiatric medication onmental patients without their consent. InWashington v. Harper, 494 U.S. 210, 237,110 S.Ct. 1028, 1045, 108 L.Ed.2d 178, 208(1990), Justice Stevens said:

‘‘The Court has undervalued respon-dent’s liberty interest; has misread theWashington involuntary medication Poli-cy TTT, and has concluded that a mocktrial before an institutionally biased tri-bunal constitutes ‘due process of law.’ ’’[Citation omitted.]

In footnote two of his dissent, Justice Ste-vens noted:

‘‘([T]he Constitution’s promise of dueprocess of law guarantees at least com-pensation for violations of the principlestated by the Nuremberg Military Tri-bunals ‘that the ‘‘voluntary consent ofthe human subject is absolutely essentialTTT to satisfy moral, ethical and legalconcepts[.’]’’ ’); ([T]he FourteenthAmendment protects the ‘freedom tocare for one’s health and person[.]’)’’

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

As can be seen from the letter from theJohns Hopkins University Joint Commit-tee on Clinical Investigation, supra, to theresearchers in this case, Justice Steven’sdoubts as to the effectiveness of such in-house review to assess the ethics of re-search were warranted. Here, the IRB,whose primary function was to insuresafety and compliance with applicable reg-ulations, encouraged the researchers tomisrepresent the purpose of the researchin order to bring the study under the labelof ‘‘therapeutic’’ and thus under a lowersafety standard of regulation. The IRB’spurpose was ethically wrong, and its un-derstanding of the experiment’s benefit in-correct.

The conflicts are inherent. This wouldbe especially so when science and privateindustry collaborate in search of materialgains. Moreover, the special relationshipbetween research entities and human sub-jects used in the research will almost al-ways impose duties.

In respect to examining that special re-lationship, we are obliged to further exam-ine its nature and its ethical constraints.In that regard, when contested cases arise,the assessment of the legal effect of re-search on human subjects must always besubject to judicial evaluation. One methodof making such evaluations is the initiation


of appropriate actions bringing such mat-ters to the attention of the courts, as hasbeen done in the cases at bar. It may wellbe that in the end, the trial courts willdetermine that no damages have been in-curred in the instant cases and thus theactions will fail for that reason. In thatregard, we note that there are substantialfactual differences in the Higgins and inthe Grimes cases. But the actions, them-selves, are not defective on the groundthat no legal duty can, according to thetrial courts, possibly exist. For the rea-sons discussed at length in the main bodyof the opinion, a legal duty normally existsbetween researcher and subject and in allprobability exists in the cases at bar.Moreover, as we shall discuss, the con-sents of the parents in these cases underMaryland law constituted contracts creat-ing duties. Additionally, under Marylandlaw, to the extent parental consent canever be effective in research projects ofthis nature, the parents may not have beensufficiently informed and, therefore, theconsents ineffective and, based on the in-formation contained in the sparse recordsbefore this court, the research project,may have invaded the legal rights of thechildren subjected to it.

I. The Cases

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

Two separate negligence actions involv-ing children who allegedly developed ele-vated levels of lead dust in their bloodwhile participating in a research studywith respondent, Kennedy Krieger Insti-tute, Inc., (KKI) are before this Court.Both cases allege that the children werepoisoned, or at least exposed to the risk ofbeing poisoned, by lead dust due to negli-gence on the part of KKI. Specifically,they allege that KKI discovered lead haz-

ards in their respective homes and, havinga duty to notify them, failed to warn in atimely manner or otherwise act to preventthe children’s exposure to the known pres-ence of lead. Additionally, plaintiffs al-leged that they were not fully informed ofthe risks of the research.

In the first case, Number 128, appellant,Ericka Grimes, by her mother ViolaHughes, appeals from a ruling of the Cir-cuit Court for Baltimore City grantingKKI’s motion for summary judgmentbased on the sole ground that as a matterof law there was no legal duty, under thecircumstances here present, on the part ofKKI, owed to the appellants. In the sec-ond case, Number 129, appellant, MyronHiggins, by his mother Catina Higgins,and Catina Higgins, individually, appealfrom a ruling of the Circuit Court forBaltimore City granting KKI’s motion forsummary judgment based on the groundthat KKI had no legal duty to warn themof the presence of lead dust. The parties,in their respective appeals, presented al-most identical issues to the Court of Spe-cial Appeals. Prior to consideration bythat court, we granted certiorari to ad-dress these similar issues. We rephrasethe issues in both cases in the languagepresented by appellants in Case Number129:

‘‘Was the trial court incorrect in rulingon a motion for summary judgment thatas a matter of law a research entityconducting an ongoing non-therapeuticscientific study does not have a duty towarn a minor volunteer participantand/or his legal guardian regarding dan-gers present when the researcher hasknowledge of the potential for harm tothe subject and the subject is unawareof the danger?’’ 10

10. Appellant, in Case No.128, phrased the question in similar language: ‘‘Did the Circuit


We answer in the affirmative. The trialcourt was incorrect. Such research pro-grams normally create special relation-ships and/or can be of a contractual na-ture, that create duties. The breaches ofsuch duties may ultimately result in viablenegligence actions. Because, at the veryleast, there are viable and genuine dis-putes of material fact concerning whethera special relationship, or other relation-ships arising out of agreements, giving riseto duties existed between KKI and bothsets of appellants, we hold that the CircuitCourt erred in granting KKI’s motions forsummary judgment in both cases beforethis Court. Accordingly, we vacate therulings of the Circuit Court for BaltimoreCity and remand these cases to that courtfor further proceedings consistent withthis opinion.

II. Facts & Procedural Background

A. The Research Study

In 1993, The Environmental ProtectionAgency (EPA) awarded Contract 68–D4–0001, entitled ‘‘Evaluation of Efficacy ofResidential Lead Based Paint Repair andMaintenance Interventions’’ to KKI. KKIwas to receive $200,000 for performing itsresponsibilities under the contract. It wasthus a compensated researcher. The pur-pose of this research study was ‘‘to charac-terize and compare the short and long-term efficacy of comprehensive lead-paintabatement and less costly and potentially

more cost-effective Repair and Mainte-nance interventions for reducing levels oflead in residential house dust which in turnshould reduce lead in children’s blood.’’As KKI acknowledged in its Clinical Inves-tigation Consent Form, ‘‘[L]ead poisoningin children is a problem in Baltimore Cityand other communities across the country.Lead in paint, house dust and outside soilare major sources of lead exposure forchildren. Children can also be exposed tolead in drinking water and other sources.’’Lead poisoning poses a distinct danger toyoung children. It adversely effects cogni-tive development, growth, and behavior.Extremely high levels have been known toresult in seizures, coma, and even death.See Centers for Disease Control and Pre-vention. Recommendations for BloodLead Screening of Young Children En-rolled in Medicaid: Targeting a Group atHigh Risk, 49 Morbidity and MortalityWeekly Report 1 (Dec. 8, 2000).

Dr. Mark R. Farfel Sc.D., Director ofKKI’s Lead Abatement Department, testi-fied in his deposition:

‘‘The scientific goal of the study is todocument the longevity of various leadbase paint abatement strategies, fac-tored in terms of reducing lead exposurein house dust and the children’s bloodlead levels.11

TTT

Court err in ruling that a research entityconducting a study does not owe a duty to ahuman subject participating in the studywhen the researcher obtains knowledge of thepotential for harm to the participant who isunaware of the danger?’’

We resolve these issues in the context of thetrial court’s granting of the appellee’s motionsfor summary judgment.

11. From the context, Dr. Farfel was referringto children in general when making this re-mark. The purpose of the study was mani-

festly not to reduce the level of lead in theblood of the children that were the subjects ofthe study, but to create a controlled researchenvironment focusing on abatement of leaddust. The success of the various abatementprocedures would be measured, in significantpart, not by reducing the levels of lead in thechildren’s blood, but by periodic measure-ments of the level of lead in their blood.Thus, it reasonably can be argued that it wasnot in KKI’s interest for the children to leavethe experiment prior to its conclusion.


A. Our study design called for collec-tion of blood lead, venous blood leadfrom participating children.

TTT

TTT [S]tudy protocol called for serialblood lead levels corresponding with thedust collection campaignsTTTT [T]hestudy goal was to get a baseline, twomonths, six months, twelve months,eighteen months evaluation.

TTT

TTT The study protocol, the data col-lection protocol was to get close in timethe environmental measurements andthe venous blood lead.’’ [Emphasis add-ed.]

The research study was sponsored joint-ly by the EPA and the Maryland Depart-ment of Housing and Community Develop-ment (DHCD). It was thus a joint federaland state project. The Baltimore CityHealth Department and Maryland Depart-ment of the Environment also collaboratedin the study. It appears 12 that, becausethe study was funded and sponsored inpart by a federal entity, certain federalconditions were attached to the fundinggrants and approvals. There are certainuniform standards required in respect tofederally funded or approved projects.We, however, are unaware of, and have notbeen directed to, any federal or state stat-ute or regulation that imposes limits onthis Court’s powers to conduct its reviewof the issues presented. None of the par-

ties have questioned this Court’s jurisdic-tion in these cases. Moreover, 45 CodeFederal Regulations (C.F.R.) 46.116(e)specifically provides: ‘‘The informed con-sent requirements in this policy are notintended to preempt any applicable feder-al, state, or local laws which require addi-tional information to be disclosed in orderfor informed consent to be legally effec-tive.’’ Those various federal or state con-ditions, recommendations, etc., may wellbe relevant at a trial on the merits as towhether any breach of a contractual orother duty occurred, or whether negli-gence did, in fact, occur; but have nolimiting effect on the issue of whether, atlaw, legal duties, via contract or ‘‘specialrelationships’’ are created in Maryland inexperimental nontherapeutic research in-volving Maryland children.

The research study included five testgroups, each consisting of twenty-fivehouses The first three groups consisted ofhouses with a considerable amount of leaddust present therein 13 and each group re-ceived assigned amounts of maintenanceand repair. The fourth group consisted ofhouses, which at one time had lead presentin the form of lead based paint but hadsince received a supposedly completeabatement of lead dust. The fifth groupconsisted of modern houses, which hadnever had a presence of lead dust. Theaim of the research study was to analyzethe effectiveness of different degrees of

12. These cases were decided below by pre-trial motions for summary judgment. Therecord is therefore not extensive.

13. For purposes of this study, the researchersconsidered lead in dust elevated if it wasmore than or equal to 200 micrograms persquare foot for floors, more than or equal to500 micrograms per square foot for windowsills, and more than or equal to 800 micro-grams per square foot for window wells.These were the maximum allowable levels or‘‘clearance standards’’ that the Maryland De-

partment of the Environment (MDE) had saidmust be met following full lead dust abate-ments. COMAR § 26.02.07.12. We note thatthese ‘‘clearance standards’’ only apply to ful-ly abated houses wherein all the lead dust hasbeen removed, not to houses, which have notbeen abated and still have lead dust present,as is the case in Groups 1, 2, and 3 discussed,infra. Additionally, the parties disagree as wediscuss, infra notes 26 and 28, as to the ap-propriate method for obtaining and analyzingaccurately such dust samples.


partial lead paint abatement in reducinglevels of lead dust present in these houses.The ultimate aim of the research was tofind a less than complete level of abate-ment that would be relatively safe, buteconomical, so that Baltimore landlordswith lower socio-economical rental unitswould not abandon the units. The re-search study was specifically designed, inpart, to do less than comprehensive leadpaint abatement in order to study the po-tential effectiveness, if any, over a periodof time, of lesser levels of repair and main-tenance on the presence of lead dust bymeasuring the presence of lead in theblood of theretofore (as far as the recordof the cases reveals) healthy children. Inessence, the study at its inception wasdesigned not only to test current levels oflead in the blood of the children, but theincrease or decrease in future lead levelsin the blood that would be affected by thevarious abatement programs. It appearsthat this study was also partially motivat-ed, as we have indicated, supra, by thereaction of property owners in BaltimoreCity to the cost of lead dust abatement.The cost of full abatement of such housingat times far exceeded the monetary worthof the property—in other words, the costof full abatement was simply too high forcertain landlords to be able to afford topay or be willing to pay. As a result, somelower level rental properties containinglead based paint in Baltimore had beensimply abandoned and left vacant. Thestudy was attempting to determine wheth-

er a less expensive means of rehabilitationcould be available to the owners of suchproperties.

One way the study was designed to mea-sure the effectiveness of such abatementmeasures was to measure the lead dustlevels in the houses at intervals and tocompare them with the levels of leadfound, at roughly the same intervals, in theblood of the children living in the respec-tive houses. The project required thatsmall children be present in the houses.To facilitate that purpose, the landlordsagreeing to permit their properties to beincluded in the studies were encouraged, ifnot required, to rent the properties totenants who had young children.

In return for permitting the propertiesto be used and in return for limiting theirtenants to families with young children,KKI assisted the landlords in applying forand receiving grants or loans of money tobe used to perform the levels of abatementrequired by KKI for each class of home.

The research study was to be composedof two main components and a total of fivegroups of study houses.14 The first com-ponent of the study concerned the firstthree groups of houses. Houses in eachgroup received different amounts of repairand maintenance.15 The following threegroups of houses within the first compo-nent of the research study were:

Group 1—Repair & Maintenance LevelI—Properties receiving a minimal levelof repair and maintenance ($1,650.00).

14. We have taken the liberty of referring tothe test groups as Groups 1, 2, 3, 4, and 5 inan attempt to clarify the verbiage of this opin-ion due to the fact that the research study didnot provide abbreviated names for Groups 4and 5.

15. Although the EPA funded and co-spon-sored the cost of the actual research, thefunds provided for maintenance and repair ofthe houses were provided by loans made by

DHCD through the Lead Paint AbatementProgram established by the General Assem-bly. Maryland Code (1957, 1988 Repl.Vol.,1990 Cum.Supp.), Art. 83B §§ 2–301 through2–313. On July 1, 1995, these loans weremade through the Lead Hazard ReductionLoan Program as enacted by 1995 MarylandLaws, Chapter 335. See Maryland Code(1957, 1998 Repl.Vol.), Art. 83B §§ 2–1401through 2–1411.


Group 2—Repair & Maintenance LevelII—Properties receiving a greater levelof repair and maintenance ($3,500.00).Group 3—Repair & Maintenance LevelIII—Properties receiving an even great-er level of repair and maintenance($6,000.00–$7,000.00).

Repair & Maintenance Level I interven-tions were capped by DHCD at $1,650 andincluded wet-scraping of peeling and flak-ing lead-based paint and paint of unknowncomposition on all interior surfaces, includ-ing walls, trim, and doors; repainting oftreated surfaces; installation of windowwell caps; repainting of all exterior win-dow trim, repainting of all interior windowsills; vacuuming of all horizontal surfacesand window components with a high effi-ciency particulate (HEPA) vacuum; andwet cleaning all horizontal surfaces. LevelII interventions were capped by DHCD at$3,500 and included all the elements ofLevel I intervention plus two key addition-al elements: use of sealants and paints tomake floors smoother and more easilycleanable, and in-place window and doortreatments to reduce abrasion of lead-painted surfaces. Level III interventionswere capped by DHCD at $6,000–$7000and added window replacement and encap-sulation of exterior door trim with alumi-num, and the use of coverings on somefloors and stairs to make them smooth andmore easily climbable.16

Measurements of lead in the blood of thechildren and vacuum dust samples fromthe houses were to be obtained at thefollowing times: pre-intervention, immedi-ately post intervention, and one, three, six,twelve, eighteen, and twenty-four monthspost intervention. Measurements of leadin the exterior soil were to be obtained atpre-intervention, immediately post inter-vention, and twelve and twenty-four

months post intervention. Measurementsof lead in drinking water were to be ob-tained at pre-intervention, and twelve andtwenty-four months post intervention.Additionally, the parents of the child sub-jects of the study were to fill out a ques-tionnaire at enrollment and at six-monthintervals.

The second component of the researchstudy was composed of two control groups:

Group 4—Properties identified as havingpreviously been completely abated oflead paint which were to receive no addi-tional repair and maintenance.Group 5—Modern Urban Dwellings—Properties constructed after 1980 andpresumed not to have lead-based paintwhich were to receive no repair andmaintenance.

The study called for similar collection andevaluation of blood, dust samples, soil, anddrinking water for lead content at similartime intervals as the first component.Measurements of lead in blood of the chil-dren and in vacuum dust samples in thesehouses were to be obtained at enrollmentand six, twelve, eighteen, and twenty-fourmonths post enrollment. Measurementsof lead in the exterior soil and drinkingwater were to be obtained at enrollment,and at twelve and twenty-four months postenrollment. The participants in the fourthand fifth groups were instructed to fill outa questionnaire at enrollment and at six-month intervals.

The research study was to collect datafrom all five groups over a period of twoyears. There were two sets of criteria forenrollment in the research study—one forthe properties and one for the residents.With respect to the properties involved inthe first three test groups, the researcherswere looking for structurally sound prop-

16. The descriptions of what repairs and main-tenance were conducted at the different levels

of intervention were provided by KKI’s briefto this Court in Case Number 129.


erties that had been built prior to 1941 17

or had documented lead-based paint in theunit based upon XRF testing.18 As Dr.Farfel testified in his deposition, ‘‘We werebasically looking for the two-story, six-room rowhouse in Baltimore City with 8 to10 windows in a structurally sound condi-tion.’’ Once a property was selected foruse in the study, it was randomly assigneda repair and maintenance intervention lev-el of I, II, or III.19

With respect to the occupants, the re-searchers recruited families that had atleast one small child. Dr. Farfel testified:

‘‘For the family participant side, wewere looking for families that obviouslywere willing to cooperate with the studyby signing informed consent statements.We were looking for families that had atleast one child under the age of 48months and older than five months atthe start of the study. These childrenwere not to be mentally retarded orseverely handicapped in any way thatwould limit their physical movement.

We were also excluding children thathad sickle cell anemia, to the best of ourknowledge, had sickle cell anemia.

We asked the families if they had anyimmediate plans to move. If they did,then they weren’t eligible because wewere interested in following the familyover a period of years.’’

In summary, KKI conducted a study offive test groups of twenty-five houses

each.20 The first three groups consisted ofhouses known to have lead present. Theamount of repair and maintenance con-ducted increased from Group 1 to Group 2to Group 3. The fourth group consisted ofhouses, which had at one time lead presentbut had since allegedly received a com-plete abatement of lead dust. The fifthgroup consisted of modern houses, whichhad never had the presence of lead dust.The twenty-five homes in each of the firstthree testing levels were then to be com-pared to the two control groups: the twen-ty-five homes in Group 4 that had previ-ously been abated and the 25 modernhomes in Group 5. The research study wasspecifically designed to do less than fulllead dust abatement in some of the catego-ries of houses in order to study the poten-tial effectiveness, if any, of lesser levels ofrepair and maintenance.

If the children were to leave the housesupon the first manifestation of lead dust, itwould be difficult, if not impossible, to test,over time, the rate of the level of leadaccumulation in the blood of the childrenattributable to the manifestation. In otherwords, if the children were removed fromthe houses before the lead dust levels intheir blood became elevated, the testswould probably fail, or at least the datathat would establish the success of thetest—or of the abatement results, wouldbe of questionable use. Thus, it wouldbenefit the accuracy of the test, and thus

17. For purposes of the study, lead dust waspresumed to be present in buildings built pri-or to 1941. The same requirements con-trolled selection of Group 4 except that thoseproperties had allegedly been fully abated.

18. XRF refers to ‘‘an x-ray fluorescence ana-lyzer which measures the lead content inpaint and other materials.’’ COMAR§ 26.16.01.02(27).

19. Actually, the random assignment wasslightly more involved. Assignment was

based on whether the property was currentlybeing used as a residence. Occupied dwell-ings were assigned either Level I or Level IIintervention at a ratio of 2:1. Vacant dwell-ings were assigned either Level III or Level IIat a ratio of 2:1. The result was an equaldistribution of houses into each of the threegroups.

20. The record indicates that only 108 housesactually participated in the study as opposedto 125.


KKI, the compensated researcher, if chil-dren remained in the houses over the peri-od of the study even after the presence oflead dust in the houses became evident.

B. Case No. 128

Appellant, Ericka Grimes, resided at1713 N. Monroe Street in Baltimore, Ma-ryland (the Monroe Street property) withmembers of her family from the time ofher birth on May 30, 1992, up until thesummer of 1994. Her mother, ViolaHughes, had lived in the property sincethe Summer of 1990. In March 1993, rep-resentatives of KKI came to Ms. Hughes’shome and successfully recruited her toparticipate in the research study. After adiscussion regarding the nature, purpose,scope, and benefits of the study, Ms.Hughes agreed to participate and signed aConsent Form dated March 10, 1993.

Nowhere in the consent form was itclearly disclosed to the mother that theresearchers contemplated that, as a resultof the experiment, the child might accumu-late lead in her blood, and that in order forthe experiment to succeed it was necessarythat the child remain in the house as thelead in the child’s blood increased or de-creased, so that it could be measured.The Consent Form states in relevant part:

‘‘PURPOSE OF STUDY:As you may know, lead poisoning inchildren is a problem in Baltimore Cityand other communities across the coun-try. Lead in paint, house dust and out-side soil are major sources of lead expo-

sure for children. Children can also beexposed to lead in drinking water andother sources. We understand thatyour house is going to have special re-pairs 21 done in order to reduce exposureto lead in paint and dust. On a randombasis, homes will receive one of two lev-els of repair. We are interested in find-ing out how well the two levels of repairwork. The repairs are not intended, orexpected, to completely remove expo-sure to lead.

We are now doing a study to learn abouthow well different practices work forreducing exposure to lead in paint anddust. We are asking you and over onehundred other families to allow us totest for lead in and around your homesup to 8 to 9 times over the next twoyears provided that your house qualifiesfor the full two years of study. Finaleligibility will be determined after theinitial testing of your home. We arealso doing free blood lead testing ofchildren aged 6 months to 7 years, up to8 to 9 times over the next two years.We would also like you to respond to ashort questionnaire every 6 months.This study is intended to monitor theeffects of the repairs and is not intendedto replace the regular medical care yourfamily obtains.

TTT

BENEFITS

To compensate you for your time an-swering questions and allowing us to

21. This Consent Form refers to repairs thatwere to be made to the Monroe Street proper-ty. KKI contends in its briefs to this Courtthat appellant’s residence had already beencompletely abated as of October 15, 1990, andwas not to be subjected to repairs and mainte-nance because it was a member of one of thecontrol groups, Group 4. The evidence sug-gests and the parties appeared to agree dur-ing oral argument before this Court that theMonroe Street property was a member of

Group 4. Regardless, because we are review-ing this matter in the context of the grantingof summary judgment based upon a trialcourt determination that no duty existed as amatter of law and, on remand, the facts ofeach case will, of necessity, need to be ad-dressed, we do not need to resolve to whichgroup it was a member or whether there was,as a matter of fact, a breach of duty in thatcase, or even damages for that matter.


sketch your home we will mail you acheck in the amount of $5.00. In thefuture we would mail you a check in theamount of $15 each time the full ques-tionnaire is completed. The dust, soil,water, and blood samples would be test-ed for lead at the Kennedy Krieger In-stitute at no charge to you. We wouldprovide you with specific blood-lead re-sults. We would contact you to discussa summary of house test results andsteps that you could take to reduce anyrisks of exposure.’’ [Emphasis added.]

Pursuant to the plans of the researchstudy, KKI collected dust samples in theMonroe Street property on March 9, 1993,August 23, 1993, March 9, 1994, September19, 1994, April 18, 1995, and November 13,1995.22 The March 9, 1993 dust testingrevealed what the researchers referred toas ‘‘hot spots’’ where the level of lead was‘‘higher than might be found in a complete-ly renovated [abated] house.’’ This infor-mation about the ‘‘hot spots’’ was not fur-nished to Ms. Hughes until December 16,1993, more than nine months after thesamples had been collected and, as wediscuss, infra, not until after ErickaGrimes’s blood was found to contain ele-vated levels of lead.

KKI drew blood from Ericka Grimes forlead content analysis on April, 9, 1993,September 15, 1993, and March 25, 1994.Unlike the lead concentration analysis indust testing, the results of the blood test-ing were typically available to KKI in amatter of days. KKI notified Ms. Hughesof the results of the blood tests by lettersdated April 9, 1993, September 29, 1993,and March 28, 1994, respectively. Theresults of the April 9, 1993 test foundEricka Grimes blood to be less than 9 Sg/dL, which placed her results in the‘‘normal’’ range according to classificationsestablished by the Centers for DiseaseControl (CDC).23 However, on two subse-quent retests, long after KKI had identi-fied ‘‘hot spots,’’ but before KKI informedMs. Hughes of the ‘‘hot spots,’’ ErickaGrimes’s blood lead level registered ClassIII—32 mg/dL on September 15, 1993 and22 mg/dL on March 25, 1994. Ms. Hughesand her daughter vacated the MonroeStreet property in the Summer of 1994,and, therefore, no further blood sampleswere obtained by KKI after March 25,1994.

In her Complaint filed in the CircuitCourt for Baltimore City, Ms. Hughessought to hold KKI liable for negligencefor failing to warn of, or abate, lead-paint

22. For some unexplained reason, processingthe dust samples typically took severalmonths. KKI notified Ms. Hughes of the dustsample results via letters dated December 16,1993, December 17, 1993, May 19, 1994, Oc-tober 28, 1994, July 19, 1995, and January 18,1996, respectively. As we discussed, supra,appellant moved out of the Monroe Streetproperty in the Summer of 1994, after thefirst three dust samples were both collected,and the results presented, to Ms. Hughes.

23. mg/dL is an abbreviation for microgramsper deciliter. A reading of 9 mg/dL means thatthe child had 9 micrograms of lead for everydeciliter of blood. See generally Jones v. Mid–Atlantic Funding Co., 362 Md. 661, 668–69 n.12, 766 A.2d 617, 621 n. 12 (2001). At the

time Ericka Grimes was tested for lead poi-soning, the CDC used the following nomen-clature to classify blood lead concentrationsin children:

Class I (Normal)—less than or equal to 9 Sg/dLClass IIA (Moderately elevated)—10–14 Sg/dLClass IIB (Moderately elevated)—15–19 Sg/dLClass III (Highly elevated)—20–44 mg/dLClass IV (Urgently elevated)—45–69 mg/dLClass V (Critically elevated)—greater thanor equal to 70 mg/dL

See Preventing Lead Poisoning in Young Chil-dren, Centers for Disease Control (October 1,1991).


hazards that KKI allegedly discovered inthe Monroe Street property during theresearch study. Specifically, she alleged:

‘‘3. As part of the [Research] Study,[appellant’s] mother agreed to allow[KKI] to periodically inspect the MonroeStreet property for the presence of lead-paint hazards. Upon inspection, [KKI]discovered the existence of lead-painthazards within [appellant’s] home, butfailed to inform and/or warn [appellant]and her mother of such hazards andfailed to take any action to abate saidhazards. As a consequence, [appellant]and her mother continued to reside inthe home unaware of the hazards andunaware of the dangers to which [appel-lant] was being exposed.’’

KKI filed a Third Party Complaintagainst JJB, Inc., (JJB) the owners of theMonroe Street property. Appellant filedan Amended Complaint to add JJB as anadditional defendant alleging negligenceand violations of the Maryland ConsumerProtection Act. KKI filed a Motion forSummary Judgment on the grounds that itdid not owe any duty to appellant that ithad breached. On July 26, 2000, the Cir-cuit Court for Baltimore City grantedKKI’s motion and entered judgment infavor of KKI. Appellant dismissed herclaims against JJB and filed a Notice ofAppeal on September 12, 2000. On Febru-ary 8, 2001, prior to consideration by theCourt of Special Appeals, we issued a Writof Certiorari.

On appeal, appellant seeks review of theCircuit Court’s decision granting KKIsummary judgment. She contends thatKKI owed a duty of care to appellantbased on the nature of its relationship withappellant and her mother arising out of:

(1) a contract between the parties; (2) avoluntary assumption by KKI; (3) a ‘‘spe-cial relationship’’ between the parties; and(4) a Federal regulation. She argues thatKKI’s failure to notify her of the lead dusthazards in the Monroe Street propertyuntil after more than nine months hadpassed since the samples had been collect-ed, and until after Ericka Grimes’s bloodwas found to be lead poisoned, constitutednegligence on the part of KKI in the per-formance of its duties to Ericka arising outof the nature of the relationship betweenthe parties.

C. Case No. 129

In 1993, Mr. Polakoff, a professionalowner and operator of rental properties,had been recruited as a landlord by KKIthrough the Property Owners Association,to volunteer the Federal Street propertyto the research study. His property metthe researchers’ criteria, which we dis-cussed, supra—that it was a structurallysound property, built prior to 1941, thathad documented levels of lead-based paintin the unit. In December of 1993, KKIhad Mr. Polakoff’s property tested by anoutside contractor and it tested positive forlead paint and dust throughout the house.Once accepted into the program, Mr. Pola-koff’s property was randomly assigned aRepair & Maintenance Level II interven-tion and subsequently underwent the re-pairs associated with Level II intervention,discussed, supra, by Environmental Resto-ration, Inc. (Environmental). Mr. Polakoffapplied for a $3,500 loan from the Mary-land Department of the Environment topay for the repairs, which was granted.The repairs were completed in approxi-mately April 1994.24

24. Mr. Polakoff, a landlord, or a landlord’srepresentative, testified in deposition aboutthe properties that KKI recruited into theprogram:

‘‘Q. It’s my understanding that this housewas subject to a study out of Kennedy Insti-tute—

A. That is correct.


Appellant, Myron Higgins, was born onDecember 23, 1989. According to Ms. Ca-tina Higgins’s deposition testimony, duringthe Spring of 1994 she was looking for ahome in which to reside with her severalsmall children. She located the propertyknown as 1906 East Federal Street (theFederal Street property) in an advertise-ment in the local newspaper listing theproperty as a rental for $315 per month.She rented the property from CFOD–2Limited Partnership.25 She signed a leasefor the property on May 13, 1994 andmoved in shortly thereafter.

On May 17, 1994, KKI collected andanalyzed immediate post intervention sam-ples of dust using an experimental Cyclonedust collector.26 A composite sample ofdust from the first floor was 533 mg/ft 2,27 acomposite sample of the first floor window-sill was 2274 mg/ft 2, and a composite sam-ple of the interior entrance was 1530 Sg/ft 2. On July 25, 1994, pursuant to theprotocols of the research study, a secondseries of dust samples were obtained fromthe Federal Street property. While sever-al of the first floor lead dust levelsdropped in value, this second sample foundthat lead dust in the second floor area,

TTT

A. I voluntarily put this property into TTT

[the] studyTTTT After that [partial abatement],a tenant with TTT at least one child under theage of three would have to move into theproperty. The child and the property wouldbe periodically tested—the children throughblood testsTTTT

TTT

A. Well, they [KKI] actually solicited meand they were looking for vacant proper-tiesTTTT

QTTTT What you said is you were aware thatthis program was only to be a partial abate-ment?

A. Yes.’’In an affidavit, Mr. Polokoff stated that KKI‘‘would refer parents with young children tothe Property.’’

25. She rented the property from CFOD–2Limited Partnership, in which Chase Manage-ment, Inc., was a general partner. Mr. Law-rence Polakoff was the President of ChaseManagement, Inc. The property was vacantand had already received the level of leaddust abatement specified by the research pro-tocols. In other words Ms. Higgens was be-ing recruited into moving her child into astudy site that was, intentionally, not com-pletely abated.

26. The parties disagree as to the validity ofthe figures presented by these samples. Ap-parently, KKI used two different dust collect-ing methods, which resulted in drasticallyvaried results. The results discussed abovewere obtained from dust samples collected byan experimental Cyclone vacuum dust collec-

tor. These samples all gave results, whichindicated that the lead present therein was farabove the accepted Maryland clearance levels.See, supra, note 13. However, according toKKI, the clearance levels are based on dustwipe collection not Cyclone collection. KKIpresented evidence that additional sampleswere collected by the dust wipe technique andthat these samples indicated a presence oflead below the Maryland clearance levels.Thus, KKI argues that there was no indicationof a lead hazard in the Federal Street proper-ty and thus no duty to inform appellant of theCyclone samples.

But, in a prior related document, a May 18,1992, renewal request for the study, KKI in-cluded the following renewal justification:‘‘Prior to the start of the main study, weconducted a study of side-by-side dust sam-ples collected by the Kennedy Institute’s tra-ditional wipe method and by the HVS3 cy-clone device selected for use in the mainstudy. We found that the HVS3 samples hadhigher lead loadings than the wipes for allsurface types, TTT possibly attributable to itsbeing more efficient at collecting dust incracks and rough surfaces.’’

As suggested at oral argument by KKI’srepresentative, KKI’s position is that lesserlevels of lead do not constitute a hazard, evenif they constitute a risk. The argument ig-nores the possibility of accumulation of leadin the blood of the children from varioussources.

27. mg/ft 2 refers to micrograms per squarefoot.


which had registered figures under theclearance level in the first sampling, weremarkedly increased.

After the Higgins family moved into thepartially abated, vacant Federal Streetproperty, KKI approached Ms. Higginsand requested that she and her son partici-pate in the research study. Her partic-ipation and consent, in addition to thelandlord’s previous consent for abatementof the property, was necessary to permitKKI to enter the property to collect futuredust samples from the Federal Streetproperty and to obtain blood samples fromher son. On May 24, 1994, Ms. Higginsagreed to participate and signed a ConsentForm regarding her and her child’s partic-ipation in the study. As in Case No. 128the consent form did not contain a cleardisclosure that the researchers contem-plated that, as a result of the experiment,the child subjects might, and perhaps wereanticipated to, accumulate some level oflead contamination of their blood, and thatthe lead content of the children’s bloodwould be one of the methods by which thestudy would determine the effectiveness ofthe various abatement procedures.

Pursuant to the protocols of the re-search study, KKI collected dust samplesin the Federal Street property on May 17,1994, July 25, 1994, and November 3, 1994.KKI informed Ms. Higgins of the dustsample results by letters dated June 24,1994, September 14, 1994, and February 7,1995, respectively. Although KKI had re-corded high levels of lead concentration inthe dust samples collected by the Cyclone

vacuum during the May 17, 1994 visit, KKIfailed to disclose this information to Ms.Higgins in the letter dated June 24, 1994.28

Instead, KKI relied on the results ob-tained from the dust wipe samples collect-ed and informed her that there was noarea in her house where the lead level washigher than what might have been found ina completely renovated house. The dustsamples collected by dust wipe methodolo-gy in July and November showed areasabove the clearance levels and KKI didinform Ms. Higgins of these elevated levelsin the subsequent letters. Ms. Higginscontends that KKI knew of the presence ofhigh levels of lead-based paint and dust inthe Federal Street property as early asDecember of 1993, that even after Level IIintervention it still had high levels as ofJune 24, 1994, and that it was not until shereceived a letter dated September 14, 1994that KKI specifically informed Ms. Hig-gins of the fact that her house had elevat-ed lead levels.

KKI drew blood from Myron Higginsfor lead content analysis on June 8, 1994,July 29, 1994, and November 9, 1994.KKI notified Ms. Higgins of the results ofthe blood tests by letters dated July 18,1994, August 2, 1994, and December 6,1994, respectively. The results of thetests were 17.5 mg/dL, 21 mg/dL, and 11 Sg/dL, respectively. The first and thirdtests placed him in the CDC Class IIAwhile the second test placed him in CDCClass III. KKI told Ms. Higgins that ithad informed the BCHD of the secondresult and that she ‘‘should provide the

28. KKI contends that it had no duty to informMs. Higgins of the high lead concentrationresults obtained from dust samples collectedby the Cyclone vacuum dust collector. KKIargues that the Maryland clearance levels forlead concentration in dust are based solely onthe dust wipe collection technique and not theCyclone vacuum testing. Thus, because theCyclone technique typically gives higher re-

sults, and because the dust wipe samples reg-istered under the clearance levels, KKI arguesthat there was no potential hazard and thusno duty to inform appellants. We have ad-dressed this argument, supra, in footnote 26.Moreover, which process is appropriate, orwhether both are, is in dispute. It is thus amatter to be resolved, if necessary, on re-mand.


test result to [her] child’s primary healthcare provider right away.’’

Ms. Higgins contends that KKI wasnegligent in its failure to inform her of itsknowledge of the high levels of lead dustrecorded by both XRF testing in Decem-ber 1993, prior to her moving into the unitand prior to the abatement modification,and from the samples collected via theCyclone vacuum in May 1994. Ms. Hig-gins asserts that this withholding of infor-mation combined with KKI’s letter datedJune 24, 1994 informing her solely of thelower results of the samples collected bydust wipe methodology was misleading toher as a participant in the study. Sheimplies that it gave her a false sense ofsecurity that there were no potential lead-based paint or dust hazards in her house.

Appellants, Myron Higgins, by his moth-er Catina Higgins, and Catina Higgins,individually, filed suit in the Circuit Courtfor Baltimore City on February 26, 1995against Mr. Polakoff. Appellants amendedtheir Complaint to add Chase Manage-ment, Inc., and CFOD–2 Limited Partner-ship as defendants to this lawsuit.29 OnApril 29, 1999, Appellants further amendedtheir Complaint to add KKI and Environ-mental as additional defendants. In herComplaint filed in the Circuit Court forBaltimore City, Ms. Higgins sought to hold

KKI liable for negligence on several differ-ent grounds. Specifically, she alleged:

‘‘8. Both [KKI] and Environmentalwere negligent in undertaking to abate,paint and repair the premises prior toand/or during the children’s occupancyand doing so in an unreasonable, incom-plete, unworkmanlike and/or illegal man-ner.

9. Both [KKI] and Environmentalwere negligent in performing the leadabatement in such a fashion as to in-crease, rather than decrease, the chil-dren’s exposure to lead, including, butnot limited to, performing the abatementusing methods, which foreseeably in-creased the lead dust in the premises,performing improper or inadequatecleanup, leaving lead debris on thepremises or in the vicinity of the premis-es accessible to the child.

10. Both [KKI] and Environmentalfailed to warn [appellants] or the adultcaretaker of the lead hazard, which[KKI] and Environmental or theiragents knew or should have known orhad reason to know existed in the prem-ises.

11. And [KKI and Environmental]were otherwise negligent.’’

KKI filed a Motion for Summary Judg-ment on the grounds that it did not oweany duty to appellants.30 On April 5, 2000,

29. In 1992, prior to Ms. Higgins beginningher tenancy at the Federal Street property,Polakoff transferred ownership of the proper-ty to CFOD–2, a limited partnership in whichChase was a general partner.

30. It continued to maintain this position atoral argument. In respect to the two cases,the following exchanges occurred:

‘‘[Case No. 128:]The Court: What you’re saying is there’s nodanger to children from lead contained indust?Respondent: Not that has ever been estab-lished by this Court.

The Court: I know that, how about scienti-fic studies, what do they show?Respondent: TTT Children do ingest leadthrough dust. But there’s nothing in therecord about how much is dangerous.

TTT

The Court: TTT It is recognized that housedust is a hazard?Respondent: I agree, and that was the pur-pose of this study was to try to eliminatethat hazard. But in terms of defining whatthat hazard is, the State has done so instatute and regulationTTTT So why thenshould Kennedy have to have a higher dutythan the landlord?


The Court: Because you were testing forsomething the landlord was not obliged toabate, namely dust.The Respondent: But the results nevercame back to the level where it was definedas a hazard.

TTT

The Court: There’s no duty to warn theparent when you find out this information?The Respondent: Not unless it’s of such alevel that it’s a hazard.

TTT

The Court: TTT The consent form apparent-ly said that Kennedy promised to test appel-lant’s home for lead, discuss the resultswith her mother, discuss steps that could betaken to reduce risksTTTT So how is thatkeyed to blood levels? My question is TTT Ifthey’re going to test the home for leadthere’s an agreement to discuss the resultswith the mother and if you find it in thedust isn’t there an obligation to discuss thatwith the mother irrespective of whetherthere’s any elevated blood levels?Respondent: The plaintiff in this case alleg-es that there was a lead hazard in the homethat needed to be discussed. And there wasno hazard in the home. Kennedy did saythat they were going to inform the parentsof the result of the dust tests. No indica-tion as to when; if that would be during thestudy or afterwards.The Court: You don’t think that a partici-pant in the study, when an institute likeKrieger comes in and says that I’m going totell you, doesn’t have a right to rely on thatrepresentation and believe that they’re go-ing to be told of that in a timely fashion,which would mean not at the end of thestudy but when it’s determined?Respondent: I think the expectation wouldbe that they would be told if there were anyproblems. And in this case TTT

The Court: What’s a problem?The Respondent: A problem is a lead haz-ard.

TTT

Respondent: There was no standard at thetime for what constitutes a hazard withrespect to lead dust in homes.The Court: But Kennedy Krieger consid-ered the hot spot levels, TTT and you intend-ed that the occupants of the house act onthat information because you gave themkits and you encouraged them to cleanthose areas better.Respondent: Sure. It’s in the best interestsof the children in the home to have TTT

The Court: How is it in their best interestthen not to advise the parent until 9 monthsafter these tests were taken? [Past the timewhen] they could do something about it?Respondent: These tests TTT were not runimmediatelyTTTT

TTT

The Court: TTT So the only benefit to theparent was the remuneration that was givenfor entering into this informed consent andallowing their children to be a part of thisstudy?The Respondent: It sounds like Your Honoris looking at this informed consent as acontract where each side is getting some-thing out of this. And that’s not the case.The informed consent is just that. It’s Ken-nedy informing the participant what it in-tends to do.

TTT

The Respondent: There was some remuner-ation involved as an incentive to get theparticipants to enroll and continue to followthrough.

TTT

The Court: Kennedy had a reason not totell these parents that their kids were ex-posed to something dangerous, because ifthey did the parents might leave and thekids wouldn’t stay in the study to be studieddown the road. That’s sort of what bothersme an awful lot. If you inform the partici-pants in the study that a danger has arisen,the participants leave the house and they’reno longer in the study and the study getsskewered. And it very specifically says inthe consent agreement that they’re going totest for lead dust TTT seven or eight timesafter the repairs are made and it very spe-cifically says that the results of testing ofthe house will be shared with the parents.They assert that you didn’t do it. That mayvery well be a factual matter, TTT a disputeas to facts TTT you went on a motion forsummary judgment. If there’s a dispute ofmaterial facts, I don’t know how you winon a motion for summary judgment.

TTT

The Respondent: TTT They were all toldwithin the time frame of the study itselfTTTT

Kennedy did nothing to hold back informa-tion to keep people in the study. Theyclearly told everybody if there was somelead in their dust during the studyTTTT

The Court: When you talk about during thestudy you’re talking about the last day, thatincludes the last day of the study, which istwenty-four months down the line.

TTT


The Court: Under your theory, if the studywent on for ten years, it would be O.K. totell them on the last day after the tenyearsTTTT

The Respondent: I’m only dealing with thecase at hand.The Court: Could you answer my question?TTT

The Respondent: If the participant had noreason to expect that the results would beforthcoming sooner.

TTT

The Court: So your position is the dutywould not arise unless the level of the leadin the dust exceeded the level established bysome other standard that wasn’t reachedhere?The Respondent: Yes.

TTT

The Court: Your contract was to protecther against a riskTTTT Why wasn’t that [hotspots] enough to require a warning? Areyou saying that there’s a difference in thewords hazard and risk?The Respondent: There is. That was notwhat she complained of in her complaint.

TTT

Respondent: TTT She claimed that therewas a lead hazard and the hazard wasn’treported.The Court: And you’re saying there wasn’ta hazard even if there was a risk?Respondent: Yes. There’s a risk with every-thing we do. In everything with life,there’s a risk.The Court: You didn’t get summary judg-ment on the ground there was insufficientallegation of a hazard.Respondent: Summary judgment wasgranted because the courtTTTT

The Court: [It was granted because] there’sno contract, no privity, no duty whatsoever,TTT no element of a cause of action. I justcan’t square that with your argument here.Respondent: I don’t see that they’re incon-sistentTTTT

The Court: First of all, he found that therewas no contractTTTT He found that therewas no governmental statute or regulation,which set up this duty. He found that alsodidn’t he? TTT He also found no specialrelationship.

TTT

Respondent: Kennedy needed the partici-pants to stay in the study the full time orthe results just weren’t validTTTT

The Court: Suppose instead of these folksbeing given five dollars and fifteen dollars,TTT for each event, suppose they were of-

fered a thousand dollars for each event,would you say this was a contract? TTT

Would you still argue this wasn’t a con-tract?Respondent: Yes. Because either side couldwithdraw without any claim for breach ofcontract from the other.The Court: You can terminate the contractunilaterally. That doesn’t mean that thereisn’t a contract prior to that pointTTTT

[Case No. 129:]Respondent: To say that the appellant inthis case did not get any benefit from thestudy is pretty disingenuous. What the ap-pellant had the benefit of in this study of[was] being able to live in a home that hadthese repairs done to itTTTT

The Court: A child that has no lead paint,that is normal, moves into a house that hasbeen partially abated and ends up with ele-vated lead paint levels and you say that’s abenefit?Respondent: We don’t know what thischild’s lead levels were before moving intothis home, nor do we know where this childwas poisoned.The Court: I thought your study requiredhealthy children to be included in thestudy?Respondent: Because that was the onlyway to measure if the children did get poi-soned as well asTTTT

TTT

Respondent: No, and this is why it doesn’tbother me. Because these homes were indisrepair. Kennedy went in there and im-proved the home and in this case the homewas improved so that it was below clear-ance standardTTTT This home was madesafe and Kennedy instructed the landlord,‘Put children in these homes that we’vemade safe.The Court: ‘So we can test them [the chil-dren] to see how safe we’ve made them [thehouses]?’Respondent: Yes.The Court: If they’re safe, why test thechildren’s blood?The Respondent: Because they had to see,they were testing to see which levelsworked the best.

TTT

The Court: Weren’t they trying to see howthey could do it most inexpensively?Respondent: Sure. Because there’s a prob-lem in Baltimore City with landlordsTTTT

The Court: But that almost assumes thatthey realize that some of the partial abate-


the Circuit Court granted KKI’s motionand entered judgment in favor of KKI. OnMay 4, 2000, appellants filed a Motion toReconsider, which the Circuit Court de-nied on May 25, 2000. Appellants dis-missed their claims against Polakoff,Chase Management and CFOD–2 LimitedPartnership and filed a Notice of Appealon July 20, 2000. On February 8, 2001,prior to consideration by the Court of Spe-cial Appeals, we issued a Writ of Certiora-ri.

D. The Trial Courts’ Findings

In Case No.128 (Grimes), the trial court,in granting KKI’s motion for summaryjudgment, stated:

‘‘Whether or not there is a duty, theCourt has to look at several factorsTTTT

[1] TTT The Court does not find thatthere is a contract as a matter oflawTTTT The Court does not find thenecessary elements of a contract, that ismutual assent, offer, acceptance, andconsideration, so as to find a bindinglegal agreement by and between theparties.

[2] TTT The Court does not so find aspecial relationship to exist in connectionwith the relationship between KennedyKrieger Institute and the plaintiff andminor plaintiffTTTT I do not find thatthere is a special relationship as at leastexpressed by our courts of appeal so asto justify a duty owed by DefendantKennedy Krieger to the plaintiff.

TTT The Court does not so find that aduty was created as a matter of law bythe statute.’’

In case No.129 (Higgins), KKI argued‘‘plaintiff cannot prove that KennedyKrieger owed any duty to the plaintiff inthis case that would arise to civil liability.’’In granting KKI’s motion for summaryjudgment, the trial court stated:

‘‘On the first instance, I see no duty atall on the part of KKI to inspect or testthis premises or to test the individual.

KKI was sort of an institutional vol-unteer in the community. Coming in tocollect dust and blood samples, the nextthing you know they get sued and Ithink that there is absolutely no duty onthe part of KKI simply because it camein to then assume a higher standard ofTTT [responsibility] in respect to thesefacts.

KKI was not the owner of the proper-ty, not an agent for the owner, it didn’t[accept] other properties from the land-lord. It did not prefer the properties tothe landlord.

There is no basis to suggest that KKIwas anything more than an institutionalvolunteer in that communityTTTT It cer-tainly cannot be raised by virtue of aconsent form to take a blood test. Itcannot be raised to the level of a stan-dard of duty under the law.’’ [Emphasisadded.]

On appeal, appellants seek review of thecircuit courts’ decisions granting KKI’s re-spective summary judgment motions.They contend, contrary to the trial courts’findings, that KKI owed a duty to warnappellants of the presence of lead-basedpaint and dust because: (1) a ‘‘special rela-tionship’’ existed between the parties; (2)of the contractual duty created by the

ments would not be successful. How canyou deny that?Respondent: What they expected was thatdifferent levels of repair would have differ-ent levels of effectiveness over time. Andthat’s what they were testing.

The Court: To see which abatement theycould use most cheaply? To try and abatemore properties in Baltimore City.Respondent: Yeah. I don’t disagree withthat. And all of that was for the benefit ofsociety at large and these children.’’


consent agreement; (3) the danger wasforeseeable; and (4) a Federal regulationexists, which created such a duty. Specifi-cally, they contend that KKI had an affir-mative duty to give appellants completeand accurate information concerning therisks and hazards of participating in thestudy—to include the XRF results and theCyclone vacuum results.

III. Discussion

A. Standard of Review

We resolve these disputes in the contextof the trial court’s granting of the appel-lee’s motions for summary judgment inthe two distinct cases. The threshold is-sues before this Court are whether, in thetwo cases presented, appellee, KKI, wasentitled to summary judgment as a matterof law on the basis that no contract exist-ed and that there is inherently no dutyowed to a research subject by a research-er. Perhaps even more important is theancillary issue of whether a parent in Ma-ryland, under the law of this State, can le-gally consent to placing a child in a nonth-erapeutic research study that carries withit any risk of harm to the health of thechild. We shall resolve all of these pri-mary issues.

[1–3] ‘‘In reviewing a grant of a sum-mary judgment, we are first concernedwith whether a genuine dispute of materialfact exists’’ and then whether the movantis entitled to summary judgment as a mat-ter of law. Williams v. Mayor & CityCouncil of Baltimore, 359 Md. 101, 113,753 A.2d 41, 47 (2000); Hartford Ins. Co.v. Manor Inn of Bethesda, Inc., 335 Md.135, 144, 642 A.2d 219, 224 (1994); Gross v.Sussex, Inc., 332 Md. 247, 255, 630 A.2d1156, 1160 (1993); Beatty v. TrailmasterProds., Inc., 330 Md. 726, 737, 625 A.2d1005, 1011 (1993); Arnold Developer, Inc.v. Collins, 318 Md. 259, 262, 567 A.2d 949,951 (1990); Bachmann v. Glazer & Glazer,

Inc., 316 Md. 405, 408, 559 A.2d 365, 366(1989); King v. Bankerd, 303 Md. 98, 110–11, 492 A.2d 608, 614 (1985). ‘‘A materialfact is a fact the resolution of which willsomehow affect the outcome of the case.’’King, 303 Md. at 111, 492 A.2d at 614(citing Lynx, Inc. v. Ordnance Prods.,Inc., 273 Md. 1, 327 A.2d 502, 509 (1974)).‘‘[A] dispute as to facts relating to groundsupon which the decision is not rested is nota dispute with respect to a material factand such dispute does not prevent theentry of summary judgment.’’ SalisburyBeauty Schs. v. State Bd. of Cosmetolo-gists, 268 Md. 32, 40, 300 A.2d 367, 374(1973).

[4–7] This Court also has stated that‘‘[t]he standard of review for a grant ofsummary judgment is whether the trialcourt was legally correct.’’ Goodwich v.Sinai Hosp. of Baltimore, Inc., 343 Md.185, 204, 680 A.2d 1067, 1076 (1996); seealso Murphy v. Merzbacher, 346 Md. 525,530–31, 697 A.2d 861, 864 (1997); ManorInn, 335 Md. at 144, 642 A.2d at 224;Gross, 332 Md. at 255, 630 A.2d at 1160;Heat & Power Corp. v. Air Prods. &Chems., Inc., 320 Md. 584, 592, 578 A.2d1202, 1206 (1990). As we have said:

‘‘Concerning summary judgment, Ma-ryland Rule 2–501(e) provides: ‘Thecourt shall enter judgment in favor of oragainst the moving party if the motionand response show that there is no gen-uine dispute as to any material fact andthat the party in whose favor judgmentis entered is entitled to judgment as amatter of law.’ In determining whethera party is entitled to judgment underthis rule, the court must view the facts,including all inferences, in the light mostfavorable to the opposing party. Beardv. American Agency, 314 Md. 235, 246,550 A.2d 677 (1988); Kramer v. Bally’sPark Place, 311 Md. 387, 389, 535 A.2d466 (1988); Liscombe v. Potomac Edi-


son Co., 303 Md. 619, 621–22, 495 A.2d838 (1985). The trial court will not de-termine any disputed facts, but rathermakes a ruling as a matter of law.Scroggins v. Dahne, 335 Md. 688, 691,645 A.2d 1160 (1994); Southland Corp.v. Griffith, 332 Md. 704, 712, 633 A.2d 84(1993); Beatty v. Trailmaster, 330 Md.726, 737, 625 A.2d 1005 (1993). Thestandard of appellate review, therefore,is whether the trial court was legallycorrect. See, e.g., Southland, supra, 332Md. at 712, 633 A.2d 84.’’

Baltimore Gas & Electric Co. v. Lane, 338Md. 34, 42–43, 656 A.2d 307, 311 (1995),overruled on other grounds by BaltimoreGas & Electric Co. v. Flippo, 348 Md. 680,705 A.2d 1144 (1998); see also Dobbins v.Washington Suburban Sanitary Comm’n,338 Md. 341, 344, 658 A.2d 675, 676–77(1995). As we said in Ashton v. Brown,339 Md. 70, 660 A.2d 447 (1995):

‘‘In reviewing the grant of summaryjudgment, this Court must consider thefacts reflected in the pleadings, deposi-tions, answers to interrogatories and af-fidavits in the light most favorable to thenon-moving parties, the plaintiffs. Evenif it appears that the relevant facts areundisputed, ‘if those facts are suscepti-ble to inferences supporting the positionof the party opposing summary judg-ment, then a grant of summary judg-ment is improper.’ ’’

Id. at 79, 660 A.2d at 452 (quoting Clea v.Mayor & City Council of Baltimore, 312Md. 662, 677, 541 A.2d 1303, 1310 (1988)).

[8, 9] The purpose of the summaryjudgment procedure is not to try the caseor to decide the factual disputes, but todecide whether there is an issue of fact,which is sufficiently material to be tried.See Goodwich, 343 Md. at 205–06, 680 A.2dat 1077; Coffey v. Derby Steel Co., 291 Md.241, 247, 434 A.2d 564, 567–68 (1981); Ber-key v. Delia, 287 Md. 302, 304, 413 A.2d

170, 171 (1980). Thus, once the movingparty has provided the court with suffi-cient grounds for summary judgment, thenonmoving party must produce sufficientevidence to the trial court that a genuinedispute to a material fact exists. See, e.g.,Hoffman Chevrolet, Inc. v. WashingtonCounty Nat’l Sav. Bank, 297 Md. 691, 712,467 A.2d 758, 769 (1983). With these con-siderations in mind, we turn to the instantcases.

B. General Discussion

Initially, we note that we know of nolaw, nor have we been directed to anyapplicable in Maryland courts, that pro-vides that the parties to a scientific study,because it is a scientific, health-relatedstudy, cannot be held to have entered intospecial relationships with the subjects ofthe study that can create duties, includingduties, the breach of which may give riseto negligence claims. We also are notaware of any general legal precept thatimmunizes nongovernmental ‘‘institutionalvolunteers’’ or scientific researchers fromthe responsibility for the breaches ofduties arising in ‘‘special relationships.’’Moreover, we, at the very least, hold that,under the particular circumstances testi-fied to by the parties, there are genuinedisputes of material fact concerning wheth-er a special relationship existed betweenKKI and Ericka Grimes, as well as be-tween KKI and Ms. Higgins and MyronHiggins. Concerning this issue, the grant-ing of the summary judgment motions wasclearly inappropriate. When a ‘‘special re-lationship’’ can exist as a matter of law, theissue of whether, given certain facts, aspecial relationship does exist, when thereis a dispute of material fact in that respect,is a decision for the finder of fact, not thetrial judge. We shall hold initially that thevery nature of nontherapeutic scientific re-search on human subjects can, and normal-


ly will, create special relationships out ofwhich duties arise. Since World War IIthe specialness or nature of such relation-ships has been frequently of concern inand outside of the research community.

As a result of the atrocities performed inthe name of science during the Holocaust,and other happenings in the World War IIera, what is now known as The NurembergCode evolved. Of special interest to thisCourt, the Nuremberg Code, at least insignificant part, was the result of legalthought and legal principles, as opposed tomedical or scientific principles, and thusshould be the preferred standard for as-sessing the legality of scientific researchon human subjects. Under it, duties toresearch subjects arise.

‘‘Following the Doctors’ Trial (the ‘Medi-cal Case’), which included charges ofconducting lethal studies of the effects ofhigh altitude and extreme cold, the ac-tion of poisons, and the response to vari-ous induced infections, the court issued‘The Nuremberg Code’ as a summary ofthe legal requirements for experimenta-tion on humans. The Code requiresthat the informed, voluntary, competent,and understanding consent of the re-search subject be obtained. Althoughthis principle is placed first in the Code’sten points, the other nine points must besatisfied before it is even appropriate toask the subject to consent.

The Nuremberg Code is the ‘mostcomplete and authoritative statement ofthe law of informed consent to humanexperimentation.’ It is also ‘part of in-ternational common law and may be ap-

plied, in both civil and criminal cases, bystate, federal and municipal courts in theUnited States.’ However, even thoughthe courts in the United States may usethe Nuremberg Code to set criminal andcivil standards of conduct, none haveused it in a criminal case and only ahandful have even cited it in the civilcontext. Even where the NurembergCode has been cited as authoritative, ithas usually been in dissent, and no Unit-ed States court has ever awarded dam-ages to an injured experimental subject,or punished an experimenter, on the ba-sis of a violation of the NurembergCode. There have, however, been veryfew court decisions involving human ex-perimentation. It is therefore very diffi-cult for a ‘common law’ of human experi-mentation to develop. This absence ofjudicial precedent makes codes, especial-ly judicially-crafted codes like the Nu-remberg Code, all the more important.’’[Footnotes omitted.] [Emphasis added.]

George J. Annas, Mengele’s Birthmark:The Nuremberg Code in United StatesCourts, 7 Journal of Contemporary HealthLaw & Policy 17, 19–21 (Spring, 1991)(citing in part to J. Appleman, MilitaryTribunals and International Crimes 141;1 Trials of War Criminals Before Nurem-berg Military Tribunals Under ControlCouncil Law No. 10, 11–14 (1946–1949); 2Trials of War Criminals Before Nurem-berg Military Tribunals Under ControlCouncil Law No. 10, 181–82 (1946–1949);G. Annas, L. Glantz & B. Katz, InformedConsent to Human Experimentation: TheSubject’s Dilemma 21 (1977)).31

31. The complete text of the Nuremberg Codeis as follows:

‘‘1. The voluntary consent of the humansubject is absolutely essential.This means that the person involved shouldhave legal capacity to give consent; shouldbe so situated as to be able to exercise freepower of choice, without the intervention

of any element of force, fraud, deceit, du-ress, over-reaching, or other ulterior formof constraint or coercion; and should havesufficient knowledge and comprehension ofthe elements of the subject matter involvedas to enable him to make an understandingand enlightened decision. This latter ele-ment requires that before the acceptance of


‘‘Why wasn’t the Nuremberg Code im-mediately adopted by United Statescourts as setting the minimum standardof care for human experimentation?One reason, perhaps, is that there waslittle opportunity. As remains true to-day, almost no experiments resulted inlawsuits in the 1940’s, 50’s, and 60’s. Asecond reason may be that the Naziexperiments were considered so extremeas to be seen as irrelevant to the UnitedStates. This may explain why our ownuse of prisoners, the institutionalized re-tarded, and the mentally ill to test ma-laria treatments during World War IIwas generally hailed as positive, makingthe war ‘everyone’s war.’ Likewise, inthe late 1940’s and early 1950’s, the test-ing of new polio vaccines on institution-alized mentally retarded children was

considered appropriate. Utilitarianismwas the ethic of the dayTTTT Noting thatthe Code applied primarily to the type ofoutrageous nontherapeutic experimentsconducted during the war, physiciangroups tended to find the Code too ‘le-galistic’ and irrelevant to their therapeu-tic experiments,’ and set about to devel-op an alternative code to guide medicalresearchers. The most successful andinfluential has been the World MedicalAssociation’s (WMA) Declaration of Hel-sinkiTTTT’’ [see infra.]

Mengele’s Birthmark, supra, at 24 (foot-notes omitted). In his conclusions the au-thor noted:

‘‘However, since American judges pro-mulgated the [Nuremberg] Code underboth natural and international law stan-dards, it is disturbing that we have not

an affirmative decision by the experimentalsubject there should be made known tohim the nature, duration, and purpose ofthe experiment; the method and means bywhich it is to be conducted; all inconve-niences and hazards reasonably to be ex-pected; and the effects upon his health orperson which may possibly come from hisparticipation in the experiment.The duty and responsibility for ascertainingthe quality of the consent rests upon eachindividual who initiates, directs, or engagesin the experiment. It is a personal duty andresponsibility which may not be delegatedto another with impunity.2. The experiment should be such as toyield fruitful results for the good of society,unprocurable by other methods or means ofstudy, and not random and unnecessary innature.3. The experiment should be so designedand based on the results of animal experi-mentation and a knowledge of the naturalhistory of the disease or other problem un-der study that the anticipated results willjustify the performance of the experiment.4. The experiment should be so conductedas to avoid all unnecessary physical andmental suffering and injury.5. No experiment should be conductedwhere there is a prior reason to believe thatdeath or disabling injury will occur; except,

perhaps, in those experiments where the ex-perimental physicians also serve as subjects.6. The degree of risk to be taken shouldnever exceed that determined by the hu-manitarian importance of the problem to besolved by the experiment.7. Proper preparations should be madeand adequate facilities provided to protectthe experimental subject against even theremote possibilities of injury, disability, ordeath.8. The experiment should be conductedonly by scientifically qualified persons. Thehighest degree of skill and care should berequired through all stages of the experi-ment of those who conduct or engage in theexperiment.9. During the course of the experiment thehuman subject should be at liberty to bringthe experiment to an end if he has reachedthe physical or mental state where continu-ation of the experiment seemed to him to beimpossible.10. During the course of the experiment thescientist in charge must be prepared to termi-nate the experiment at any stage, if he hasprobable cause to believe, in the exercise ofthe good faith, superior skill and carefuljudgement required of him that a continua-tion of the experiment is likely to result ininjury, disability, or death to the experimen-tal subject. [Emphasis added.]


taken it more seriously in areas wherethere is no question that it has directapplicationTTTT

TTT We have yet to succeed in eradi-cating our birthmark that impels us totrample human rights and welfare wheneither society’s welfare seems in jeopar-dy, or the promise of ‘progress’ is dan-gled before usTTTT Neither Alymer norMengele will be called to account in aworld that puts expediency over ethics,and exalts progress over human rights.’’

Id. at 43–44 (footnotes omitted).

Karine Morin in her article, The Stan-dard of Disclosure in Human Subject Ex-perimentation, 19 Journal of Legal Medi-cine 157 (June 1998), after discussing thehistory of informed consent as it developedin medical practice, describes nonthera-peutic experimental research, differentiat-ing it from therapeutic medical treatment.She stated that ‘‘any manipulation, obser-vation, or other study of a human being—or of anything related to that human beingthat might subsequently result in manipu-lation of that human being—done with theintent of developing new knowledge andwhich differs in any form from customarymedical (or other professional) practice.’’Id. at 166 (quoting from a paper by RobertLevine to the National Commission for theProtection of Human Subjects of Biomedi-cal and Behavioral Research). She thenstates further: ‘‘Research is usually de-scribed in a formal protocol that sets forthan objective and a set of procedures de-signed to reach that objective.’’ Id. at 167.

In respect to the difference between re-search involving treatment and nonthera-peutic research, she further notes that:

‘‘[P]ractice represents the utilization ofknowledge, while research amounts toits creation. Because experimentationtakes place in the realm of the unknown,or at least the ‘scientifically unproven,’several aspects distinguish it from treat-

ment: risks may be unforeseeable; as-sumptions are not supported by scienti-fic evidence and expertise is thereforemore vulnerable than it is in clinicalpractice; a subject’s consent cannot bebased on anticipated benefits; and re-searchers and subjects may have con-flicting interests.’’

Id. at 213, (footnotes omitted) (citing Del-gado & Leskovac, Informed Consent inHuman Experimentation: Bridging theGap Between Ethical Thought and Cur-rent Practice, 34 UCLA L. Rev. 67, 69(1986)).

Morin, in respect to nontherapeutic re-search, also postulates that:

‘‘It is essential to recognize that soci-ety’s interest in knowledge may not co-incide with an individual subject’s inter-est; the individual subject stands to gainnothing and lose everything, includinghis or her right of self–determina-tionTTTT

TTT

TTT Some analysts contend that IRBreview tends to focus exclusively on con-sent requirements, rather than fullyevaluating the merits of the research.Yet, it is important to recognize that,even before consent becomes an issue,the scientific merits and the acceptabili-ty of risks need to be appraised. As atleast one author has argued, this aspectof the review may be jeopardized ifmembers who have institutional alle-giances are caught between the desire topromote the interests of the institutionand the need to protect the subjectTTTT

C. Investigator–Subject Relationship

Another notable difference betweentreatment and experimentation lies inthe relationship between physician-pa-tient and investigator-subjectTTTT

TTT


TTT Indeed, as discussed in relation tothe notion of uncertainty, the nature ofthe information held by the investigatorcan be very different from that of theinformation held by a treating physi-cianTTTT

TTT

Other than through the differencethat relates to the disclosure of informa-tion, the relationship between investiga-tor and subject is unique in terms of thepurpose for which information is gath-eredTTTT Data are collected to confirmor revoke a hypothesis, independently ofthe subject. Finally, investigators’ moti-vations differ from those of treatingphysicians. The experiment is driven bythe investigator’s dedication to the ad-vancement of knowledge, and often by acommitment to those who have fundedthe research; it is also driven by soci-ety’s interest in future benefits that willflow from medical discoveries. As oneauthor remarks; ‘the price of a badoutcome is exacted from the individualwho suffers the untoward reaction,whereas the benefit of the breakthroughis available to society as a whole.’ ’’

Id. at 215–18 (emphasis added) (footnotesomitted). In arguing that a fuller disclo-sure should be made when consent issought for nontherapeutic research, as op-posed to therapeutic research, Morinnotes:

‘‘Furthermore, as long as courts con-tinue to interpret the doctrine of in-formed consent in experimentation as itapplies in the context of treatment, theuniqueness of the protection needed forhuman research subjects will be over-looked. Failing to recognize that sub-jects who volunteer for the sake of theadvancement of science are differentlysituated from the patients who stand tobenefit from treatment results in ananalysis that misconceives the purpose

of disclosure. Beyond informing the pa-tient as to means available to treat himor her, a subject must become a volun-tary and willing participant in an en-deavor that may yield no direct benefitto him or her, or worse, that may causeharm.’’

Id. at 220.

Just recently the research communityhas been subjected to question as a resultof genetic experimentation on a Pennsylva-nia citizen. Jesse Gelsinger consented toparticipate in a research project at theUniversity of Pennsylvania’s Institute ofHuman Gene Therapy. After Gelsinger’sdeath, the U.S. Food and Drug Adminis-tration ordered a halt to eight human genetherapy experiments at the Institute. Ad-ditionally, other similar projects were halt-ed elsewhere. The FDA took the actionafter a ‘‘discovery of a number of seriousproblems in the Institute’s informed con-sent procedures and, more generally, alapse in the researchers’ ethical responsi-bilities to experimental subjects.’’ JeffreyH. Barker, Human Experimentation andthe Double Facelessness of a MercilessEpoch, 25 New York University Review ofLaw and Social Change 603, 616 (1999).

Gelsinger had a different type of ornith-ine transcarbamylase deficiency (OTC) dis-ease, than that addressed by the research.His particular brand of the disease wasunder control. There was no possibilitythat the research being conducted woulddirectly benefit him. It was thus, as tohim, as it was to the children in the case atbar, nontherapeutic; a way to study theaffects on the subjects (in the present case,the children) in order to measure the suc-cess of the experiment. In Gelsinger’scase, the research was to test the efficien-cy of disease vectors. In other words,weakened adenovirus (common-cold virus-es) were used to deliver trillions of parti-cles of a particular OTC gene into his


artery and thus to his liver. Gelsingerexperienced a massive and fatal immunesystem reaction to the introduction of thecommon-cold virus.

There were problems with the extent ofthe informed consent there obtained.Barker noted that:

‘‘Is this just a case of rogue experi-menters giving a bad name to all geneticresearch? Not at all. The program inPhiladelphia is (or at least was) one ofthe most prestigious in the world andthe researchers there were first–rate.Rather, the problems with that programare indicative of systemic problems withgenetic research and informed consentas a protection of the autonomy of re-search subjectsTTTT

TTT

Why are there such serious problemswith informed consent in some of thesetrials, and why is there almost totalnoncompliance with regulations concern-ing serious side effects? The answers tothese questions are related. Informed

consent has suffered from pressure toget results—as quickly as possibleTTTT

Informed consent procedures, properlyfollowed, are troublesome, time-consum-ing, costly, and may even threaten pro-prietary information valuable to the bio-tech companies. The ethical face of theresearch subject can be obscured bysuch factors.

TTT

TTT Researchers, under competitivepressure and also financial pressurefrom corporate backers, operate under apaternalistic approach to research sub-jects, asserting professional expertiseand arguing experimental necessitywhile minimizing the right to self-deter-mination—a key aspect of the exerciseof autonomy—of their subjects. The re-sult is a greater or lesser degree ofethical effacement.’’

Id. at 617–20.32

Because of the way the cases sub judicehave arrived, as appeals from the granting

32. In the past several months, the country hasalso learned of another research project ap-proved by the scientific ‘‘community’’ andconducted by ‘‘institutional volunteers,’’ thatwas performed without appropriate concernfor the children that were used as subjects toattempt to prove a scientific hypothesis. Theparticular experiment was conducted byAmerican scientists, and was discontinued,and then concealed in the post-World War IIperiod because of concerns raised by studentsthat it was a ‘‘monster experiment’’ thatwould, if discovered, be compared to theWorld War II experiments and would ruin thecareers of the scientists and researchers in-volved. The leader of the experiment, a pro-fessor at the State University of Iowa, prior tothe experiment being uncovered, even had aprestigious scientific institute named afterhim—the Wendell Johnson Speech and Hear-ing Center.

Wendell Johnson was a stutterer. As hiseducation and career advanced, he formulat-ed hypotheses that stuttering is emphasizedand conditioned in children by environmentalcauses rather than by genetic or inherited

traits. He believed that criticism by parents,and others, during childhood years, causedchildren to lose confidence in their ability tocommunicate by speech, resulting, in theworst cases, in stuttering.

At that point, Johnson was a scientist with atheory searching for subjects to prove it. Ob-viously, educated and/or knowledgeable par-ents would not, if aware of his methods, per-mit him to attempt to turn their children intostutterers.

Accordingly, with the university’s blessing,he approached a nearby state orphanage thathad been utilized in other research by theuniversity, and, under the guise of improvingthe speech of the orphans involved, had aresearch assistant begin the experiment.

Over time, she conditioned several of theorphans who had not theretofore stuttered, tobecome stutterers. She was very successful.Thereafter, only minimal and unsuccessful ef-forts were made to cure the affected orphansof the stuttering that the scientists had in-duced.

Shortly thereafter, when the project wascompared to World War II experiments, it


of summary judgments, there is no com-plete record of the specific compensationof the researchers involved. Although theproject was funded by the EPA, at therequest of KKI the EPA has declined tofurnish such information to the attorneyfor one of the parties, who requested itunder the federal Freedom of InformationAct. Whether the research’s character as aco-sponsored state project opens the rec-ords under the Maryland Public Informa-tion Act has apparently not been consid-ered. Neither is there in the record anydevelopment of what pressures, if any,were exerted in respect to the researchersobtaining the consents of the parents andconducting the experiment. Nor, for thesame reason, is there a sufficient indica-tion as to the extent to which the Institutehas joined with commercial interests, if ithas, for the purposes of profit, that mightpotentially impact upon the researcher’smotivations and potential conflicts of inter-est—motivations that generally are as-

sumed, in the cases of prestigious entitiessuch as John Hopkins University, to be forthe public good rather then a search forprofit.

We do note that the institution involved,the respondent here, like the WendellJohnson Speech and Hearing Center, is ahighly respected entity, considered to be aleader in the development of treatments,and treatment itself, for children infectedwith lead poisoning. With reasonable as-surance, we can note that its reputationalone might normally suggest that therewas no realization or understanding on theInstitute’s part that the protocols of theexperiment were questionable, except forthe letter from the IRB requesting thatthe researchers mischaracterize the study.

We shall further address both the factu-al and legal bases for the findings of thetrial courts, holding, ultimately, that therespective courts erred in both respects.

was terminated. No research was ever pub-lished, although in the speech pathology sci-entific community there was some knowledgeof it. The study documents were concealedor destroyed and have not survived.

The theretofore unstuttering orphans thathad been conditioned to stutter remainedstutterers for their entire lives, experiencingsevere lifelong problems because of the exper-iment. It was not until a letter from one ofthe orphans caused the now aged researchassistant to have an attack of conscience andshe contacted the press, that the sixty-year-oldexperiment came to light. The University ofIowa, the successor to the State University ofIowa, confirmed the experiment in a recentapology.

The nation was informed of the experimentin a series of articles by Jim Dyer in the SanJose (California) Mercury News beginning onJune 10, 2001. A university spokesmantermed the experiment ‘‘regrettable.’’ Hestated further: ‘‘This is not a study thatshould ever be considered defensible in anyera.’’ When it was suggested that its researchand clinical institute should be renamed, theuniversity spokesman stated: ‘‘In no waywould I ever think of defending this study. In

no way. It’s more than unfortunate.’’ JimDyer, A lifetime later, experiment on orphanshaunts researcher, San Jose Mercury News(June 10, 2001); Jim Dyer, Orphans retainscars from long-ago experiment, San Jose Mer-cury News (June 11, 2001); Jim Dyer, Univer-sity issues apology for 1939 experiment thatinduced orphans to stutter, San Jose MercuryNews (June 14, 2001); Nancy Marshall, J.Dyer Discusses a 1930s Study on Stuttering,Weekly Edition: The Best of National PublicRadio News (June 23, 2001).

Similar to the research at issue in the caseat bar, the children in the stuttering studywere deliberately placed in a potentiallyharmful experimental environment for thegood of science in order to test a theory that,if proven, might have helped many more chil-dren. The University of Iowa, however belat-edly, has acknowledged the impropriety ofthat experiment and apologized for its in-volvement. KKI continues to assert the pro-priety of a study that is inherently inappropri-ate—no less so than the stuttering research onvulnerable orphans in the Midwest sixty yearsago.

Inappropriate experimentation in this coun-try involving children as subjects is not new.


C. Negligence

It is important for us to remember thatappellants allege that KKI was negligent.Specifically, they allege that KKI, as amedical researcher, owed a duty of care tothem, as subjects in the research study,based on the nature of the agreementsbetween them and also based on the na-ture of the relationship between the par-ties. They contend specifically that KKIwas negligent because KKI breached itsduty to: (1) design a study that did notinvolve placing children at unnecessaryrisk; (2) inform participants in the studyof results in a timely manner; and (3) tocompletely and accurately inform partici-pants in the research study of all the haz-ards and risks involved in the study.

[10] In order to establish a claim fornegligence under Maryland law, a partymust prove four elements: ‘‘(1) that thedefendant was under a duty to protect theplaintiff from injury, (2) that the defendantbreached that duty, (3) that the plaintiffsuffered actual injury or loss33 and (4) thatthe loss or injury proximately resultedfrom the defendant’s breach of the duty.’’(Emphasis added.) Rosenblatt v. Exxon,335 Md. 58, 76, 642 A.2d 180, 188 (1994)(citing Faya v. Almaraz, 329 Md. 435, 448,620 A.2d 327, 333 (1993) and Lamb v.Hopkins, 303 Md. 236, 241, 492 A.2d 1297,1300 (1985)); see Brown v. Dermer, 357Md. 344, 356, 744 A.2d 47, 54 (2000); Rich-wind Joint Venture 4 v. Brunson, 335 Md.661, 670, 645 A.2d 1147, 1151 (1994); Man-or Inn, 335 Md. at 147–48, 642 A.2d at 225;Southland Corp., 332 Md. 704, 712, 633A.2d 84, 88 (1993). Because this is a re-view of the granting of the two summaryjudgments based solely on the groundsthat there was no legal duty to protect thechildren, we are primarily concerned with

the first prong-whether KKI was under aduty to protect appellants from injury.

We noted in West Virginia CentralRailroad Co. v. Fuller, 96 Md. 652, 666, 54A. 669, 671 (1903):

‘‘[T]here can be no negligence wherethere is no duty that is due; for negli-gence is the breach of some duty thatone person owes to another. It is conse-quently relative and can have no exis-tence apart from some duty expressly orimpliedly imposed. In every instancebefore negligence can be predicated of agiven act, back of the act must be soughtand found a duty to the individual com-plaining, the observance of which dutywould have averted or avoided the inju-ryTTTT As the duty owed varies withcircumstances and with the relation toeach other of the individuals concerned,so the alleged negligence varies, and theact complained of never amounts to neg-ligence in law or in fact; if there hasbeen no breach of duty.’’

See Dermer, 357 Md. at 357, 744 A.2d at54.

In Ashburn v. Anne Arundel County,306 Md. 617, 627–28, 510 A.2d 1078, 1083(1986), we also analyzed this first elementof whether a duty existed:

‘‘ ‘Duty’ in negligence has been definedas ‘an obligation, to which the law willgive recognition and effect, to conformto a particular standard of conduct to-ward another.’ Prosser and Keeton [onTorts ] § 53 [ (W. Keeton 5th ed.1984) ].There is no set formula for this determi-nation. As Dean Prosser noted, ‘duty isnot sacrosanct in itself, but is only anexpression of the sum total of thoseconsiderations of policy which lead thelaw to say that the particular plaintiff is

33. We note that there was little suggestion ofactual permanent injury to the children in-volved with these two cases. Our opinion is

not directed to the matter of whether dam-ages can be proven in the present cases.


entitled to protection.’ Id. In broadterms, these policies include: ‘conve-nience of administration, capacity of theparties to bear the loss, a policy of pre-venting future injuries, [and] the moralblame attached to the wrongdoerTTTT’Id. As one court suggested, there are anumber of variables to be considered indetermining if a duty exists to another,such as:

the foreseeability of harm to theplaintiff, the degree of certainty thatthe plaintiff suffered the injury, thecloseness of the connection betweenthe defendant’s conduct and the injurysuffered, the moral blame attached tothe defendant’s conduct, the policy ofpreventing future harm, the extent ofthe burden to the defendant and con-sequences to the community of impos-ing a duty to exercise care with re-sulting liability for breach, and theavailability, cost and prevalence of in-surance for the risk involved.

Tarasoff v. Regents of University of Cali-fornia, 17 Cal.3d 425, 434, 131 Cal.Rptr.14, 22, 551 P.2d 334, 342 (1976).

Perhaps among these the factordeemed most important is foreseeability.See id. However, ‘foreseeability’ mustnot be confused with ‘duty.’ The factthat a result may be foreseeable doesnot itself impose a duty in negligenceterms.’’ [Some alterations in original.]

See also Dermer, 357 Md. at 357, 744 A.2dat 54; Rosenblatt, 335 Md. at 76–77, 642A.2d at 189. With regard to the connec-tion between the harm and the relationshipbetween the parties, we recently stated inWalpert, Smullian & Blumenthal, P.A. v.Katz, 361 Md. 645, 658, 762 A.2d 582, 589(2000) (quoting Jacques v. First Nat’lBank, 307 Md. 527, 534–35, 515 A.2d 756,759–60 (1986)):

‘‘ ‘Where the failure to exercise due carecreates a risk of economic loss only,

courts have generally required an inti-mate nexus between the parties as acondition to the imposition of tort liabili-ty. This intimate nexus is satisfied bycontractual privity or its equivalent. Bycontrast, where the risk created is oneof personal injury, no such direct rela-tionship need be shown, and the princi-pal determinant of duty becomes fore-seeability.’ ’’

Furthermore, as we stated in Almaraz,329 Md. at 449, 620 A.2d at 333, ‘‘legalscholars have long agreed that the serious-ness of potential harm, as well as its prob-ability, contributes to a duty to prevent it.’’As we emphasized in Bobo v. State, 346Md. 706, 714–15, 697 A.2d 1371, 1375–76(1997):

‘‘Two of the relevant factors to consid-er in determining whether such a dutyshould be recognized are ‘the nature ofthe harm likely to result from a failureto exercise due care, and the relation-ship that exists between the parties.’Jacques v. First Nat’l Bank, 307 Md.527, 534, 515 A.2d 756, 759 (1986)TTTT

Such a relationship may be establishedin a number of ways: (1) by statute orrule; (2) by contractual or other privaterelationship; or (3) indirectly or impli-edly by virtue of the relationship be-tween the tortfeasor and a third party.’’[Some citations omitted.]

The relationship that existed betweenKKI and both sets of appellants in thecase at bar was that of medical researcherand research study subject. Though notexpressly recognized in the MarylandCode or in our prior cases as a type ofrelationship which creates a duty of care,evidence in the record suggests that such arelationship involving a duty or dutieswould ordinarily exist, and certainly couldexist, based on the facts and circumstancesof each of these individual cases. Once wehave determined that the facts and circum-


stances of the present cases, considered ina light most favorable to the nonmovingparties, are susceptible to inferences sup-porting the position of the party opposingsummary judgment, we are mandated tohold that the granting of summary judg-ment in the lower court was improper. Inaddition to the trial courts’ erroneous con-clusions on the law, the facts and circum-stances of both of these cases are suscepti-ble to inferences that a special relationshipimposing a duty or duties was created inthe arrangements in the cases sub judice,and, ordinarily, could be created in similarresearch programs involving human sub-jects.

IV. The Special Relationships

A. The Consent Agreement

Contract

Both sets of appellants signed a similarConsent Form prepared by KKI in whichKKI expressly promised to: (1) financiallycompensate (however minimally) appel-lants for their participation in the study; 34

(2) collect lead dust samples from appel-lants’ homes, analyze the samples, discussthe results with appellants, and discusssteps that could be taken, which couldreduce exposure to lead; and (3) collectblood samples from children in the house-hold and provide appellants with the re-sults of the blood tests. In return, appel-lants agreed to participate in the study,by: (1) allowing KKI into appellants’

homes to collect dust samples; (2) periodi-cally filling out questionnaires; and (3)allowing the children’s blood to be drawn,tested, and utilized in the study. If con-sent agreements contain such provisions,and the trial court did not find otherwise,and we hold from our own examination ofthe record that such provisions were socontained, mutual assent, offer, accep-tance, and consideration existed, all ofwhich created contractual relationships im-posing duties by reason of the consentagreement themselves (as well, as we dis-cuss elsewhere, by the very nature of suchrelationships).

[11] By having appellants sign thisConsent Form, both KKI and appellantsexpressly made representations, which, inour view, created a bilateral contract be-tween the parties. At the very least, itsuggests that appellants were agreeingwith KKI to participate in the researchstudy with the expectation that they wouldbe compensated, albeit, more or less, mini-mally, be informed of all the informationnecessary for the subject to freely choosewhether to participate, and continue toparticipate, and receive promptly any in-formation that might bear on their willing-ness to continue to participate in thestudy. This includes full, detailed, prompt,and continuing warnings as to all the po-tential risks and hazards inherent in theresearch or that arise during the research.KKI, in return, was getting the children to

34. The record reflects that in addition to the$5.00 and $15.00 sums mentioned in the con-sent form as periodic payments for partic-ipation in stages of the study, there was astream of compensation flowing to the re-search subjects and the parents. Gifts, trink-ets, coupons for food, etc., would be given tothe subjects or their parents periodically.Moreover, the researchers informed theE.P.A., when seeking funding approval, that:

‘‘A number of incentives are planned bothin the clinic and in the home of the type

that were well received in the recently com-pleted Maryland Lead in Soil Project, i.e.(1) coupons for things ranging from skatingtrips to groceries; (2) gifts for the childrensuch as T-shirts in the summer, and hatsand gloves during winter clinic appoint-ments and (3) ongoing incentives for par-ents such as $10.00–$20.00 food couponsprovided at each clinic visit for blood col-lection. Lastly, respondents will be reim-bursed $15.00 each time they provide ques-tionnaire information.’’


move into the houses and/or to remainthere over time, and was given the right totest the children’s blood for lead. As con-sideration to KKI, it got access to thehouses and to the blood of children thathad been encouraged to live in a ‘‘risk’’environment. In other words, KKI re-ceived a measuring tool—the children’sblood. Considerations existed, mainlymoney, food coupons, trinkets, bilateralpromises, blood to be tested in order tomeasure success. ‘‘Informed consent’’ ofthe type used here, which imposes obli-gation and confers consideration on bothresearcher and subject (in these cases, theparents of the subjects) may differ fromthe more one-sided ‘‘informed consent’’normally used in actual medical practice.Researcher/subject consent in nonthera-peutic research can, and in this case did,create a contract.35

B. The Sufficiency of the Consent Form

[12] The consent form did not directlyinform the parents of the fact that it wascontemplated that some of the childrenmight ingest lead dust particles, and thatone of the reasons the blood of the chil-dren was to be tested was to evaluate howeffective the various abatement measureswere.

A reasonable parent would expect to beclearly informed that it was at least con-templated that her child would ingest leaddust particles, and that the degree towhich lead dust contaminated the child’sblood would be used as one of the ways inwhich the success of the experiment wouldbe measured. The fact that if such infor-mation was furnished, it might be difficultto obtain human subjects for the research,does not affect the need to supply theinformation, or alter the ethics of failing to

provide such information. A human sub-ject is entitled to all material information.The respective parent should also havebeen clearly informed that in order for themeasurements to be most helpful, the childneeded to stay in the house until the con-clusion of the study. Whether assessed bya subjective or an objective standard, thechildren, or their surrogates, should havebeen additionally informed that the re-searchers anticipated that, as a result ofthe experiment, it was possible that theremight be some accumulation of lead in theblood of the children. The ‘‘informed’’consent was not valid because full materialinformation was not furnished to the sub-jects or their parents.

C. Special Relationship

In Case Number 128, Ms. Hughessigned a Consent Form in which KKIagreed to provide her with ‘‘specific blood-lead results’’ and discuss with her ‘‘a sum-mary of house test results and steps that[she] could take to reduce any risks ofexposure.’’ She contends that this agree-ment between the parties gave rise to aduty owed by KKI to provide her with thatinformation in a timely manner. Shesigned the Consent Form on March 10,1993. The project began almost simulta-neously. KKI collected dust samples inthe Monroe Street property on March 9,1993, August 23, 1993, March 9, 1994, Sep-tember 19, 1994, April 18, 1995, and No-vember 13, 1995. The March 9, 1993 dusttesting revealed what the researchers re-ferred to as ‘‘hot spots,’’ where the level oflead was ‘‘higher than might be found in acompletely renovated house.’’ As we indi-cated, supra, this information was not fur-nished to Ms. Hughes until December 16,1993, more than nine months after the

35. We make no determination as to whetherinformed consent in a therapeutic medical

context can generate contractual obligations.


samples had been collected and not untilafter Ericka Grimes’s blood was found tocontain elevated levels of lead. She con-tends that not only did KKI have a duty toreport such information in a timely man-ner but that it breached this duty by de-laying to such a time that her daughterwas allowed to contract lead poisoning.Looking at the relevant facts of CaseNumber 128, they are susceptible to infer-ences supporting the position of appellant,Ericka Grimes, and, moreover, that, iftrue, would create a ‘‘special relationship’’out of which duties would be created.Therefore, for this reason alone, the grantof summary judgment was improper.

In Case Number 129, Ms. Higgins alsosigned a Consent Form in which KKIagreed to provide her with ‘‘specific blood-lead results’’ in respect to her child and todiscuss with her ‘‘a summary of house testresults and steps that [she] could take toreduce any risks of exposure.’’ She con-tends that this agreement between theparties gave rise to a duty owed by KKI toprovide her with complete and accurateinformation. Pursuant to the plans of theresearch study, KKI collected dust sam-ples in the Federal Street property onMay 17, 1994, July 25, 1994, and Novem-ber 3, 1994. KKI informed Ms. Higgins ofthe dust sample results by letters datedJune 24, 1994, September 14, 1994, andFebruary 7, 1995, respectively. AlthoughKKI had recorded high levels of lead con-centration in the dust samples collected bythe Cyclone vacuum during the May 17,1994 visit, KKI failed to disclose this infor-mation to Ms. Higgins in the letter datedJune 24, 1994. Instead, KKI relied on theresults obtained from the dust wipe sam-ples collected and informed her that therewas no area in her house where the leadlevel was higher than what might havebeen found in a completely renovatedhouse.

Ms. Higgins contends that KKI knew ofthe presence of high levels of lead-basedpaint and dust in the Federal Street prop-erty as early as December of 1993, thateven after Level II intervention such highlevels still existed as of June of 1994, andthat it was not until she received a letterdated September 14, 1994 that KKI specif-ically informed Ms. Higgins of the fact thather house had elevated lead levels. Thiswas after her child, Myron, was diagnosedwith elevated levels of lead in his blood.

Specifically, Ms. Higgins contends thatKKI was negligent in its failure to informher of its knowledge of the high levels oflead dust recorded by both XRF testing inDecember 1993 and from the samples col-lected via the Cyclone vacuum in May 1994and that this withholding of informationcombined with KKI’s letter dated June 24,1993, informing her solely of the lowerresults of the samples collected by dustwipe methodology, was misleading to heras a participant in the study. KKI doesnot argue the facts as appellant presentsthem. Instead, it argues that no duty toinform existed because although the Cy-clone readings were high, they were not anindication of a potential hazard because theclearance levels were based on dust wipemethodology and the dust wipe resultswere not above the clearance levels.Looking at the relevant facts of CaseNumber 129, they are susceptible to infer-ences supporting the position of appellant,Ms. Higgins. Accordingly, for this reasonalone, the grant of summary judgment wasimproper.

As we indicated earlier, the trial courtsappear to have held that special relation-ships out of which duties arise cannot becreated by the relationship between re-searchers and the subjects of the research.While in some rare cases that may becorrect, it is not correct when researchersrecruit people, especially children whose


consent is furnished indirectly, to partici-pate in nontherapeutic procedures that arepotentially hazardous, dangerous, or dele-terious to their health. As opposed tocompilation of already extant statistics forpurposes of studying human health mat-ters, the creation of study conditions orprotocols or participation in the recruit-ment of otherwise healthy subjects to in-teract with already existing, or potentiallyexisting, hazardous conditions, or both, forthe purpose of creating statistics fromwhich scientific hypotheses can be sup-ported, would normally warrant or createsuch special relationships as a matter oflaw.

It is of little moment that an entity is aninstitutional volunteer in a community. Ifotherwise, the legitimacy of the claim tonoble purpose would always depend uponthe particular institution and the particularcommunity it is serving in a given case.As we have indicated, history is repletewith claims of noble purpose for institu-tions and institutional volunteers in a widevariety of communities.

Institutional volunteers may intend to dogood or, as history has proven, even to doevil and may do evil or good depending onthe institution and the community theyserve. Whether an institutional volun-teer 36 in a particular community should begranted exceptions from the application oflaw is a matter that should be scrutinizedclosely by an appropriate public policymaker. Generally, but not always, the leg-islative branch is appropriately the bestfirst forum to consider exceptions to thetort laws of this State—even then it should

consider all ramifications of the policy—especially considering the general vulnera-bility of subjects of such studies—in thiscase, small children. In the absence of theexercise of legislative policymaking, wehold that special relationships, out of whichduties arise, the breach of which can con-stitute negligence, can result from the re-lationships between researcher and re-search subjects.

D. The Federal Regulations

[13] A duty may be prescribed by astatute, or a special relationship creatingduties may arise from the requirement forcompliance with statutory provisions. Al-though there is no duty of which we areaware prescribed by the Maryland Code inrespect to scientific research of the naturehere present, federal regulations havebeen enacted that impose standards ofcare that attach to federally funded orsponsored research projects that use hu-man subjects. See 45 C.F.R. Part 46(2000). 45 C.F.R. Part 46, Subpart A, isentitled ‘‘Basic HHS 37 Policy for Protec-tion of Human Research Subjects’’ andSubpart D of the regulation is entitled‘‘Additional Protections for Children In-volved as Subjects in Research.’’ 45C.F.R. section 46.101(a) (2000) provides:

‘‘Sec. 46.101(a) Except as provided in paragraph

(b) of this section, this policy applies toall research involving human subjectsconducted, supported or otherwise sub-ject to regulation by any federal depart-ment or agency which takes appropriateadministrative action to make the poli-cy applicable to such research. This

36. Moreover, it is not clear that KKI was amere volunteer in any event. It receivedfunding for developing and conducting theresearch. Whether it recognized a profit isunknown from the record. The ‘‘for profit’’nature of some research may well increasethe duties of researchers to insure the safety

of research subjects, and may well increaseresearchers’ or an institution’s susceptibilityfor damages in respect to any injuries in-curred by research subjects.

37. HHS refers to the Department of Healthand Human Services.


includes research conducted by federalcivilian employees or military personnel,except that each department or agencyhead may adopt such procedural modifi-cations as may be appropriate from anadministrative standpoint. It also in-cludes research conducted, supported, orotherwise subject to regulation by thefederal government outside the UnitedStates.’’ [Emphasis added.]

As we discussed, supra, this study wasfunded, and co-sponsored, by the EPA andpresumably was therefore subject to thesefederal conditions. These conditions, if ap-propriate administrative action has beentaken, require fully informed consent inany research using human subjects con-ducted, supported, or otherwise subject toany level of control or funding by anyfederal department or agency. 45 C.F.R.section 46.116 provides in relevant part:

‘‘Sec. 46.116 General requirements forinformed consent.

Except as provided elsewhere in thispolicy, no investigator may involve ahuman being as a subject in researchcovered by this policy unless the inves-tigator has obtained the legally effectiveinformed consent of the subject or thesubject’s legally authorized representa-tive. An investigator shall seek suchconsent only under circumstances thatprovide the prospective subject or therepresentative sufficient opportunity toconsider whether or not to participateand that minimize the possibility ofcoercion or undue influence. The in-formation that is given to the subject orthe representative shall be in languageunderstandable to the subject or therepresentative. No informed consent,whether oral or written, may includeany exculpatory language throughwhich the subject or the representativeis made to waive or appear to waiveany of the subject’s legal rights, or re-

leases or appears to release the investi-gator, the sponsor, the institution or itsagents from liability for negligence.

(a) Basic elements of informed con-sent. Except as provided in paragraph(c) or (d) of this section, in seekinginformed consent the following informa-tion shall be provided to each subject:

TTT

(2) A description of any reasonablyforeseeable risks or discomforts to thesubject;

TTT

(4) A disclosure of appropriate alter-native procedures or courses of treat-ment, if any, that might be advantageousto the subject;

TTT

(6) For research involving more thanminimal risk, an explanation as towhether any compensation and an expla-nation as to whether any medical treat-ments are available if injury occurs and,if so, what they consist of, or wherefurther information may be obtained;

TTT

(b) Additional elements of informedconsent. When appropriate, one ormore of the following elements of infor-mation shall also be provided to eachsubject:

(1) A statement that the particulartreatment or procedure may involverisks to the subject (or to the embryo orfetus, if the subject is or may becomepregnant) which are currently unfore-seeable;

TTT

(5) A statement that significant newfindings developed during the course ofthe research which may relate to thesubject’s willingness to continue partic-ipation will be provided to the subjectTTTT’’ [Emphasis added.]


Subpart D of the regulation concerns chil-dren involved as subjects in research. 45C.F.R. section 46.407 therefore additional-ly provides:

‘‘Sec. 46.407 Research not otherwiseapprovable which presents an

opportunity to understand, prevent, oralleviate a serious problem affectingthe health or welfare of children.

HHS will conduct or fund researchthat the IRB does not believe meetsthe requirements of Sec. 46.404, Sec.46.405, or Sec. 46.406 only if:

(a) The IRB finds that the researchpresents a reasonable opportunity tofurther the understanding, prevention,or alleviation of a serious problem affect-ing the health or welfare of children;and

(b) The Secretary,38 after consultationwith a panel of experts in pertinentdisciplines (for example: science, medi-cine, education, ethics, law) and follow-ing opportunity for public review andcomment, has determined either:

(1) That the research in fact satisfiesthe conditions of Sec. 46.404, Sec.46.405, or Sec. 46.406, as applicable, or

(2) The following:

(i) The research presents a reason-able opportunity to further the under-standing, prevention, or alleviation of aserious problem affecting the health orwelfare of children;

(ii) The research will be conducted inaccordance with sound ethical princi-ples;

(iii) Adequate provisions are made forsoliciting the assent of children and thepermission of their parents or guard-ians, as set forth in Sec. 46.408.’’ [Em-phasis added.]

These federal regulations, especially therequirement for adherence to sound ethicalprinciples, strike right at the heart ofKKI’s defense of the granting of the Mo-tions for Summary Judgment. Fully in-formed consent is lacking in these cases.The research did not comply with the reg-ulations. There clearly was more than aminimal risk involved. Under the regula-tions, children should not have been usedfor the purpose of measuring how muchlead they would accumulate in their bloodwhile living in partially abated houses towhich they were recruited initially or en-couraged to remain, because of the study.

In the case of Whitlock v. Duke Univer-sity, 637 F.Supp. 1463 (M.D.N.C.1986), af-firmed by, 829 F.2d 1340 (4th Cir.1987),the United States District Court for theMiddle District of North Carolina decidedthat in determining what duty a research-er owes to a subject of nontherapeuticexperimentation, it would analyze a dutyconsistent with 45 C.F.R. section 46.116.Id. at 1471. That court held that a re-searcher has a duty to inform the subjectof all risks that are reasonably foreseeable.Whitlock involved a subject who sufferedorganic brain damage from decompression

38. We have found no indication in the rec-ord that the research protocols were ap-proved by The Secretary. We again em-phasize, however, that these cases weredetermined on summary judgment motionsand the record is, accordingly, incomplete.Moreover, perhaps because of the limitingeffect of summary judgment proceduresearly in the case, there is no indicationthat we can find in the record, or towhich we were directed, that indicates that

a ‘‘National Review’’ was conducted. TheNational Commission for the Protection ofHuman Rights of Biomedical and BehaviorResearch (National Commission) report,which is incorporated in the federal regu-lations at 45 C.F.R. section 46.407(b), re-quires ‘‘national review’’ where nonthera-peutic research involving children entailsrisks over a minimal risk, which is definedas risks beyond that which a child con-fronts in every day life.


experiments. The District Court ultimate-ly held (and was affirmed by the Court ofAppeals for the Fourth Circuit) that al-though a heightened duty existed betweena researcher and an adult research partici-pant requiring the researcher to discloseall foreseeable risks, in Whitlock there wasno evidence presented that the risk oforganic brain damage was foreseeable.

That result is clearly distinguishablefrom the present cases, where the risksassociated with exposing children to lead-based paint were not only foreseeable, butwere well known by KKI, and, in fact, ithad to have been reasonably foreseeableby KKI that the children’s blood might becontaminated by lead because the extent ofcontamination of the blood of the childrenwould, in significant part, be used to mea-sure the effectiveness of the various abate-ment methods. Moreover, in the presentcases, the consent forms did not directlyinform the parents that it was possible,even contemplated, that some level of lead,a harmful substance depending upon accu-mulation, might contaminate the blood ofthe children.

Clearly, KKI, as a research institution,is required to obtain a human participant’sfully informed consent, using sound ethicalprinciples. It is clear from the wording ofthe applicable federal regulations that thisrequirement of informed consent continuesduring the duration of the research studyand applies to new or changing risks. Inthis case, a special relationship out ofwhich duties might arise might be createdby reason of the federally imposed regula-tions. The question becomes whether this

duty of informed consent created by feder-al regulation, as a matter of state law,translates into a duty of care arising out ofthe unique relationship that is researcher-subject, as opposed to doctor-patient. Weanswer that question in the affirmative.In this State, it may, depending on thefacts, create such a duty.

Additionally, the Nuremberg Code, in-tended to be applied internationally, andnever expressly rejected in this country,inherently and implicitly, speaks stronglyto the existence of special relationshipsimposing ethical duties on researchers whoconduct nontherapeutic experiments onhuman subjects. The Nuremberg Codespecifically requires researches to makeknown to human subjects of research ‘‘allinconveniences and hazards reasonably tobe expected, and the effects upon hishealth or person which may possibly comefrom his participation in the experiment.’’(Emphasis added.) The breach of obli-gations imposed on researchers by the Nu-remberg Code, might well support actionssounding in negligence in cases such asthose at issue here. We reiterate as wellthat, given the facts and circumstances ofboth of these cases, there were, at the veryleast, genuine disputes of material factsconcerning the relationship and duties ofthe parties, and compliance with the regu-lations.

V. The Ethical Appropriatenessof the Research

The World Medical Association in itsDeclaration of Helsinki 39 included a code

39. The Declaration of Helsinki was crafted bythe international medical profession, as pref-erable to the Nuremberg Code crafted by law-yers and judges and adopted right after theSecond World War. The Declaration, or, forthat matter, the Nuremberg Code, have neverbeen formally adopted by the relevant govern-mental entities, although the Nuremberg

Code was intended to apply universally. Themedical profession, and its ancillary researchorgans, felt that the Nuremberg Code was toorestrictive because of its origins from the Nazihorrors of that era. Serious questions arisein this case under either code, even under themore general provisions of the Declaration of


of ethics for investigative researchers andwas an attempt by the medical communityto establish its own set of rules for con-ducting research on human subjects. TheDeclaration states in relevant part:

‘‘III. Non–therapeutic biomedical re-search involving human subjects

(Non–clinical biomedical research)

1. In the purely scientific applicationof medical research carried out on ahuman being, it is the duty of the physi-cian to remain the protector of the lifeand health of that person on whombiomedical research is being carriedout.2. The subjects should be volunteers—either healthy persons or patients forwhom the experimental design is notrelated to the patient’s illness.3. The investigator or the investigatingteam should discontinue the research ifin his/her or their judgement it may, ifcontinued, be harmful to the individual.4. In research on man, the interest ofscience and society should never takeprecedence over considerations relatedto the well being of the subject.’’ [Em-phasis added.]

Adopted in Declaration of Helsinki, WorldMedical Assembly (WMA) 18th Assembly(June 1964), amended by 29th WMA To-kyo, Japan (October, 1975), 35th WMAVenice, Italy (October 1983), and the 41stWMA Hong Kong (September 1989).

[14] The determination of whether aduty exists under Maryland law is theultimate function of various policy consid-erations as adopted by either the Legisla-ture, or, if it has not spoken, as it has notin respect to this situation, by Marylandcourts. In our view, otherwise healthychildren should not be the subjects ofnontherapeutic experimentation or re-

search that has the potential to be harmfulto the child. It is, first and foremost, theresponsibility of the researcher and theresearch entity to see to the harmlessnessof such nontherapeutic research. Consentof parents can never relieve the researcherof this duty. We do not feel that it servesproper public policy concerns to permitchildren to be placed in situations of poten-tial harm, during nontherapeutic proce-dures, even if parents, or other surrogates,consent. Under these types of circum-stances, even where consent is given, al-beit inappropriately, policy considerationssuggest that there remains a special rela-tionship between researchers and partici-pants to the research study, which imposesa duty of care. This is entirely consistentwith the principles found in the Nurem-berg Code.

[15] Researchers cannot ever be per-mitted to completely immunize themselvesby reliance on consents, especially whenthe information furnished to the subject, orthe party consenting, is incomplete in amaterial respect. A researcher’s duty isnot created by, or extinguished by, theconsent of a research subject or by IRBapproval. The duty to a vulnerable re-search subject is independent of consent,although the obtaining of consent is one ofthe duties a researcher must perform. Allof this is especially so when the subjects ofresearch are children. Such legal duties,and legal protections, might additionally bewarranted because of the likely conflict ofinterest between the goal of the researchexperimenter and the health of the humansubject, especially, but not exclusively,when such research is commercialized.There is always a potential substantial con-flict of interest on the part of researchersas between them and the human subjectsused in their research. If participants in

Helsinki apparently favored by doctors and scientists.


the study withdraw from the researchstudy prior to its completion, then theresults of the study could be renderedmeaningless. There is thus an inherentreason for not conveying information tosubjects as it arises, that might cause thesubjects to leave the research project.That conflict dictates a stronger reason forfull and continuous disclosure.

In research, the study participant’s‘‘well-being is subordinated to the dictatesof a research protocol designed to advanceknowledge for the sake of future patients.’’Jay Katz, Human Experimentation andHuman Rights, 38 St. Louis U. L.J. 7, 8(1993). In a recent report, the NationalBioethics Advisory Commission recognizedthat this conflict between pursuit of scien-tific knowledge and the well-being of re-search participants requires some over-sight of scientific investigators:

‘‘However noble the investigator’s inten-tions, when research involves humanparticipants, the uncertainties inherentin any research study raise the prospectof unanticipated harm. In designing aresearch study an investigator must fo-cus on finding or creating situations inwhich one can test important scientifichypotheses. At the same time, no mat-ter how important the research ques-tions, it is not ethical to use humanparticipants without appropriate protec-tions. Thus, there can be a conflictbetween the need to test hypotheses andthe requirement to respect and protectindividuals who participate in research.This conflict and the resulting tensionthat can arise within the research enter-prise suggest a need for guidance andoversight.’’

National Bioethics Advisory Commission,Ethical and Policy Issues in ResearchInvolving Human Participants, 2–3 (Dec.19, 2000) (emphasis added). When humansubjects are used in scientific research, the

rights of the human subjects are affordedthe protection of the courts when suchsubjects seek redress for any wrongs com-mitted.

A special relationship giving rise toduties, the breach of which might consti-tute negligence, might also arise because,generally, the investigators are in a betterposition to anticipate, discover, and under-stand the potential risks to the health oftheir subjects. Practical inequalities existbetween researchers, who have superiorknowledge, and participants ‘‘who are of-ten poorly placed to protect themselvesfrom risk.’’ Id. at 3. ‘‘[G]iven the gap inknowledge between investigators and par-ticipants and the inherent conflict of inter-est faced by investigators, participantscannot and should not be solely responsi-ble for their own protection.’’ Id. at 3–4.

[16] This duty requires the protectionof the research subjects from unreasonableharm and requires the researcher to com-pletely and promptly inform the subjectsof potential hazards existing from time totime because of the profound trust thatparticipants place in investigators, institu-tions, and the research enterprise as awhole to protect them from harm. ‘‘Facedwith seemingly knowledgeable and presti-gious investigators engaged in a noble pur-suit, participants may simply assume thatresearch is socially important or of benefitto them individually; they may not beaware that participation could be harmfulto their interests.’’ Id.

As is evident from the cases discussed inthis opinion, abuses with regard to theprotection of human subjects in experi-mental research still occur in this country.This is also recognized by the federal gov-ernment’s attempts to insure the protec-tions of human research subjects. SeeDonna Shalala, Ph.D., Protecting ResearchSubjects—What Must Be Done, 343 New


England Journal of Medicine 11 (Septem-ber 14, 2000).

The purpose of the study in the case atbar was, in the words of Dr. Mark R.Farfel Sc.D., Director of KKI’s LeadAbatement Department ‘‘to document thelongevity of various lead base paint abate-ment strategies, factored in terms of re-ducing lead exposure in house dust and thechildren’s blood lead levels.’’ In otherwords, the purpose of the experiment wasto determine whether there was a lessexpensive way than full abatement thatwould be cost-effective in reducing leadpoisoning in children from a lower econom-ic background. The study, by its design,placed and/or retained children in areaswhere they might come into contact withelevated levels of lead dust. Clearly, KKIcontemplated that at least some of thechildren would develop elevated blood leadlevels while participating in the study. At45 C.F.R. section 46.111 Criteria for IRBapproval of research, the regulations re-quire IRBs to encourage the safety as-pects of research rather than encouragingnoncompliance with regulations: ‘‘(b)When some or all of the subjects TTT suchas children TTT, [are] economically or edu-cationally disadvantaged persons addition-al safeguards have been included TTT toprotect the rights and welfare of thesesubjects.’’ (Emphasis added.)

While we acknowledge that foreseeabil-ity does not necessarily create a duty, werecognize that potential harm to the chil-dren participants of this study was bothforeseeable and potentially extreme. A‘‘special relationship’’ also exists in circum-stances where such experiments are con-ducted.

VI. Parental Consent for Children toBe Subjects of Potentially Hazardous

Nontherapeutic Research

The issue of whether a parent can con-sent to the participation of her or his child

in a nontherapeutic health-related studythat is known to be potentially hazardousto the health of the child raises seriousquestions with profound moral and ethicalimplications. What right does a parenthave to knowingly expose a child not inneed of therapy to health risks or other-wise knowingly place a child in danger,even if it can be argued it is for thegreater good? The issue in these specificcontested cases does not relate primarilyto the authority of the parent, but to theprocedures of KKI and similar entitiesthat may be involved in such health-relatedstudies. The issue of the parents’ right toconsent on behalf of the children has notbeen fully presented in either of thesecases, but should be of concern not only tolawyers and judges, but to moralists, ethi-cists, and others. The consenting parentsin the contested cases at bar were not thesubjects of the experiment; the childrenwere. Additionally, this practice presentsthe potential problems of children initiat-ing actions in their own names upon reach-ing majority, if indeed, they have beendamaged as a result of being used asguinea pigs in nontherapeutic scientific re-search. Children, it should be noted, arenot in our society the equivalent of rats,hamsters, monkeys, and the like. Becauseof the overriding importance of this matterand this Court’s interest in the welfare ofchildren—we shall address the issue.

Most of the relatively few cases in thearea of the ethics of protocols of variousresearch projects involving children havemerely assumed that a parent can giveinformed consent for the participation oftheir children in nontherapeutic research.The single case in which the issue has beenaddressed, and resolved, a case with whichwe agree, will be discussed further, infra.

[17] It is not in the best interest of aspecific child, in a nontherapeutic research


project, to be placed in a research envi-ronment, which might possibly be, orwhich proves to be, hazardous to thehealth of the child. We have longstressed that the ‘‘best interests of thechild’’ is the overriding concern of thisCourt in matters relating to children.Whatever the interests of a parent, andwhatever the interests of the general pub-lic in fostering research that might, ac-cording to a researcher’s hypothesis, befor the good of all children, this Court’sconcern for the particular child and partic-ular case, over-arches all other interests.It is, simply, and we hope, succinctly put,not in the best interest of any healthychild to be intentionally put in a nonthera-peutic situation where his or her healthmay be impaired, in order to test methodsthat may ultimately benefit all children.

To think otherwise, to turn over humanand legal ethical concerns solely to thescientific community, is to risk embarkingon slippery slopes, that all to often in thepast, here and elsewhere, have resulted inpractices we, or any community, should beever unwilling to accept.

We have little doubt that the generalmotives of all concerned in these contestedcases were, for the most part, proper, al-beit in our view not well thought out. Theprotocols of the research, those of whichwe have been made aware, were, in anyevent, unacceptable in a legal context.One simply does not expose otherwisehealthy children, incapable of personal as-sent (consent), to a nontherapeutic re-search environment that is known at theinception of the research, might cause thechildren to ingest lead dust. It is especial-ly troublesome, when a measurement ofthe success of the research experiment is,in significant respect, to be determined bythe extent to which the blood of the chil-dren absorbs, and is contaminated by, asubstance that the researcher knows can,

in sufficient amounts, whether solely fromthe research environment or cumulativefrom all sources, cause serious and longterm adverse health effects. Such a prac-tice is not legally acceptable.

In Hart v. Brown, 29 Conn.Supp. 368,289 A.2d 386 (1972), that court was faced,prospectively, with whether to approve thetransplant of a kidney from one seven-year-old identical twin to the other twin.The medical information presented to thecourt indicated that without the transplantthe recipient twin would have to undergoan extensive period of dialysis treatmentwith the expectation of only a 50% chancethat she could survive that treatment formore than five years; the donor twin wasexpected to live a normal and productivelife with one kidney. There were severerejection problems with the transplant of akidney from the parents that would havesubjected the recipient twin to the possibleside effects of immuno-suppressive drugs.

The parents brought an action in behalfof the recipient twin against the doctor andthe hospital that had refused to performthe operation absent a court order that theparents or a guardian had the right toconsent to the operation. The action,therefore, sought a declaratory judgementconcerning whether the parents or aguardian ad litem had the right to consentto the transplant in behalf of the donortwin.

The court first appointed as guardian adlitems an attorney to represent the donortwin, and another person to represent therecipient twin. After citing three unre-ported cases from the State of Massachu-setts, and the case of Strunk v. Strunk,445 S.W.2d 145 (Ky.1969), the Connecticutcourt adopted the ‘‘doctrine of substitutedjudgment.’’ It upheld the giving of theconsent of the parents, but only after not-ing the extensive process that the parties


and the court had undertaken. The courtnoted:

‘‘One of the legal problems in thismatter presents a balancing of therights of the natural parents and therights of minor children—more directly,the rights of the donor child. Becauseof the unusual circumstances of this caseand the fact of great medical progress inthis field, it would appear that the natu-ral parents would be able to substitutetheir consent for that of their minorchildren after a close, independent andobjective investigation of their motiva-tion and reasoning. This has been ac-complished in this matter by the partic-ipation of a clergyman, the defendantphysicians, and attorney guardian ad li-tem for the donor, the guardian ad litemfor the donee, and, indeed, this courtitself.

A further question before this court iswhether it should abandon the donee toa brief medically complicated life andeventual death or permit the naturalparents to take some action based onreason and medical probability in orderto keep both children aliveTTTT

There is authority in our Americanjurisdiction that nontherapeutic opera-tions can be legally permitted on a mi-nor as long as the parents or otherguardians consent to the procedure.’’

Hart at 375–76, 289 A.2d at 390. Thecourt then cited the cases of Strunk v.Strunk, supra; Bonner v. Moran, 75U.S.App.D.C. 156, 126 F.2d 121 (1941) andthe unreported Massachusetts cases.

[18] Bonner was an unusual case thatinvolved the grafting of skin from a minordonor cousin to a badly burned doneecousin. In that case, the court did notanswer whether a parent, or other appro-

priate relative or guardian, could give con-sent for a nontherapeutic (as to the donorcousin) procedure. The issue was whethertheir consent was necessary under the cir-cumstances, in that the donor cousin hadapparently donated the skin without anyexpress consent (and may have alreadydone so when an aunt improperly consent-ed as a surrogate). The trial court foundthat the minor cousin was sufficiently ma-ture so as to be able to assent to theprocedure, thus avoiding a determinationas to whether a parent, or appropriaterelative, could have given surrogated con-sent. The trial court gave a ‘‘mature mi-nor’’ instruction to the jury.40 The trialcourt’s decision was ultimately overturned.The appellate court, reversing, stated:

‘‘We are constrained, therefore, to feelthat the court below should, in the cir-cumstances we have outlined, have in-structed that the consent of the parentwas necessaryTTTT But by his own testi-mony, it clearly appears that he [thephysician] failed to explain, even to theinfant, the nature or extent of the pro-posed first operation.’’

Bonner, 75 U.S.App.D.C. at 156, 126 F.2dat 123. As is clear, that court did not saythat parental consent would always be suf-ficient itself, only that it was a necessaryingredient in the equation.

In the Strunk case, the proposed donorwas a mentally incompetent adult. Herparents sought permission of the court toconsent to having one of the incompetentadult’s kidneys transplanted to her twenty-six-year-old brother. The court grantedpermission to the parents, adopting the‘‘doctrine of substituted judgment.’’

What is of primary importance to begleaned in the Hart and Strunk cases is

40. The doctrine of ‘‘mature minor’’ recog-nizes that some minors are sufficiently ma-

ture to consent.


not that the parents or guardians consent-ed to the procedures, but that they firstsought permission of the courts, and re-ceived that permission, before consentingto a nontherapeutic procedure in respectto some of their minor children, but thatwas therapeutic to other of their children.

[19] In the case sub judice, no impar-tial judicial review or oversight wassought by the researchers or by the par-ents. Additionally, in spite of the IRB’simproper attempt to manufacture a thera-peutic value, there was absolutely no suchvalue of the research in respect to theminor subjects used to measure the effec-tiveness of the study. In the absence of arequirement for judicial review, in such acircumstance, the researchers, and theirscientific based review boards would be, ifpermitted, the sole judges of whether it isappropriate to use children in nonthera-peutic research of the nature here present,where the success of an experiment is tobe measured, in substantial part, by thedegree to which the research environmentscause the absorption of poisons into theblood of children. Science cannot be per-mitted to be the sole judge of the appro-priateness of such research methods onhuman subjects, especially in respect tochildren. We hold that in these contestedcases, the research study protocols, thoseof which we are aware, were not appropri-ate.

[20, 21] When it comes to children in-volved in nontherapeutic research, with thepotential for health risks to the subjectchildren in Maryland, we will not defer toscience to be the sole determinant of theethicality or legality of such experiments.The reason, in our view, is apparent fromthe research protocols at issue in the caseat bar. Moreover, in nontherapeutic re-search using children, we hold that theconsent of a parent alone cannot make

appropriate that which is innately inappro-priate.

In T.D. v. New York State Office ofMental Health, 165 Misc.2d 62, 626N.Y.S.2d 1015 (1995), that court was pre-sented with a dispute as between whichstate agency had control over the approvalof experiments using persons generally in-capable of giving consent. Most weremental patients and included both adultand minor subjects. The trial courtagreed with the representatives of the sub-jects, granting a partial summary judge-ment to that effect. In its opinion, itstated:

‘‘The plaintiffs seek a declaratoryjudgment as to the validity of the OMHregulations promulgated November 7,1990 (14 NYCRR 527.10) which set forththe procedures to be followed for thenonconsensual participation by mentalpatients in potentially high-risk experi-ments. It is important to note at theoutset that this action is not a broad-based challenge by the plaintiffs to anyand all research performed on humansubjects. It is limited to those proce-dures which may cause stroke, heartattack, convulsions, hallucinations, orother diseases and disabilities includingdeath, and which, while possibly shed-ding light on possible future treatmentsto others, offer no direct therapeuticbenefit to the participating subject.Plaintiffs contend that their challengeaffects only approximately 10 studieswhich utilize incapable individuals orchildren, involve more than a minimalriskTTTT

TTT

What is most objected to are the pro-visions for substituted TTT decision mak-ers. Courts tread cautiously when thirdparties are relied on to make decisionsfor an incapable patient. When the pro-posed medical course does not involve an


emergency and is not for the purpose ofbettering the patient’s condition, or end-ing suffering, it may be doubtful if asurrogate decision maker—a guardian, acommittee, a health-care proxy holder, arelative, or even a parent could properlygive consent to permitting a ward to beused in experimental research with noprospect of direct therapeutic benefit tothe patient himself. ‘Parents may befree to become martyrs themselves.But it does not follow they are free, inidentical circumstances, to make mar-tyrs of their children before they havereached the age of full and legal discre-tion when they can make that choice forthemselves.’ (Prince v. Massachusetts,321 U.S. 158, 170, 64 S.Ct. 438, 88 L.Ed.645[ (1944)].)’’

Id. at 65–71, 626 N.Y.S.2d at 1017–21 (cita-tions omitted) (some emphasis added).

The intermediate appellate court of NewYork, affirmed and modified the trialcourt’s declaration, finding additional sec-tions of the statute at issue inappropriate.In respect to the reasonableness of accept-ing parental consent for minors to partici-pate in potentially harmful, nontherapeuticresearch, that court stated:

‘‘We also find unacceptable the provi-sions that allow for consent to be ob-tained on behalf of minors for partic-ipation in greater than minimal risk 41

nontherapeutic research from the mi-nor’s parent or legal guardian, or, whereno parent or guardian is available, froman adult family member involved inmaking treatment decisions for thechildTTTT

We are not dealing here with parentalchoice among reasonable treatment al-ternatives, but with a decision to subjectthe child to nontherapeutic treatmentsand procedures that may cause harmfulpermanent or fatal side effects. It fol-lows therefore that a parent or guard-ian, TTT may not consent to have a childsubmit to painful and/or potentially life-threatening research procedures thathold no prospect of benefit for the childTTTT We do not limit a parent or legalguardian’s right to consent to a child’sparticipation in therapeutic researchthat represents a valid alternative andmay be the functional equivalent oftreatment.’’

T.D. v. New York State Office of MentalHealth, 228 A.D.2d 95, 123–24, 650N.Y.S.2d 173, 191–92 (1996). We concurwith that assessment.

Additionally, there are conflicting viewsin respect to nontherapeutic research, asto whether consent, even of a person capa-ble of consenting, can justify a researchprotocol that is otherwise unjustifiable.

‘‘This ‘justifying’ side of consent raisessome timeless and thorny questions.What if people consent to activities andresults which are repugnant, or evenevil? Even John Stuart Mill worriedabout consensual slaveryTTTT Today, wewonder whether a woman’s consent toappear in graphic, demeaning, or evenviolent pornography justifies or immun-izes the pornographer. If she appearsto consent to a relationship in which sheis repeatedly brutalized, does her con-sent stymie our efforts to stop the bru-tality or punish the brute?

41. Minimal risk has been defined as ‘‘mean-ing ‘that the probability and magnitude ofharm or discomfort anticipated in the re-search are not greater in and of themselvesthan those ordinarily encountered in daily lifeor during the routine physical or psychologi-cal examinations or tests.’ ’’ Katerberg, Insti-

tutional Review Boards, Research on Children,and Informed Consent of Parents: Walking theTightrope Between Encouraging Vital Experi-mentation and Protecting Subject’s Rights, 24Journal of College and University Law 545,555 (Winter 1998), in part quoting from 45Code Federal Regulations section 46.102(i).


These problems make us squirm alittle, just as they did Mill. We havethree ways out: We can say, first, ‘Yes,consent justifies whatever is consentedto—you consented, so case closed;’ sec-ond, ‘This particular consent is defi-cient—you did not really consent and sothe result or action is not justified;’ orthird, ‘You consented, but your consentcannot justify this action or result.’TTT

Note the subtle yet crucial differencebetween these three options: In thefirst, consent is king, while the thirdoption assumes a moral universe shapedand governed by extra-consensual con-siderations. The second option, howev-er, reflects the tension between the oth-er two. We might block the consented–to action, but we pay lip service to con-sent’s justifying role by assuring our-selves that had the consent been un-tainted, had it been ‘informed,’ it wouldhave had moral force. In fact, we paylip service precisely because we oftensilently suspect that consent cannot anddoes not always justifyTTTT Rather thanadmit that the consent does not andcould not justify the act, we denigratethe consent and, necessarily, the consen-ter as well.

This is cheating; it is a subterfugedesigned to hide our unease and to allowus to profess simultaneous commitmentto values that often conflict.’’

Garnett, Why Informed Consent? Hu-man Experimentation and the Ethics ofAutonomy, 36 Catholic Lawyer 455, 458–60 (1996) (footnotes omitted). The articlecontinues:

‘‘We should worry about the behavior ofthe experimenter, about our own culpa-bility, and not about the subject’s choos-ing capacities.

Such restrictions on consent, whichaim at objective behaviors and resultsrather than at subjective decision-mak-ing processes, are common in the crimi-nal law. For example, guilty pleas mustusually be supported by a factual basis,and be knowing and voluntary. We rec-ognize that defendants might quite ra-tionally plead guilty to crimes they didnot commit and that prosecutors mightbe willing to accept such pleas. Howev-er, because such pleas embroil the legalsystem in a monstrous falsehood, werefuse to accept them while admittingthat they might indeed be in the defen-dant’s correctly perceived best interests.

TTT

Similarly, in contract and consumerlaw, we often balance our general pref-erence for unfettered respect for con-sensual arrangements against other con-cernsTTTT One purpose of these rules isundeniably to substitute the supposedlybetter judgment of the legislature andthe judiciary about what is really in aperson’s best interestTTTT

TTT

TTT The Nuremberg Code explicitlyrecognized the need to place non-pater-nalistic limits on the scope of experi-ments. The Code asks more of an ex-periment, a researcher, or society thanmere consent.’’

Id. at 494–97.42 Based on the record be-fore us, no degree of parental consent, and

42. ‘‘Categorical limitations on human re-search and experimentation, TTT [would]unavoidably slow us downTTTT Many mightdie of AIDS who would otherwise be will-ing to take risks on the slight chance thatthe next miracle drug might reallyworkTTTT But these losses might be—like

the occasionally guilty defendant goingfree—a price worth paying. The question isnot so much whether we can afford to hon-or our commitment to human dignity, freefrom subterfuges TTT, but whether we canafford not to, or whether we ought to.


no degree of furnished information to theparents could make the experiment at is-sue here, ethically or legally permissible.It was wrong in the first instance.

VII. Conclusion

[22] We hold that in Maryland a par-ent, appropriate relative, or other applica-ble surrogate, cannot consent to the partic-ipation of a child or other person underlegal disability in nontherapeutic researchor studies in which there is any risk ofinjury or damage to the health of thesubject.

[23–25] We hold that informed consentagreements in nontherapeutic researchprojects, under certain circumstances canconstitute contracts; and that, under cer-tain circumstances, such research agree-ments can, as a matter of law, constitute‘‘special relationships’’ giving rise to duties,out of the breach of which negligence ac-tions may arise. We also hold that, nor-mally, such special relationships are creat-ed between researchers and the humansubjects used by the researchers. Addi-tionally, we hold that governmental regula-tions can create duties on the part of re-searchers towards human subjects out ofwhich ‘‘special relationships’’ can arise.Likewise, such duties and relationships areconsistent with the provisions of the Nu-remberg Code.

[26–28] The determination as towhether a ‘‘special relationship’’ actuallyexists is to be done on a case by case basis.See Williams, 359 Md. at 150, 753 A.2d at68. The determination as to whether aspecial relationship exists, if properly pled,

lies with the trier of fact. We hold thatthere was ample evidence in the cases atbar to support a fact finder’s determina-tion of the existence of duties arising outof contract, or out of a special relationship,or out of regulations and codes, or out ofall of them, in each of the cases.

We hold that on the present record, theCircuit Courts erred in their assessment ofthe law and of the facts as pled in grantingKKI’s motions for summary judgment inboth cases before this Court. Accordingly,we vacate the rulings of the Circuit Courtfor Baltimore City and remand these casesto that court for further proceedings con-sistent with this opinion.43

CASE NO. 128: RULING OF THECIRCUIT COURT FOR BALTIMORECITY GRANTING APPELLEE’S MO-TION FOR SUMMARY JUDGMENT ISVACATED AND CASE REMANDEDTO THAT COURT FOR PROCEED-INGS CONSISTENT WITH THIS OPIN-ION; COSTS TO BE PAID BY KKI.

CASE NO. 129: RULING OF THECIRCUIT COURT FOR BALTIMORECITY GRANTING APPELLEE’S MO-TION FOR SUMMARY JUDGMENT ISVACATED AND CASE REMANDEDTO THAT COURT FOR PROCEED-INGS CONSISTENT WITH THIS OPIN-ION; COSTS TO BE PAID BY KKI.

RAKER, Judge, concurring in resultonly:

These appeals present the narrow ques-tion of whether the Circuit Courts erred ingranting summary judgments to appellee,

TTT The lure of perfectionism and of theall-consuming pursuit of knowledge, boththe conceit and the curiosity of the scientist,all conspire to tempt us to play fast andloose with the dignity of our research sub-jects and ourselves.

Id. at 502.

43. The appellants also asserted that the con-sent agreements required KKI to again repairtheir homes if lead dust appeared after theoriginal abatement measures were taken.The consent agreements do not so provide.In light of our opinion, we do not address thisissue further.


the Kennedy Krieger Institute, a researchentity, on the ground that, as a matter oflaw, it owed no duty to warn appellants,Ericka Grimes and Myron Higgins, et al.,human subjects participating in its re-search study. I concur in the judgment ofthe Court only and join in the Court’sjudgment that the Circuit Courts erred ingranting summary judgments to appellee.These cases should be remanded for fur-ther proceedings.

I concur in the Court’s judgment be-cause I find that appellants have allegedsufficient facts to establish that there ex-isted a special relationship between theparties in these cases, which created aduty of care that, if breached, gives rise toan action in negligence. See Ashburn v.Anne Arundel County, 306 Md. 617, 630–31, 510 A.2d 1078, 1083 (1986). I wouldhold that a special relationship giving riseto a duty of care, the breach of whichwould be the basis for an action in negli-gence, existed in these cases and wouldremand the cases at bar to the CircuitCourts for further proceedings. I agreewith the majority that this duty includesthe protection of research subjects fromunreasonable harm and requires the re-searcher to inform research subjects com-pletely and promptly of potential hazardsresulting from participation in the study.See maj. op. at 846, 848–849, 858. As aresult of the existence of this tort duty, Ifind it unnecessary to reach the thornyquestion, not even raised by any of theparties, of whether the informed consentagreements in these cases constitute legal-ly binding contracts. See maj. op. at 818(stating that ‘‘the consents of the parentsin these cases under Maryland law consti-tuted contracts creating duties’’); id. at843 (stating that ‘‘we hold from our ownexamination of the record that such provi-sions were so contained, mutual assent,offer, acceptance, and consideration exist-ed, all of which created contractual rela-

tionships imposing duties by reason of theconsent agreements themselves TTT’’); id.at 858 (stating that ‘‘[w]e hold that in-formed consent agreements in nonthera-peutic research projects, under certain cir-cumstances can constitute contracts TTT’’).

I have some concern with the mixedmessage sent by the majority as to wheth-er the existence of a tort duty arising froma special relationship existed is a questionof law for the court or a question to bedetermined by the trier of fact. For ex-ample, the majority states that ‘‘the cre-ation of study conditions or protocols orparticipation in the recruitment of other-wise healthy subjects to interact with TTT

hazardous conditions TTT would normallywarrant or create TTT special relationshipsas a matter of law.’’ Maj. op. at 845–846(emphasis added). The majority also con-cludes that ‘‘informed consent agreementsin nontherapeutic research projects TTT,under certain circumstances, TTT can, as amatter of law, constitute ‘special relation-ships’ giving rise to duties, out of thebreach of which negligence actions mayarise.’’ Id. at 858 (emphasis added).

On the other hand, citing Williams v.Maynard, 359 Md. 379, 754 A.2d 379(2000), the majority ultimately concludesthat the determination as to whether aduty of care existed between the parties isa question to be determined by the trier offact on a case-by-case basis. See maj. op.at 858. I disagree with that conclusion.The holding in Williams relied upon Ash-burn, which stated only that ‘‘[i]n order forsuch a [special] relationship to be foundbetween police and perpetrator, it must bealleged that there was some type of ongo-ing custodial relationship between the po-lice officer and the actor.’’ Ashburn, 306Md. at 631 n. 2, 510 A.2d at 1085 n. 2.Prior to Williams, Maryland case law es-


tablished that existence of a duty of care isa legal question to be determined by thetrial court, in the first instance, and thisCourt on appeal. See Rosenblatt v. ExxonCo., 335 Md. 58, 76, 642 A.2d 180, 189(1994) (stating that ‘‘the question whetherExxon owed a duty to Rosenblatt is anissue of law, to be determined by thecourt’’); Jacques v. First Nat’l Bank, 307Md. 527, 533, 515 A.2d 756, 759 (1986)(stating that ‘‘the duty with which we arehere concerned is a duty imposed by lawas a matter of sound policy, for the viola-tion of which a person may be held torespond in damages in tort.’’); cf. W.Page Keeton et al., Prosser and Keeton onTorts § 45, at 320 (5th ed.1984). I see noprincipled reason to create an express ex-ception to this rule for tort duties arisingout of special relationships, particularly incases like those sub judice where there areno material facts relating to the existenceof a special relationship in dispute. Incontrast, it is the question of whether suchduty was breached in the two cases pre-sented that is a factual determination to bemade by the finder of fact after a trial onthe merits on remand. Cf. maj. op. at 824n. 21.

As I have indicated, this case presents anarrow question of whether a duty in tortexists between the plaintiffs and the defen-dants. The majority recites the standardof review on summary judgment, and iter-ates that ‘‘[t]he purpose of the summaryjudgment procedure is not to try the caseor to decide the factual disputes, but todecide whether there is an issue of fact,which is sufficiently material to be tried.’’Maj. op. at 834. Nonetheless, the majorityappears to have decided the issue ofwhether such duty of care was, in fact,breached as a matter of law, without ahearing or a trial on the merits.

I cannot join in the majority’s sweepingfactual determinations that the risks asso-

ciated with exposing children to lead-based paint were foreseeable and wellknown to appellees and that appellees con-templated lead contamination in partici-pants’ blood, see id. at 848–849, 852; thatthe children’s health was put at risk, seeid. at 815–816; that there was no completeand clear explanation in the consentagreements that the research to be con-ducted was designed to measure the suc-cess of the abatement procedures bymeasuring the extent to which the chil-dren’s blood was being contaminated andthat a certain level of lead accumulationwas anticipated, see id. at 812–813, 824,828, 848–849; that the parental consentwas ineffective, see id. at 818, 848; thatthe consent form was insufficient becauseit lacked certain specific warnings, see id.at 844; that the consent agreements didnot provide that appellees would providerepairs in the event of lead dust contami-nation subsequent to the original abate-ment measures, see id. at 858 n. 43; thatthe Institutional Review Board involved inthese cases abdicated its responsibility toprotect the safety of the research subjectsby misconstruing the difference betweentherapeutic and nontherapeutic researchand aiding researchers in circumventingfederal regulations, see id. at 813–814, 817;that Institutional Review Boards are notsufficiently objective to regulate the ethicsof experimental research, see id. at 817;that it is never in the best interest of anychild to be placed in a nontherapeutic re-search study that might be hazardous tothe child’s health, see id. at 852–853; thatthere was no therapeutic value in the re-search for the child subjects involved, seeid. at 854–855; that the research did notcomply with applicable regulations, see id.at 848; or that there was more than aminimal risk involved in this study, see id.at 848. I do not here condone the conductof appellee, and it may well be that themajority’s conclusions are warranted by


the facts of these cases, but the recordbefore us is limited. Indeed, the majorityrecognizes that the record is ‘‘sparse.’’Maj. op. at 818. The critical point is thatthese are questions for the jury on re-mand and are not properly before thisCourt at this time.

I emphasize that we are deciding thepropriety of granting summary judgment.Therefore, upon remand, appellee is freeto offer evidence to support its position.

Unfortunately, the majority chooses togo far beyond the narrow question pre-sented in these appeals and addresses anumber of ancillary issues in dicta. Icannot join the majority in holding that, inMaryland, a parent or guardian cannotconsent to the participation of a minorchild in a nontherapeutic research study inwhich there is any risk of injury or dam-age to the health of the child without priorjudicial approval and oversight. See id. at814, 817–818, 850–851, 855, 858. Nor can Ijoin in the majority’s holding that the re-search conducted in these cases was per seinappropriate, unethical, and illegal, see id.at 814–815, 817–818, 848–849, 853, 855, 857.Such sweeping holdings are far beyond thequestion presented in these appeals, andtheir resolution by the Court, at this time,is inappropriate. I also do not join in whatI perceive as the majority’s wholesaleadoption of the Nuremberg Code into Ma-ryland state tort law. See id. at 849–850,851. Finally, I do not join in the majori-ty’s comparisons between the research atissue in this case and extreme historicalabuses, such as those of the Nazis or theTuskegee Syphilis Study. See id. at 816–817.

Accordingly, I join the majority only inthe judgment to reverse the Circuit

Courts’ granting of summary judgments toappellees.

ON MOTION FORRECONSIDERATION

PER CURIAM.

The Court has considered the motion forreconsideration and the submissions by thevarious amici curiae. The motion is de-nied, with this explanation.

Some of the issues raised in this case, inthe briefs and at oral argument, were im-portant ones of first impression in thisState, and the Court therefore attemptedto address those issues in a full and ex-haustive manner. The case reached us inthe context of summary judgments en-tered by the Circuit Court, which entailedrulings that the evidence presented by theplaintiffs, for purposes of the motions,even when taken in a light most favorableto them, was insufficient as a matter of lawto establish the prospect of liability. Wedisagreed with that determination. Al-though we discussed the various issues andarguments in considerable detail, the onlyconclusion that we reached as a matter oflaw was that, on the record currently be-fore us, summary judgment was improper-ly granted—that sufficient evidence waspresented in both cases which, if taken in alight most favorable to the plaintiffs andbelieved by a jury, would suffice to justifyverdicts in favor of the plaintiffs. Thus,the cases were remanded for further pro-ceedings in the Circuit Court. Every issuebearing on liability or damages remainsopen for further factual development, andany relevant evidence not otherwise pre-cluded under our rules of evidence is ad-missible.

Much of the argument in support of andin opposition to the motion for reconsidera-


tion centered on the question of what limi-tations should govern a parent’s authorityto provide informed consent for the partic-ipation of his or her minor child in amedical study. In the Opinion, we said atone point that a parent ‘‘cannot consent tothe participation of a child TTT in nonther-apeutic research or studies in which thereis any risk of injury or damage to thehealth of the subject.’’ As we think isclear from Section VI of the Opinion, by‘‘any risk,’’ we meant any articulable riskbeyond the minimal kind of risk that isinherent in any endeavor. The context ofthe statement was a non-therapeutic studythat promises no medical benefit to thechild whatever, so that any balance be-tween risk and benefit is necessarily nega-tive. As we indicated, the determinationof whether the study in question offeredsome benefit, and therefore could be re-garded as therapeutic in nature, or in-volved more than that minimal risk is openfor further factual development on re-mand.

RAKER, Judge, dissenting.

I respectfully dissent from the orderdenying the motions for reconsideration.I adhere to the views previously expressedin my concurring opinion filed herein onAugust 16, 2001.

The majority’s discussion of the abilityof a parent or guardian to consent to theparticipation of a minor child in a nonther-apeutic research study and the discussionregarding the ethics of the research con-ducted in these cases involve serious publicpolicy considerations. The statements area declaration of public policy that, in theposture of this case, are best left to theGeneral Assembly. See Gaver v. Harrant,316 Md. 17, 28–29, 557 A.2d 210, 217(1989); Harrison v. Mont. Co. Bd. ofEduc., 295 Md. 442, 460, 456 A.2d 894, 903(1983). Inasmuch as these issues were

never raised by the pleadings or the par-ties below, this Court had no basis toaddress these very complex issues; if achange is to be made in the State’s policyof regulating research studies, unlessclearly presented to the court, it should bemade by legislative enactment. See Md.Nat’l Bk. v. United Jewish App., 286 Md.274, 407 A.2d 1130 (1979). This mattermerits the close scrutiny of the GeneralAssembly. See Cotham and Maldonado v.Board, 260 Md. 556, 273 A.2d 115 (1971).

,

366 Md. 121

Aaron A. SCOTT

v.

STATE of Maryland.

No. 143, Sept. Term, 2000.

Court of Appeals of Maryland.

Oct. 11, 2001.

Defendant was convicted in the Cir-cuit Court for Baltimore County, Law-rence R. Daniels, J., of possession withintent to distribute cocaine, and he appeal-ed. The Court of Appeals, Wilner, J., heldthat, as matter of first impression, ‘‘knockand talk’’ procedure whereby police ran-domly knocked on motel room doors at11:30 p.m. to question occupants in hopesthat occupants would allow police to enterand ultimately consent to a search did notviolate Fourth Amendment when such pro-cedure was carried out in absence of artic-ulable suspicion or probable cause.

Affirmed.

grimes v. kennedy krieger md. 807 - columbia university

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