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HEALTH POLICY AND ETHICS FORUM |
Leonard H. Glantz is Professor of Health Law at the Boston University School of Public Health. Requests for reprints should be sent to Leonard H. Glantz, JD, Boston University School of Public Health, 715 Albany St T-3, Boston, MA 02215 (e-mail: lglantz{at}bu.edu).
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ABSTRACT |
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 TOP ABSTRACT INTRODUCTIONTHE COURT OF APPEALS...ARTICULATING ACCEPTABLE RiskCONCLUSIONReferences |
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Research with young children raises difficult issues of law and ethics. A recent Maryland case, Grimes v Kennedy Krieger Institute, Inc, appears to impose restrictive rules on research with children when the subjects are put at risk but cannot derive direct benefit from their involvement in the research project. This case exemplifies the tension that exists between the goal of science to increase knowledge and the protection of the rights and welfare of nonconsenting research subjects. While some language in the opinion may be difficult to understand or apply, for the most part the case reflects the problems other courts and ethicists have had in delineating the role of children in "nontherapeutic" research. (Am J Public Health. 2002;92:1070–1073)
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONTHE COURT OF APPEALS...ARTICULATING ACCEPTABLE RiskCONCLUSIONReferences |
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The decision addresses issues raised in 2 negligence cases in which the plaintiffs were young children involved in research projects that were designed to determine the relative effectiveness of different methods of lead paint abatement. The projects were funded by the Environmental Protection Agency.
Both cases allege that the children were "poisoned" or put at the risk of being lead poisoned as a result of being research subjects. In particular, the plaintiffs alleged that KKI required that certain homes undergo only partial lead paint abatement; required landlords to rent premises to families with young children; encouraged the families of these children to remain in the study houses so that the children's blood could be tested over time; knew that one of the children had a dangerously elevated blood lead level and failed to notify the parents of this in a timely manner; and failed to provide the parents with a complete and clear explanation of the research. Only low-income children were involved as subjects, and their parents were "enticed" by food stamps, money, or other items.
The trial court granted KKI's motion for summary judgment and dismissed the case. That court based its judgment on the ground that the researchers had no legal duty to warn the plaintiffs of the presence of lead dust. The specific issue the plaintiffs appealed is the following:
Was the trial court incorrect . . . that as a matter of law a research entity conducting an ongoing nontherapeutic study does not have a duty to warn a minor volunteer participant and/or his legal guardian regarding the dangers present when the researcher has knowledge of the potential for harm to the subject and the subject is unaware of the danger?3
On its face, this is a relatively narrow question of law, simply involving a duty to warn. However, in answering it the court of appeals covered a great deal of legal territory.
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THE COURT OF APPEALS RULING |
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1.Contractual obligations. The court found that "[r]esearcher/subject consent can, and in this case did, create a contract." Whether researchers and subjects enter into a contract as a result of the consent process has been a matter of some question. Here the court held that in the nontherapeutic research circumstance in which subjects are compensated, no matter how small the compensation, a contact is created as a result of the consent process. This means that the consent form can create legally binding obligations on researchers. The court specifically reserved judgment about whether such contractual obligations are created in therapeutic research.
2.Regulatory obligations. The court held that the federal regulations that govern federally funded research might create affirmative duties for researchers that are enforceable in state negligence lawsuits. This is an important ruling because the federal regulations are merely conditions on the receipt of federal funding, with the remedy for failure to meet these conditions being suspension of federal funding as a result of governmental action. Enabling individuals to essentially enforce the federal regulations provides a new means for ensuring subjects' rights.
3.The Nuremberg Code. The Nuremberg Code is a set of principles that came out of the trials of Nazi doctors after World War II. There has been significant controversy as to whether courts would perceive this code as applicable to US researchers.4 The Maryland court stated that the Nuremberg Code "might well support actions sounding in negligence in cases such as those at issue here."3 This is the first time any US court has so explicitly adopted the Nuremberg Code as a source of legally enforceable ethical standards.
These 3 rulings standing alone would make this a notable case. But the part of the case that has engendered the most concern is the section dealing with the legality of enrolling young children in research projects that present a risk of harm but no possibility of direct benefit to the individual research subjects. The court held:
In our view, otherwise healthy children should not be the subjects of nontherapeutic research that has the potential to be harmful to the child. It is, first and foremost, the responsibility of the researcher and the research entity to see to the harmlessness of such nontherapeutic research. Consent of parents can never relieve the researcher of this duty.3
This language would appear to impose a requirement of "harmlessness" on researchers and institutions that wish to perform nontherapeutic research with subjects who are incapable of consenting.
Similarly, the court restricted parental authority to consent to their children's participation in such research. After noting that children are not "the equivalent of rats, hamsters, monkeys and the like," that parents are supposed to act in their children's best interests, and that it is not in the best interests of a healthy child to be "intentionally put in a nontherapeutic situation where his or her health may be impaired, in order to test methods that may ultimately benefit all children," the court stated,
We hold that in Maryland a parent, appropriate relative, or other appropriate surrogate, cannot consent to the participation of a child or other person under legal disability in nontherapeutic research or studies in which there is any risk of injury or damage to the health of the subject [emphasis added].3
It is the restrictiveness of this standard that has caused a great deal of concern at KKI and elsewhere, because research that compares the effectiveness of preventive interventions with children is widely conducted by public health investigators. This no-risk standard is considerably stricter than current federal regulations, which permit research that presents no greater than minimal risk.5 Even research that presents greater than minimal risk with no prospect of benefit to the individual child subject is permissible under the federal regulations in certain circumstances.6
The no-risk standard adopted by the court led KKI, supported by several academic organizations, to ask the court to reconsider its ruling, essentially arguing that the court's strict standard would prohibit important research. The court denied the motion for reconsideration but attempted to clarify its position by noting,
[B]y "any risk," we meant any articulable risk beyond the minimal kind of risk that is inherent in any endeavor. The context of the statement was a nontherapeutic study that promises no medical benefit to the child whatsoever, so that any balance between risk and benefit is necessarily negative.3
It is difficult to reconcile the first sentence of this statement, which seems to permit some minimal risk, with the second sentence, which seems to mean that any risk is too great in the context of nontherapeutic research.
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ARTICULATING ACCEPTABLE Risk |
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In 1996 an intermediate appellate court in New York confronted a similar issue regarding nontherapeutic research involving incompetent subjects. In that case the plaintiffs brought an action to challenge the regulations of the New York Department of Mental Health that sanctioned the performance of greater-than-minimal-risk nontherapeutic experiments on incapable adults and children. The court found,
[A] parent or guardian . . . may not consent to have a child submit to painful and/or potentially life-threatening research procedures that hold no prospect of benefit for the child and that may have the same result as a denial of necessary medical treatment.7
It is easy to accept the notion that parents may not submit their children to life-threatening research procedures that offer no prospect of direct benefit, but the prohibition on "painful" procedures would seem to prohibit even the drawing of blood.
The federal research regulations define minimal risk as a situation in which "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests,"8 but the reference to daily life is nebulous at best. The question is, "whose ‘daily life’ is the reference point?"9 Since the daily lives of inner-city adolescents are likely to be riskier than those of middle-aged suburban adults, a literal application of this standard would appear to permit riskier research with the adolescents than with the adults.
A report by the National Bioethics Advisory Commission recommended, "Minimal risk should be defined as the probability and magnitude of harms that are normally encountered in the daily lives of the general population."10 But trying to apply this to the KKI case makes it apparent that this definition does not resolve the issue. What is the risk of lead paint exposure in the "daily lives of the general population"? While inner-city children in Baltimore have a significant risk of such exposure, this is certainly not typical of the general population in the United States.
Another report by the commission suggests a procedural resolution of the problem.11 This solution would permit nontherapeutic research with incompetent subjects that presents greater than minimal risk if the research were approved by a special standing panel that would be appointed by the Secretary of Health and Human Services—approval by a local institutional review board would not be sufficient to authorize such research.
In one of the great intellectual debates concerning the ethics of involving children in nontherapeutic research, Paul Ramsey argued that the use of young children as research subjects when they could derive no benefit from participating is never justified,12 while Richard McCormick argued that research on children is ethically permissible so long as it involves "no discernible risks, no notable pain, [and] no notable inconvenience."13 But McCormick's formulation is not particularly helpful. Is there a difference between "no risk" and "no discernible risk?" How much pain constitutes "notable" pain? Anyone who has experienced the reaction of an infant to an injection would have to conclude that the pain was notable to the child, although perhaps not notable to a typical adult.
The KKI court of appeals is in good company both in its attempt to protect child subjects and in its failure to fashion a satisfactorily clear standard.
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CONCLUSION |
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TOPABSTRACTINTRODUCTIONTHE COURT OF APPEALS...ARTICULATING ACCEPTABLE RiskCONCLUSIONReferences |
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The court of appeals was clearly correct in reversing the trial court's general ruling that institutions and researchers do not have a duty to protect subjects. It was also correct in arguing for a very cautious approach toward nontherapeutic research with children. Indeed, it is in agreement with the earlier New York court in adopting this protective approach. What we do not know, however, is how the court would apply its approach to a particular factual circumstance—and no facts have yet been proven in the KKI case.
It is important to remember that the plaintiffs' allegations have not been proven, because the trial court dismissed the case before the trial was held. When a defendant asks for summary judgment, the judge is supposed to view the plaintiff's evidence "in a light most favorable to them." The appeals court applied this rule in rendering its decision, which gives the impression that the appeals court believed the plaintiffs' allegations. The appeals court sent the case back to the trial court. The outcome of the trial is far from certain. As the appeals court noted in the last line of its order rejecting the defendants' motion for reconsideration, "the determination of whether the study in question offered some benefit, and therefore could be regarded as therapeutic in nature, or involved more than that minimal risk is open for further factual development on remand."3
While some may characterize this case as an example of an overly zealous court's intruding into the prerogatives of the research community, such a characterization would be unfortunate and shortsighted. There is no doubt that parts of the opinion are vague and potentially difficult to apply. It is not uncommon for courts to encounter these types of problems when they enter a new area of jurisprudence with little precedent upon which they can rely. But it is important to keep in mind that the only 2 courts that have addressed the issue of nontherapeutic research with nonconsenting subjects have voiced strikingly similar concerns. The research community would do well to closely examine, understand, and try to address the legitimate legal and ethical issues that so concerned these courts.
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Footnotes |
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Accepted for publication March 19, 2002.
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References |
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2. Grodin MA, Glantz LH, eds. Children as Research Subjects: Science, Ethics and Law. New York, NY: Oxford University Press; 1994.
3. 366 Md 29; 782 A2d 807; 2001 Md LEXIS 496 (2001). Also available at: http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf (PDF file). Accessed May 2, 2002.
4. Annas GJ. Mengele's birthmark: The Nuremberg Code in United States courts. J Contemp Health Law Policy. 1991;7:17–45.[Medline]
7. TD v NY State Office of Mental Health, 228 AD 2d 95, 650 NYS 2d 173 (1996) rev on other grounds, 690 NE2d 1259 (NY 1997).
9. Freedman B, Fuks A, Weijer C. In loco parentis: minimal risks as an ethical threshold for research upon children. Hastings Center Rep.1993;23:13–19.
10. National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants—Volume 1. August 2001. Available at: http://www.ntis.gov. Accessed April 30, 2002.
11. National Bioethics Advisory Commission. Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity. December 1998. Available at: http://www.ntis.gov. Accessed April 30, 2002.
12. Ramsey P. The Patient as Person. New Haven, Conn: Yale University Press; 1970:11–12.
13. McCormick RA. Proxy consent in the experimentation situation. Perspect Biol Med. 1974; 18:2–20. Cited by: Mnookin RH, Weissberg DK. Child, Family and State. 3rd ed. New York, NY: Aspen Publishers Inc; 1995:667.
This article has been cited by other articles:
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  D. Wendler and T. Jenkins Children's and Their Parents' Views on Facing Research Risks for the Benefit of Others Arch Pediatr Adolesc Med, January 1, 2008; 162(1): 9 - 14. [Abstract] [Full Text] [PDF]
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R. H. Pasternak, G. Geller, C. Parrish, and T. L. Cheng Adolescent and parent perceptions on youth participation in risk behavior research. Arch Pediatr Adolesc Med, November 1, 2006; 160(11): 1159 - 1166. [Abstract] [Full Text] [PDF]
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 D. R. Buchanan and F. G. Miller Justice and Fairness in the Kennedy Krieger Institute Lead Paint Study: the Ethics of Public Health Research on Less Expensive, Less Effective Interventions Am J Public Health, May 1, 2006; 96(5): 781 - 787. [Abstract] [Full Text] [PDF]
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 M Spriggs Canaries in the mines: children, risk, non-therapeutic research, and justice J. Med. Ethics, April 1, 2004; 30(2): 176 - 181. [Abstract] [Full Text]
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R. P. Wedeen ETHICS IN PUBLIC HEALTH INSTITUTIONS Am J Public Health, December 1, 2002; 92(12): 1884 - 1885. [Full Text] [PDF]
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| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
46.404.