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Every one interested in this case should read this article on the real story of this research - JOANNE POLLAK, J.D., THE LEAD-BASED PAINT ABATEMENT REPAIR & MAINTENANCE STUDY IN BALTIMORE: HISTORIC FRAMEWORK AND STUDY DESIGN - Published in the Journal of Health Care Law & Policy, Vol. 6, Issue 1, 2002 and used with their permission.
Government study on lead that was the basis for the research - Comprehensive and workable Plan for the Abatement of Lead-Based Paint in Privately Owned Housing Report to Congress U.S. Department of Housing and Urban Development Washington, DC December 7,1990. (7 meg PDF)
This is a landmark case in human experimentation law. It involves a non-therapeutic experiment on children, done with their parents consent. The core legal case is one of failure of informed consent on the part of the parent as substituted decisionmaker, which was allegedly supported evidence that the consent form did not specify the material risks posed to the children. The court, in a lengthy opinion, went beyond the issue on appeal in the case and questioned the right of parents to consent to any non-therapeutic research on health children. The court's dicta, in that it did not address the legal issue on appeal, seems to require court approval for non-therapeutic research on healthy children. This opinion has far reaching consequences in that it creates a new standard for reviewing research that raises federalism concerns, and in that it puts a significant limit on the rights of parents to consent to medical research. To some extent this case was driven by the bad facts as presented by the plaintiff - as an appeal arising from a motion for summary judgment, the defendant is in the unfortunate position of not being able to rebut the plaintiff's charges and thus appears monstrous.
Later information indicates that the facts in this case are dramatically different from those recited by the plaintiff. While it is job of an attorney to state his case in the most persuasive way, it is also the duty of the court to look skeptically on these claims. In this case, the court noted that the facts might differ from the plaintiff's statement, but then, except for one judge, forgot their admonition and treated the plaintiff's outlandish story as gospel. The court in this case has raised the risks to defendant through its posture in this opinion. The court analogizes this case to the Tuskegee syphilis experiment and also harkens back to the Nazi medical experiments done in the death camps. This is opinion is most valuable because it illustrates how the courts can make very bad policy when they forget that the advocates duty is not tell the truth, but to present facts in the most favorable light for the client. The following statement of the case draws from the courts own language because it so clearly conveys that court's frustration with the defendant's alleged conduct and how this drove the court to its far reaching holding. Ironically, the core ruling - that researchers owe a legal duty to subjects - is correct, yet it almost none of this rant addresses that issue.
[quotation marks omitted through out]
In these present cases, a prestigious research institute, associated with Johns Hopkins University, based on this record, created a nontherapeutic research program *fn2 whereby it required certain classes of homes to have only partial lead paint abatement modifications performed, and in at least some instances, including at least one of the cases at bar, arranged for the landlords to receive public funding by way of grants or loans to aid in the modifications. The research institute then encouraged, and in at least one of the cases at bar, required, the landlords to rent the premises to families with young children. In the event young children already resided in one of the study houses, it was contemplated that a child would remain in the premises, and the child was encouraged to remain, in order for his or her blood to be periodically analyzed. In other words, the continuing presence of the children that were the subjects of the study was required in order for the study to be complete. Apparently, the children and their parents involved in the cases sub judice were from a lower economic strata and were, at least in one case, minorities.
The purpose of the research was to determine how effective varying degrees of lead paint abatement procedures were. Success was to be determined by periodically, over a two-year period of time, measuring the extent to which lead dust remained in, or returned to, the premises after the varying levels of abatement modifications, and, as most important to our decision, by measuring the extent to which the theretofore healthy children's blood became contaminated with lead, and comparing that contamination with levels of lead dust in the houses over the same periods of time. In respect to one of the protocols presented to the Environmental Protection Agency and/or the Johns Hopkins Joint Committee on Clinical Investigation, the Johns Hopkins Institutional Review Board (IRB), the researchers stated: "To help insure that study dwellings are occupied by families with young children, City Homes *fn3 will give priority to families with young children when renting the vacant units following R & M [Repair and Maintenance] interventions."
The same researchers had completed a prior study on abatement and partial abatement methods that indicated that lead dust remained and/or returned to abated houses over a period of time. In an article reporting on that study, the very same researchers said: "Exposure to lead-bearing dust is particularly hazardous for children because hand to mouth activity is recognized as a major source of entry of lead dust into the body and because absorption of lead dust is inversely related to particulate size." R. Farfel & J. Chisolm, Health and Environmental Outcomes of Traditional and Modified Practices for Abatement of Residential Lead-Based Paint, - American Journal of Public Health -(1990). After publishing this report, the researchers began the present research project in which children were encouraged to reside in households where the possibility of lead dust was known to the researcher to be likely, so that the lead dust content of their blood could be compared with the level of lead dust in the houses at periodic intervals over a two-year period.
Apparently, it was anticipated that the children, who were the human subjects in the program, would, or at least might, accumulate lead in their blood from the dust, thus helping the researchers to determine the extent to which the various partial abatement methods worked. There was no complete and clear explanation in the consent agreements signed by the parents of the children that the research to be conducted was designed, at least in significant part, to measure the success of the abatement procedures by measuring the extent to which the children's blood was being contaminated. It can be argued that the researchers intended that the children be the canaries in the mines but never clearly told the parents. (It was a practice in earlier years, and perhaps even now, for subsurface miners to rely on canaries to determine whether dangerous levels of toxic gasses were accumulating in the mines. Canaries were particularly susceptible to such gasses. When the canaries began to die, the miners knew that dangerous levels of gasses were accumulating.)
The researchers and their Institutional Review Board apparently saw nothing wrong with the search protocols that anticipated the possible accumulation of lead in the blood of otherwise healthy children as a result of the experiment, or they believed that the consents of the parents of the children made the research appropriate. Institutional Review Boards (IRB) are oversight entities within the institutional family to which an entity conducting research belongs. In research experiments, an IRB can be required in some instances by either federal or state regulation, or sometimes by the conditions attached to governmental grants that are used to fund research projects. *fn4 Generally, their primary functions are to assess the protocols of the project to determine whether the project itself is appropriate, whether the consent procedures are adequate, whether the methods to be employed meet proper standards, whether reporting requirements are sufficient, and the assessment of various other aspects of a research project. One of the most important objectives of such review is the review of the potential safety and the health hazard impact of a research project on the human subjects of the experiment, especially on vulnerable subjects such as children. Their function is not to help researchers seek funding for research projects.
In the instant case, as is suggested by some commentators as being endemic to the research community as a whole, infra, the IRB involved here, the Johns Hopkins University Joint Committee on Clinical Investigation, in part, abdicated that responsibility, instead suggesting to the researchers a way to miscast the characteristics of the study in order to avoid the responsibility inherent in nontherapeutic research involving children. In a letter dated May 11, 1992, the Johns Hopkins University Joint Committee on Clinical Investigation (the IRB for the University ), charged with insuring the safety of the subjects and compliance with federal regulations, wrote to Dr. Farfel, the person in charge of the research: "A number of questions come up. . . . Please respond to the following points:
2. The next issue has to do with drawing blood from the control population, namely children growing up in modern urban housing. Federal guidelines are really quite specific regarding using children as controls in property in which there are no potential benefits [to the particular children]. To call a control a normal control is to indicate that there is no benefit to be received [by the particular children]. . . . So we think it would be much more acceptable to indicate that the `control group' is being studied to determine what exposure outside the home may play in total lead exposure thereby indicating that these control individuals are gaining some benefit, namely learning whether safe housing alone is sufficient to keep the blood levels in acceptable bounds. We suggest you modify . . . consent forms . . . accordingly." [Emphasis added by the court.]
While the suggestion of the IRB would not make this experiment any less nontherapeutic or, thus, less regulated, this statement shows two things: (1) that the IRB had a partial misperception of the difference between therapeutic and nontherapeutic research and the IRB's role in the process and (2) that the IRB was willing to aid researchers in getting around federal regulations designed to protect children used as subjects in nonthereapeutic research. An IRB's primary role is to assure the safety of human research subjects - not help researchers avoid safety or health-related requirements. The IRB, in this case, misconceived, at least partially, its own role.
The provisions or conditions imposed by the federal funding entities, pursuant to federal regulations, are conditions attached to funding. As far as we are aware, or have been informed, there are no federal or state (Maryland) statutes that mandate that all research be subject to certain conditions. Certain international "codes" or "declarations" exist (one of which is supposedly binding but has never been so held) that, at least in theory, establish standards. We shall describe them, infra. Accordingly, we write on a clean slate in this case. We are guided, as we determine what is appropriate, by those international "codes" or "declarations," as well as by studies conducted by various governmental entities, by the treatises and other writings on the ethics of using children as research subjects, and by the duties, if any, arising out of the use of children as subjects of research.
Otherwise healthy children, *fn5 in our view, should not be enticed into living in, or remaining in, potentially lead-tainted housing and intentionally subjected to a research program, which contemplates the probability, or even the possibility, of lead poisoning or even the accumulation of lower levels of lead in blood, in order for the extent of the contamination of the children's blood to be used by scientific researchers to assess the success of lead paint or lead dust abatement measures. Moreover, in our view, parents, whether improperly enticed by trinkets, food stamps, money or other items, have no more right to intentionally and unnecessarily place children in potentially hazardous nontherapeutic research surroundings, than do researchers. In such cases, parental consent, no matter how informed, is insufficient.
While the validity of the consent agreement and its nature as a contract, the existence or nonexistence of a special relationship, and whether the researchers performed their functions under that agreement pursuant to any special relationships are important issues in these cases that we will address, the very inappropriateness of the research itself cannot be overlooked. It is apparent that the protocols of research are even more important than the method of obtaining parental consent and the extent to which the parents were, or were not, informed. If the research methods, the protocols, are inappropriate then, especially when the IRB is willing to help researchers avoid compliance with applicable safety requirements for using children in nontherapeutic research, the consent of the parents, or of any consent surrogates, in our view, cannot make the research appropriate or the actions of the researchers and the Institutional Review Board proper.
The research relationship proffered to the parents of the children the researchers wanted to use as measuring tools, should never have been presented in a nontherapeutic context in the first instance. Nothing about the research was designed for treatment of the subject children. They were presumed to be healthy at the commencement of the project. As to them, the research was clearly nontherapeutic in nature. The experiment was simply a "for the greater good" project *fn6 . The specific children's health was put at risk, in order to develop low-cost abatement measures that would help all children, the landlords, and the general public as well.
...
The research project at issue here, and its apparent protocols, differs in large degree from, but presents similar problems as those in the Tuskegee Syphilis Study conducted from 1932 until 1972 (The Tuskagee Syphilis Study, 289 New England Journal of Medicine 730 (1973)), the intentional exposure of soldiers to radiation in the 1940s and 50s (Jaffee v. United States, 663 F.2d 1226 (3d Cir. 1981), cert. denied, 456 U.S. 972, 102 S. Ct. 2234, 72 L. Ed. 2d 845 (1982)), the tests involving the exposure of Navajo miners to radiation (Begay v. United States, 591 F. Supp. 991 (1984), aff'd, 768 F.2d 1059 (9th Cir. 1985), *fn7 and the secret administration of LSD to soldiers by the CIA and the Army in the 1950s and 60s (United States v. Stanley, 483 U.S. 669, 107 S. Ct. 3054, 97 L. Ed. 2d 550 (1987); Central Intelligence Agency v. Sims, 471 U.S. 159, 105 S. Ct. 1881, 85 L. Ed. 2d 173 (1985)). The research experiments that follow were also prior instances of research subjects being intentionally exposed to infectious or poisonous substances in the name of scientific research. They include the Tuskegee Syphilis Study, aforesaid, where patients infected with syphilis were not subsequently informed of the availability of penicillin for treatment of the illness, in order for the scientists and researchers to be able to continue research on the effects of the illness, the Jewish Hospital study, *fn8 and several other post-war research projects. Then there are the notorious use of "plague bombs" by the Japanese military in World War II where entire villages were infected in order for the results to be "studied"; *fn9 and perhaps most notorious, the deliberate use of infection in a nontherapeutic project in order to study the degree of infection and the rapidity of the course of the disease in the Rose and Mrugowsky typhus experiments at Buchenwald concentration camp during World War II. These programs were somewhat alike in the vulnerability of the subjects; uneducated African-American men, debilitated patients in a charity hospital, prisoners of war, inmates of concentration camps and others falling within the custody and control of the agencies conducting or approving the experiments. In the present case, children, especially young children, living in lower economic circumstances, albeit not as vulnerable as the other examples, are nonetheless, vulnerable as well.
It is clear to this Court that the scientific and medical communities cannot be permitted to assume sole authority to determine ultimately what is right and appropriate in respect to research projects involving young children free of the limitations and consequences of the application of Maryland law. The Institutional Review Boards, IRBs, are, primarily, in-house organs. In our view, they are not designed, generally, to be sufficiently objective in the sense that they are as sufficiently concerned with the ethicality of the experiments they review as they are with the success of the experiments. This has been the subject of comment in a constitutional context, in dissent, in a case involving the use of psychiatric medication on mental patients without their consent. In Washington v. Harper, 494 U.S. 210, 238, 110 S. Ct. 1028, 1045, 108 L. Ed. 2d (1990), Justice Stevens said:
"The Court has undervalued respondents' liberty interest; has misread the Washington involuntary medication policy . . . , and has concluded that a mock trial before an institutionally biased tribunal constitutes `due process of law.'"
In footnote two of his dissent, Justice Stevens noted:
"(The Constitution's promise of due process of law guarantees at least compensation for violations of the principle stated by the Nuremberg Military Tribunals `that the voluntary consent of the human subject is absolutely essential . . . to satisfy moral, ethical and legal concepts.') (The Fourteenth Amendment protects the `freedom to care for one's health and person.') . . . ." 494 U.S. at 238, 110 S. Ct. at ___, 108 L. Ed. 2d at ___.
...
Just recently the research community has been subjected to question as a result of genetic experimentation on a Pennsylvania citizen. Jesse Gelsinger consented to participate in a research project at the University of Pennsylvania's Institute of Human Gene Therapy. After Gelsinger's death, the U.S. Food and Drug Administration ordered a halt to eight human gene therapy experiments at the Institute. Additionally, other similar projects were halted elsewhere. The FDA took the action after a "discovery of serious problems in the Institute's informed consent procedures and, more generally, a lapse in the researcher's ethical responsibilities to experimental subjects." J. Barker, Human Experimentation and the Double Facelessness of a Merciless Epoch, 25 New York University Review of Law and Social Change 603, 615 (1999).
Gelsinger had a different type of ornithine transcarbamylase deficiency (OTC) disease, than that addressed by the research. His particular brand of the disease was under control. There was no possibility that the research being conducted would directly benefit him. It was thus, as to him, as it was to the children in the case at bar, nontherapeutic; a way to study the affects on the subjects (in the present case, the children) in order to measure the success of the experiment. In Gelsinger's case, the research was to test the efficiency of disease vectors. In other words, weakened adenovirus (common-cold viruses) were used to deliver trillions of particles of a particular OTC gene into his artery and thus to his liver. Gelsinger experienced a massive and fatal immune system reaction to the introduction of the common-cold virus.
There were problems with the extent of the informed consent there obtained. Barker noted that:
"Is this a case of rogue experimenters giving a bad name to all genetic research? Not at all. The program in Philadelphia is (or at least was) one of the most prestigious in the world and the researchers there were first rate. Rather, the problems with that program are indicative of systemic problems with genetic research and informed consent as a protection of the autonomy of research subjects. . . .
Why are there such serious problems with informed consent in some of these trials, and why is there almost total noncompliance with regulations concerning serious side effects? The answers to these questions are related. Informed consent has suffered from pressure to get results-as quickly as possible. . . . Informed consent procedures, properly followed, are troublesome, time-consuming, costly, and may even threaten proprietary information valuable to the biotech companies. The ethical face of the research subject may be obscured by such factors.
...
The consent form did not directly inform the parents of the fact that it was contemplated that some of the children might ingest lead dust particles, and that one of the reasons the blood of the children was to be tested was to evaluate how effective the various abatement measures were.
A reasonable parent would expect to be clearly informed that it was at least contemplated that her child would ingest lead dust particles, and that the degree to which lead dust contaminated the child's blood would be used as one of the ways in which the success of the experiment would be measured. The fact that if such information was furnished, it might be difficult to obtain human subjects for the research, does not affect the need to supply the information, or alter the ethics of failing to provide such information. A human subject is entitled to all material information. The respective parent should also have been clearly informed that in order for the measurements to be most helpful, the child needed to stay in the house until the conclusion of the study. Whether assessed by a subjective or an objective standard, the children, or their surrogates, should have been additionally informed that the researchers anticipated that, as a result of the experiment, it was possible that there might be some accumulation of lead in the blood of the children. The "informed" consent was not valid because full material information was not furnished to the subjects or their parents.
...
As we indicated earlier, the trial courts appear to have held that special relationships out of which duties arise cannot be created by the relationship between researchers and the subjects of the research. [Interestingly, the court never refers to Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990), which also deals with special/fiduciary duties in medical research.] While in some rare cases that may be correct, it is not correct when researchers recruit people, especially children whose consent is furnished indirectly, to participate in nontherapeutic procedures that are potentially hazardous, dangerous, or deleterious to their health. As opposed to compilation of already extant statistics for purposes of studying human health matters, the creation of study conditions or protocols or participation in the recruitment of otherwise healthy subjects to interact with already existing, or potentially existing, hazardous conditions, or both, for the purpose of creating statistics from which scientific hypotheses can be supported, would normally warrant or create such special relationships as a matter of law.
...
Clearly, KKI, as a research institution, is required to obtain a human participant's fully informed consent, using sound ethical principles. It is clear from the wording of the applicable federal regulations that this requirement of informed consent continues during the duration of the research study and applies to new or changing risks. In this case, a special relationship out of which duties might arise might be created by reason of the federally imposed regulations. The question becomes whether this duty of informed consent created by federal regulation, as a matter of state law, translates into a duty of care arising out of the unique relationship that is researcher-subject, as opposed to doctor-patient. We answer that question in the affirmative. In this State, it may, depending on the facts, create such a duty.
Additionally, the Nuremberg Code, intended to be applied internationally, and never expressly rejected in this country, inherently and implicitly, speaks strongly to the existence of special relationships imposing ethical duties on researchers who conduct nontherapeutic experiments on human subjects. The Nuremberg Code specifically requires researches to make known to human subjects of research "all inconveniences and hazards reasonably to be expected, and the effects upon his health or person which may possibly come from his participation in the experiment." The breach of obligations imposed on researchers by the Nuremberg Code, might well support actions sounding in negligence in cases such as those at issue here. We reiterate as well that, given the facts and circumstances of both of these cases, there were, at the very least, genuine disputes of material facts concerning the relationship and duties of the parties, and compliance with the regulations.
...
The determination of whether a duty exists under Maryland law is the ultimate function of various policy considerations as adopted by either the Legislature, or, if it has not spoken, as it has not in respect to this situation, by Maryland courts. In our view, otherwise healthy children should not be the subjects of nontherapeutic experimentation or 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. We do not feel that it serves proper public policy concerns to permit children to be placed in situations of potential harm, during nontherapeutic procedures, even if parents, or other surrogates, consent. Under these types of circumstances, even where consent is given, albeit inappropriately, policy considerations suggest that there remains a special relationship between researchers and participants to the research study, which imposes a duty of care. This is entirely consistent with the principles found in the Nuremberg Code.
Researchers cannot ever be permitted to completely immunize themselves by reliance on consents, especially when the information furnished to the subject, or the party consenting, is incomplete in a material respect. A researcher's duty is not created by, or extinguished by, the consent of a research subject or by IRB approval. The duty to a vulnerable research subject is independent of consent, although the obtaining of consent is one of the duties a researcher must perform. All of this is especially so when the subjects of research are children. Such legal duties, and legal protections, might additionally be warranted because of the likely conflict of interest between the goal of the research experimenter and the health of the human subject, especially, but not exclusively, when such research is commercialized. There is always a potential substantial conflict of interest on the part of researchers as between them and the human subjects used in their research. If participants in the study withdraw from the research study prior to its completion, then the results of the study could be rendered meaningless. There is thus an inherent reason for not conveying information to subjects as it arises, that might cause the subjects to leave the research project. That conflict dictates a stronger reason for full and continuous disclosure.
...
In the case sub judice, no impartial judicial review or oversight was sought by the researchers or by the parents. Additionally, in spite of the IRB's improper attempt to manufacture a therapeutic value, there was absolutely no such value of the research in respect to the minor subjects used to measure the effectiveness of the study. In the absence of a requirement for judicial review, in such a circumstance, the researchers, and their scientific based review boards would be, if permitted, the sole judges of whether it is appropriate to use children in nontherapeutic research of the nature here present, where the success of an experiment is to be measured, in substantial part, by the degree to which the research environments cause the absorption of poisons into the blood of children. Science cannot be permitted to be the sole judge of the appropriateness of such research methods on human subjects, especially in respect to children. We hold that in these contested cases, the research study protocols, those of which we are aware, were not appropriate.
When it comes to children involved in nontherapeutic research, with the potential for health risks to the subject children in Maryland, we will not defer to science to be the sole determinant of the ethicality or legality of such experiments. The reason, in our view, is apparent from the research protocols at issue in the case at bar. Moreover, in nontherapeutic research using children, we hold that the consent of a parent alone cannot make appropriate that which is innately inappropriate.
The holding of this case is clear - at least for healthy children, parental consent is not sufficient for non-therapeutic research that poses health risks to the children. It is not clear whether the court would have a different standard for sick children, but based on the reasoning presented in this case it would not seem so. This is an opinion that goes far beyond the legal issues presented on appeal in the case, one that could have been resolved as a simple failure of informed consent without reaching the issue of parental right to consent to non-therapeutic research. Whether this is a better resolution depends on one's perception of both the ethics of non-therapeutic research and the effectiveness of IRBs in assuring that human subjects receive the protections expected by the state tort law, as opposed to the more technical and limited requirements of the federal regulations on research.
Non-therapeutic research has always been the hard problem in human experimentation. It conjures up horrible experiments in Nazi death camps, the Tuskegee syphilis experiment, and the full litany of human experimentation nightmares. Yet even the definition of non-therapeutic research is very ambiguous. Most cancer drug trials are non-therapeutic in that there is no evidence that the drugs are effective against the cancer and many prove not to be. This is clearly non-therapeutic research, but it is also clearly not what this court is concerned with, and it would not be surprising to see an opinion defending the right of the parents of terminally ill children to try anything that might have any benefit, as long as they were not lied to. At the same time, this court would probably not permit children who were terminally ill with cancer to be subjects in a phase I HIV trial which included the chance of getting HIV.
If it is the risk without any possible benefit that is at issue, then even the Gelsinger case might fail the analysis: there was some small chance that he would benefit from the experiment. It was not likely, but it was probably not much different from the chances taken by some cancer patients. While the court stressed no benefit, it would be interesting to find if they really want a risk-benefit calculation, but never reached that question because the facts of this case, as presented by plaintiff, were so outrageous. It is precisely those facts that support the appropriateness of a tort remedy rather than a ban on such research. The court assumes that the parental consent process must be abandoned because it did not prevent such an experiment from being done. As the concurrence points, there is no evidence that the court needed to go so far beyond the legal issues on appeal.
Had this study been as plaintiff described it, no IRB could have approved it. If an IRB failed in its duty, it might be more appropriate to hold the IRB members liable for their negligence, rather than adding the requirement of judicial review to all non-therapeutic research on children (and probably all incompetents). Such judicial review will be very problematic because of the problem of overinclusiveness and the difficulty of assuring that the court does a better job than a properly motivated IRB. The review will be overinclusive because any attorney advising an IRB in Maryland will have to say that every piece of non-therapeutic research on children is now suspect, plus any research where the benefit may be only marginal, i.e., every case of an alternative drug trial where the child is already adequately controlled with medication. Rather than risk the public relations and liability nightmare of being linked to Nazi research, all but the most benign research on children in Maryland should be submitted to the courts.
The second problem is judicial decisionmaking. Are
judges really the right decisionmakers for these issues? Whether a given
study poses unjustified risks to children is a factual issue, which is usually
the province of the jury. While juries are not any better at sorting out
scientific information than judges, they are the vehicle our society has chosen
to make these determinations. When this case progresses to trial, it is
the jury that will decide if the IRB failed in its duty. It remains to
be seen if prospective judicial review will cure this problem or whether it
will just end non-therapeutic research in Maryland. It is clear that IRBs
can not longer evaluate research on children in Maryland without also getting
a legal opinion on whether the research should be reviewed by a judge and, if
so, then an attorney will need to present the case to the court and manage the
hearing.
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