In discussing the Lead Poisoning Prevention Study (the "Study") conducted by the Kennedy Krieger Institute ("KKI"), the press and the recent court decision portray the KKI researchers as ill-intentioned persons seeking to lure families into hazardous housing with intent to expose their children to lead while withholding results from their parents.

The facts of the Study provide an entirely different picture, one where KKI sought to improve lead safety in children's homes so they would not be poisoned and to monitor the effectiveness of these measures so that all children, similarly trapped by poverty with limited or no housing choice, could be helped.

The Court of Appeals of Maryland, the highest court in the State, ruled on a procedural matter sending two cases against KKI back to the Circuit Court for Baltimore City for trial. Those cases involve claims of possible negligence by KKI researchers in the timeliness of lead dust level reporting, and any liability of KKI in those cases will be decided by that court.

However, in its decision, the Court of Appeals went far beyond the procedural question before the Court and condemned the Study itself. The Court of Appeals held that a parent or guardian cannot consent to the participation of a child or other person under legal disability in nontherapeutic research in which there is any risk of injury or damage to the health of the subject.

    - This will prohibit the conduct of many kinds of nontherapeutic research in Maryland, even if only minimal risk is involved, unless prior court approval is sought in each case. This includes research involving vaccines, Alzheimer's disease, autism, investigational new drugs for children, marketed drugs for children, etc.

    - This ruling overrides the carefully designed federal regulations applicable to research involving children and the disabled, which regulations are the result of years of study, debate and consideration by a host of government agencies, patient advocacy groups, bioethicists and academic organizations.

    - The ruling stigmatized and impugned the character of a group of dedicated researchers at KKI who have devoted a substantial part of their lives to the treatment of a poison that governments at all levels had chosen to ignore for decades.

While in the lower court, KKI's insurance lawyers made a legalistic argument that KKI had "no legal duty" to report the dust lead levels to families. KKI regrets this technical argument and wants to reassure the public that in this Study, and in all past and future studies, KKI has been and is committed to the families and all persons in its research trials.

In the late 1800's, scientists in Australia discovered that humans could be poison ed by lead-based paint.

In the early 1900's almost all industrialized nations outlawed the use of lead-based paint for interior painting-- except for the United States. It was not until the 1950's that the lead paint industry, under increasing pressure, adopted a voluntary standard limiting the amount of lead in interior paints. And it was not until 1978, after the federal ban on the use of lead paint, that one could be assured that new homes would be free of lead-based paint.

Baltimore City's heritage from this history of governmental tolerance of an identified poison, and that of most inner-cities in the U.S., is a housing stock ripe with houses filled with lead paint, posing hazards for all young children, particularly in low-income neighborhoods, where poor management and upkeep of properties dramatically increase the potential for children ingesting lead dust and paint chips.

In the late 1980's and early 1990's, when the Study was being formulated, 95% of the housing in Baltimore's low-income, high risk neighborhoods was filled with lead. There were no state or federal laws requiring lead abatement in homes or blood lead level testing of children or dust lead level testing of homes. This was the case despite existing studies that showed that of the high risk children then tested, 40-50% showed lead levels in blood (generally called "blood lead levels") of over 10 micrograms of lead per deciliter (m/d) (against a baseline of 5 m/d) and 15-22% showed blood lead levels of over 20 m/d. Baltimore City had, however, embarked on a demonstration program to perform comprehensive lead abatement on a few select homes. Unfortunately, the cost of performing this comprehensive abatement was, in most cases, more expensive than the value of the homes themselves, and the search for alternative preventive measures for lead reduction in homes became an important public health objective.

It is always a tragedy when a child is poisoned by lead paint hazards. Because of this continuing tragedy KKI has been a leader in attempting to learn how to safely reduce and control residential lead-based paint hazards before they cause lead poisoning in children.

For several decades, KKI, which is situated in the heart of a low income, high risk neighborhood, has been treating lead poisoned children who live in Baltimore. But rather than merely reacting and treating the results of lead poisoning, KKI wanted to be proactive in preventing lead poisoning in children.

In the late 1980's, KKI's research disclosed the dangers of traditional methods of lead abatement, e.g., burning off lead paint, and directed attention to the dangers of lead dust and the value of new safety measures for abatement of lead dust in homes, such as paint stabilization, window and floor treatments, specialized cleaning, worker training, occupant protection, offsite disposal of debris and professional testing.

In the late 1980's, KKI tested different lead reduction methods in empty properties and demonstrated that these improved lead reduction techniques were safe and effective in reducing lead paint and dust in properties by about 80% or more.

In 1990, in cooperation with the Environmental Protection Agency ("EPA"), Congress and other federal and state agencies, KKI discussed a research study which would abate the lead paint hazards, using methods that were then believed to be best practices within high-risk housing while at the same time measuring which strategies work, how well and for how long. KKI hoped that the results could be used to set standards and shape practices to protect all children who could not simply afford to move out to new housing.

The Study, titled the "Repair and Maintenance Study" was funded and sponsored by EPA's Office of Pollution Prevention and Toxics and HUD's Office of Lead Hazard Control.

The Study was designed to characterize and compare the short-term (6 months) and longer term (up to 24 months) efficacy of the lead abatement methods which KKI had proven to be effective in reducing children's exposure to residential paint and dust, and thereby reducing children's risk of lead poisoning.

There were five groups of homes in the Study. The Study was designed so that every participating family in every category of housing would have the opportunity to live in safer housing than 95% of the non-lead abated housing stock in Baltimore City -- and safer than required by then-federal, state or local law. At that time, there were no legal requirements for lead paint hazard intervention or prevention. The five categories of housing involved in the Study were as follows:

- Three Categories of Repair and Maintenance Properties:

(i) These properties (the "R&M Properties") were existing homes which all received lead safety interventions designed to reduce lead paint and dust exposure. The interventions were grouped in three tiers, with average costs varying from $1,650 to $3,500 to $6,500. From KKI's earlier research, KKI knew that all three tiers of intervention reduced lead dust by approximately 80% from that found in untreated properties, that is, the overwhelming majority of affordable rental housing stock then available in Baltimore's low-income, high risk neighborhoods.

(ii) The Maryland Department of Housing and Development ("MDHD"), as part of the State Residential Lead Paint Abatement Program, committed funds to make loans available to owners whose properties underwent lead paint repair and maintenance.

(iii) MDHD made loans available to owners of R&M Properties who rented to low-income families and to owners of R&M Properties who themselves were low income.

(iv) About half of the R&M Properties were occupied before the improvements to the R&M Properties were made. The first group of homes were occupied by the same families before and after the improvements. Approximately one half of the second group of homes were occupied by the same families before and after the improvements. None of the third group of homes was occupied when the improvements were performed. The highest level of abatement was done in the third level of homes, i.e. , the non-occupied residences, because vacancy allowed more abatement to be done safely.

(v) Each of the R&M Properties received an intervention designed to lower the exposure to lead.

- It is unlikely that this intervention would have occurred in these houses without the loan program because there were no requirements for property owners to proactively reduce lead exposure in their rental properties.

- These interventions provided the immediate benefit of a safer home to the families previously occupying the houses in the Study. (As noted above, about half of the families already had been living in their houses which then were not lead reduced. The remainder of families were enrolled in the Study when they moved into the vacant R&M Properties which had received extensive hazard control treatments and lead dust clearance testing.)

- The City Lead Abated Houses.

(i) The fourth group consisted of houses that were abated by the City under a local government program, and every known intervention had been employed to make these homes as safe as possible.

- Post-1978 Properties.

The fifth category of houses were homes build after 1978.

(i) These properties were presumably free of lead based paint, but were located in neighborhoods known to have high levels of at risk houses.

(ii) It was known that lead poisoning could occur outside the home due to other sources of lead in the neighborhood, e.g., other lead painted homes, lead dust in playgrounds, etc.

It is extremely important to emphasize that the Study did not include a control group of families living in properties with unattended lead hazards. KKI believed the inclusion of such a control group to be unethical. It is ironic that the Court found improving homes and monitoring blood and dust levels to be unethical, but made no note of the thousands of children remaining in lead filled houses.

All families participating in all five categories of homes in the Study:

- signed consent forms,

- received free periodic blood lead testing which was more frequent than then recommended and much more frequent than experienced in the population,

- received free transportation to the KKI clinic to ensure that blood lead testing was done,

- received free cleaning supplies for the properties and were encouraged to use them,

- received small payments and tokens for their time doing interviews with researchers,

- received results of lead dust and blood lead testing (indeed, it is the timing of some of the lead dust test results that is at issue in the cases which have been remanded to the lower courts for trial), and

- received free lead-safety education.

The Study called for follow-up by KKI researchers if there were an increase of 5 or more micrograms per deciliter in lead blood levels or if a blood lead level reached 20+ micrograms per deciliter. These follow-up procedures included contacting the health care provider and the Health Department, visual inspection of the home, advice to the landlord on repair if obvious deterioration was noted, and advice on cleaning and diet. These interventions were greater than those these children would have received without the Study and likely would not have occurred without the Study.

The EPA conducted internal and external reviews of the Study.

- The EPA's Office of Pollution Prevention and Toxics reviewed the Quality Assurance Project Plan for the Study.

- The EPA's Office of Research and Development reviewed the Study.

- Staff from the Centers for Disease Control reviewed the Study.

The Study was then approved and funded by EPA.

The Joint Committee on Clinical Investigation of The Johns Hopkins University School of Medicine and The Johns Hopkins Hospital reviewed and approved the Study.

The interventions performed on the R&M Properties were developed by experts around the country. The specifications for application of the repair and maintenance interventions were finally formulated by KKI Quality Assurance Staff.

The interventions were expected to markedly reduce lead dust levels in the home and to provide continuing dust monitoring of the house. These benefits would apply to the families occupying or moving into the homes.

The repair and maintenance interventions were performed by a well-respected firm in Baltimore, with extensive experience in reducing lead hazards in pre-1978 properties.

KKI researchers performed the measurement of dust using two methods: the wipe method and the cyclone-based prototype dust vacuum. The wipe method, used after the improvements were made for clearance testing, had standard levels of measurement recognized by the EPA. The cyclone method was experimental and had no standard measurement guidelines recognized by any external agency.

KKI lead clinic personnel performed the blood lead testing and KKI outreach staff interacted with the families if blood levels changed or reflected more than expected levels. Results of blood levels were provided to families either on the day of testing or by letter promptly after the day of testing.

KKI also reported blood lead levels to the Maryland Department of Environment's Lead Registry (the "Lead Registry").

The Lead Registry, in turn, reported blood lead levels to the Baltimore City Health Department Lead Poisoning Prevention Program, which was responsible for follow-up and case management.

The Study did not supplant any State or Local programs; rather, it was an enhancement to these programs.

EPA and KKI believed this Study would provide benefits to the Study participants since all participants would be living in housing that had been improved or was new and would be monitored for blood lead levels on an ongoing basis.

EPA and KKI believed this Study offered a potential benefit to families, in general, particularly minority and low income residents of Baltimore's highest risk neighborhoods, because the research would result in knowledge allowing advocacy for programs addressing lead hazards, which disproportionately affected these groups.

Notwithstanding EPA's and KKI's clear beliefs in this regard, the Maryland Court of Appeals found this Study to be "non-therapeutic" to the participants, i.e., an experiment only to expand knowledge for the greater good rather than a study intended to benefit participants.

- The Court also found that The Johns Hopkins University School of Medicine Joint Committee on Clinical Investigation tried to avoid federal research rules when it suggested that the control group living in the post-1978 houses would receive a benefit from the Study through the blood lead testing and monitoring involved in the program. However, under federal rules, even if the Study were non-therapeutic and offered no benefit (which Johns Hopkins, EPA and KKI dispute), the research would have been permissible as a "minimal risk" study for those in the post-1978 houses.

Although it is unclear from the opinion, the Court may have concluded that a study focusing on housing interventions to reduce exposure to lead poisoning was not "clinical" or "medical" and therefore was not therapeutic by definition.

- Unfortunately, this reasoning harkens back to a reactive model where one treats lead poisoning in children after it happens rather than preventing it through safer homes and blood testing.

- Equally disappointing, this reasoning ignores the very model of the Study itself that allowed monitoring of effectiveness only in structurally sound properties that had undergone lead reduction measures that had improved the properties over almost all other existing housing alternatives in these neighborhoods by approximately 80%.

As expected, lead abatement measures resulted in significant reductions in the lead dust lead for all five types of property treatments. Overall the blood lead levels of most children residing in the study homes stayed constant or went down, even though in a few cases, they rose.

The Study was influential in bringing national recognition to the value of safe lead abatement measures as tools necessary to prevent lead poisoning. Many of these measures have been incorporated in state and local laws and in HUD's lead-safety regulation for federally assisted housing and HUD's national guidelines for residential lead hazard reduction. The Study has been replicated by HUD in 13 other cities involving 1,200 houses. These studies have had similar findings of lead reduction.

The Court did not recognize that the Study design itself created a safer environment for families then living in high risk neighborhoods in Baltimore City; rather, the Court found the Study to be a callous science experiment which put children in harm's way. The Court compared the Study to the Tuskegee syphilis study and Nazi research on prisoners.

- The Court believed families were "enticed" into living in R&M Properties that had not been fully abated. (The fact is that at least one-half of the families in the R&M Properties had been living in the same non-abated properties prior to the Study and the other half were inner city families who may have had no choice but to rent non-abated properties elsewhere in Baltimore.)

- The Court appeared to believe the children were A"guinea pigs" being sacrificed for the good of science. (In fact, if anything, the Study deliberately avoided having just such a control group. Only families living in lead abated properties or new homes were recruited to be in the Study. The Study required researchers to inform participants of dust and blood level tests if lead levels were high. The lower court case will test whether KKI did dust level reporting properly, but the protocol called for this reporting.)

The Court condemned KKI's enrollment of families into the Study because the Court did not recognize that the Study was designed so that every participating family could obtain benefits from the Study.

- Suggesting that KKI had an affirmative obligation to move these families out of Baltimore is to misunderstand KKI's role and its authority. The Court was silent with respect to the obligations of various levels of government that tolerated the evidence of lead paint for decades, and a society that does not offer realistic options for low income families to move out of high risk neighborhoods.

- Suggesting that KKI should have told all of these families to move out of Baltimore is also to misunderstand KKI's role, and the financial reality for most of these families. The families in the thousands of non-abated homes were most at risk, and there was no other effort to improve these non-abated properties or relocate these families.

First, the Court of Appeals made a procedural ruling that the cases brought by the families of two children whose blood lead levels were tested with elevated lead blood levels during the period of the Study may proceed to trial.

- The question of whether KKI did anything wrong in the monitoring of these two cases is now a question for the Circuit Court of Baltimore City.

- Although KKI never had an opportunity before the lower court or the Court of Appeals to explain the possible delay in the reporting of dust lead levels, KKI was attempting to meet stringent EPA guidelines for the reporting, batching, quality assurance, interpretation and notification of dust lead levels which, particularly at the beginning of the Study, resulted in delay of the reporting of dust lead levels to the participants in the Study. If KKI was at fault, this will be determined by the Circuit Court for Baltimore City.

Second, the Court of Appeals made a substantive ruling with respect to a parent's or surrogate's right to consent to participation in a research study on behalf of children or disabled individuals. Specifically, the Court held that a parent or guardian 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. Because no research may be performed without informed consent, this ruling will prohibit the conduct of most nontherapeutic research in the State of Maryland unless prior court approval is sought in each case. Obtaining such approval (and only in Maryland, as no other state has this requirement), would likely result in such research being done elsewhere.

The types of non-therapeutic research affected include:

- all pediatric research, including vaccine research;

- all research involving illnesses afflicting adults under a mental disability such as Alzheimer's disease and mental disorders;

- all research evaluating investigational new drugs which may be given to children since FDA regulations require that all such new drugs must be tested in children before they gain FDA approval;

- all research evaluating currently marketed drugs which are given to children since the FDA suggests testing to develop pediatric indications for marketed drugs; and

- all research protocols in children limited to gathering information about how a drug works in children, or where the drug is being used short-term without any intent to show a therapeutic effect.

The Court's decision contradicts and overrides the carefully designed federal regulations applicable to research involving human subjects and those specifically applicable to research involving children. These regulations were the result of years of study, debate and consideration by a host of government agencies, patient advocacy groups, bioethicists and academic organizations.

KKI plans to ask the Court of Appeals to reconsider two aspects of the ruling: first the characterization of the Study as unethical, and second, the holding that a parent/guardian cannot consent to the participation of a child or person under a legal disability in nontherapeutic research or studies in which there is any risk. Johns Hopkins and others will support that effort.

The consequences of failure to revise the ruling are obvious:

- first, and most directly, the years of work by dedicated researchers at KKI will be denigrated and discredited and the researchers themselves characterized as unethical actors cited by the Court of Appeals. All this, even in the face of KKI's success at effecting the dramatic reversal of prior governmental indifference to this danger;

- second, the unrealistic standards suggested by the Court for future studies involving children and adults under a disability, which ignore the thoughtful and realistic approaches in every other state, will be the law in Maryland; and

- finally, the State of Maryland will be avoided for any thoughtful research involving children and adults under a disability, causing the loss of valued researchers and investigators, who will be forced to relocate elsewhere in order to conduct their research.