Grimes v. Kennedy Krieger Institute, Inc.

• Decision Date: 16 August 2001
• Docket Number: No. 128, No. 129
• Citation: 782 A.2d 807,366 Md. 29
• Parties: Ericka GRIMES v. KENNEDY KRIEGER INSTITUTE, INC. Myron Higgins, a minor, etc., et al., v. Kennedy Krieger Institute, Inc.
• Court: Maryland Court of Appeals

782 A.2d 807

366 Md. 29

Ericka GRIMES v. KENNEDY KRIEGER INSTITUTE, INC.

Myron Higgins, a minor, etc., et al., v. Kennedy Krieger Institute, Inc.

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

Court of Appeals of Maryland.

August 16, 2001.

Reconsideration Denied October 11, 2001.

Kenneth W. Strong, Baltimore, for appellant, 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 and Susan B. Boyce of Godard, West, Adelman, Sheff & Smith, LLC, on brief), Rockville, for appellees.

Deborah Thompson Eisenberg, Marc E. Steinberg, Tara Andrews, Baltimore, brief of the Public Justice Center, the National Health Law Program, and the East Harbor Village Center for appellants, amici curiae.

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

Shale D. Stiller, George A. Nilson, William L. Reynolds and Evelyn W. Pasquier of Piper, Marbury, Rudnick & Wolfe, LLP, Baltimore; S. Allan Adelman and Michael I. Joseph of Godard, West, Adelman, Sheff and Smith, LLC, Rockville, for appellee, on reconsideration.

C. Christopher Brown of Brown, Goldstein and Levy, LLP, Baltimore, for National Center for Lead-Safe Housing, on reconsideration.

J. Joseph Curran, Jr., Attorney General of Maryland and Jack Schwartz, Assistant Attorney General of Maryland for University of Maryland Baltimore, on reconsideration.

Deborah Thompson Eisenberg and Marc Steinberg, Baltimore, for Public Justice Center, on reconsideration.

Ralph S. Tyler and Joseph H. Young of Hogan & Hartson, LLP, Baltimore, for American Medical Colleges, Association of American Universities, Johns Hopkins University and University of Maryland Medical System Corp., on reconsideration.

Vera Hassner Sharav of New York, NY, and Howard Fishman, Philadelphia, PA, for Alliance for Human Research Protection, 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 of first impression for this Court. For that matter, precious few courts in the United States have addressed the issues presented in the cases at bar.¹ In respect to nontherapeutic research using minors, it has been noted that "consent to research has been virtually unanalyzed by courts and legislatures." Robert J. Katerberg, Institutional Review Boards, Research on Children, and Informed Consent of Parents: Walking the Tightrope Between Encouraging Vital Experimentation and Protecting Subjects' Rights, 24 J.C. & U.L. 545, 562, quoting National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Report and Recommendations [National Commission]: Research Involving Children 79-80 (1977). Our research reveals this statement remains as accurate now as it was in 1977.

In these present cases, a prestigious research institute, associated with Johns Hopkins University, based on this record, created a nontherapeutic research program² 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 Homes³ 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 route of entry of lead into the body and because absorption of lead is inversely related to particule size." Mark R. Farfel & J. Julian Chisolm, Health and Environmental Outcomes of Traditional and Modified Practices for Abatement of Residential Lead-Based Paint,—80 American Journal of Public Health—1240, 1243 (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.⁴ 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 came 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 projects in which there is no potential benefit [to the particular children]. To call a subject a normal control is to indicate that there is no real benefit to be received [by the particular children].... So we think it would be much more acceptable to indicate that the `control group' is

...