Johns Hopkins & KKI Remodeling and Maintenance Study in Baltimore

In the early 1990’s Kennedy Krieger Institute sought financing from the Environmental Protection Agency to test whether making cheaper repairs to affordable housing that contained lead based paint hazards would be safe enough. The study was known as the Remodeling and Maintenance Study in Baltimore ( R&M Study). Kennedy Krieger Institute (KKI) explained their proposal to Johns Hopkins Institutional Review Board, who gave their ethics approval to move forward with the study. But the R&M Study was designed to measure the blood lead levels in children from 1 to 4 years old to test how well the repairs worked. KKI also measured the amount of lead in the duct in the homes every 6 months, but did not tell the families to move away even when they knew there was ongoing poisoning. The children were used as guinea pigs to measure the safety of experimental cheaper repair methods. Their young brothers and sisters were often poisoned also.

Read the Baltimore Sun’s article about lawsuits surrounding the Johns Hopkins & KKI Remodeling and Maintenance Study

Read the Baltimore Sun article: “Hopkins Faces $1B Lawsuit Over Role in Government Study That Gave Subjects STDs”

LEAD poisoning exposure

KKI enrolled approximately 125 families and placed 75 families in experimentally altered housing, to see if the children in each family would become lead poisoned or remain safe. KKI went into the homes every 6 months to test what level of toxic lead dust remained in the children’s living areas. KKI also took blood lead tests from the children to see if their blood lead levels matched the increases in lead duct in the homes. Each family was to be exposed for a minimum of 2 years and families were not timely made aware of their children’s blood lead levels. When children’s blood lead levels rose, KKI did not intervene to stop the poisoning.

KKI originally told the court it owed no responsibility to keep the children in the study safe. The highest appellate court in Maryland made clear that KKI and all researchers in Maryland owed a duty to not expose children to even a minimal risk of harm, when the study offered the child no direct medical benefit or possibility of a cure for a medical condition. Their opinion in Grimes v. Kennedy Krieger Institute was a landmark decision giving guidance to other courts across the country. The court harshly criticized Johns Hopkins Institutional Review Board for approving the study. The court condemned their conduct for failing to protect the children in the study and instead suggesting to the KKI researchers how to phrase their application to make the study not appear unethical on its face.