Human Research Studies

The international community has periodically come together to establish rules for the protection of human dignity in scientific research.  The Nurenberg War Crimes Tribunals addressed research abuses by the Nazi regime in World War II.

The result was the international Nurenberg Code which set rules that had to be met for scientific research to be legally conducted. In 1964 the World Medical Association approved the Declaration of Helsinki where the medical community established ethical limitations that doctors had to follow to protect the health and safety of human research subjects.

But medical researchers and scientists continued to conduct studies, even in the United States, that was abusive to human subjects and did not meet the legal and ethical standards of the Nurenberg Code or Declaration of Helsinki.

The Tuskegee Syphilis Study

American scientists conducted a notorious experiment which intentionally deprived human test subjects of needed medical attention. The Tuskegee Syphilis Study followed patients diagnosed with syphilis over a period of decades in order for the scientists and researchers to observe the progression of the disease and deterioration of the patients.

The Tuskegee Airmen in the study were uneducated African American servicemen from rural Alabama who were deprived of a simple cure, penicillin, without their consent or knowledge. Eventually, the federal government commissioned a panel of ethicists to report to Congress on the limits that should be placed on research in the United States. They produced the Belmont Report to the federal congress in 1974.

This report became the basis for the federal law today to protect human beings in scientific research experiments. These laws protect the most vulnerable members of our society from being subjected to unreasonable risk of harm, or not being fully informed of all the risks of a research study as was the case repeatedly through history.

The state of Maryland went even further by outlawing studies involving any risk to young children when the research was not expected to provide a direct medical benefit to the child. Maryland’s highest appellate court, in the reported public opinion of Grimes v. Kennedy Krieger Institute, Inc., stated, “children … are not in our society the equivalent of rats, hamsters, monkeys and the like.”

In Maryland, researchers cannot lawfully enroll the poor, the uneducated, or most vulnerable members of our society into research experiment which subject children to risks without the possibility of a medical cure or treatment.

Kennedy Krieger Institute TLC Study
Kennedy Krieger Institute R&M Study