Tutorial Chapter 1: Why are human subjects research regulations necessary?

Regulation of research involving humans appeared after World War II when the world found out about the type of experiments that Nazis physicians had been conducting on persons they had imprisoned.

In the United States, regulations were spurred by these studies:

The Tuskegee Study

The Tuskegee study was initiated by the United States Public Health Service to discover the long-term effects of untreated syphilis. The subjects were African-American men from disadvantaged backgrounds who were not informed of their diagnosis and were denied treatment even after a cure was found.

The Atomic Energy Commission Study

The Atomic Energy Commission study involved 815 pregnant women who were given a “vitamin cocktail” by their doctors. In 1993, these women discovered that they had, in fact, been drinking radioactive iron as part of government sponsored research. Many of the children born of these pregnancies died prematurely of cancer.

Radiation studies of this sort continued for more than 30 years, from the 1940s through the 1970s, well after the effects of exposure to radiation were known.

Yale University Study

The 40 men used in the Yale University study were brought into a laboratory and told they would play the role of teachers. Forty students were then led into another room and strapped into chairs with electrodes attached. The “teachers” were seated in front of a control panel with voltage settings, some of which read “Extreme Intensity Shock” and others “Danger: Severe Shock.”

The "teachers” read a list of word pairs to the students. Each time a student gave an incorrect answer, the “teacher” was told to administer a shock. Each mistake led to an increase in voltage. “Teachers” could hear the students who, by the end of the experiment, were screaming, kicking the wall, and finally silent.

In reality, the “students” were researchers and there was no electricity hooked up to the electrodes nor were any shocks actually transmitted. The only real subjects were the “teachers.”

From these and other studies it became clear that regulations were needed to control the type of research and experiments that could be conducted when human subjects were involved.

Chapter Review

Question 1

Regulation of research involving humans in the U.S. was enacted due to abuses in (select all that apply):

• medical research
• social sciences research
• archival research
• all of the above

Question 2

The Tuskegee study involved therapeutic benefit.

• True
• False

Question 3

The pregnant women in the Atomic Energy Commission study were deliberately deceived by their doctors with disastrous results.

• True
• False

Question 4

The Yale University study involved which of the following (select all that apply):

• beneficence
• deception
• therapeutic benefit
• informed consent

Next Chapter: What are the basic elements of the research code of ethics?