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

Case Study:

Researchers in the University's Psychology Department are interested in establishing whether participants in a study will react differently if they are given different versions of the same situation, one with a negative outcome and another with a positive one.

For example, a researcher may wish to study the effect of negative expectations on exam performance. Therefore, half of the subjects are told that this is a very difficult test and they are not likely to do well. The other half are told that it is a relatively simple exam and they are likely to do well. The hypothesis is that people live up to expectations.

In setting up the experiment, the researchers realize that they will have to practice deception since, in fact, both groups of subjects will take the same exam although it will be described differently. However, after weighing all the elements of the study, they are convinced that there is no risk to the people who are participating. They are all over the age of 18 and the deception required is mild.

What course should the investigators follow?

  • A: Since the risk is minimal and the participants are all over the age of 18, it is not necessary to seek approval from the UCAIHS.
  • B: Since any research involving human subjects requires prior approval from the UCAIHS, the researchers must start by submitting an Application for Review to the UCAIHS, which includes details of the study.

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.

Question 3

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

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?

Human Subjects Tutorial

  • Introduction
  • Chapter 1: Why are human subjects research regulations necessary?
  • Chapter 2: What are the basic elements of the research code of ethics?
  • Chapter 3: What are the current regulations concerning human subjects research?
  • Chapter 4: Do you need to apply to the UCAIHS?
  • Chapter 5: What do HIPAA regulations entail and how do they relate to the regulations governing human subjects?
  • Chapter 6: What process does the University use for implementing the regulations?
  • Chapter 7: What are the investigator’s responsibilities?
  • Chapter 8: What are the categories of application?
  • Chapter 9: What information must investigators give to the UCAIHS?
  • Chapter 10: What criteria does the Committee use when evaluating applications?
  • Chapter 11: How should researchers select and recruit subjects?
  • Chapter 12: What is informed consent and how is it documented?
  • Chapter 13: How must researchers deal with protected populations?
  • Chapter 14: How do researchers protect subject privacy and confidentiality?
  • Chapter 15: What are researchers’ obligations when cooperating institutions are involved?
  • Chapter 16: What are researchers’ obligations when doing research in foreign countries?
  • Chapter 17: What types of decisions can the UCAIHS make?
  • Chapter 18: What should investigators do during the application process and the course of their projects?
  • Glossary
  • References