Protection of Human Subjects in Research

Protection of Human Subjects in Research
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  • 0:02 Why Use Human Subjects?
  • 1:07 History of Protection
  • 2:44 Guidelines
  • 4:04 Protections in Universities
  • 4:40 Lesson Summary
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Lesson Transcript
Instructor: Emily Cummins
Many research studies use human subjects in an effort to understand an array of social issues. In this lesson, we'll talk about how different protocols protect these human subjects from harm during experiments.

Why Use Human Subjects?

Many researchers use humans in their projects and experiments. A psychologist might want to study how a person reacts to a violent video game or investigate how the presence of an authority figure impacts a person's performance of simple and complex tasks.

A physiologist might want to study the impact of physical activity on a person with a heart condition. Late stage medical trials might include humans to test the efficacy and side effects of a new drug.

While these are all very different studies, they all have one thing in common: They involve protocols that need to account for the protection of humans in research studies. In scientific research, any time an experiment requires the involvement of humans, researchers need to get special permission and ensure that the research design will not cause any harm. Government agencies and universities have developed guidelines to make sure human subjects are protected during the research process. In order to really understand what led to the protection of human subjects in experiments, we need to look back into the past a little bit.

History of Protection

In the 1930s and 1940s, Nazi scientists and medical doctors conducted experiments on prisoners in concentration camps. These experiments ranged from intentionally infecting prisoners with diseases to depriving prisoners of oxygen. When WWII ended, the U.S. government created a tribunal to assess whether or not these and other horrible acts constituted war crimes.

Known as the Nuremberg Trials, these trials brought attention to the exploitation of vulnerable humans in research. The trial put forth what came to be known as the Nuremberg Code, or a set of guidelines to ensure the protection of humans in research.

There are other notable examples of experiments that brought attention to the use of humans in research. In general, these experiments used vulnerable populations, such as the poor or minorities, and didn't properly get consent. In many cases, subjects were exposed to harm intentionally. As a result, federal policy stepped in to help protect subjects.

One particularly influential report was made 1979. Known as the Belmont Report, it laid out guidelines to make sure that human subjects are safe. It outlines the moral obligations of researchers, including respect for persons, beneficence, and justice. It also outlines the appropriate applications, including informed consent, assessment of risk and benefits, and selection of subjects.

Many agencies adopt these guidelines, and now with some revisions, the U.S. Department of Health and Human Services adopted the Belmont Report guidelines as the 'common rule' regarding subject protection.

Guidelines

There are several common guidelines that dictate how researchers may use human subjects. Here are some of the key principles researchers must abide by.

First, all research must adhere to the concept of beneficence, which means that subjects must be treated in an ethical manner at all times. Researchers must do everything they can to reduce the chance that people would be hurt during a study.

Next, researchers must use informed consent, which means that subjects must be made aware of everything they are asked to do in a study. A researcher needs to explain in full detail the study to a subject before it begins, and subjects must have the option to withdraw participation without any penalty.

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