What is Human Subjects Research?

What is Human Subjects Research?
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  • 0:04 Human Subjects Research
  • 1:03 Guidelines for Human…
  • 2:31 Institutional Review Boards
  • 4:02 Lesson Summary
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Lesson Transcript
Instructor: Emily Cummins
Any study that involves human participation must follow guidelines to make sure no one is harmed. In this lesson, we'll talk about what humans subjects research is and the guidelines in place to protect people who participate in research studies.

Humans Subjects Research

Let's say you're designing a research project to determine whether there is a relationship between grade point average and participation in extracurricular activities in college. You round up a group of college students and start your study. Not so fast! Any research involving humans is carefully monitored.

Human subjects research refers to any research that intends to investigate something involving people. This could be anything from clinical drug trials to a grade point average study. Before a research project can begin, approval is needed to make sure the research doesn't hurt anyone.

The U.S. Government regulates any research that's done on human subjects, whether it happens in a university or a hospital. Researchers must get permission from a body of reviewers in order to conduct research on humans.

The overall goal of human subjects research is fairly straightforward: researchers must do everything they can to ensure that human subjects aren't harmed in any way during the course of research.

Guidelines for Human Subjects Research

Okay, let's talk a bit more about the guidelines. There are some main ethical standards that apply to any research involving human subjects, no matter what you're studying. Let's go over those now. The United States Department of Health and Human Services created a document known as the Belmont Report, which summarizes the major guidelines that the Department of Health and Human Services came up with regarding human subjects research.

For starts, researchers must respect human subjects. This means that people must be treated as autonomous individuals. If researchers are working with people who lack self-determination, such as mentally handicapped individuals or individuals with dementia, then extra precautions must be taken.

Researchers must also take care to use what's called beneficence, which basically means that research participants need to be protected from harm and researchers must be sure they are looking out for their participants' well-being. The Belmont report contains two rules about this: first, do no harm, and second, try and maximize the benefits your participants might receive from participating and do everything you can to minimize any risks.

Finally, researchers must use justice in their research. Everyone must have equal access to or an equal chance of gaining any benefit from research. Some participants cannot be unfairly denied benefits. For example, if a clinical trial finds a drug has life-saving effects, researchers cannot deny treatment to research subjects so as not to interfere with research.

Institutional Review Boards

So how do you get approval for a project? Well, it depends on where your funding is coming from or where you work. So, for example, if you want a grant from the National Institute of Health, you will submit an application to them and they'll decide if your research is ethical.

If you're a University Professor, your university's Institutional Review Board (IRB), which is a body of professionals that decides if research meets ethical standards, will decide. If you're a researcher working in a hospital, you may need approval from your hospital's IRB.

There are a few important things that research applications need to meet ethical standards, including:

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