Protecting Research Participants: Mandated & Federal Regulations

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  • 0:07 Protection By Law
  • 0:29 Mandated Reporting
  • 1:39 Oversight
  • 3:57 Laws
  • 4:49 Lesson Summary
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Lesson Transcript
Instructor: Devin Kowalczyk

Devin has taught psychology and has a master's degree in clinical forensic psychology. He is working on his PhD.

How are laws and federal regulations protecting research participants? This lesson explores some of the ways people are protected from each other, themselves, and researchers when they are participants in a study.

Protection by Law

Researchers cannot put their subjects in harm's way. I know this sounds like a no-brainer, but sometimes the race to prove something outpaces the need to protect. This is the reason the government has stepped in and enacted certain laws and strictures to help ensure the participants are protected from the research as well as other sources of harm.

Mandated Reporting

Let's say you're a researcher examining the effects of emotions on study habits in young children. Your work involves interviewing children, and during one interview, a child admits that his parent hits him.

Psychological researchers are mandated reporters, which can be defined as individuals required to report to authorities abuse and neglect of vulnerable populations, as well as those in imminent danger. Vulnerable populations include children, elders, and dependent adults - basically any group that can't take care of themselves. Abuses can be physical, sexual, financial, and emotional.

Imminent danger is defined as immediate risk of harm. Often in psychology, this typically means suicidal or homicidal ideations. Ideations is a term used by psychologists as a way to encompass thoughts, feelings, and beliefs. The intention here is to protect those in danger. Research participants are varied and different, and in this wide net, researchers often find people who need protecting.


Each research project must be approved by the researcher's Institutional Review Board, which is tasked with reviewing accurate information about the research proposal to ensure they protect human and animal rights and that they fall in line with federal, state, local, and ethical guidelines.

The Review Board acts as a gatekeeper for allowing or forbidding studies from occurring. Prior to research beginning, a researcher will submit his or her planned methodology for the research to the Review Board. The Board will then determine if there is a heightened level of risk and if so, how it is to be mitigated. If there is minimal risk or the high risk is negated, then a research proposal is given the green light.

If a researcher does not follow his or her own methodology, then they run the risk of being reported to the U.S. Department of Health and Human Services. Why would a study go off methodology? Sometimes in the process of a study, a researcher may find something really interesting and want to look at it in more depth.

In the previous example about interviewing kids about study habits and emotions, what if something like eye color, gender, or number of freckles became strongly correlated with grades? If the researcher then decides to focus on these areas that weren't outlined in the methodology, that introduces a risk of being reported. These aren't big things that will likely get one reported, but they might be.

Real examples of things that might get a researcher reported include, but are not limited to:

  • Not obtaining a subject's informed consent prior to participation
  • Failing to document a subject's informed consent
  • Using language that participants would not understand to describe the research
  • Performing studies on fetuses or newborns without prior animal research to back up the theory
  • Excessive reward for inmate or prisoner participation

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