IRB Training on Human Subjects

When you are a professor or a researcher at a hospital or in government, you likely work with Institutional Review Boards (IRB) frequently, maybe even daily. If you are a college student, you are probably just beginning to navigate the IRB process. IRBs review and, if they conclude that you will satisfactorily safeguard human participants, approve proposed research projects. Some IRBs require human subjects training as part of the approval process.
  1. Function

    • Organizations that conduct research, generally, have IRBs that review proposed studies if they involve human subjects. Even if you are administering a simple survey, the IRB needs to see your study before you begin data collection. In many cases, IRBs want to ensure that you understand the history and significance of protecting--or not protecting--the rights and safety of human research subjects. Simply put, you need to minimize and mitigate the risk faced by the human subjects that participate in your project. By mandating completion of a training course in the area, the IRB increases the likelihood that the proposals it receives will meet its standards with no or fewer required revisions.

    Internal or External

    • Some organizations, such as the University of Texas and the U.S. Department of Health and Human Services' Health Resources and Services Administration (HRSA), have their own internal human subjects research training. Other entities, such as Stanford University, rely on outside programs for their training. Stanford, for instance, uses the Collaborative Institutional Training Initiative (CITI) Program as their resource for human subjects training. CITI is an international program used by universities and other entities around the world. In either case, if an IRB requires training, you generally must complete it and submit verification with your research protocol and application.

    Features

    • Most human subject training begins with classic examples of the misuse of human subjects that lead to ethical standards and the formulation of IRBs. The University of Texas tutorial, for instance, notes the Nazi regime forcing people to take part in research without consent in the 1940s and the Tuskegee Study in which treatment for syphilis in infected African American study participants in Alabama was withheld for decades. The University of Texas program is similar to others in that it goes on to cover accepted federal ethical standards and guidelines for proper treatment of human research subjects.

    Types

    • As noted, you usually need to provide proof to the IRB that you complete the required human subjects training. Some organizations, such as the University of Texas, require that you simply read tutorials and upload or print a verification form upon completion. Others require that you take a quiz after studying a tutorial. HRSA uses an audio tutorial that you must download from its website. This training takes about 90 minutes to complete.

    Considerations

    • Some groups require ongoing human subjects training. Stanford University, for instance, mandates training every two years for most affiliated researchers. Researchers associated with their VA Hospital must renew their training yearly. In most cases, all researchers involved in a study must complete any required training. Even if you are merely assisting the principal investigator--your professor, for example--you are considered part of the research team, which means you are responsible for human subjects research ethical considerations.

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